New Moves - Obesity Prevention Among Adolescent Girls

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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New Moves: Obesity Prevention Among Adolescent Girls

Conditions
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Obesity

Intervention / Treatment
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* Behavioral: New Moves


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 14 Years
Maximum Age: 19 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: New Moves Intervention Group<br>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<br>* 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.<br>|
| No Intervention: control group<br>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. | |

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Level of Physical Activity | 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. | One year | 
| Fruits and Vegetables |  | One year | 
| Sedentary Activity | 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 | One Year | 
| Unhealthy Weight Control Behaviors | 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. | One Year | 
| Body Satisfaction | 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. | One year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Adolescent, Girls, Physical Activity, Exercise, Diet, Body image