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New Moves - Obesity Prevention Among Adolescent Girls

New Moves: Obesity Prevention Among Adolescent Girls

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00250497
Enrollment
356
Registered
2005-11-08
Start date
2005-09-30
Completion date
2009-06-30
Last updated
2019-11-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Obesity

Keywords

Adolescent, Girls, Physical Activity, Exercise, Diet, Body image

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.

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.

Interventions

BEHAVIORALNew 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.

Sponsors

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
CollaboratorNIH
University of Minnesota
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE

Eligibility

Sex/Gender
FEMALE
Age
14 Years to 19 Years
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

Design outcomes

Primary

MeasureTime frameDescription
Percent Body FatBaseline and One yearMeasured with DEX-A at baseline and 1 year follow-up

Secondary

MeasureTime frameDescription
Level of Physical ActivityOne yearThe 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.
Fruits and VegetablesOne year
Sedentary ActivityOne YearThe 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
Unhealthy Weight Control BehaviorsOne YearTen 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.
Body SatisfactionOne yearTen 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.

Countries

United States

Participant flow

Participants by arm

ArmCount
Intervention Group
New Moves Intervention
182
Control Group
All Girls PE Control Group
174
Total356

Baseline characteristics

CharacteristicControl GroupIntervention GroupTotal
Age, Categorical
<=18 years
165 Participants174 Participants339 Participants
Age, Categorical
>=65 years
0 Participants0 Participants0 Participants
Age, Categorical
Between 18 and 65 years
9 Participants8 Participants17 Participants
Age, Continuous15.8 years
STANDARD_DEVIATION 1.22
15.7 years
STANDARD_DEVIATION 1.13
15.8 years
STANDARD_DEVIATION 1.17
Region of Enrollment
United States
174 participants182 participants356 participants
Sex: Female, Male
Female
174 Participants182 Participants356 Participants
Sex: Female, Male
Male
0 Participants0 Participants0 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
— / —— / —
other
Total, other adverse events
0 / 1820 / 174
serious
Total, serious adverse events
0 / 1820 / 174

Outcome results

Primary

Percent Body Fat

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

Time frame: Baseline and One year

ArmMeasureValue (MEAN)Dispersion
Intervention GroupPercent Body Fat37.2 % body fat (DXA)Standard Deviation 9.55
Control GroupPercent Body Fat37.7 % body fat (DXA)Standard Deviation 8.84
Secondary

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.

Time frame: One year

ArmMeasureValue (MEAN)Dispersion
Intervention GroupBody Satisfaction40.7 units on a scaleStandard Deviation 12.8
Control GroupBody Satisfaction36.6 units on a scaleStandard Deviation 12.4
Secondary

Fruits and Vegetables

Time frame: One year

ArmMeasureValue (MEAN)Dispersion
Intervention GroupFruits and Vegetables2.06 Servings/dayStandard Deviation 2.18
Control GroupFruits and Vegetables1.82 Servings/dayStandard Deviation 1.76
Secondary

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.

Time frame: One year

ArmMeasureValue (MEAN)Dispersion
Intervention GroupLevel of Physical Activity4.92 average number of 30-minute blocks/dayStandard Deviation 3.52
Control GroupLevel of Physical Activity3.72 average number of 30-minute blocks/dayStandard Deviation 3.65
Secondary

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

Time frame: One Year

ArmMeasureValue (MEAN)Dispersion
Intervention GroupSedentary Activity31.0 average number of 30-minute blocks/dayStandard Deviation 3.82
Control GroupSedentary Activity32.3 average number of 30-minute blocks/dayStandard Deviation 3.89
Secondary

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.

Time frame: One Year

ArmMeasureValue (NUMBER)
Intervention GroupUnhealthy Weight Control Behaviors49.5 percentage of participants
Control GroupUnhealthy Weight Control Behaviors63.3 percentage of participants

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026