New Moves - Obesity Prevention Among Adolescent Girls

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
University of Minnesota - Clinical and Translational Science Institute
ClinicalTrials.gov Identifier:
NCT00250497
First received: November 7, 2005
Last updated: July 6, 2015
Last verified: July 2015
  Purpose

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 Intervention
Obesity
Behavioral: New Moves

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: New Moves: Obesity Prevention Among Adolescent Girls

Resource links provided by NLM:


Further study details as provided by University of Minnesota - Clinical and Translational Science Institute:

Primary Outcome Measures:
  • Percent Body Fat [ Time Frame: One year ] [ Designated as safety issue: No ]
    Measured with DEX-A at baseline and 1 year follow-up


Secondary Outcome Measures:
  • Level of Physical Activity [ Time Frame: One year ] [ Designated as safety issue: No ]
    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.

  • Fruits and Vegetables [ Time Frame: One year ] [ Designated as safety issue: No ]
  • Sedentary Activity [ Time Frame: One Year ] [ Designated as safety issue: No ]
    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

  • Unhealthy Weight Control Behaviors [ Time Frame: One Year ] [ Designated as safety issue: No ]
    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.

  • Body Satisfaction [ Time Frame: One year ] [ Designated as safety issue: No ]
    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.


Enrollment: 356
Study Start Date: September 2005
Study Completion Date: June 2009
Primary Completion Date: June 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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.

  Eligibility

Ages Eligible for Study:   14 Years to 19 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00250497

Locations
United States, Minnesota
University of Minnesota Division of Epidemiology and Community Health
Minneapolis, Minnesota, United States, 55454
Sponsors and Collaborators
University of Minnesota - Clinical and Translational Science Institute
Investigators
Principal Investigator: Dianne Neumark-Sztainer, Ph.D. University of Minnesota - Clinical and Translational Science Institute
  More Information

No publications provided by University of Minnesota - Clinical and Translational Science Institute

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: University of Minnesota - Clinical and Translational Science Institute
ClinicalTrials.gov Identifier: NCT00250497     History of Changes
Other Study ID Numbers: DK63107 (completed), R01DK063107
Study First Received: November 7, 2005
Results First Received: July 12, 2012
Last Updated: July 6, 2015
Health Authority: United States: Federal Government

Keywords provided by University of Minnesota - Clinical and Translational Science Institute:
Adolescent
Girls
Physical Activity
Exercise
Diet
Body image

Additional relevant MeSH terms:
Obesity
Body Weight
Nutrition Disorders
Overnutrition
Overweight
Signs and Symptoms

ClinicalTrials.gov processed this record on August 03, 2015