Girls on the Move Intervention to Increase Physical Activity Among Middle School Girls
| Tracking Information | |||||
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| First Received Date ICMJE | December 23, 2011 | ||||
| Last Updated Date | May 16, 2013 | ||||
| Start Date ICMJE | September 2011 | ||||
| Estimated Primary Completion Date | February 2016 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
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 |
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| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | Complete list of historical versions of study NCT01503333 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
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| Original Secondary Outcome Measures ICMJE |
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| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Girls on the Move Intervention to Increase Physical Activity Among Middle School Girls | ||||
| Official Title ICMJE | Girls on the Move Intervention | ||||
| Brief Summary | 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. |
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| 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. |
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| Study Type ICMJE | Interventional | ||||
| Study Phase | Phase 3 | ||||
| Study Design ICMJE | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Prevention |
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| Condition ICMJE | Physical Activity | ||||
| Intervention ICMJE | Behavioral: Physical activity intervention
Receiving individual counseling with the school nurse, tailored feedback from computer program, and after-school physical activity club. |
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| Study Arm (s) |
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| Publications * | Not Provided | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Active, not recruiting | ||||
| Estimated Enrollment ICMJE | 1488 | ||||
| Estimated Completion Date | February 2016 | ||||
| Estimated Primary Completion Date | February 2016 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Female | ||||
| Ages | 9 Years to 14 Years | ||||
| Accepts Healthy Volunteers | Yes | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | United States | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT01503333 | ||||
| Other Study ID Numbers ICMJE | 1R01HL109101 | ||||
| Has Data Monitoring Committee | Yes | ||||
| Responsible Party | Lorraine Robbins, Michigan State University | ||||
| Study Sponsor ICMJE | Michigan State University | ||||
| Collaborators ICMJE | University of Michigan | ||||
| Investigators ICMJE |
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| Information Provided By | Michigan State University | ||||
| Verification Date | May 2013 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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