Physical Activity
Conditions
Keywords
exercise, adolescent, intervention, female, counseling
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.
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.
Interventions
BEHAVIORALPhysical activity intervention
Receiving individual counseling with the school nurse, tailored feedback from computer program, and after-school physical activity club.
Sponsors
University of Michigan
Michigan State University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
9 Years to 14 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Minutes of Moderate to Vigorous Physical Activity (MVPA) Post-intervention | 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
| Measure | Time frame | Description |
|---|---|---|
| Cardiovascular Fitness (Aerobic Performance) | 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. |
| Body Mass Index (BMI) Z-score | 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. |
| Percent Body Fat | 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
| Measure | Time frame | Description |
|---|---|---|
| Social Support for Physical Activity | 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. |
| Minutes of Moderate-to-Vigorous Physical Activity 9-month Follow up | 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.). |
| Motivation for Physical Activity | 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. |
| Enjoyment of Physical Activity | 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. |
| Perceived Benefits of Physical Activity | 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. |
| Perceived Barriers to Physical Activity | 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. |
| Physical Activity Self-Efficacy | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Control The control condition completed data collection activities and received their usual school offerings, such as physical education. | 766 |
| 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. | 753 |
| Total | 1,519 |
Baseline characteristics
| Characteristic | Control | Physical Activity Intervention | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 766 Participants | 753 Participants | 1519 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Continuous | 12.05 years STANDARD_DEVIATION 1.02 | 12.05 years STANDARD_DEVIATION 0.99 | 12.05 years STANDARD_DEVIATION 1.01 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 90 Participants | 111 Participants | 201 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 629 Participants | 603 Participants | 1232 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 47 Participants | 39 Participants | 86 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 7 Participants | 6 Participants | 13 Participants |
| Race (NIH/OMB) Asian | 15 Participants | 26 Participants | 41 Participants |
| Race (NIH/OMB) Black or African American | 416 Participants | 340 Participants | 756 Participants |
| Race (NIH/OMB) More than one race | 94 Participants | 96 Participants | 190 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 2 Participants | 0 Participants | 2 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 34 Participants | 71 Participants | 105 Participants |
| Race (NIH/OMB) White | 198 Participants | 214 Participants | 412 Participants |
| Sex: Female, Male Female | 766 Participants | 753 Participants | 1519 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 777 | 0 / 766 |
| serious Total, serious adverse events | 0 / 777 | 0 / 766 |
Outcome results
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.).
Time frame: Minutes of moderate to vigorous physical activity per hour at post-intervention (after 17-week intervention)
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Control | Minutes of Moderate to Vigorous Physical Activity (MVPA) Post-intervention | 3.27 mean minutes per hour | Standard Deviation 1.49 |
| Physical Activity Intervention | Minutes of Moderate to Vigorous Physical Activity (MVPA) Post-intervention | 3.27 mean minutes per hour | Standard Deviation 1.49 |
Comparison: Hypotheses: Post-intervention, weighted mean minutes of MVPA/week will be greater by 16 minutes among girls in intervention than control schools. Mean minutes per week is determined by multiplying mean minutes/hour by 90 hours that girls are awake in a week (10 hours awake on each weekend day; 14 hours awake on each weekday).p-value: 0.20795% CI: [-0.21, 0.05]Mixed Models Analysis
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.
Time frame: Body mass index z-score at post-intervention (after 17-week intervention)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Control | Body Mass Index (BMI) Z-score | 1.01 z-score | Standard Error 0.01 |
| Physical Activity Intervention | Body Mass Index (BMI) Z-score | 0.99 z-score | Standard Error 0.01 |
Comparison: Immediately post-intervention, BMI z-score will be significantly lower among girls in the intervention than control schools.p-value: 0.19195% CI: [-0.05, 0.01]Mixed Models Analysis
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.
Time frame: Cardiovascular fitness after 17-week intervention (post-intervention)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Control | Cardiovascular Fitness (Aerobic Performance) | 37.32 ml/kg/min | Standard Deviation 5.28 |
| Physical Activity Intervention | Cardiovascular Fitness (Aerobic Performance) | 37.51 ml/kg/min | Standard Deviation 5.19 |
Comparison: Immediately post-intervention, cardiovascular (CV) fitness will be higher among girls in the intervention than control schools.p-value: 0.01895% CI: [0.03, 0.36]Mixed Models Analysis
Secondary
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)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Control | Percent Body Fat | 30.67 percent body fat | Standard Error 0.14 |
| Physical Activity Intervention | Percent Body Fat | 30.30 percent body fat | Standard Error 0.14 |
Comparison: Immediately post-intervention, percent body fat will be significantly lower among girls in the intervention than control schools.p-value: 0.00795% CI: [-0.64, -0.1]Mixed Models Analysis
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.
Time frame: baseline to post-intervention
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Control | Enjoyment of Physical Activity | 2.11 score on a scale | Standard Deviation 0.72 |
| Physical Activity Intervention | Enjoyment of Physical Activity | 2.11 score on a scale | Standard Deviation 0.67 |
Comparison: Path analysis was performed to examine study mediation model. Maximum likelihood estimates were computed. Model fit was evaluated based on fit indices: (a) Goodness-of-Fit Index (GFI) ≥.95, (b) Comparative Fit Index (CFI) ≥.95, (c) Root Mean Square Error of Approximation (RMSEA) ≤.05; (d) standardized root mean squared residual (SRMR) ≤.08; and (e) chi-squarp-value: <0.001Path analysis
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.).
Time frame: 9 months after the end of the 17-week intervention
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Control | Minutes of Moderate-to-Vigorous Physical Activity 9-month Follow up | 2.64 mean minutes per hour | Standard Deviation 1.15 |
| Physical Activity Intervention | Minutes of Moderate-to-Vigorous Physical Activity 9-month Follow up | 2.59 mean minutes per hour | Standard Deviation 1.19 |
p-value: 0.11895% CI: [-0.21, 0.02]Mixed Models Analysis
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.
Time frame: baseline to post-intervention
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Control | Motivation for Physical Activity | 3.48 score on a scale | Standard Deviation 0.69 |
| Physical Activity Intervention | Motivation for Physical Activity | 3.48 score on a scale | Standard Deviation 0.68 |
Comparison: Path analysis was performed to examine study mediation model. Maximum likelihood estimates were computed. Model fit was evaluated based on fit indices: (a) Goodness-of-Fit Index (GFI) ≥.95, (b) Comparative Fit Index (CFI) ≥.95, (c) Root Mean Square Error of Approximation (RMSEA) ≤.05; (d) standardized root mean squared residual (SRMR) ≤.08; and (e) chi-squar
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.
Time frame: Baseline to post-intervention
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Control | Perceived Barriers to Physical Activity | 1.14 score on a scale | Standard Deviation 0.6 |
| Physical Activity Intervention | Perceived Barriers to Physical Activity | 1.26 score on a scale | Standard Deviation 0.63 |
Comparison: Path analysis was performed to examine study mediation model. Maximum likelihood estimates were computed. Model fit was evaluated based on fit indices: (a) Goodness-of-Fit Index (GFI) ≥.95, (b) Comparative Fit Index (CFI) ≥.95, (c) Root Mean Square Error of Approximation (RMSEA) ≤.05; (d) standardized root mean squared residual (SRMR) ≤.08; and (e) chi-squar
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.
Time frame: baseline to post-intervention
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Control | Perceived Benefits of Physical Activity | 2.22 score on a scale | Standard Deviation 0.51 |
| Physical Activity Intervention | Perceived Benefits of Physical Activity | 2.29 score on a scale | Standard Deviation 0.53 |
Comparison: Path analysis was performed to examine study mediation model. Maximum likelihood estimates were computed. Model fit was evaluated based on fit indices: (a) Goodness-of-Fit Index (GFI) ≥.95, (b) Comparative Fit Index (CFI) ≥.95, (c) Root Mean Square Error of Approximation (RMSEA) ≤.05; (d) standardized root mean squared residual (SRMR) ≤.08; and (e) chi-square test p\>.05.26.
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.
Time frame: baseline to post-intervention
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Control | Physical Activity Self-Efficacy | 2.14 score on a scale | Standard Deviation 0.6 |
| Physical Activity Intervention | Physical Activity Self-Efficacy | 2.12 score on a scale | Standard Deviation 0.64 |
Comparison: Path analysis was performed to examine study mediation model. Maximum likelihood estimates were computed. Model fit was evaluated based on fit indices: (a) Goodness-of-Fit Index (GFI) ≥.95, (b) Comparative Fit Index (CFI) ≥.95, (c) Root Mean Square Error of Approximation (RMSEA) ≤.05; (d) standardized root mean squared residual (SRMR) ≤.08; and (e) chi-squar
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.
Time frame: baseline to post-intervention
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Control | Social Support for Physical Activity | 1.73 score on a scale | Standard Deviation 0.86 |
| Physical Activity Intervention | Social Support for Physical Activity | 1.87 score on a scale | Standard Deviation 0.82 |
Comparison: Path analysis was performed to examine study mediation model. Maximum likelihood estimates were computed. Model fit was evaluated based on fit indices: (a) Goodness-of-Fit Index (GFI) ≥.95, (b) Comparative Fit Index (CFI) ≥.95, (c) Root Mean Square Error of Approximation (RMSEA) ≤.05; (d) standardized root mean squared residual (SRMR) ≤.08; and (e) chi-squarp-value: <0.001Path analysis