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| Name | Class |
|---|---|
| University of Michigan | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control | No Intervention | The control condition will complete data collection activities and receive their usual school offerings. | |
| Physical activity intervention | Experimental | Receiving Physical activity intervention which includes individual counseling with the school nurse, tailored feedback from computer program, and after-school physical activity club. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Physical activity intervention | Behavioral | Receiving individual counseling with the school nurse, tailored feedback from computer program, and after-school physical activity club. |
| Measure | Description | Time Frame |
|---|---|---|
| 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.). | Minutes of moderate to vigorous physical activity per hour at post-intervention (after 17-week intervention) |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Cardiovascular fitness after 17-week intervention (post-intervention) |
| Body Mass Index (BMI) Z-score |
| Measure | Description | Time Frame |
|---|---|---|
| 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.). |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Lorraine B Robbins, PhD | Michigan State University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Michigan State University | East Lansing | Michigan | 48824 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23672272 | Background | 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. | |
| 25207514 | Background | Ling J, Robbins LB, Resnicow K, Bakhoya M. Social support and peer norms scales for physical activity in adolescents. Am J Health Behav. 2014 Nov;38(6):881-9. doi: 10.5993/AJHB.38.6.10. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Control | The control condition completed data collection activities and received their usual school offerings, such as physical education. |
| FG001 | Physical Activity Intervention | The intervention group completed data collection activities and received the 17-week intervention which included 3 components to help the girls increase their physical activity: 1) two face-to-face motivational interviewing sessions (one at the beginning and the other near the end of the intervention period) with a school nurse/trained counselor; 2) motivational feedback tailored based on each girl's survey responses and delivered via an iPad shortly after the intervention midpoint; and 3) after-school physical activity club for 90 minutes 3 days per week at each girl's school. Physical activity intervention: Receiving individual counseling with the school nurse, tailored feedback from computer program, and after-school physical activity club. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Control | The control condition completed data collection activities and received their usual school offerings, such as physical education. |
| BG001 | Physical Activity Intervention |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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.). | 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. | Posted | Mean | Standard Deviation | mean minutes per hour | Minutes of moderate to vigorous physical activity per hour at post-intervention (after 17-week intervention) |
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)
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Control | The control condition will complete data collection activities and receive their usual school offerings. |
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Costs were not analyzed. Attendance at the physical activity (PA) club was less than optimal. Study lacked a plan for girls to sustain PA in post-intervention period. Generalizability may be limited (sample selected from certain geographical area).
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Lorraine Robbins | Michigan State University College of Nursing | 517-353-3011 | Lorraine.Robbins@hc.msu.edu |
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| ID | Term |
|---|---|
| D009043 | Motor Activity |
| ID | Term |
|---|---|
| D001519 | Behavior |
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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. |
| 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. | Percent body fat at post-intervention (immediately after 17-week intervention) |
| 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. | 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. | 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. | 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. | 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. | 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. | baseline to post-intervention |
| 26325276 | Background | Vermeesch AL, Ling J, Voskuil VR, Bakhoya M, Wesolek SM, Bourne KA, Pfeiffer KA, Robbins LB. Biological and Sociocultural Differences in Perceived Barriers to Physical Activity Among Fifth- to Seventh-Grade Urban Girls. Nurs Res. 2015 Sep-Oct;64(5):342-50. doi: 10.1097/NNR.0000000000000113. |
| 26730556 | Background | Robbins LB, Ling J, Wesolek SM, Kazanis AS, Bourne KA, Resnicow K. Reliability and Validity of the Commitment to Physical Activity Scale for Adolescents. Am J Health Promot. 2017 Jul;31(4):343-352. doi: 10.4278/ajhp.150114-QUAN-665. Epub 2016 Nov 17. |
| 26942487 | Background | Gammon C, Pfeiffer KA, Kazanis A, Ling J, Robbins LB. Cardiorespiratory fitness in urban adolescent girls: associations with race and pubertal status. J Sports Sci. 2017 Jan;35(1):29-34. doi: 10.1080/02640414.2016.1154594. Epub 2016 Mar 4. |
| 27473613 | Background | Robbins LB, Ling J, Toruner EK, Bourne KA, Pfeiffer KA. Examining reach, dose, and fidelity of the "Girls on the Move" after-school physical activity club: a process evaluation. BMC Public Health. 2016 Jul 30;16:671. doi: 10.1186/s12889-016-3329-x. |
| 27579509 | Background | Bakhoya M, Ling J, Pfeiffer KA, Robbins LB. Evaluating Mailed Motivational, Individually Tailored Postcard Boosters for Promoting Girls' Postintervention Moderate-to-Vigorous Physical Activity. Nurs Res. 2016 Sep-Oct;65(5):415-20. doi: 10.1097/NNR.0000000000000173. |
| 28030983 | Background | Ling J, Robbins LB. Psychometric Evaluation of Three Psychosocial Measures Associated With Physical Activity Among Adolescent Girls. J Sch Nurs. 2017 Oct;33(5):344-354. doi: 10.1177/1059840516685857. Epub 2016 Dec 29. |
| 28824487 | Background | Voskuil VR, Pierce SJ, Robbins LB. Comparing the Psychometric Properties of Two Physical Activity Self-Efficacy Instruments in Urban, Adolescent Girls: Validity, Measurement Invariance, and Reliability. Front Psychol. 2017 Aug 3;8:1301. doi: 10.3389/fpsyg.2017.01301. eCollection 2017. |
| 29207976 | Background | Robbins LB, Ling J, Resnicow K. Demographic differences in and correlates of perceived body image discrepancy among urban adolescent girls: a cross-sectional study. BMC Pediatr. 2017 Dec 6;17(1):201. doi: 10.1186/s12887-017-0952-3. |
| 29266689 | Background | Robbins LB, Ling J, Dalimonte-Merckling DM, Sharma DB, Bakhoya M, Pfeiffer KA. Sources and Types of Social Support for Physical Activity Perceived by Fifth to Eighth Grade Girls. J Nurs Scholarsh. 2018 Mar;50(2):172-180. doi: 10.1111/jnu.12369. Epub 2017 Dec 21. |
| 32120378 | Derived | Robbins LB, Ling J, Wen F. Moderators in a physical activity intervention for adolescent girls. Pediatr Res. 2020 Nov;88(5):810-817. doi: 10.1038/s41390-020-0818-5. Epub 2020 Mar 2. |
| 31267695 | Derived | Pfeiffer KA, Robbins LB, Ling J, Sharma DB, Dalimonte-Merckling DM, Voskuil VR, Kaciroti N, Resnicow K. Effects of the Girls on the Move randomized trial on adiposity and aerobic performance (secondary outcomes) in low-income adolescent girls. Pediatr Obes. 2019 Nov;14(11):e12559. doi: 10.1111/ijpo.12559. Epub 2019 Jul 3. |
| 29985968 | Derived | Robbins LB, Ling J, Sharma DB, Dalimonte-Merckling DM, Voskuil VR, Resnicow K, Kaciroti N, Pfeiffer KA. Intervention Effects of "Girls on the Move" on Increasing Physical Activity: A Group Randomized Trial. Ann Behav Med. 2019 Mar 28;53(5):493-500. doi: 10.1093/abm/kay054. |
The intervention group completed data collection activities and received the 17-week intervention which included 3 components to help the girls increase their physical activity: 1) two face-to-face motivational interviewing sessions (one at the beginning and the other near the end of the intervention period) with a school nurse/trained counselor; 2) motivational feedback tailored based on each girl's survey responses and delivered via an iPad shortly after the intervention midpoint; and 3) after-school physical activity club for 90 minutes 3 days per week at each girl's school.
Physical activity intervention: Receiving individual counseling with the school nurse, tailored feedback from computer program, and after-school physical activity club.
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Single item multiple choice: How old are you? | 766 are in control group, and 753 are in intervention group. | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
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| Secondary | 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. | Posted | Mean | Standard Deviation | ml/kg/min | Cardiovascular fitness after 17-week intervention (post-intervention) |
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| Secondary | 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. | Posted | Mean | Standard Error | z-score | Body mass index z-score at post-intervention (after 17-week intervention) |
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| Secondary | Percent Body Fat | Percent body fat estimated via a foot-to-foot body weight scale with bioelectrical impedance analysis capabilities. | Posted | Mean | Standard Error | percent body fat | Percent body fat at post-intervention (immediately after 17-week intervention) |
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| Other Pre-specified | 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.). | Posted | Mean | Standard Deviation | mean minutes per hour | 9 months after the end of the 17-week intervention |
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| Other Pre-specified | 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. | Posted | Mean | Standard Deviation | score on a scale | baseline to post-intervention |
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| Other Pre-specified | 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. | Posted | Mean | Standard Deviation | score on a scale | Baseline to post-intervention |
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| Other Pre-specified | 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. | Posted | Mean | Standard Deviation | score on a scale | baseline to post-intervention |
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| Other Pre-specified | 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. | Posted | Mean | Standard Deviation | score on a scale | baseline to post-intervention |
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| Other Pre-specified | 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. | Posted | Mean | Standard Deviation | score on a scale | baseline to post-intervention |
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| Other Pre-specified | 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. | Posted | Mean | Standard Deviation | score on a scale | baseline to post-intervention |
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| 0 |
| 777 |
| 0 |
| 777 |
| EG001 | 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. Physical activity intervention: Receiving individual counseling with the school nurse, tailored feedback from computer program, and after-school physical activity club. | 0 | 766 | 0 | 766 |
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