ObesityNCT01063413
Physical Activity, Weight and Fitness Outcomes in Children in After-Care
An observational study of Obesity and Exercise, run by Wake Forest University Health Sciences at 2 sites in United States.
Trial summary
The purpose of this study is to compare the effect of two after-school programs on children's physical activity, fitness, body composition, and academic performance. Read more about this study
- Who is it for?
- Ages 5 to 15 yearsHealthy volunteers can take part
- How many people
- 97 participants
- Where
- 2 sitesUnited States
- Study dates
- Feb 2010to May 2010
- Phase
- Observational
- Are there results?
- None posted in the registry
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 5 to 15 years
- All sexes
- Healthy volunteers accepted
- Child
Study population: public school students
Who may be able to join
- 5 - 15 years
- enrolled in public school district
- parental permission to access school records
Who cannot join
- under 5 or over 15
- no parental permission to access school records
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Metro Parks & Recreation - Coleman Park Regional Center
Nashville, Tennessee, 37211
YMCA Fun Company - Glencliff Elementary School
Nashville, Tennessee, 37211
About this study
Official title: Impact Analysis of Metro Parks' After-School Programming on Physical Activity, Weight and Fitness Outcomes
The purpose of this study is to compare the effect of two after-school programs on children's physical activity, fitness, body composition, and academic performance.
Read the detailed description
Tennessee ranks 4th for the highest prevalence of adult obesity in the nation (30.2%), and ranks 5th for the highest rate of youth obesity (36.5%). The Division of General Pediatrics at Vanderbilt has a specific research focus to develop community engagement projects that measurably reduce childhood obesity. Metro Parks and Recreation has been showcased by the National Recreation and Parks Association (NRPA) as a national model for its leadership role in community health and wellness. The two have created a unique academic-community partnership, guided by principals of community-based participatory research (CBPR), that is working to test and disseminate effective Metro Parks-based programs to reduce pediatric obesity. The proposed study will examine the impact of the Coleman Community Center after-school program on routine physical activity, weight and fitness outcomes in children who belong to the low-income and racial and ethnic minority populations at highest risk for childhood obesity. This study was requested by Metro Parks and has significant policy implications: If the program is deemed effective in improving daily physical activity, weight and/or fitness outcomes in students, the proposed study will serve as the rationale to expand the program to Metro Parks' 22 community centers, all of which are located in under-resourced neighborhoods.
- Keywords
- Behavioral Research, Community-Based Participatory Research
- Medical subject headings
- Obesity, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Coleman Afterschool Program | Children enrolled in a community center-based after-school program. | |
| YMCA Fun Company | Children enrolled in a school-based after-school program. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Physical activity measured by actigraphy
Measured: 3 weeks over 3 months
Secondary outcomes (2)
Body composition measured by bioelectrical impedance
Measured: 3 times over 3 months
Cardiovascular fitness measured by 1/2 mile run/walk
Measured: 3 times over 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2010 (estimated)
- Study startFeb 2010
- Primary completionMay 2010
- Study completionMay 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for ObesityStudies of the same condition, open and under way.
- More trials run by Wake Forest University Health SciencesThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 97 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wake Forest University Health Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sabina B. Gesell, PhD, Principal investigator, Wake Forest University Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01063413
- Sponsor's protocol ID
- 090986
- Status last verified
- Jan 2017
- First submitted
- 3 Feb 2010
- Last updated
- 6 Nov 2017
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Yes: These data have been shared with researchers who have contacted the PI, Dr. Sabina Gesell at sgesell@wakehealth.edu.
Publications
Gesell SB, Tesdahl E, Ruchman E. The distribution of physical activity in an after-school friendship network. Pediatrics. 2012 Jun;129(6):1064-71. doi: 10.1542/peds.2011-2567. Epub 2012 May 28.
PubMed 22641755Gesell SB, Sommer EC, Lambert EW, Vides de Andrade AR, Whitaker L, Davis L, Beech BM, Mitchell SJ, Arinze N, Neloms S, Ryan CK, Barkin SL. Comparative effectiveness of after-school programs to increase physical activity. J Obes. 2013;2013:576821. doi: 10.1155/2013/576821. Epub 2013 Aug 4.
PubMed 23984052Zhang J, Shoham DA, Tesdahl E, Gesell SB. Network interventions on physical activity in an afterschool program: an agent-based social network study. Am J Public Health. 2015 Apr;105 Suppl 2(Suppl 2):S236-43. doi: 10.2105/AJPH.2014.302277. Epub 2015 Feb 17.
PubMed 25689202Henry T, Gesell SB, Ip EH. Analyzing heterogeneity in the effects of physical activity in children on social network structure and peer selection dynamics. Netw Sci (Camb Univ Press). 2016 Sep;4(3):336-363. doi: 10.1017/nws.2016.2. Epub 2016 May 12.
PubMed 27867518
Study at a glance
From the registry record, last updated by the sponsor on 6 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact Analysis of Metro Parks' After-School Programming on Physical Activity, Weight and Fitness Outcomes
- ClinicalTrials.gov ID
- NCT01063413
- Acronym / sponsor ID
- 090986
- Keywords
- Behavioral Research, Community-Based Participatory Research
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 97 participants (actual)
- Lead sponsor
- Wake Forest University Health SciencesUniversity, hospital or other
- Study start
- Feb 2010
- Primary completion
- May 2010 (actual)
- Study completion
- May 2010 (actual)
- First posted
- 5 Feb 2010 (estimated)
- Results
- Not posted in the source record
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 study is to compare the effect of two after-school programs on children's physical activity, fitness, body composition, and academic performance.
Detailed description
Tennessee ranks 4th for the highest prevalence of adult obesity in the nation (30.2%), and ranks 5th for the highest rate of youth obesity (36.5%). The Division of General Pediatrics at Vanderbilt has a specific research focus to develop community engagement projects that measurably reduce childhood obesity. Metro Parks and Recreation has been showcased by the National Recreation and Parks Association (NRPA) as a national model for its leadership role in community health and wellness. The two have created a unique academic-community partnership, guided by principals of community-based participatory research (CBPR), that is working to test and disseminate effective Metro Parks-based programs to reduce pediatric obesity. The proposed study will examine the impact of the Coleman Community Center after-school program on routine physical activity, weight and fitness outcomes in children who belong to the low-income and racial and ethnic minority populations at highest risk for childhood obesity. This study was requested by Metro Parks and has significant policy implications: If the program is deemed effective in improving daily physical activity, weight and/or fitness outcomes in students, the proposed study will serve as the rationale to expand the program to Metro Parks' 22 community centers, all of which are located in under-resourced neighborhoods.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Coleman Afterschool Program | – | –Children enrolled in a community center-based after-school program. |
| YMCA Fun Company | – | –Children enrolled in a school-based after-school program. |
Who may qualify
- Ages
- 5 to 15 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- public school students
Key inclusion criteria (3 listed)
- 5 - 15 years
- enrolled in public school district
- parental permission to access school records
Key exclusion criteria (2 listed)
- under 5 or over 15
- no parental permission to access school records
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Physical activity measured by actigraphy
Time frame: 3 weeks over 3 months
2 secondary outcomes
Body composition measured by bioelectrical impedance
Time frame: 3 times over 3 months
Cardiovascular fitness measured by 1/2 mile run/walk
Time frame: 3 times over 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Nov 2017.
- Results publication: PubMed 22641755Gesell SB, Tesdahl E, Ruchman E. The distribution of physical activity in an after-school friendship network. Pediatrics. 2012 Jun;129(6):1064-71. doi: 10.1542/peds.2011-2567. Epub 2012 May 28.
- Results publication: PubMed 23984052Gesell SB, Sommer EC, Lambert EW, Vides de Andrade AR, Whitaker L, Davis L, Beech BM, Mitchell SJ, Arinze N, Neloms S, Ryan CK, Barkin SL. Comparative effectiveness of after-school programs to increase physical activity. J Obes. 2013;2013:576821. doi: 10.1155/2013/576821. Epub 2013 Aug 4.
- Results publication: PubMed 25689202Zhang J, Shoham DA, Tesdahl E, Gesell SB. Network interventions on physical activity in an afterschool program: an agent-based social network study. Am J Public Health. 2015 Apr;105 Suppl 2(Suppl 2):S236-43. doi: 10.2105/AJPH.2014.302277. Epub 2015 Feb 17.
- Results publication: PubMed 27867518Henry T, Gesell SB, Ip EH. Analyzing heterogeneity in the effects of physical activity in children on social network structure and peer selection dynamics. Netw Sci (Camb Univ Press). 2016 Sep;4(3):336-363. doi: 10.1017/nws.2016.2. Epub 2016 May 12.
- Individual participant dataSharing planned: Yes. These data have been shared with researchers who have contacted the PI, Dr. Sabina Gesell at sgesell@wakehealth.edu.
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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.
Sabina B. Gesell, PhD principal investigator
Wake Forest University Health Sciences
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Obesity and Exercise, run by Wake Forest University Health Sciences at 2 sites 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 3 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 6 Nov 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Physical activity measured by actigraphy (time frame: 3 weeks over 3 months). 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 NCT01063413, which also lists 4 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 6 Nov 2017.