OLOL: Our Lifestyles Our Lives

• Sponsor: Pennington Biomedical Research Center (Other)
• Overall Status: Completed
• CT.gov ID: NCT02965729
• Collaborator: Our Lady of the Lake Regional Medical Center (Other), American Council on Exercise (Other)
• Enrollment: 105
• Arms: 3
• Duration (Months): 23

Study Details

Study Description

Brief Summary

The purpose of the study was to examine the influence of step goals with pedometers to improve children's weight loss, physical activity, and psychosocial health during behavioral treatment. Children with overweight or obesity were assigned to receive the behavioral treatment alone, plus pedometers, or plus pedometers with step goals.

Condition or Disease	Intervention/Treatment	Phase
Pediatric Obesity; Weight Loss	Behavioral: Family-based weight management; Behavioral: Pedometer; Behavioral: Individualized step goals	N/A

Detailed Description

A total of 105 overweight and obese children ages 8 to 17 years participated in a 10-week family-based weight management intervention focusing on physical activity, nutrition, and behavioral modification. A quasi-experimental design was used to group cohorts into three conditions: two cohorts had no pedometer (n=24); two cohorts had pedometer only (n=25); and four cohorts had pedometer with step goals (i.e. 500 steps/day weekly increase above baseline; n=56). Height and weight were measured at baseline and week 10 and used to calculate body mass index (BMI). Analysis of covariance was performed to examine difference by condition for change in weight, BMI, and BMI z-score, controlling for age and baseline value. Differences in steps/day and psychosocial health were compared between the two pedometer conditions.

Study Design

• Study Type: Interventional
• Actual Enrollment: 105 participants
• Allocation: Non-Randomized
• Intervention Model: Factorial Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Our Lifestyles, Our Lives: Obesity Treatment and Physical Activity Promotion for Underserved Children and Adolescents
• Study Start Date: Jul 1, 2014
• Actual Primary Completion Date: Jun 1, 2016
• Actual Study Completion Date: Jun 1, 2016

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: No Pedometer Participants only participated in the family-based weight management intervention. Participants were not given a pedometer or step goals.	Behavioral: Family-based weight management; The "Our Lifestyles, Our Lives" family-based weight management intervention consisted of 10 weekly 90-minute group sessions focused on physical activity, nutrition, and behavioral modification. Parents and siblings were encouraged to join the participant in these sessions. Sessions were interactive and included cooking demonstrations, light to moderate intensity physical activity that engaged all family members, and behavioral counseling sessions in both mixed (parent and child) and parent-only format.
Active Comparator: Pedometer Only In addition to participating in the family-based weight management intervention, participants were given a pedometer and instructions at session 1. Participants were asked to wear the pedometer every day for the entirety of the program and return at session 10. No step goals were provided.	Behavioral: Family-based weight management; The "Our Lifestyles, Our Lives" family-based weight management intervention consisted of 10 weekly 90-minute group sessions focused on physical activity, nutrition, and behavioral modification. Parents and siblings were encouraged to join the participant in these sessions. Sessions were interactive and included cooking demonstrations, light to moderate intensity physical activity that engaged all family members, and behavioral counseling sessions in both mixed (parent and child) and parent-only format.; Behavioral: Pedometer; In addition to participating in the family-based weight management intervention, participants were given a pedometer (Omron HJ-324U, Omron Healthcare, Lake Forest, IL) and instructions at session 1. Participants were asked to wear the pedometer every day for the entirety of the program and return at session 10.; Other Names: Activity monitor
Active Comparator: Pedometer Plus Step Goals In addition to participating in the family-based weight management intervention, participants were given a pedometer and instructions at session 1. Participants were asked to wear the pedometer every day for the entirety of the program and return at session 10. Participants were given individualized step goals to increase their activity by 500 steps each week (above baseline calculated as average daily steps/day during week 1).	Behavioral: Family-based weight management; The "Our Lifestyles, Our Lives" family-based weight management intervention consisted of 10 weekly 90-minute group sessions focused on physical activity, nutrition, and behavioral modification. Parents and siblings were encouraged to join the participant in these sessions. Sessions were interactive and included cooking demonstrations, light to moderate intensity physical activity that engaged all family members, and behavioral counseling sessions in both mixed (parent and child) and parent-only format.; Behavioral: Pedometer; In addition to participating in the family-based weight management intervention, participants were given a pedometer (Omron HJ-324U, Omron Healthcare, Lake Forest, IL) and instructions at session 1. Participants were asked to wear the pedometer every day for the entirety of the program and return at session 10.; Other Names: Activity monitor ; Behavioral: Individualized step goals; In addition to participating in the family-based weight management intervention, participants were given a step goal to increase their activity by 500 steps each week (above baseline calculated as average daily steps/day during week 1).

Outcome Measures

Primary Outcome Measures

1. BMI Z-score Change [10 weeks]

   Height was measured at sessions 1 and 10 using a stadiometer. Weight was measured at each session using a calibrated scale. BMI z-score was calculated from the Centers for Disease Control and Prevention macro program based on the sex, height, and age of the child. Change was calculated as difference between baseline and end of 10-week study.

Secondary Outcome Measures

1. BMI Change [10 weeks]

   BMI was calculated as weight in kg divided by height in meters squared. Change was calculated as difference between baseline and end of 10-week study.

2. Body Weight Change [10 weeks]

   Weight was measured using a calibrated scale. Change was calculated as difference between baseline and end of 10-week study.

3. Quality of Life Kidscreen-10 Index Change [10 weeks]

   Health-related quality of life was measured using the Kidscreen-10 Index. Change was calculated as difference between baseline and end of 10-week study. the scale ranged from 0 to 15, with higher values indicating a better outcome.

4. Physical Activity Enjoyment Change [10 weeks]

   Physical activity enjoyment was measured using the Physical Activity Enjoyment Scale (PACES). Change was calculated as difference between baseline and end of 10-week study. The scale ranged from 0 to 32, with higher values indicating a better outcome.

5. Subjective Health Change [10 weeks]

   Subjective health was measured using a 1-item Likert scale ("In general, how would you say your health is?"). Change was calculated as difference between baseline and end of 10-week study. The scale ranged from 0 to 4, with higher values indicating a better outcome.

6. Physical Activity Change [10 weeks]

   Physical activity was measured in the pedometer only and pedometer plus goals groups using an Omron pedometer (Omron HJ-324U, Omron Healthcare, Lake Forest, IL). Change was calculated as difference between baseline and end of 10-week study.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 8 Years to 17 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

• Aged 8-17 years old

• BMI ≥ 95th percentile or have a BMI ≥ 85th percentile with comorbidities (e.g. hypertension, heart disease, type 2 diabetes, insulin resistance, sleep apnea, orthopedic problems, or fatty liver disease)

Exclusion Criteria:

• None.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• Pennington Biomedical Research Center
• Our Lady of the Lake Regional Medical Center
• American Council on Exercise

Investigators

• Principal Investigator: Amanda E Staiano, PhD, Pennington Biomedical Research Center

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Amanda Staiano, Assistant Professor - Research, Pennington Biomedical Research Center
• ClinicalTrials.gov Identifier: NCT02965729
• Other Study ID Numbers: PBRC 2014-012
• First Posted: Nov 17, 2016
• Last Update Posted: Jan 18, 2022
• Last Verified: Jan 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Keywords provided by Amanda Staiano, Assistant Professor - Research, Pennington Biomedical Research Center: behavior goals; self-monitoring; pedometer; physical activity
• Additional relevant MeSH terms: Obesity; Pediatric Obesity; Weight Loss

Study Results

Participant Flow

Arm/Group Title	No Pedometer	Pedometer Only	Pedometer Plus Step Goals
Arm/Group Description	Participants only participated in the family-based weight management intervention. Participants were not given a pedometer or step goals.	In addition to participating in the family-based weight management intervention, participants were given a pedometer and instructions at session 1. Participants were asked to wear the pedometer every day for the entirety of the program and return at session 10. No step goals were provided.	In addition to participating in the family-based weight management intervention, participants were given a pedometer and instructions at session 1. Participants were asked to wear the pedometer every day for the entirety of the program and return at session 10. Participants were given individualized step goals to increase their activity by 500 steps each week (above baseline calculated as average daily steps/day during week 1).
Period Title: Overall Study
STARTED	24	25	56
COMPLETED	17	22	45
NOT COMPLETED	7	3	11

Baseline Characteristics

Arm/Group Title	No Pedometer	Pedometer Only	Pedometer Plus Step Goals	Total
Arm/Group Description	Participants only participated in the family-based weight management intervention. Participants were not given a pedometer or step goals.	In addition to participating in the family-based weight management intervention, participants were given a pedometer and instructions at session 1. Participants were asked to wear the pedometer every day for the entirety of the program and return at session 10. No step goals were provided.	In addition to participating in the family-based weight management intervention, participants were given a pedometer and instructions at session 1. Participants were asked to wear the pedometer every day for the entirety of the program and return at session 10. Participants were given individualized step goals to increase their activity by 500 steps each week (above baseline calculated as average daily steps/day during week 1).	Total of all reporting groups
Overall Participants	24	25	56	105
Age (Count of Participants)
<=18 years	24 100%	25 100%	56 100%	105 100%
Between 18 and 65 years	0 0%	0 0%	0 0%	0 0%
>=65 years	0 0%	0 0%	0 0%	0 0%
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	11.4 (2.5)	11.7 (2.1)	13.1 (2.6)	12.4 (2.5)
Sex: Female, Male (Count of Participants)
Female	18 75%	16 64%	39 69.6%	73 69.5%
Male	6 25%	9 36%	17 30.4%	32 30.5%
Region of Enrollment (participants) [Number]
United States	24 100%	25 100%	56 100%	105 100%

Outcome Measures

1. Primary Outcome

Title	BMI Z-score Change
Description	Height was measured at sessions 1 and 10 using a stadiometer. Weight was measured at each session using a calibrated scale. BMI z-score was calculated from the Centers for Disease Control and Prevention macro program based on the sex, height, and age of the child. Change was calculated as difference between baseline and end of 10-week study.
Time Frame	10 weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	No Pedometer	Pedometer Only	Pedometer Plus Step Goals
Arm/Group Description	Participants only participated in the family-based weight management intervention. Participants were not given a pedometer or step goals.	In addition to participating in the family-based weight management intervention, participants were given a pedometer and instructions at session 1. Participants were asked to wear the pedometer every day for the entirety of the program and return at session 10. No step goals were provided.	In addition to participating in the family-based weight management intervention, participants were given a pedometer and instructions at session 1. Participants were asked to wear the pedometer every day for the entirety of the program and return at session 10. Participants were given individualized step goals to increase their activity by 500 steps each week (above baseline calculated as average daily steps/day during week 1).
Measure Participants	17	22	45
Mean (Standard Deviation) [z score]	0.01 (0.04)	-0.03 (0.04)	-0.03 (0.05)

2. Secondary Outcome

Title	BMI Change
Description	BMI was calculated as weight in kg divided by height in meters squared. Change was calculated as difference between baseline and end of 10-week study.
Time Frame	10 weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	No Pedometer	Pedometer Only	Pedometer Plus Step Goals
Arm/Group Description	Participants only participated in the family-based weight management intervention. Participants were not given a pedometer or step goals.	In addition to participating in the family-based weight management intervention, participants were given a pedometer and instructions at session 1. Participants were asked to wear the pedometer every day for the entirety of the program and return at session 10. No step goals were provided.	In addition to participating in the family-based weight management intervention, participants were given a pedometer and instructions at session 1. Participants were asked to wear the pedometer every day for the entirety of the program and return at session 10. Participants were given individualized step goals to increase their activity by 500 steps each week (above baseline calculated as average daily steps/day during week 1).
Measure Participants	17	22	45
Mean (Standard Deviation) [kg/m2]	0.43 (0.82)	-0.24 (0.78)	-0.37 (0.92)

3. Secondary Outcome

Title	Body Weight Change
Description	Weight was measured using a calibrated scale. Change was calculated as difference between baseline and end of 10-week study.
Time Frame	10 weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	No Pedometer	Pedometer Only	Pedometer Plus Step Goals
Arm/Group Description	Participants only participated in the family-based weight management intervention. Participants were not given a pedometer or step goals.	In addition to participating in the family-based weight management intervention, participants were given a pedometer and instructions at session 1. Participants were asked to wear the pedometer every day for the entirety of the program and return at session 10. No step goals were provided.	In addition to participating in the family-based weight management intervention, participants were given a pedometer and instructions at session 1. Participants were asked to wear the pedometer every day for the entirety of the program and return at session 10. Participants were given individualized step goals to increase their activity by 500 steps each week (above baseline calculated as average daily steps/day during week 1).
Measure Participants	17	22	45
Mean (Standard Deviation) [kg]	1.12 (1.9)	0.23 (1.87)	-0.49 (2.06)

4. Secondary Outcome

Title	Quality of Life Kidscreen-10 Index Change
Description	Health-related quality of life was measured using the Kidscreen-10 Index. Change was calculated as difference between baseline and end of 10-week study. the scale ranged from 0 to 15, with higher values indicating a better outcome.
Time Frame	10 weeks

Outcome Measure Data

Analysis Population Description

Data were not collected for the ''No Pedometer'' cohorts.

Arm/Group Title	No Pedometer	Pedometer Only	Pedometer Plus Step Goals
Arm/Group Description	Participants only participated in the family-based weight management intervention. Participants were not given a pedometer or step goals.	In addition to participating in the family-based weight management intervention, participants were given a pedometer and instructions at session 1. Participants were asked to wear the pedometer every day for the entirety of the program and return at session 10. No step goals were provided.	In addition to participating in the family-based weight management intervention, participants were given a pedometer and instructions at session 1. Participants were asked to wear the pedometer every day for the entirety of the program and return at session 10. Participants were given individualized step goals to increase their activity by 500 steps each week (above baseline calculated as average daily steps/day during week 1).
Measure Participants	0	20	39
Mean (Standard Deviation) [units on a scale]	2.2 (4.5)	0.9 (5.3)

5. Secondary Outcome

Title	Physical Activity Enjoyment Change
Description	Physical activity enjoyment was measured using the Physical Activity Enjoyment Scale (PACES). Change was calculated as difference between baseline and end of 10-week study. The scale ranged from 0 to 32, with higher values indicating a better outcome.
Time Frame	10 weeks

Outcome Measure Data

Analysis Population Description

Data were not collected for the ''No Pedometer'' cohorts.

Arm/Group Title	No Pedometer	Pedometer Only	Pedometer Plus Step Goals
Arm/Group Description	Participants only participated in the family-based weight management intervention. Participants were not given a pedometer or step goals.	In addition to participating in the family-based weight management intervention, participants were given a pedometer and instructions at session 1. Participants were asked to wear the pedometer every day for the entirety of the program and return at session 10. No step goals were provided.	In addition to participating in the family-based weight management intervention, participants were given a pedometer and instructions at session 1. Participants were asked to wear the pedometer every day for the entirety of the program and return at session 10. Participants were given individualized step goals to increase their activity by 500 steps each week (above baseline calculated as average daily steps/day during week 1).
Measure Participants	0	20	39
Mean (Standard Deviation) [units on a scale]	0.02 (8.25)	2.66 (10.9)

6. Secondary Outcome

Title	Subjective Health Change
Description	Subjective health was measured using a 1-item Likert scale ("In general, how would you say your health is?"). Change was calculated as difference between baseline and end of 10-week study. The scale ranged from 0 to 4, with higher values indicating a better outcome.
Time Frame	10 weeks

Outcome Measure Data

Analysis Population Description

Data were not collected for the ''No Pedometer'' cohorts.

Arm/Group Title	No Pedometer	Pedometer Only	Pedometer Plus Step Goals
Arm/Group Description	Participants only participated in the family-based weight management intervention. Participants were not given a pedometer or step goals.	In addition to participating in the family-based weight management intervention, participants were given a pedometer and instructions at session 1. Participants were asked to wear the pedometer every day for the entirety of the program and return at session 10. No step goals were provided.	In addition to participating in the family-based weight management intervention, participants were given a pedometer and instructions at session 1. Participants were asked to wear the pedometer every day for the entirety of the program and return at session 10. Participants were given individualized step goals to increase their activity by 500 steps each week (above baseline calculated as average daily steps/day during week 1).
Measure Participants	0	20	39
Mean (Standard Deviation) [units on a scale]	0.55 (1.34)	0.66 (1.00)

7. Secondary Outcome

Title	Physical Activity Change
Description	Physical activity was measured in the pedometer only and pedometer plus goals groups using an Omron pedometer (Omron HJ-324U, Omron Healthcare, Lake Forest, IL). Change was calculated as difference between baseline and end of 10-week study.
Time Frame	10 weeks

Outcome Measure Data

Analysis Population Description

Pedometers were not worn in the "No Pedometer" cohorts and so data were not collected.

Arm/Group Title	No Pedometer	Pedometer Only	Pedometer Plus Step Goals
Arm/Group Description	Participants only participated in the family-based weight management intervention. Participants were not given a pedometer or step goals.	In addition to participating in the family-based weight management intervention, participants were given a pedometer and instructions at session 1. Participants were asked to wear the pedometer every day for the entirety of the program and return at session 10. No step goals were provided.	In addition to participating in the family-based weight management intervention, participants were given a pedometer and instructions at session 1. Participants were asked to wear the pedometer every day for the entirety of the program and return at session 10. Participants were given individualized step goals to increase their activity by 500 steps each week (above baseline calculated as average daily steps/day during week 1).
Measure Participants	0	22	45
Mean (Standard Deviation) [steps]	-162 (620)	1185 (425)

Adverse Events

Arm/Group Title	No Pedometer		Pedometer Only		Pedometer Plus Step Goals
Arm/Group Description	Participants only participated in the family-based weight management intervention. Participants were not given a pedometer or step goals.		In addition to participating in the family-based weight management intervention, participants were given a pedometer and instructions at session 1. Participants were asked to wear the pedometer every day for the entirety of the program and return at session 10. No step goals were provided.		In addition to participating in the family-based weight management intervention, participants were given a pedometer and instructions at session 1. Participants were asked to wear the pedometer every day for the entirety of the program and return at session 10. Participants were given individualized step goals to increase their activity by 500 steps each week (above baseline calculated as average daily steps/day during week 1).
All Cause Mortality
	No Pedometer		Pedometer Only		Pedometer Plus Step Goals
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/24 (0%)		0/25 (0%)		0/56 (0%)
Serious Adverse Events
	No Pedometer		Pedometer Only		Pedometer Plus Step Goals
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/24 (0%)		0/25 (0%)		0/56 (0%)
Other (Not Including Serious) Adverse Events
	No Pedometer		Pedometer Only		Pedometer Plus Step Goals
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/24 (0%)		0/25 (0%)		0/56 (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.