Physical ActivityNCT01503333
Girls on the Move Intervention to Increase Physical Activity Among Middle School Girls
A study testing Physical activity intervention in people with Physical Activity, run by Michigan State University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 9 to 14 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Physical Activity
- What is being tested?
- Physical activity intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,543 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2011to May 2016
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 9 to 14 years
- Women only
- Healthy volunteers accepted
- Child
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Michigan State University
East Lansing, Michigan, 48824
About this study
Official title: Girls on the Move Intervention
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.
Read the 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.
- Conditions
- Physical Activity
- Being tested
- Physical activity intervention
- Keywords
- exercise, adolescent, intervention, female, counseling
- Medical subject headings
- Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Physical activity interventionBehavioural
Receiving individual counseling with the school nurse, tailored feedback from computer program, and after-school physical activity club.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Physical activity intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.).
Measured: Minutes of moderate to vigorous physical activity per hour at post-intervention (after 17-week intervention)
Secondary outcomes (3)
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.
Measured: 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.
Measured: 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.
Measured: Percent body fat at post-intervention (immediately after 17-week intervention)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jan 2012 (estimated)
- Study startSep 2011
- Primary completionMay 2016
- Study completionMay 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (14)Papers the sponsor has linked to this study.
- Other trials for Physical ActivityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 1,543 participants (actual)
Sponsor and investigators
- Lead sponsor
- Michigan State University
- Sponsor type
- University, hospital or other
- Collaborators
- University of Michigan
- Responsible party
- Principal investigator, Lorraine Robbins, Michigan State University
- Investigators
- Lorraine B Robbins, PhD, Principal investigator, Michigan State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01503333
- Sponsor's protocol ID
- 1R01HL109101
- Status last verified
- Nov 2018
- First submitted
- 23 Dec 2011
- Last updated
- 21 Nov 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
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.
PubMed 23672272Ling 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.
PubMed 25207514Vermeesch 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.
PubMed 26325276Robbins 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.
PubMed 26730556Gammon 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.
PubMed 26942487Robbins 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.
PubMed 27473613Bakhoya 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.
PubMed 27579509Ling 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.
PubMed 28030983Voskuil 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.
PubMed 28824487Robbins 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.
PubMed 29207976Robbins 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.
PubMed 29266689Robbins 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.
PubMed 32120378Pfeiffer 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.
PubMed 31267695Robbins 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.
PubMed 29985968
Study at a glance
From the registry record, last updated by the sponsor on 21 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Girls on the Move Intervention
- ClinicalTrials.gov ID
- NCT01503333
- Acronym / sponsor ID
- 1R01HL109101
- Conditions
- Physical Activity
- Keywords
- exercise, adolescent, intervention, female, counseling
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,543 participants (actual)
- Lead sponsor
- Michigan State UniversityUniversity, hospital or other
- Collaborators
- University of Michigan
- Study start
- Sep 2011
- Primary completion
- May 2016 (actual)
- Study completion
- May 2016 (actual)
- First posted
- 4 Jan 2012 (estimated)
- Results
- Posted 21 Nov 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | No intervention | –The control condition will complete data collection activities and receive their usual school offerings. |
| Physical activity intervention | Experimental | Behavioral: Physical activity interventionReceiving Physical activity intervention which includes individual counseling with the school nurse, tailored feedback from computer program, and after-school physical activity club. |
Who may qualify
- Ages
- 9 to 14 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Physical activity interventionReceiving individual counseling with the school nurse, tailored feedback from computer program, and after-school physical activity club. | Behavioural | Physical activity intervention |
Primary outcome
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.).
3 secondary outcomes
Cardiovascular Fitness (Aerobic Performance)
Time frame: Cardiovascular fitness after 17-week intervention (post-intervention)
Body Mass Index (BMI) Z-score
Time frame: Body mass index z-score at post-intervention (after 17-week intervention)
Percent Body Fat
Time frame: Percent body fat at post-intervention (immediately after 17-week intervention)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Nov 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 23672272Robbins 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.
- Background: PubMed 25207514Ling 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.
- Background: PubMed 26325276Vermeesch 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.
- Background: PubMed 26730556Robbins 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.
- Background: PubMed 26942487Gammon 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.
- Background: PubMed 27473613Robbins 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.
- Background: PubMed 27579509Bakhoya 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.
- Background: PubMed 28030983Ling 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.
- Background: PubMed 28824487Voskuil 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.
- Background: PubMed 29207976Robbins 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.
- Background: PubMed 29266689Robbins 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.
- Derived from this study: PubMed 32120378Robbins 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lorraine B Robbins, PhD principal investigator
Michigan State University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Physical activity intervention in people with Physical Activity, run by Michigan State University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Nov 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 21 Nov 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01503333, which also lists 14 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Nov 2018.