New Moves - Obesity Prevention Among Adolescent Girls

• Sponsor: University of Minnesota (Other)
• Overall Status: Completed
• CT.gov ID: NCT00250497
• Collaborator: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) (NIH)
• Enrollment: 356
• Location: 1
• Arms: 2
• Duration (Months): 45
• Patients Per Site Per Month: 7.9

Study Details

Study Description

Brief Summary

The New Moves study will evaluate the impact of a school based program for inactive high school girls who are overweight or at risk for being overweight due to low levels of physical activity. The primary study hypothesis is that girls in the intervention schools will significantly decrease their percent body fat as compared to girls in the control schools. Secondary research hypotheses include that girls in the intervention condition will significantly increase their physical activity levels and improve the quality of their dietary intake.

Condition or Disease	Intervention/Treatment	Phase
Obesity	Behavioral: New Moves	N/A

Detailed Description

The purpose of the New Moves study is to evaluate the effectiveness of a school-based all girls alternative to regular physical education class for inactive high school girls. New Moves uses a large-scale community randomized controlled study involving girls from six intervention schools and six control schools. The New Moves class includes physical activity, nutritional guidance, and social support within a supportive, non-competitive environment. In addition the program includes individual counseling sessions.

The primary research hypothesis is that girls in the intervention condition will significantly decrease their percent body fat as compared to girls in the control condition. Secondary research hypothesis to be tested are that girls in the intervention condition will significantly increase their level of physical activity and improve the quality of their dietary intake as compared to girls in the control condition. In addition a range of socioenvironmental, personal, and behavioral variables will be compared across conditions.

Study Design

• Study Type: Interventional
• Actual Enrollment: 356 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Prevention
• Official Title: New Moves: Obesity Prevention Among Adolescent Girls
• Study Start Date: Sep 1, 2005
• Actual Primary Completion Date: Jun 1, 2009
• Actual Study Completion Date: Jun 1, 2009

Arms and Interventions

Arm	Intervention/Treatment
Experimental: New Moves Intervention Group The New Moves intervention is an all girls physical education class that provides a supportive environment for girls. Girls participate in noncompetitive physical activities. They also receive lessons on nutrition and social support. After the class is over, girls continue to receive intervention messages through weekly lunch meetings. Girls meet individually with a personal coach.	Behavioral: New Moves; The New Moves intervention is an all girls physical education class that provides a supportive environment for girls. Girls participate in noncompetitive physical activities. They also receive lessons on nutrition and social support. After the class is over, girls continue to receive intervention messages through weekly lunch meetings. Girls meet individually with a personal coach.
No Intervention: control group Girls in the control group participated in an all-girls physical education class but did not receive additional components offered in the intervention such as individual coaching.

Outcome Measures

Primary Outcome Measures

1. Percent Body Fat [Baseline and One year]

   Measured with DEX-A at baseline and 1 year follow-up

Secondary Outcome Measures

1. Level of Physical Activity [One year]

   The 3DPAR assessed the sedentary behaviors and physical activities that study participants engaged in during each half hour time block between 6 AM and midnight on the three days previous to the day of data collection. In order to complete the 3DPAR, participants were provided with a list of 65 common sedentary behaviors and physical activities and were asked to select the activity that they participated in for the majority of every 30-minute block. The number of blocks of physical activity were summed for each day and then averaged over the 3 days. Outcomes was the average # of 30 minute blocks of physical activity.

2. Fruits and Vegetables [One year]

3. Sedentary Activity [One Year]

   The 3DPAR assessed the sedentary behaviors and physical activities that study participants engaged in during each half hour time block between 6 AM and midnight on the three days previous to the day of data collection. In order to complete the 3DPAR, participants were provided with a list of 65 common sedentary behaviors and physical activities and were asked to select the activity that they participated in for the majority of every 30-minute block. The number of blocks of sedentary activity were summed for each day and then averaged over the 3 days. Outcomes was the average # of 30 minute blocks of sedentary activity per day

4. Unhealthy Weight Control Behaviors [One Year]

   Ten questions assessing use of unhealthy weight control behaviors in the past month (yes/no). Behavior categories included fasted, ate very little, took diet pills, made myself vomit, used laxatives, used diuretics, used food substitutes, skipped meals, smoked more cigarettes, and went on a diet. If a respondent reported doing any of these behaviors, they were classified as having used unhealthy weight control behaviors.

5. Body Satisfaction [One year]

   Ten questions assessing satisfaction with weight, height, and specific parts of the body; six Likert response categories.Body Satisfaction Scale Range=10-60 with higher values indicating increased body satisfaction.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 14 Years to 19 Years
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

• High school girls

• Low levels of physical activity - defined as being in precontemplation, contemplation, or preparation stages of change for physical activity with activity levels at, or below, 30 minutes per day/three days per week outside of school physical education class

• Priority will be given to girls with a body mass index (BMI) greater than or equal to the 75th percentile for age and gender

Exclusion Criteria:

• BMI less than the 25th percentile for age and gender

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Minnesota Division of Epidemiology and Community Health	Minneapolis	Minnesota	United States	55454

Sponsors and Collaborators

• University of Minnesota
• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Investigators

• Principal Investigator: Dianne Neumark-Sztainer, Ph.D., University of Minnesota

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: University of Minnesota
• ClinicalTrials.gov Identifier: NCT00250497
• Other Study ID Numbers: 0309S51763; R01DK063107
• First Posted: Nov 8, 2005
• Last Update Posted: Nov 1, 2019
• Last Verified: Oct 1, 2019

• Keywords provided by University of Minnesota: Adolescent; Girls; Physical Activity; Exercise; Diet; Body image
• Additional relevant MeSH terms: Obesity

Study Results

Participant Flow

Arm/Group Title	Intervention Group	Control Group
Arm/Group Description	New Moves Intervention	All Girls PE Control group
Period Title: Overall Study
STARTED	182	174
COMPLETED	177	159
NOT COMPLETED	5	15

Baseline Characteristics

Arm/Group Title	Intervention Group	Control Group	Total
Arm/Group Description	New Moves Intervention	All Girls PE Control Group	Total of all reporting groups
Overall Participants	182	174	356
Age (Count of Participants)
<=18 years	174 95.6%	165 94.8%	339 95.2%
Between 18 and 65 years	8 4.4%	9 5.2%	17 4.8%
>=65 years	0 0%	0 0%	0 0%
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	15.7 (1.13)	15.8 (1.22)	15.8 (1.17)
Sex: Female, Male (Count of Participants)
Female	182 100%	174 100%	356 100%
Male	0 0%	0 0%	0 0%
Region of Enrollment (participants) [Number]
United States	182 100%	174 100%	356 100%

Outcome Measures

1. Primary Outcome

Title	Percent Body Fat
Description	Measured with DEX-A at baseline and 1 year follow-up
Time Frame	Baseline and One year

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Intervention Group	Control Group
Arm/Group Description	New Moves Intervention Group	All Girls PE Control Group
Measure Participants	177	159
Mean (Standard Deviation) [% body fat (DXA)]	37.2 (9.55)	37.7 (8.84)

2. Secondary Outcome

Title	Level of Physical Activity
Description	The 3DPAR assessed the sedentary behaviors and physical activities that study participants engaged in during each half hour time block between 6 AM and midnight on the three days previous to the day of data collection. In order to complete the 3DPAR, participants were provided with a list of 65 common sedentary behaviors and physical activities and were asked to select the activity that they participated in for the majority of every 30-minute block. The number of blocks of physical activity were summed for each day and then averaged over the 3 days. Outcomes was the average # of 30 minute blocks of physical activity.
Time Frame	One year

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Intervention Group	Control Group
Arm/Group Description	New Moves Intervention Group	All Girls PE Control Group
Measure Participants	177	159
Mean (Standard Deviation) [average number of 30-minute blocks/day]	4.92 (3.52)	3.72 (3.65)

3. Secondary Outcome

Title	Fruits and Vegetables
Time Frame	One year

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Intervention Group	Control Group
Arm/Group Description	New Moves Intervention Group	All Girls PE Control Group
Measure Participants	177	159
Mean (Standard Deviation) [Servings/day]	2.06 (2.18)	1.82 (1.76)

4. Secondary Outcome

Title	Sedentary Activity
Description	The 3DPAR assessed the sedentary behaviors and physical activities that study participants engaged in during each half hour time block between 6 AM and midnight on the three days previous to the day of data collection. In order to complete the 3DPAR, participants were provided with a list of 65 common sedentary behaviors and physical activities and were asked to select the activity that they participated in for the majority of every 30-minute block. The number of blocks of sedentary activity were summed for each day and then averaged over the 3 days. Outcomes was the average # of 30 minute blocks of sedentary activity per day
Time Frame	One Year

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Intervention Group	Control Group
Arm/Group Description	New Moves Intervention Group	All Girls PE Control Group
Measure Participants	177	159
Mean (Standard Deviation) [average number of 30-minute blocks/day]	31.0 (3.82)	32.3 (3.89)

5. Secondary Outcome

Title	Unhealthy Weight Control Behaviors
Description	Ten questions assessing use of unhealthy weight control behaviors in the past month (yes/no). Behavior categories included fasted, ate very little, took diet pills, made myself vomit, used laxatives, used diuretics, used food substitutes, skipped meals, smoked more cigarettes, and went on a diet. If a respondent reported doing any of these behaviors, they were classified as having used unhealthy weight control behaviors.
Time Frame	One Year

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Intervention Group	Control Group
Arm/Group Description	New Moves Intervention Group	All Girls PE Control Group
Measure Participants	177	159
Number [percentage of participants]	49.5 27.2%	63.3 36.4%

6. Secondary Outcome

Title	Body Satisfaction
Description	Ten questions assessing satisfaction with weight, height, and specific parts of the body; six Likert response categories.Body Satisfaction Scale Range=10-60 with higher values indicating increased body satisfaction.
Time Frame	One year

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Intervention Group	Control Group
Arm/Group Description	New Moves Intervention Group	All Girls PE Control Group
Measure Participants	177	159
Mean (Standard Deviation) [units on a scale]	40.7 (12.8)	36.6 (12.4)

Adverse Events

Arm/Group Title	Intervention Group		Control Group
Arm/Group Description	New Moves Intervention Group		All Girls PE Control Group
All Cause Mortality
	Intervention Group		Control Group
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	Intervention Group		Control Group
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/182 (0%)		0/174 (0%)
Other (Not Including Serious) Adverse Events
	Intervention Group		Control Group
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/182 (0%)		0/174 (0%)

Limitations/Caveats

Control group also had all-girls PE. Some girls missing body composition data.

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.