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

This study is ongoing, but not recruiting participants.
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: May 16, 2013
Last verified: May 2013

December 23, 2011
May 16, 2013
September 2011
February 2016   (final data collection date for primary outcome measure)
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
Same as current
Complete list of historical versions of study NCT01503333 on ClinicalTrials.gov Archive Site
  • 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
  • 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 acceleromter
Not Provided
Not Provided
 
Girls on the Move Intervention to Increase Physical Activity Among Middle School Girls
Girls on the Move Intervention

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.

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.

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Physical Activity
Behavioral: Physical activity intervention
Receiving individual counseling with the school nurse, tailored feedback from computer program, and after-school physical activity club.
  • 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.
    Intervention: Behavioral: Physical activity intervention
Robbins LB, Pfeiffer KA, Vermeesch A, Resnicow K, You Z, An L, Wesolek SM. "Girls on the Move" intervention protocol for increasing physical activity among low-active underserved urban girls: a group randomized trial. BMC Public Health. 2013 May 15;13:474. doi: 10.1186/1471-2458-13-474.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
1488
February 2016
February 2016   (final data collection date for primary outcome measure)

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.
Female
9 Years to 14 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01503333
1R01HL109101
Yes
Lorraine Robbins, Michigan State University
Michigan State University
University of Michigan
Principal Investigator: Lorraine B Robbins, PhD Michigan State University
Michigan State University
May 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP