A Web-Based Physical Activity Intervention in Adolescent Survivors of Childhood Cancer

• Sponsor: St. Jude Children's Research Hospital (Other)
• Overall Status: Completed
• CT.gov ID: NCT01778127
• Collaborator: (none)
• Enrollment: 105
• Location: 1
• Arms: 3
• Duration (Months): 13.9
• Patients Per Site Per Month: 7.5

Study Details

Study Description

Brief Summary

Five year survival following a diagnosis of childhood cancer has reached 83%, making long term health outcomes among survivors an important concern. The growing population of survivors is at an increased risk of physical inactivity and associated adverse health outcomes. Regular physical activity is associated with better cardiovascular and musculoskeletal health. Despite the known benefits of physical activity, nearly half of all childhood cancer survivors do not meet recommended guidelines for physical activity.

Researchers at St. Jude Children's Research Hospital (SJCRH) want to determine if a rewards-based physical activity intervention delivered via an interactive website among young adolescent childhood cancer survivors, aged 11 through 14 years, will increase physical activity levels and improve cardiovascular and musculoskeletal health. The investigators also want to learn if this rewards-based intervention is effective. To achieve this goal the investigators have designed a three-arm prospective, randomized study with two reward-based intervention groups and a control group.

Condition or Disease	Intervention/Treatment	Phase
Cancer	Behavioral: Activity Monitor; Behavioral: Interactive Website; Behavioral: Educational Materials	N/A

Detailed Description

PRIMARY OBJECTIVE:

• To compare changes in levels of moderate and vigorous physical activity over 24 weeks.

SECONDARY OBJECTIVE:

• To compare changes in cardiorespiratory fitness, muscular strength and flexibility over 24 weeks.

Participants will be randomized to one of three groups. Participants in the control group will receive an activity monitor and educational materials, but will not have access to the interactive website. Participants randomized to the two intervention groups will be given access to a rewards program delivered via an interactive website, an activity monitor, and educational materials. Individual physical activity data can be viewed by study participants after uploading information from their monitors to the interactive website. One intervention group will receive minimal rewards, while the other group will receive immediate incentives as well as the minimal rewards as they move from one level to the other on the website.

After 24 weeks, changes in cardiorespiratory fitness, muscular strength, flexibility, and physical function will be compared between the two intervention groups and the control group.

Study Design

• Study Type: Interventional
• Actual Enrollment: 105 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Investigator, Outcomes Assessor)
• Primary Purpose: Supportive Care
• Official Title: A Randomized Web-Based Physical Activity Intervention in Adolescent Survivors of Childhood Cancer
• Study Start Date: Feb 1, 2013
• Actual Primary Completion Date: Apr 1, 2014
• Actual Study Completion Date: Apr 1, 2014

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Group A: Minimal Rewards Participants use an activity monitor and the interactive website. They will receive minimal rewards based on their physical activity levels.	Behavioral: Activity Monitor; Measurement of physical activity.; Other Names: Tri-Axial Accelerometer Zamzee ; Behavioral: Interactive Website; Zamzee is a meter that measures activity and a website that makes moving fun. Parents of participants can set activity goals. Activity is uploaded to the website where participants track progress and earn rewards by increasing their level of activity. Participants can view leaderboards and check how other participants are doing.; Other Names: Zamzee Website ; Behavioral: Educational Materials; All participants will receive educational handouts about physical activity. Participants will receive the educational handouts again via mail three and five months into the study to reinforce the importance of physical activity and maintain compliance.; Other Names: Educational Brochure
Experimental: Group B: Immediate Incentives Participants use an activity monitor and the interactive website. In addition to minimal rewards, participants will receive immediate incentives as they move from one level to the other on the website.	Behavioral: Activity Monitor; Measurement of physical activity.; Other Names: Tri-Axial Accelerometer Zamzee ; Behavioral: Interactive Website; Zamzee is a meter that measures activity and a website that makes moving fun. Parents of participants can set activity goals. Activity is uploaded to the website where participants track progress and earn rewards by increasing their level of activity. Participants can view leaderboards and check how other participants are doing.; Other Names: Zamzee Website ; Behavioral: Educational Materials; All participants will receive educational handouts about physical activity. Participants will receive the educational handouts again via mail three and five months into the study to reinforce the importance of physical activity and maintain compliance.; Other Names: Educational Brochure
Experimental: Group C: Control Participants in the control group will receive an activity monitor and educational materials, but will not have access to the interactive website. No rewards will be offered for their participation.	Behavioral: Activity Monitor; Measurement of physical activity.; Other Names: Tri-Axial Accelerometer Zamzee ; Behavioral: Educational Materials; All participants will receive educational handouts about physical activity. Participants will receive the educational handouts again via mail three and five months into the study to reinforce the importance of physical activity and maintain compliance.; Other Names: Educational Brochure

Outcome Measures

Primary Outcome Measures

1. Differences in Change in Daily Average of Moderate and Vigorous Physical Activity (MVPA) Levels Between Groups [Baseline, Week 24]

   The impact of the intervention was assessed at the end of 24 weeks by comparing the mean difference in physical activity levels from baseline to 24-weeks between groups.

Secondary Outcome Measures

1. Differences in Change in Cardiovascular Function Between Groups Over 24 Weeks [Baseline and 24 weeks]

   The difference in mean change in peak oxygen uptake from baseline to 24-weeks was compared between groups.

2. Differences in Change in Flexibility Between Groups Over 24 Weeks: Sit and Reach [Baseline and 24 weeks]

   The difference in mean changes of sit and reach from baseline to 24-weeks was compared between groups

3. Differences in Change in Flexibility Between Groups Over 24 Weeks: Active Dorsiflexion [Baseline and 24 weeks]

   The difference between mean changes from baseline to 24-weeks in active dorsiflexion was compared between groups.

4. Differences in Change in Muscular Strength Between Groups Over 24 Weeks: Hand Grip [Baseline and 24 weeks]

   The difference from baseline to 24-weeks in mean changes in grip strength (kilograms) was compared between groups.

5. Differences in Change in Muscular Strength Between Groups Over 24 Weeks: Sit-up [Baseline and 24 weeks]

   The number of sit-ups completed in 30 seconds was assessed, and the differences from baseline to 24-weeks in mean changes on the strength subtests of the Bruininks-Oseretsky Test of Motor Proficiency were compared between groups.

6. Differences in Change in Muscular Strength Between Groups Over 24 Weeks: Pushup [Baseline and 24 weeks]

   The number of push-ups completed in 30 seconds was assessed, and the differences from baseline to 24-weeks in mean changes on the strength subtests of the Bruininks-Oseretsky Test of Motor Proficiency were compared between groups.

7. Differences in Change in Muscular Strength Between Groups Over 24 Weeks: Quadriceps at 60 Degrees/Second [Baseline and 24 weeks]

   The difference from baseline to 24-weeks in mean changes in knee extension strength 60 degrees per second (Newton meters) was compared between groups.

8. Differences in Change in Muscular Strength Between Groups Over 24 Weeks: Quadriceps at 120 Degrees/Second [Baseline and 24 weeks]

   The difference from baseline to 24-weeks in mean changes in knee extension strength 120 degrees per second (Newton meters) was compared between groups.

9. Differences in Change in Muscular Strength Between Groups Over 24 Weeks: Quadriceps at 180 Degrees/Second [Baseline and 24 weeks]

   The difference from baseline to 24-weeks in mean changes in knee extension strength at 180 degrees per second (Newton meters) was compared between groups

10. Differences in Change in Muscular Strength Between Groups Over 24 Weeks: Dorsiflexion at 30 Degrees/Second [Baseline and 24 weeks]

    The differences from baseline to 24-weeks in mean changes in ankle dorsiflexion strength 30 degrees per second (Newton meters) was compared between groups.

11. Differences in Change in Muscular Strength Between Groups Over 24 Weeks: Dorsiflexion at 60 Degrees/Second [Baseline and 24 weeks]

    The differences from baseline to 24-weeks in mean changes in ankle dorsiflexion strength at 60 degrees per second (Newton meters) was compared between groups.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 11 Years to 14 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Previously treated for childhood cancer at St. Jude Children's Research Hospital (SJCRH)

• 11 through 14 years of age

• Not undergoing active treatment for cancer

• Medical clearance from participant's attending physician via email

• Does not meet the Centers for Disease Control (CDC) physical activity guidelines. CDC guidelines for children age 11 to 14 are defined as 60 minutes or more per day of physical activity, seven days a week

• Internet access and a computer that has software that is compatible with the study device (Windows XP, Windows Vista, Windows 7, Mac OSX 10.5 and Mac OSX 10.6)

Exclusion Criteria:

• Global cognitive impairment (Full Scale Intelligence Quotient < 70) that prevents use of the interactive website

• Pregnant female

• Inability to read and write English

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	St. Jude Children's Research Hospital	Memphis	Tennessee	United States	38105

Sponsors and Collaborators

• St. Jude Children's Research Hospital

Investigators

• Principal Investigator: Kirsten K. Ness, PT, PhD, St. Jude Children's Research Hospital

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• St. Jude Children's Research Hospital
• Clinical Trials Open at St. Jude

Publications

None provided.

• Responsible Party: St. Jude Children's Research Hospital
• ClinicalTrials.gov Identifier: NCT01778127
• Other Study ID Numbers: ZAMZEE; NCI-2013-00384
• First Posted: Jan 29, 2013
• Last Update Posted: May 21, 2015
• Last Verified: Apr 1, 2015

• Keywords provided by St. Jude Children's Research Hospital: Cancer Survivor; Physical Activity; Health Outcomes; Rewards-Based Intervention; Cardiovascular Health; Musculoskeletal Health; Exercise

Study Results

Participant Flow

Recruitment Details	This protocol enrolled 105 participants at St. Jude Children's Research Hospital from 9/2013 through 4/2014. Of the 105, 5 were determined to be ineligible after baseline screening (4 too active; 1 did not meet IQ criteria), and 2 withdrew prior to randomization but after baseline testing. The remaining 98 were randomized.
Pre-assignment Detail	98 participants were randomized 1:1:1 stratified by gender into 3 groups. Randomization was implemented using software based on Zelen's methodology. The principal investigator and study staff were blind to group assignment.

Arm/Group Title	Group A: Minimal Rewards	Group B: Immediate Incentives	Group C: Control
Arm/Group Description	Participants use an activity monitor and the interactive website. They will receive minimal rewards based on their physical activity levels. Activity Monitor: Measurement of physical activity. Interactive Website: Zamzee is a meter that measures activity and a website that makes moving fun. Parents of participants can set activity goals. Activity is uploaded to the website where participants track progress and earn rewards by increasing their level of activity. Participants can view leaderboards and check how other participants are doing. Educational Materials: All participants will receive educational handouts about physical activity. Participants will receive the educational handouts again via mail three and five months into the study to reinforce the importance of physical activity and maintain compliance.	Participants use an activity monitor and the interactive website. In addition to minimal rewards, participants will receive immediate incentives as they move from one level to the other on the website. Activity Monitor: Measurement of physical activity. Interactive Website: Zamzee is a meter that measures activity and a website that makes moving fun. Parents of participants can set activity goals. Activity is uploaded to the website where participants track progress and earn rewards by increasing their level of activity. Participants can view leaderboards and check how other participants are doing. Educational Materials: All participants will receive educational handouts about physical activity. Participants will receive the educational handouts again via mail three and five months into the study to reinforce the importance of physical activity and maintain compliance.	Participants in the control group will receive an activity monitor and educational materials, but will not have access to the interactive website. No rewards will be offered for their participation. Activity Monitor: Measurement of physical activity. Educational Materials: All participants will receive educational handouts about physical activity. Participants will receive the educational handouts again via mail three and five months into the study to reinforce the importance of physical activity and maintain compliance.
Period Title: Overall Study
STARTED	33	33	32
COMPLETED	25	31	26
NOT COMPLETED	8	2	6

Baseline Characteristics

Arm/Group Title	Group A: Minimal Rewards	Group B: Immediate Incentives	Group C: Control	Total
Arm/Group Description	Participants use an activity monitor and the interactive website. They will receive minimal rewards based on their physical activity levels. Activity Monitor: Measurement of physical activity. Interactive Website: Zamzee is a meter that measures activity and a website that makes moving fun. Parents of participants can set activity goals. Activity is uploaded to the website where participants track progress and earn rewards by increasing their level of activity. Participants can view leaderboards and check how other participants are doing. Educational Materials: All participants will receive educational handouts about physical activity. Participants will receive the educational handouts again via mail three and five months into the study to reinforce the importance of physical activity and maintain compliance.	Participants use an activity monitor and the interactive website. In addition to minimal rewards, participants will receive immediate incentives as they move from one level to the other on the website. Activity Monitor: Measurement of physical activity. Interactive Website: Zamzee is a meter that measures activity and a website that makes moving fun. Parents of participants can set activity goals. Activity is uploaded to the website where participants track progress and earn rewards by increasing their level of activity. Participants can view leaderboards and check how other participants are doing. Educational Materials: All participants will receive educational handouts about physical activity. Participants will receive the educational handouts again via mail three and five months into the study to reinforce the importance of physical activity and maintain compliance.	Participants in the control group will receive an activity monitor and educational materials, but will not have access to the interactive website. No rewards will be offered for their participation. Activity Monitor: Measurement of physical activity. Educational Materials: All participants will receive educational handouts about physical activity. Participants will receive the educational handouts again via mail three and five months into the study to reinforce the importance of physical activity and maintain compliance.	Total of all reporting groups
Overall Participants	25	31	26	82
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	13.0 (1.2)	12.8 (0.9)	12.6 (1.2)	12.8 (1.1)
Age, Customized (years) [Mean (Standard Deviation) ]
Age at diagnosis	3.0 (3.1)	4.2 (3.0)	3.6 (2.5)	3.6 (2.9)
Time since diagnosis	10.0 (3.0)	8.6 (3.1)	9.0 (2.7)	9.2 (2.9)
Sex: Female, Male (Count of Participants)
Female	14 56%	16 51.6%	14 53.8%	44 53.7%
Male	11 44%	15 48.4%	12 46.2%	38 46.3%
Race/Ethnicity, Customized (participants) [Number]
Non-White	3 12%	6 19.4%	8 30.8%	17 20.7%
White	22 88%	25 80.6%	18 69.2%	65 79.3%
Diagnosis (participants) [Number]
Leukemia	5 20%	7 22.6%	7 26.9%	19 23.2%
Central Nervous System Tumor	7 28%	7 22.6%	4 15.4%	18 22%
Lymphoma	2 8%	2 6.5%	4 15.4%	8 9.8%
Retinoblastoma	6 24%	5 16.1%	2 7.7%	13 15.9%
Other Solid Tumor	5 20%	10 32.3%	9 34.6%	24 29.3%
Daily Moderate to Vigorous Physical Activity (MVPA) (minutes) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [minutes]	26.8 (15.7)	28.0 (16.6)	32.3 (22.6)	29.0 (18.2)
Body mass index (BMI) (kg/m^2) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [kg/m^2]	25.0 (6.6)	22.6 (6.3)	22.8 (5.5)	23.4 (6.1)
Resting heart rate (HR) (beats/minute) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [beats/minute]	82.8 (11.2)	80.4 (14.5)	81.5 (14.9)	81.5 (13.6)
Resting respiratory rate (RR) (breaths/minute) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [breaths/minute]	19.2 (1.1)	19.0 (1.3)	18.4 (1.7)	18.9 (1.4)
Blood pressure (BP) (mmHG) [Mean (Standard Deviation) ]
Systolic	115.6 (9.8)	113.5 (9.9)	117.6 (11.2)	115.4 (10.3)
Diastolic	68.2 (7.3)	66.2 (7.2)	68.5 (9.3)	67.5 (7.9)
Peak VO2 (ml/kg/min) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [ml/kg/min]	30.0 (7.9)	30.0 (7.8)	31.2 (6.6)	30.4 (7.5)
Sit and reach (cm) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [cm]	21.7 (8.9)	19.6 (9.8)	22.2 (10.4)	21.1 (9.7)
Active dorsiflexion (degrees) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [degrees]	13.1 (7.6)	13.6 (8.1)	14.3 (8.6)	13.7 (8.1)
Hand grip (kg) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [kg]	20.9 (6.3)	19.0 (5.6)	22.5 (7.1)	20.7 (6.3)
Sit-up (sit-ups) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [sit-ups]	14.3 (5.1)	15.2 (6.1)	16.2 (6.2)	15.2 (5.8)
Pushup (push-ups) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [push-ups]	9.6 (6.6)	13.3 (5.9)	12.4 (7.5)	11.9 (6.6)
Quadriceps (Newton meters (Nm)/kg) [Mean (Standard Deviation) ]
at 60 degrees/second	156.3 (46.0)	164.2 (46.3)	159.9 (41.0)	160.4 (44.5)
at 120 degrees/second	136.5 (36.2)	142.0 (41.7)	137.8 (36.5)	139.0 (38.4)
at 180 degrees/second	117.6 (32.9)	121.7 (36.7)	118.6 (29.5)	119.4 (33.3)
Dorsiflexion (Nm/kg) [Mean (Standard Deviation) ]
at 30 degrees/second	21.7 (8.7)	26.5 (14.9)	27.9 (15.0)	25.5 (13.0)
at 60 degrees/second	19.9 (7.4)	24.7 (12.0)	25.5 (11.1)	23.5 (10.3)

Outcome Measures

1. Primary Outcome

Title	Differences in Change in Daily Average of Moderate and Vigorous Physical Activity (MVPA) Levels Between Groups
Description	The impact of the intervention was assessed at the end of 24 weeks by comparing the mean difference in physical activity levels from baseline to 24-weeks between groups.
Time Frame	Baseline, Week 24

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Group A: Minimal Rewards	Group B: Immediate Incentives	Group C: Control
Arm/Group Description	Participants use an activity monitor and the interactive website. They will receive minimal rewards based on their physical activity levels. Activity Monitor: Measurement of physical activity. Interactive Website: Zamzee is a meter that measures activity and a website that makes moving fun. Parents of participants can set activity goals. Activity is uploaded to the website where participants track progress and earn rewards by increasing their level of activity. Participants can view leaderboards and check how other participants are doing. Educational Materials: All participants will receive educational handouts about physical activity. Participants will receive the educational handouts again via mail three and five months into the study to reinforce the importance of physical activity and maintain compliance.	Participants use an activity monitor and the interactive website. In addition to minimal rewards, participants will receive immediate incentives as they move from one level to the other on the website. Activity Monitor: Measurement of physical activity. Interactive Website: Zamzee is a meter that measures activity and a website that makes moving fun. Parents of participants can set activity goals. Activity is uploaded to the website where participants track progress and earn rewards by increasing their level of activity. Participants can view leaderboards and check how other participants are doing. Educational Materials: All participants will receive educational handouts about physical activity. Participants will receive the educational handouts again via mail three and five months into the study to reinforce the importance of physical activity and maintain compliance.	Participants in the control group will receive an activity monitor and educational materials, but will not have access to the interactive website. No rewards will be offered for their participation. Activity Monitor: Measurement of physical activity. Educational Materials: All participants will receive educational handouts about physical activity. Participants will receive the educational handouts again via mail three and five months into the study to reinforce the importance of physical activity and maintain compliance.
Measure Participants	25	31	26
Mean (Standard Deviation) [minutes]	-2.58 (13.70)	-2.12 (12.95)	-7.78 (13.70)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Group A: Minimal Rewards, Group B: Immediate Incentives
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.90
	Comments
	Method	t-test, 2 sided
	Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Group A: Minimal Rewards, Group C: Control
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.18
	Comments
	Method	t-test, 2 sided
	Comments

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Group B: Immediate Incentives, Group C: Control
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.14
	Comments
	Method	t-test, 2 sided
	Comments

2. Secondary Outcome

Title	Differences in Change in Cardiovascular Function Between Groups Over 24 Weeks
Description	The difference in mean change in peak oxygen uptake from baseline to 24-weeks was compared between groups.
Time Frame	Baseline and 24 weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Group A: Minimal Rewards	Group B: Immediate Incentives	Group C: Control
Arm/Group Description	Participants use an activity monitor and the interactive website. They will receive minimal rewards based on their physical activity levels. Activity Monitor: Measurement of physical activity. Interactive Website: Zamzee is a meter that measures activity and a website that makes moving fun. Parents of participants can set activity goals. Activity is uploaded to the website where participants track progress and earn rewards by increasing their level of activity. Participants can view leaderboards and check how other participants are doing. Educational Materials: All participants will receive educational handouts about physical activity. Participants will receive the educational handouts again via mail three and five months into the study to reinforce the importance of physical activity and maintain compliance.	Participants use an activity monitor and the interactive website. In addition to minimal rewards, participants will receive immediate incentives as they move from one level to the other on the website. Activity Monitor: Measurement of physical activity. Interactive Website: Zamzee is a meter that measures activity and a website that makes moving fun. Parents of participants can set activity goals. Activity is uploaded to the website where participants track progress and earn rewards by increasing their level of activity. Participants can view leaderboards and check how other participants are doing. Educational Materials: All participants will receive educational handouts about physical activity. Participants will receive the educational handouts again via mail three and five months into the study to reinforce the importance of physical activity and maintain compliance.	Participants in the control group will receive an activity monitor and educational materials, but will not have access to the interactive website. No rewards will be offered for their participation. Activity Monitor: Measurement of physical activity. Educational Materials: All participants will receive educational handouts about physical activity. Participants will receive the educational handouts again via mail three and five months into the study to reinforce the importance of physical activity and maintain compliance.
Measure Participants	25	31	26
Mean (Standard Deviation) [ml/kg/min]	-0.21 (5.15)	-1.19 (4.70)	0.09 (5.25)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Group A: Minimal Rewards, Group B: Immediate Incentives
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.49
	Comments
	Method	t-test, 2 sided
	Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Group A: Minimal Rewards, Group C: Control
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.84
	Comments
	Method	t-test, 2 sided
	Comments

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Group B: Immediate Incentives, Group C: Control
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.37
	Comments
	Method	t-test, 2 sided
	Comments

3. Secondary Outcome

Title	Differences in Change in Flexibility Between Groups Over 24 Weeks: Sit and Reach
Description	The difference in mean changes of sit and reach from baseline to 24-weeks was compared between groups
Time Frame	Baseline and 24 weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Group A: Minimal Rewards	Group B: Immediate Incentives	Group C: Control
Arm/Group Description	Participants use an activity monitor and the interactive website. They will receive minimal rewards based on their physical activity levels. Activity Monitor: Measurement of physical activity. Interactive Website: Zamzee is a meter that measures activity and a website that makes moving fun. Parents of participants can set activity goals. Activity is uploaded to the website where participants track progress and earn rewards by increasing their level of activity. Participants can view leaderboards and check how other participants are doing. Educational Materials: All participants will receive educational handouts about physical activity. Participants will receive the educational handouts again via mail three and five months into the study to reinforce the importance of physical activity and maintain compliance.	Participants use an activity monitor and the interactive website. In addition to minimal rewards, participants will receive immediate incentives as they move from one level to the other on the website. Activity Monitor: Measurement of physical activity. Interactive Website: Zamzee is a meter that measures activity and a website that makes moving fun. Parents of participants can set activity goals. Activity is uploaded to the website where participants track progress and earn rewards by increasing their level of activity. Participants can view leaderboards and check how other participants are doing. Educational Materials: All participants will receive educational handouts about physical activity. Participants will receive the educational handouts again via mail three and five months into the study to reinforce the importance of physical activity and maintain compliance.	Participants in the control group will receive an activity monitor and educational materials, but will not have access to the interactive website. No rewards will be offered for their participation. Activity Monitor: Measurement of physical activity. Educational Materials: All participants will receive educational handouts about physical activity. Participants will receive the educational handouts again via mail three and five months into the study to reinforce the importance of physical activity and maintain compliance.
Measure Participants	25	31	26
Mean (Standard Deviation) [cm]	-0.71 (4.85)	2.25 (4.50)	-0.02 (4.85)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Group A: Minimal Rewards, Group B: Immediate Incentives
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.03
	Comments
	Method	t-test, 2 sided
	Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Group A: Minimal Rewards, Group C: Control
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.63
	Comments
	Method	t-test, 2 sided
	Comments

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Group B: Immediate Incentives, Group C: Control
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.09
	Comments
	Method	t-test, 2 sided
	Comments

4. Secondary Outcome

Title	Differences in Change in Flexibility Between Groups Over 24 Weeks: Active Dorsiflexion
Description	The difference between mean changes from baseline to 24-weeks in active dorsiflexion was compared between groups.
Time Frame	Baseline and 24 weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Group A: Minimal Rewards	Group B: Immediate Incentives	Group C: Control
Arm/Group Description	Participants use an activity monitor and the interactive website. They will receive minimal rewards based on their physical activity levels. Activity Monitor: Measurement of physical activity. Interactive Website: Zamzee is a meter that measures activity and a website that makes moving fun. Parents of participants can set activity goals. Activity is uploaded to the website where participants track progress and earn rewards by increasing their level of activity. Participants can view leaderboards and check how other participants are doing. Educational Materials: All participants will receive educational handouts about physical activity. Participants will receive the educational handouts again via mail three and five months into the study to reinforce the importance of physical activity and maintain compliance.	Participants use an activity monitor and the interactive website. In addition to minimal rewards, participants will receive immediate incentives as they move from one level to the other on the website. Activity Monitor: Measurement of physical activity. Interactive Website: Zamzee is a meter that measures activity and a website that makes moving fun. Parents of participants can set activity goals. Activity is uploaded to the website where participants track progress and earn rewards by increasing their level of activity. Participants can view leaderboards and check how other participants are doing. Educational Materials: All participants will receive educational handouts about physical activity. Participants will receive the educational handouts again via mail three and five months into the study to reinforce the importance of physical activity and maintain compliance.	Participants in the control group will receive an activity monitor and educational materials, but will not have access to the interactive website. No rewards will be offered for their participation. Activity Monitor: Measurement of physical activity. Educational Materials: All participants will receive educational handouts about physical activity. Participants will receive the educational handouts again via mail three and five months into the study to reinforce the importance of physical activity and maintain compliance.
Measure Participants	25	31	26
Mean (Standard Deviation) [degrees]	-1.72 (6.40)	-0.55 (5.70)	-0.32 (6.25)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Group A: Minimal Rewards, Group B: Immediate Incentives
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.49
	Comments
	Method	t-test, 2 sided
	Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Group A: Minimal Rewards, Group C: Control
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.43
	Comments
	Method	t-test, 2 sided
	Comments

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Group B: Immediate Incentives, Group C: Control
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.89
	Comments
	Method	t-test, 2 sided
	Comments

5. Secondary Outcome

Title	Differences in Change in Muscular Strength Between Groups Over 24 Weeks: Hand Grip
Description	The difference from baseline to 24-weeks in mean changes in grip strength (kilograms) was compared between groups.
Time Frame	Baseline and 24 weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Group A: Minimal Rewards	Group B: Immediate Incentives	Group C: Control
Arm/Group Description	Participants use an activity monitor and the interactive website. They will receive minimal rewards based on their physical activity levels. Activity Monitor: Measurement of physical activity. Interactive Website: Zamzee is a meter that measures activity and a website that makes moving fun. Parents of participants can set activity goals. Activity is uploaded to the website where participants track progress and earn rewards by increasing their level of activity. Participants can view leaderboards and check how other participants are doing. Educational Materials: All participants will receive educational handouts about physical activity. Participants will receive the educational handouts again via mail three and five months into the study to reinforce the importance of physical activity and maintain compliance.	Participants use an activity monitor and the interactive website. In addition to minimal rewards, participants will receive immediate incentives as they move from one level to the other on the website. Activity Monitor: Measurement of physical activity. Interactive Website: Zamzee is a meter that measures activity and a website that makes moving fun. Parents of participants can set activity goals. Activity is uploaded to the website where participants track progress and earn rewards by increasing their level of activity. Participants can view leaderboards and check how other participants are doing. Educational Materials: All participants will receive educational handouts about physical activity. Participants will receive the educational handouts again via mail three and five months into the study to reinforce the importance of physical activity and maintain compliance.	Participants in the control group will receive an activity monitor and educational materials, but will not have access to the interactive website. No rewards will be offered for their participation. Activity Monitor: Measurement of physical activity. Educational Materials: All participants will receive educational handouts about physical activity. Participants will receive the educational handouts again via mail three and five months into the study to reinforce the importance of physical activity and maintain compliance.
Measure Participants	25	31	26
Mean (Standard Deviation) [kg]	1.47 (3.50)	0.98 (3.20)	1.00 (3.45)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Group A: Minimal Rewards, Group B: Immediate Incentives
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.61
	Comments
	Method	t-test, 2 sided
	Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Group A: Minimal Rewards, Group C: Control
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.64
	Comments
	Method	t-test, 2 sided
	Comments

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Group B: Immediate Incentives, Group C: Control
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.99
	Comments
	Method	t-test, 2 sided
	Comments

6. Secondary Outcome

Title	Differences in Change in Muscular Strength Between Groups Over 24 Weeks: Sit-up
Description	The number of sit-ups completed in 30 seconds was assessed, and the differences from baseline to 24-weeks in mean changes on the strength subtests of the Bruininks-Oseretsky Test of Motor Proficiency were compared between groups.
Time Frame	Baseline and 24 weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Group A: Minimal Rewards	Group B: Immediate Incentives	Group C: Control
Arm/Group Description	Participants use an activity monitor and the interactive website. They will receive minimal rewards based on their physical activity levels. Activity Monitor: Measurement of physical activity. Interactive Website: Zamzee is a meter that measures activity and a website that makes moving fun. Parents of participants can set activity goals. Activity is uploaded to the website where participants track progress and earn rewards by increasing their level of activity. Participants can view leaderboards and check how other participants are doing. Educational Materials: All participants will receive educational handouts about physical activity. Participants will receive the educational handouts again via mail three and five months into the study to reinforce the importance of physical activity and maintain compliance.	Participants use an activity monitor and the interactive website. In addition to minimal rewards, participants will receive immediate incentives as they move from one level to the other on the website. Activity Monitor: Measurement of physical activity. Interactive Website: Zamzee is a meter that measures activity and a website that makes moving fun. Parents of participants can set activity goals. Activity is uploaded to the website where participants track progress and earn rewards by increasing their level of activity. Participants can view leaderboards and check how other participants are doing. Educational Materials: All participants will receive educational handouts about physical activity. Participants will receive the educational handouts again via mail three and five months into the study to reinforce the importance of physical activity and maintain compliance.	Participants in the control group will receive an activity monitor and educational materials, but will not have access to the interactive website. No rewards will be offered for their participation. Activity Monitor: Measurement of physical activity. Educational Materials: All participants will receive educational handouts about physical activity. Participants will receive the educational handouts again via mail three and five months into the study to reinforce the importance of physical activity and maintain compliance.
Measure Participants	25	31	26
Mean (Standard Deviation) [Sit-ups]	2.67 (5.65)	3.29 (5.25)	2.43 (5.80)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Group A: Minimal Rewards, Group B: Immediate Incentives
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.69
	Comments
	Method	t-test, 2 sided
	Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Group A: Minimal Rewards, Group C: Control
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.89
	Comments
	Method	t-test, 2 sided
	Comments

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Group B: Immediate Incentives, Group C: Control
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.59
	Comments
	Method	t-test, 2 sided
	Comments

7. Secondary Outcome

Title	Differences in Change in Muscular Strength Between Groups Over 24 Weeks: Pushup
Description	The number of push-ups completed in 30 seconds was assessed, and the differences from baseline to 24-weeks in mean changes on the strength subtests of the Bruininks-Oseretsky Test of Motor Proficiency were compared between groups.
Time Frame	Baseline and 24 weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Group A: Minimal Rewards	Group B: Immediate Incentives	Group C: Control
Arm/Group Description	Participants use an activity monitor and the interactive website. They will receive minimal rewards based on their physical activity levels. Activity Monitor: Measurement of physical activity. Interactive Website: Zamzee is a meter that measures activity and a website that makes moving fun. Parents of participants can set activity goals. Activity is uploaded to the website where participants track progress and earn rewards by increasing their level of activity. Participants can view leaderboards and check how other participants are doing. Educational Materials: All participants will receive educational handouts about physical activity. Participants will receive the educational handouts again via mail three and five months into the study to reinforce the importance of physical activity and maintain compliance.	Participants use an activity monitor and the interactive website. In addition to minimal rewards, participants will receive immediate incentives as they move from one level to the other on the website. Activity Monitor: Measurement of physical activity. Interactive Website: Zamzee is a meter that measures activity and a website that makes moving fun. Parents of participants can set activity goals. Activity is uploaded to the website where participants track progress and earn rewards by increasing their level of activity. Participants can view leaderboards and check how other participants are doing. Educational Materials: All participants will receive educational handouts about physical activity. Participants will receive the educational handouts again via mail three and five months into the study to reinforce the importance of physical activity and maintain compliance.	Participants in the control group will receive an activity monitor and educational materials, but will not have access to the interactive website. No rewards will be offered for their participation. Activity Monitor: Measurement of physical activity. Educational Materials: All participants will receive educational handouts about physical activity. Participants will receive the educational handouts again via mail three and five months into the study to reinforce the importance of physical activity and maintain compliance.
Measure Participants	25	31	26
Mean (Standard Deviation) [Pushups]	2.37 (5.70)	1.93 (5.40)	2.27 (5.95)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Group A: Minimal Rewards, Group B: Immediate Incentives
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.78
	Comments
	Method	t-test, 2 sided
	Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Group A: Minimal Rewards, Group C: Control
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.95
	Comments
	Method	t-test, 2 sided
	Comments

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Group B: Immediate Incentives, Group C: Control
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.83
	Comments
	Method	t-test, 2 sided
	Comments

8. Secondary Outcome

Title	Differences in Change in Muscular Strength Between Groups Over 24 Weeks: Quadriceps at 60 Degrees/Second
Description	The difference from baseline to 24-weeks in mean changes in knee extension strength 60 degrees per second (Newton meters) was compared between groups.
Time Frame	Baseline and 24 weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Group A: Minimal Rewards	Group B: Immediate Incentives	Group C: Control
Arm/Group Description	Participants use an activity monitor and the interactive website. They will receive minimal rewards based on their physical activity levels. Activity Monitor: Measurement of physical activity. Interactive Website: Zamzee is a meter that measures activity and a website that makes moving fun. Parents of participants can set activity goals. Activity is uploaded to the website where participants track progress and earn rewards by increasing their level of activity. Participants can view leaderboards and check how other participants are doing. Educational Materials: All participants will receive educational handouts about physical activity. Participants will receive the educational handouts again via mail three and five months into the study to reinforce the importance of physical activity and maintain compliance.	Participants use an activity monitor and the interactive website. In addition to minimal rewards, participants will receive immediate incentives as they move from one level to the other on the website. Activity Monitor: Measurement of physical activity. Interactive Website: Zamzee is a meter that measures activity and a website that makes moving fun. Parents of participants can set activity goals. Activity is uploaded to the website where participants track progress and earn rewards by increasing their level of activity. Participants can view leaderboards and check how other participants are doing. Educational Materials: All participants will receive educational handouts about physical activity. Participants will receive the educational handouts again via mail three and five months into the study to reinforce the importance of physical activity and maintain compliance.	Participants in the control group will receive an activity monitor and educational materials, but will not have access to the interactive website. No rewards will be offered for their participation. Activity Monitor: Measurement of physical activity. Educational Materials: All participants will receive educational handouts about physical activity. Participants will receive the educational handouts again via mail three and five months into the study to reinforce the importance of physical activity and maintain compliance.
Measure Participants	25	31	26
Mean (Standard Deviation) [Newton meters (Nm)/kg]	-4.10 (34.80)	-2.05 (31.55)	-1.91 (34.80)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Group A: Minimal Rewards, Group B: Immediate Incentives
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.83
	Comments
	Method	t-test, 2 sided
	Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Group A: Minimal Rewards, Group C: Control
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.83
	Comments
	Method	t-test, 2 sided
	Comments

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Group B: Immediate Incentives, Group C: Control
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.99
	Comments
	Method	t-test, 2 sided
	Comments

9. Secondary Outcome

Title	Differences in Change in Muscular Strength Between Groups Over 24 Weeks: Quadriceps at 120 Degrees/Second
Description	The difference from baseline to 24-weeks in mean changes in knee extension strength 120 degrees per second (Newton meters) was compared between groups.
Time Frame	Baseline and 24 weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Group A: Minimal Rewards	Group B: Immediate Incentives	Group C: Control
Arm/Group Description	Participants use an activity monitor and the interactive website. They will receive minimal rewards based on their physical activity levels. Activity Monitor: Measurement of physical activity. Interactive Website: Zamzee is a meter that measures activity and a website that makes moving fun. Parents of participants can set activity goals. Activity is uploaded to the website where participants track progress and earn rewards by increasing their level of activity. Participants can view leaderboards and check how other participants are doing. Educational Materials: All participants will receive educational handouts about physical activity. Participants will receive the educational handouts again via mail three and five months into the study to reinforce the importance of physical activity and maintain compliance.	Participants use an activity monitor and the interactive website. In addition to minimal rewards, participants will receive immediate incentives as they move from one level to the other on the website. Activity Monitor: Measurement of physical activity. Interactive Website: Zamzee is a meter that measures activity and a website that makes moving fun. Parents of participants can set activity goals. Activity is uploaded to the website where participants track progress and earn rewards by increasing their level of activity. Participants can view leaderboards and check how other participants are doing. Educational Materials: All participants will receive educational handouts about physical activity. Participants will receive the educational handouts again via mail three and five months into the study to reinforce the importance of physical activity and maintain compliance.	Participants in the control group will receive an activity monitor and educational materials, but will not have access to the interactive website. No rewards will be offered for their participation. Activity Monitor: Measurement of physical activity. Educational Materials: All participants will receive educational handouts about physical activity. Participants will receive the educational handouts again via mail three and five months into the study to reinforce the importance of physical activity and maintain compliance.
Measure Participants	25	31	26
Mean (Standard Deviation) [Nm/kg]	-6.62 (28.95)	-0.59 (25.70)	4.16 (28.35)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Group A: Minimal Rewards, Group B: Immediate Incentives
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.44
	Comments
	Method	t-test, 2 sided
	Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Group A: Minimal Rewards, Group C: Control
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.19
	Comments
	Method	t-test, 2 sided
	Comments

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Group B: Immediate Incentives, Group C: Control
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.54
	Comments
	Method	t-test, 2 sided
	Comments

10. Secondary Outcome

Title	Differences in Change in Muscular Strength Between Groups Over 24 Weeks: Quadriceps at 180 Degrees/Second
Description	The difference from baseline to 24-weeks in mean changes in knee extension strength at 180 degrees per second (Newton meters) was compared between groups
Time Frame	Baseline and 24 weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Group A: Minimal Rewards	Group B: Immediate Incentives	Group C: Control
Arm/Group Description	Participants use an activity monitor and the interactive website. They will receive minimal rewards based on their physical activity levels. Activity Monitor: Measurement of physical activity. Interactive Website: Zamzee is a meter that measures activity and a website that makes moving fun. Parents of participants can set activity goals. Activity is uploaded to the website where participants track progress and earn rewards by increasing their level of activity. Participants can view leaderboards and check how other participants are doing. Educational Materials: All participants will receive educational handouts about physical activity. Participants will receive the educational handouts again via mail three and five months into the study to reinforce the importance of physical activity and maintain compliance.	Participants use an activity monitor and the interactive website. In addition to minimal rewards, participants will receive immediate incentives as they move from one level to the other on the website. Activity Monitor: Measurement of physical activity. Interactive Website: Zamzee is a meter that measures activity and a website that makes moving fun. Parents of participants can set activity goals. Activity is uploaded to the website where participants track progress and earn rewards by increasing their level of activity. Participants can view leaderboards and check how other participants are doing. Educational Materials: All participants will receive educational handouts about physical activity. Participants will receive the educational handouts again via mail three and five months into the study to reinforce the importance of physical activity and maintain compliance.	Participants in the control group will receive an activity monitor and educational materials, but will not have access to the interactive website. No rewards will be offered for their participation. Activity Monitor: Measurement of physical activity. Educational Materials: All participants will receive educational handouts about physical activity. Participants will receive the educational handouts again via mail three and five months into the study to reinforce the importance of physical activity and maintain compliance.
Measure Participants	25	31	26
Mean (Standard Deviation) [Nm/kg]	-0.64 (28.10)	0.78 (25.50)	2.55 (28.10)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Group A: Minimal Rewards, Group B: Immediate Incentives
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.17
	Comments
	Method	t-test, 2 sided
	Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Group A: Minimal Rewards, Group C: Control
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.13
	Comments
	Method	t-test, 2 sided
	Comments

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Group B: Immediate Incentives, Group C: Control
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.81
	Comments
	Method	t-test, 2 sided
	Comments

11. Secondary Outcome

Title	Differences in Change in Muscular Strength Between Groups Over 24 Weeks: Dorsiflexion at 30 Degrees/Second
Description	The differences from baseline to 24-weeks in mean changes in ankle dorsiflexion strength 30 degrees per second (Newton meters) was compared between groups.
Time Frame	Baseline and 24 weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Group A: Minimal Rewards	Group B: Immediate Incentives	Group C: Control
Arm/Group Description	Participants use an activity monitor and the interactive website. They will receive minimal rewards based on their physical activity levels. Activity Monitor: Measurement of physical activity. Interactive Website: Zamzee is a meter that measures activity and a website that makes moving fun. Parents of participants can set activity goals. Activity is uploaded to the website where participants track progress and earn rewards by increasing their level of activity. Participants can view leaderboards and check how other participants are doing. Educational Materials: All participants will receive educational handouts about physical activity. Participants will receive the educational handouts again via mail three and five months into the study to reinforce the importance of physical activity and maintain compliance.	Participants use an activity monitor and the interactive website. In addition to minimal rewards, participants will receive immediate incentives as they move from one level to the other on the website. Activity Monitor: Measurement of physical activity. Interactive Website: Zamzee is a meter that measures activity and a website that makes moving fun. Parents of participants can set activity goals. Activity is uploaded to the website where participants track progress and earn rewards by increasing their level of activity. Participants can view leaderboards and check how other participants are doing. Educational Materials: All participants will receive educational handouts about physical activity. Participants will receive the educational handouts again via mail three and five months into the study to reinforce the importance of physical activity and maintain compliance.	Participants in the control group will receive an activity monitor and educational materials, but will not have access to the interactive website. No rewards will be offered for their participation. Activity Monitor: Measurement of physical activity. Educational Materials: All participants will receive educational handouts about physical activity. Participants will receive the educational handouts again via mail three and five months into the study to reinforce the importance of physical activity and maintain compliance.
Measure Participants	25	31	26
Mean (Standard Deviation) [Nm/kg]	3.94 (16.25)	-3.74 (14.75)	-2.81 (16.65)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Group A: Minimal Rewards, Group B: Immediate Incentives
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.08
	Comments
	Method	t-test, 2 sided
	Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Group A: Minimal Rewards, Group C: Control
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.15
	Comments
	Method	t-test, 2 sided
	Comments

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Group B: Immediate Incentives, Group C: Control
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.83
	Comments
	Method	t-test, 2 sided
	Comments

12. Secondary Outcome

Title	Differences in Change in Muscular Strength Between Groups Over 24 Weeks: Dorsiflexion at 60 Degrees/Second
Description	The differences from baseline to 24-weeks in mean changes in ankle dorsiflexion strength at 60 degrees per second (Newton meters) was compared between groups.
Time Frame	Baseline and 24 weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Group A: Minimal Rewards	Group B: Immediate Incentives	Group C: Control
Arm/Group Description	Participants use an activity monitor and the interactive website. They will receive minimal rewards based on their physical activity levels. Activity Monitor: Measurement of physical activity. Interactive Website: Zamzee is a meter that measures activity and a website that makes moving fun. Parents of participants can set activity goals. Activity is uploaded to the website where participants track progress and earn rewards by increasing their level of activity. Participants can view leaderboards and check how other participants are doing. Educational Materials: All participants will receive educational handouts about physical activity. Participants will receive the educational handouts again via mail three and five months into the study to reinforce the importance of physical activity and maintain compliance.	Participants use an activity monitor and the interactive website. In addition to minimal rewards, participants will receive immediate incentives as they move from one level to the other on the website. Activity Monitor: Measurement of physical activity. Interactive Website: Zamzee is a meter that measures activity and a website that makes moving fun. Parents of participants can set activity goals. Activity is uploaded to the website where participants track progress and earn rewards by increasing their level of activity. Participants can view leaderboards and check how other participants are doing. Educational Materials: All participants will receive educational handouts about physical activity. Participants will receive the educational handouts again via mail three and five months into the study to reinforce the importance of physical activity and maintain compliance.	Participants in the control group will receive an activity monitor and educational materials, but will not have access to the interactive website. No rewards will be offered for their participation. Activity Monitor: Measurement of physical activity. Educational Materials: All participants will receive educational handouts about physical activity. Participants will receive the educational handouts again via mail three and five months into the study to reinforce the importance of physical activity and maintain compliance.
Measure Participants	25	31	26
Mean (Standard Deviation) [Nm/kg]	3.82 (12.85)	-3.00 (11.65)	-2.14 (13.15)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Group A: Minimal Rewards, Group B: Immediate Incentives
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.05
	Comments
	Method	t-test, 2 sided
	Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Group A: Minimal Rewards, Group C: Control
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.11
	Comments
	Method	t-test, 2 sided
	Comments

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Group B: Immediate Incentives, Group C: Control
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.81
	Comments
	Method	t-test, 2 sided
	Comments

Adverse Events

Time Frame	Adverse events were collected from the on-study date until the completion of the intervention up to 24 weeks later.
Arm/Group Title	Group A: Minimal Rewards		Group B: Immediate Incentives		Group C: Control
Arm/Group Description	Participants use an activity monitor and the interactive website. They will receive minimal rewards based on their physical activity levels. Activity Monitor: Measurement of physical activity. Interactive Website: Zamzee is a meter that measures activity and a website that makes moving fun. Parents of participants can set activity goals. Activity is uploaded to the website where participants track progress and earn rewards by increasing their level of activity. Participants can view leaderboards and check how other participants are doing. Educational Materials: All participants will receive educational handouts about physical activity. Participants will receive the educational handouts again via mail three and five months into the study to reinforce the importance of physical activity and maintain compliance.		Participants use an activity monitor and the interactive website. In addition to minimal rewards, participants will receive immediate incentives as they move from one level to the other on the website. Activity Monitor: Measurement of physical activity. Interactive Website: Zamzee is a meter that measures activity and a website that makes moving fun. Parents of participants can set activity goals. Activity is uploaded to the website where participants track progress and earn rewards by increasing their level of activity. Participants can view leaderboards and check how other participants are doing. Educational Materials: All participants will receive educational handouts about physical activity. Participants will receive the educational handouts again via mail three and five months into the study to reinforce the importance of physical activity and maintain compliance.		Participants in the control group will receive an activity monitor and educational materials, but will not have access to the interactive website. No rewards will be offered for their participation. Activity Monitor: Measurement of physical activity. Educational Materials: All participants will receive educational handouts about physical activity. Participants will receive the educational handouts again via mail three and five months into the study to reinforce the importance of physical activity and maintain compliance.
All Cause Mortality
	Group A: Minimal Rewards		Group B: Immediate Incentives		Group C: Control
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)		/ (NaN)
Serious Adverse Events
	Group A: Minimal Rewards		Group B: Immediate Incentives		Group C: Control
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/25 (0%)		0/31 (0%)		0/26 (0%)
Other (Not Including Serious) Adverse Events
	Group A: Minimal Rewards		Group B: Immediate Incentives		Group C: Control
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	2/25 (8%)		0/31 (0%)		0/26 (0%)
Cardiac disorders
Abnormal ECG	2/25 (8%)	25	0/31 (0%)	0	0/26 (0%)	0

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.