An interventional study of Physical activity intervention in Physical Activity, sponsored by Michigan State University. Completed at 1 site in United States. Open to female participants aged 9 Years to 14 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2018-11-21.
Sponsored by Michigan State University · Not applicable, Interventional, and Prevention
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.
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.
Michigan State University is the lead sponsor of 139 studies on the registry; 26 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
The control condition will complete data collection activities and receive their usual school offerings.
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.
Minutes of Moderate to Vigorous Physical Activity (MVPA) Post-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.).
Time frame: Minutes of moderate to vigorous physical activity per hour at post-intervention (after 17-week intervention)
Cardiovascular Fitness (Aerobic Performance)
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.
Time frame: Cardiovascular fitness after 17-week intervention (post-intervention)
Body Mass Index (BMI) Z-score
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.
Time frame: Body mass index z-score at post-intervention (after 17-week intervention)
Percent Body Fat
Percent body fat estimated via a foot-to-foot body weight scale with bioelectrical impedance analysis capabilities.
Time frame: Percent body fat at post-intervention (immediately after 17-week intervention)
Minutes of Moderate-to-Vigorous Physical Activity 9-month Follow up
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.).
Time frame: 9 months after the end of the 17-week intervention
Perceived Benefits of Physical Activity
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.
Time frame: baseline to post-intervention
Perceived Barriers to Physical Activity
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.
Time frame: Baseline to post-intervention
Physical Activity Self-Efficacy
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.
Time frame: baseline to post-intervention
Social Support for Physical Activity
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.
Time frame: baseline to post-intervention
Enjoyment of Physical Activity
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.
Time frame: baseline to post-intervention
Motivation for Physical Activity
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.
Time frame: baseline to post-intervention
| Milestone | Control | Physical Activity Intervention |
|---|---|---|
| Started | 777 | 766 |
| Completed baseline | 766 | 753 |
| Completed post-intervention | 680 | 706 |
| Completed | 437 | 461 |
| Not completed | 340 | 305 |
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.).
| mean minutes per hour | Control | Physical Activity Intervention |
|---|---|---|
| Minutes of Moderate to Vigorous Physical Activity (MVPA) Post-intervention | 3.27 ± 1.49 | 3.27 ± 1.49 |
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.
| ml/kg/min | Control | Physical Activity Intervention |
|---|---|---|
| Cardiovascular Fitness (Aerobic Performance) | 37.32 ± 5.28 | 37.51 ± 5.19 |
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.
| z-score | Control | Physical Activity Intervention |
|---|---|---|
| Body Mass Index (BMI) Z-score | 1.01 ± 0.01 | 0.99 ± 0.01 |
Percent body fat estimated via a foot-to-foot body weight scale with bioelectrical impedance analysis capabilities.
| percent body fat | Control | Physical Activity Intervention |
|---|---|---|
| Percent Body Fat | 30.67 ± 0.14 | 30.30 ± 0.14 |
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.).
| mean minutes per hour | Control | Physical Activity Intervention |
|---|---|---|
| Minutes of Moderate-to-Vigorous Physical Activity 9-month Follow up | 2.64 ± 1.15 | 2.59 ± 1.19 |
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.
| score on a scale | Control | Intervention |
|---|---|---|
| Perceived Benefits of Physical Activity | 2.22 ± 0.51 | 2.29 ± 0.53 |
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.
| score on a scale | Control | Intervention |
|---|---|---|
| Perceived Barriers to Physical Activity | 1.14 ± 0.60 | 1.26 ± 0.63 |
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.
| score on a scale | Control | Intervention |
|---|---|---|
| Physical Activity Self-Efficacy | 2.14 ± 0.60 | 2.12 ± 0.64 |
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.
| score on a scale | Control | Intervention |
|---|---|---|
| Social Support for Physical Activity | 1.73 ± 0.86 | 1.87 ± 0.82 |
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.
| score on a scale | Control | Intervention |
|---|---|---|
| Enjoyment of Physical Activity | 2.11 ± 0.72 | 2.11 ± 0.67 |
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.
| score on a scale | Control | Intervention |
|---|---|---|
| Motivation for Physical Activity | 3.48 ± 0.69 | 3.48 ± 0.68 |
Collected over From baseline data collection through post-intervention data collection after the 17-week intervention to 9-month post-intervention follow up (1 year, 2 months). Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Control | — | 0/777 (0%) | 0/777 (0%) |
| Physical Activity Intervention | — | 0/766 (0%) | 0/766 (0%) |
| Age, Categorical(Participants) | Control | Physical Activity Intervention | Total |
|---|---|---|---|
| <=18 years | 766 | 753 | 1519 |
| Between 18 and 65 years | 0 | 0 | 0 |
| >=65 years | 0 | 0 | 0 |
| Age, Continuous(years) | Control | Physical Activity Intervention | Total |
|---|---|---|---|
| Mean | 12.05 ± 1.02 | 12.05 ± 0.99 | 12.05 ± 1.01 |
| Sex: Female, Male(Participants) | Control | Physical Activity Intervention | Total |
|---|---|---|---|
| Female | 766 | 753 | 1519 |
| Male | 0 | 0 | 0 |
| Ethnicity (NIH/OMB)(Participants) | Control | Physical Activity Intervention | Total |
|---|---|---|---|
| Hispanic or Latino | 90 | 111 | 201 |
| Not Hispanic or Latino | 629 | 603 | 1232 |
| Unknown or Not Reported | 47 | 39 | 86 |
| Race (NIH/OMB)(Participants) | Control | Physical Activity Intervention | Total |
|---|---|---|---|
| American Indian or Alaska Native | 7 | 6 | 13 |
| Asian | 15 | 26 | 41 |
| Native Hawaiian or Other Pacific Islander | 2 | 0 | 2 |
| Black or African American | 416 | 340 | 756 |
| White | 198 | 214 | 412 |
| More than one race | 94 | 96 | 190 |
| Unknown or Not Reported | 34 | 71 | 105 |
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Michigan State University