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

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ClinicalTrials.gov Identifier: NCT01503333
Recruitment Status : Completed
First Posted : January 4, 2012
Results First Posted : November 21, 2018
Last Update Posted : November 21, 2018
Sponsor:
Collaborator:
University of Michigan
Information provided by (Responsible Party):
Lorraine Robbins, Michigan State University

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, 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 or disease Intervention/treatment Phase
Physical Activity Behavioral: Physical activity intervention Not Applicable

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 MVPA 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 : Interventional  (Clinical Trial)
Actual Enrollment : 1543 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Girls on the Move Intervention
Study Start Date : September 2011
Actual Primary Completion Date : May 2016
Actual Study Completion Date : May 2016

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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.




Primary Outcome Measures :
  1. Minutes of Moderate to Vigorous Physical Activity (MVPA) Post-intervention [ Time Frame: Minutes of moderate to vigorous physical activity per hour at post-intervention (after 17-week intervention) ]
    Minutes of MVPA were measured via ActiGraph GT3X+ accelerometers worn on an elastic belt at the right hip for 7 consecutive days, including 5 weekdays and 2 weekend days at post-intervention. Monitors were set to start collecting and storing data in raw format beginning 5:00 A.M. on the day after they were distributed to girls each school. Data were re-integrated to 15-second epochs and processed using established intensity cut-points. One week after distribution, data collectors returned to each school to collect the accelerometers. The majority (1386 [post-intervention] of 1519 girls [baseline], 91.24%) provided at least 8 hours of data on 3 weekdays and 1 weekend day. An imputation approach based on all available data in hour blocks on all 7 days was implemented. Wear time was standardized to 14 hours/weekday (one hour before each school's actual start time; 7 hours during school; 6 hours after school) and 10 hours/weekend day (later awake time from 11 a.m. to 9 p.m.).


Secondary Outcome Measures :
  1. Cardiovascular Fitness (Aerobic Performance) [ Time Frame: Cardiovascular fitness after 17-week intervention (post-intervention) ]
    Between group comparison measured by number of laps run in a progressive shuttle run test. CV fitness was assessed via estimation of maximal oxygen consumption.

  2. Body Mass Index (BMI) Z-score [ Time Frame: Body mass index z-score at post-intervention (after 17-week intervention) ]

    To obtain BMI-z score, height and weight were assessed. Height was measured to nearest 0.1 cm using portable stadiometer.

    Weight was assessed to nearest 0.1 kg with foot-to-foot bioelectric impedance analysis scale. BMI was calculated and then converted into a percentile using age- and sex-specific reference values from the Centers for Disease Control and Prevention growth charts to determine BMI-z score.


  3. Percent Body Fat [ Time Frame: Percent body fat at post-intervention (immediately after 17-week intervention) ]
    Percent body fat estimated via a foot-to-foot body weight scale with bioelectrical impedance analysis capabilities.


Other Outcome Measures:
  1. Minutes of Moderate-to-Vigorous Physical Activity 9-month Follow up [ Time Frame: 9 months after the end of the 17-week intervention ]
    Minutes of MVPA were measured via ActiGraph GT3X+ accelerometers worn on an elastic belt at the right hip for 7 consecutive days, including 5 weekdays and 2 weekend days at 9-month follow up. Monitors were set to start collecting and storing data in raw format beginning 5:00 A.M. on the day after they were distributed to girls each school. Data were re-integrated to 15-second epochs and processed using established intensity cut-points. One week after distribution, data collectors returned to each school to collect the accelerometers. An imputation approach based on all available data in hour blocks on all 7 days was implemented. Wear time was standardized to 14 hours/weekday (one hour before each school's actual start time; 7 hours during school; 6 hours after school) and 10 hours/weekend day (later awake time from 11 a.m. to 9 p.m.).

  2. Perceived Benefits of Physical Activity [ Time Frame: baseline to post-intervention ]
    To assess positive consequences of physical activity, girls completed 10-item Perceived Benefits Scale. Response choices ranged form (0) not at all true to (3) very true. Higher score means better outcome.

  3. Perceived Barriers to Physical Activity [ Time Frame: Baseline to post-intervention ]
    To assess obstacles interfering with physical activity, girls completed a 16-item Perceived Barriers Scale. Response choices ranged from (0) not at all true to (3) very true. Higher score means worse outcome.

  4. Physical Activity Self-Efficacy [ Time Frame: baseline to post-intervention ]
    To measure girls' confidence in their ability to attain physical activity during their free time when facing barriers or not, a 6-item Physical Activity Self-Efficacy scale was used. Response choices ranged from (0) disagree a lot to (3) agree a lot. Higher score means better outcome.

  5. Social Support for Physical Activity [ Time Frame: baseline to post-intervention ]
    To measure assistance for physical activity received form others, an 8-item Social Support Scale was used. Response choices ranged form (0) never to (3) often. Higher score means better outcome.

  6. Enjoyment of Physical Activity [ Time Frame: baseline to post-intervention ]
    To assess feelings or fun regarding physical activity, a 6-item Physical Activity Enjoyment Scale was used. Response choices ranged form (0) not at all true to (3) very true. Higher score means better outcome.

  7. Motivation for Physical Activity [ Time Frame: baseline to post-intervention ]
    To assess feelings regarding physical activity, a 10-item scale was used. Response choices ranged from (0) not true to (4) very true. Higher score means better outcome.



Information from the National Library of Medicine

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Ages Eligible for Study:   9 Years to 14 Years   (Child)
Sexes 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01503333


Locations
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United States, Michigan
Michigan State University
East Lansing, Michigan, United States, 48824
Sponsors and Collaborators
Michigan State University
University of Michigan
Investigators
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Principal Investigator: Lorraine B Robbins, PhD Michigan State University

Publications:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Lorraine Robbins, Associate Professor, Michigan State University
ClinicalTrials.gov Identifier: NCT01503333     History of Changes
Other Study ID Numbers: 1R01HL109101 ( U.S. NIH Grant/Contract )
First Posted: January 4, 2012    Key Record Dates
Results First Posted: November 21, 2018
Last Update Posted: November 21, 2018
Last Verified: November 2018

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