Physical Activity Clinical Trial
Official title:
Girls on the Move Intervention
NCT number | NCT01503333 |
Other study ID # | 1R01HL109101 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | September 2011 |
Est. completion date | May 2016 |
Verified date | November 2018 |
Source | Michigan State University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 1543 |
Est. completion date | May 2016 |
Est. primary completion date | May 2016 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Female |
Age group | 9 Years to 14 Years |
Eligibility |
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. |
Country | Name | City | State |
---|---|---|---|
United States | Michigan State University | East Lansing | Michigan |
Lead Sponsor | Collaborator |
---|---|
Michigan State University | University of Michigan |
United States,
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. — View Citation
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. Epub 2016 Mar 4. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
* Note: There are 11 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | 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.). | 9 months after the end of the 17-week intervention | |
Other | 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 | |
Other | 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 | |
Other | 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 | |
Other | 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 | |
Other | 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 | |
Other | 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 | |
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.). | Minutes of moderate to vigorous physical activity per hour at post-intervention (after 17-week intervention) | |
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. | Cardiovascular fitness after 17-week intervention (post-intervention) | |
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. |
Body mass index z-score at post-intervention (after 17-week intervention) | |
Secondary | 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) |
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