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Girls on the Move Intervention to Increase Physical Activity Among Middle School Girls

This study is currently recruiting participants. (see Contacts and Locations)
Verified November 2014 by Michigan State University
Sponsor:
Collaborator:
University of Michigan
Information provided by (Responsible Party):
Lorraine Robbins, Michigan State University
ClinicalTrials.gov Identifier:
NCT01503333
First received: December 23, 2011
Last updated: November 5, 2014
Last verified: November 2014
  Purpose

The purpose of this school-based trial is to test the efficacy of an intervention to increase moderate to vigorous physical activity (MVPA) among middle school girls. The 17-week "Girls on the Move" (GOTM) intervention has 3 components. Two individual-level components occurring during school hours include: (1) two face-to-face motivational, individually tailored counseling sessions with a school nurse, and (2) an interactive Internet-based session during which each girl receives motivational, individually tailored feedback messages (at 9 weeks). A group-level component, 90-minute Physical Activity (PA) Club provides an important venue after school that includes activities to assist girls in establishing a behavioral pattern of MVPA. The control condition will complete data collection activities and receive their usual school offerings.

The investigators hypothesize that immediately post-intervention, minutes of MVPA will be greater by 16 min./wk. in the intervention than control group; At 9 months post-intervention follow-up, minutes of MVPA will be greater in the intervention than control group; and immediately post-intervention and 9-mo. post-intervention follow-up, cardiovascular (CV) fitness will be higher and body mass index (BMI) and percent body fat will be lower in the intervention than control group.


Condition Intervention Phase
Physical Activity
Behavioral: Physical activity intervention
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Girls on the Move Intervention

Further study details as provided by Michigan State University:

Primary Outcome Measures:
  • Minutes of moderate to vigorous physical activity per day [ Time Frame: Change from baseline in minutes of moderate to vigorous physical activity per day at 17 weeks ] [ Designated as safety issue: No ]
    Between-group comparison measured by accelerometer


Secondary Outcome Measures:
  • Cardiovascular fitness [ Time Frame: Change from baseline in cardiovascular fitness at 17 weeks ] [ Designated as safety issue: No ]
    Between group comparison measured by number of laps run in a progressive shuttle run test

  • Body mass index [ Time Frame: Change from baseline in body mass index at 17 weeks ] [ Designated as safety issue: No ]
  • Percent body fat [ Time Frame: Change from baseline in percent body fat at 17 weeks ] [ Designated as safety issue: No ]
    Between group comparison of percent body fat estimated via a weight scale with bioelectrical impedance analysis capabilities

  • Minutes of moderate to vigorous physical activity per day [ Time Frame: Change from baseline in minutes of moderate to vigorous physical activity per day at 9 months after end of intervention ] [ Designated as safety issue: No ]
    Between-group comparison measured by accelerometer


Estimated Enrollment: 1488
Study Start Date: September 2011
Estimated Study Completion Date: February 2016
Estimated Primary Completion Date: February 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: Control
The control condition will complete data collection activities and receive their usual school offerings.
Experimental: Physical activity intervention
Receiving Physical activity intervention which includes individual counseling with the school nurse, tailored feedback from computer program, and after-school physical activity club.
Behavioral: Physical activity intervention
Receiving individual counseling with the school nurse, tailored feedback from computer program, and after-school physical activity club.

Detailed Description:

Our 17-week "Girls on the Move" (GOTM) intervention for middle school girls applies the Health Promotion Model (HPM) and Self-Determination Theory (SDT) and has 3 components. Two individual-level components occurring during school hours include: (1) two face-to-face motivational, individually tailored counseling sessions with a school nurse (occurring at baseline and near 17 wks.), and (2) an interactive Internet-based session during which each girl receives motivational, individually tailored feedback messages (at 9 wks.). A group-level component, 90-min. PA Club, led by PA instructors (e.g., individuals from community; teachers, including physical education (PE); and sports team coaches) provides an important venue after school that includes MVPAs (requested by girls in pilot) to assist girls in establishing a behavioral pattern of MVPA. The control condition will complete data collection activities and receive their usual school offerings.

The purpose of this school-based group randomized trial (GRT) is to evaluate the efficacy of the comprehensive GOTM intervention to increase middle school girls' min. of MVPA and improve cardiovascular (CV) fitness, body mass index (BMI), and percent body fat (% BF) immediately post-intervention (after 17 wks.) and at 9-mo. follow-up (F/U; 9 mos. after end of intervention). Secondary analyses will examine if MVPA is mediated by cognitive (e.g., perceived benefits of PA, barriers to PA, and PA self-efficacy; social support) and affective variables (e.g., enjoyment of and motivation for PA).

Based on demographics of the urban schools, we expect a low-SES, mixed-race, predominately African American, sample. Eight schools will be randomly assigned to the PA intervention (n = 4) or comparison condition (n = 4) in the fall of yrs. 2, 3, and 4 (total N = 8 X 3 = 24 different schools). Sixty-two girls meeting inclusion criteria based on answers to a screening tool will be recruited in each school during each of the three yrs.

The long-term goal is to increase MVPA as a means to address the high overweight and obesity prevalence among adolescent girls.

  Eligibility

Ages Eligible for Study:   9 Years to 14 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 5th- 6th- and 7th-grade girls (ages 9-14; 8th-graders if needed in middle schools having only 7th- and 8th- grades)
  • Available and willing to participate in PA Club 3 days/wk. for 17wks.
  • Available for follow-up (9 mos. after intervention ends)
  • Agree to random assignment
  • Able to read, understand, and speak English.

Exclusion Criteria:

  • Involved in or planning to be involved in school or community sports or other organized PAs, such as dance lessons, that involve MVPA and require participation 3 or more days/wk. after school during every season of the school year
  • A health condition precluding safe MVPA.
  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: NCT01503333

Contacts
Contact: Lorraine B Robbins, PhD 517-353-3011 robbin76@msu.edu
Contact: Stacey M Wesolek, MS 517-884-0579 stacey.wesolek@hc.msu.edu

Locations
United States, Michigan
Michigan State University Recruiting
East Lansing, Michigan, United States, 48824
Contact: Lorraine B Robbins, PhD    517-353-3011    robbin76@msu.edu   
Contact: Stacey M Wesolek, MS    517-884-0579    stacey.wesolek@hc.msu.edu   
Sub-Investigator: Karin A Pfeiffer, PhD         
Sponsors and Collaborators
Michigan State University
University of Michigan
Investigators
Principal Investigator: Lorraine B Robbins, PhD Michigan State University
  More Information

No publications provided by Michigan State University

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Lorraine Robbins, Associate Professor, Michigan State University
ClinicalTrials.gov Identifier: NCT01503333     History of Changes
Other Study ID Numbers: 1R01HL109101
Study First Received: December 23, 2011
Last Updated: November 5, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Michigan State University:
exercise
adolescent
intervention
female
counseling

ClinicalTrials.gov processed this record on November 27, 2014