Obesity PreventionPhase 4HOP'NNCT01015599
Healthy Opportunities for Physical Activity and Nutrition (HOP'N) After-School Project
A Phase 4 study testing HOP'N After-school Program in people with Obesity Prevention, run by Kansas State University at 1 site in United States.
Trial summary
This study presents evaluates the effectiveness of the Healthy Opportunities for Physical Activity(HOP'N) After-School Program on preventing obesity in children. The investigators hypothesized that normal and overweight/obese children attending after-school sites randomized to the control condition will increase in… Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Obesity Prevention
- What is being tested?
- HOP'N After-school Program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 273 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2005to May 2008
- Phase
- Phase 4
- 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- after-school program participant in fourth grade group
- informed parental consent
- assent to participate in Body Mass Index assessment
Who cannot join
- third or fourth grade student
- participant in study in previous year
Trial locations and contacts
1 site in 1 country.
About this study
This study presents evaluates the effectiveness of the Healthy Opportunities for Physical Activity(HOP'N) After-School Program on preventing obesity in children. The investigators hypothesized that normal and overweight/obese children attending after-school sites randomized to the control condition will increase in weight status to a greater extent compared to children at sites randomized to receive the HOP'N program. The investigators also hypothesized that after-school intervention HOP'N sites will increase in physical activity and healthful eating opportunities compared to control sites.
Read the detailed description
The dramatic increase in the prevalence of overweight among children and adolescents has led to obesity prevention becoming a major national health priority. Although schools offer a logical choice for a setting to reach a great number of youth, these disappointing findings may be due in part to the difficulties of implementing interventions in school settings where competing demands for time have made it difficult to add anything other than academics to the school day. After-school programs may provide promise for preventing child obesity because there are fewer bureaucratic obstacles and curricular inflexibilities. A three-year group-randomized controlled trial will be conducted with random assignment at the school level . The study will use a nested cross section design with a baseline year, and two subsequent intervention years.
- Conditions
- Obesity Prevention
- Being tested
- HOP'N After-school Program
- Keywords
- Obesity prevention, after-school, physical activity, fruit, vegetable, children
- Medical subject headings
- Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HOP'N After-school ProgramBehavioural
Daily 30 minutes of physical activity following CATCH guidelines, Daily healthful snack with fruit/vegetables, Weekly nutrition and physical activity education based on social cognitive theory.
| Study group | Role | What they receive |
|---|---|---|
| HOP'N After-School Program | Experimental | After-school program with daily physical activity following CATCH guidelines, daily fruit/vegetable snack, and weekly nutrition and physical activity education based on social cognitive theory. Receives: Behavioral: HOP'N After-school Program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Body Mass Index Z-Score
Measured: Fall 2005, Spring 2006, Fall 2006, Spring 2007, Fall 2007, Spring 2008
Secondary outcomes (1)
physical activity
Measured: Six times yearly
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2009 (estimated)
- Study startAug 2005
- Primary completionMay 2008 (estimated)
- Study completionMay 2008 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Obesity PreventionStudies 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 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 273 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kansas State University
- Sponsor type
- University, hospital or other
- Collaborators
- Iowa State University
- Investigators
- David A Dzewaltowski, Ph.D., Principal investigator, Kansas State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01015599
- Sponsor's protocol ID
- USDA no. 2005-35215-15418
- Acronym
- HOP'N
- Status last verified
- Nov 2009
- First submitted
- 17 Nov 2009
- Last updated
- 30 Apr 2010
- Results posted
- No
- Data monitoring committee
- No
Publications
Geller KS, Dzewaltowski DA. Longitudinal and cross-sectional influences on youth fruit and vegetable consumption. Nutr Rev. 2009 Feb;67(2):65-76. doi: 10.1111/j.1753-4887.2008.00142.x.
PubMed 19178647Geller KS, Dzewaltowski DA. Examining elementary school--aged children's self-efficacy and proxy efficacy for fruit and vegetable consumption. Health Educ Behav. 2010 Aug;37(4):465-78. doi: 10.1177/1090198109347067. Epub 2009 Oct 26.
PubMed 19858314Geller KS, Dzewaltowski DA, Rosenkranz RR, Karteroliotis K. Measuring children's self-efficacy and proxy efficacy related to fruit and vegetable consumption. J Sch Health. 2009 Feb;79(2):51-7. doi: 10.1111/j.1746-1561.2008.00376.x.
PubMed 19187083Coleman KJ, Geller KS, Rosenkranz RR, Dzewaltowski DA. Physical activity and healthy eating in the after-school environment. J Sch Health. 2008 Dec;78(12):633-40. doi: 10.1111/j.1746-1561.2008.00359.x.
PubMed 19000239Trost SG, Rosenkranz RR, Dzewaltowski D. Physical activity levels among children attending after-school programs. Med Sci Sports Exerc. 2008 Apr;40(4):622-9. doi: 10.1249/MSS.0b013e318161eaa5.
PubMed 18317385Virgara R, Phillips A, Lewis LK, Baldock K, Wolfenden L, Ferguson T, Richardson M, Okely A, Beets M, Maher C. Interventions in outside-school hours childcare settings for promoting physical activity amongst schoolchildren aged 4 to 12 years. Cochrane Database Syst Rev. 2021 Sep 27;9(9):CD013380. doi: 10.1002/14651858.CD013380.pub2.
PubMed 34694005Rosenkranz RR, Welk GJ, Dzewaltowski DA. Environmental correlates of objectively measured physical activity and sedentary behavior in after-school recreation sessions. J Phys Act Health. 2011 Sep;8 Suppl 2:S214-21.
PubMed 21918235Dzewaltowski DA, Rosenkranz RR, Geller KS, Coleman KJ, Welk GJ, Hastmann TJ, Milliken GA. HOP'N after-school project: an obesity prevention randomized controlled trial. Int J Behav Nutr Phys Act. 2010 Dec 13;7:90. doi: 10.1186/1479-5868-7-90.
PubMed 21144055
Study at a glance
From the registry record, last updated by the sponsor on 30 Apr 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Healthy Opportunities for Physical Activity and Nutrition (HOP'N) After-School Project
- ClinicalTrials.gov ID
- NCT01015599
- Acronym / sponsor ID
- HOP'N / USDA no. 2005-35215-15418
- Conditions
- Obesity Prevention
- Keywords
- Obesity prevention, after-school, physical activity, fruit, vegetable, children
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 273 participants (actual)
- Lead sponsor
- Kansas State UniversityUniversity, hospital or other
- Collaborators
- Iowa State University
- Study start
- Aug 2005
- Primary completion
- May 2008 (estimated)
- Study completion
- May 2008 (estimated)
- First posted
- 18 Nov 2009 (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.
This study presents evaluates the effectiveness of the Healthy Opportunities for Physical Activity(HOP'N) After-School Program on preventing obesity in children. The investigators hypothesized that normal and overweight/obese children attending after-school sites randomized to the control condition will increase in weight status to a greater extent compared to children at sites randomized to receive the HOP'N program. The investigators also hypothesized that after-school intervention HOP'N sites will increase in physical activity and healthful eating opportunities compared to control sites.
Detailed description
The dramatic increase in the prevalence of overweight among children and adolescents has led to obesity prevention becoming a major national health priority. Although schools offer a logical choice for a setting to reach a great number of youth, these disappointing findings may be due in part to the difficulties of implementing interventions in school settings where competing demands for time have made it difficult to add anything other than academics to the school day. After-school programs may provide promise for preventing child obesity because there are fewer bureaucratic obstacles and curricular inflexibilities. A three-year group-randomized controlled trial will be conducted with random assignment at the school level . The study will use a nested cross section design with a baseline year, and two subsequent intervention years.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| HOP'N After-School Program | Experimental | Behavioral: HOP'N After-school ProgramAfter-school program with daily physical activity following CATCH guidelines, daily fruit/vegetable snack, and weekly nutrition and physical activity education based on social cognitive theory. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- after-school program participant in fourth grade group
- informed parental consent
- assent to participate in Body Mass Index assessment
Key exclusion criteria (2 listed)
- third or fourth grade student
- participant in study in previous year
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 |
|---|---|---|
| HOP'N After-school ProgramDaily 30 minutes of physical activity following CATCH guidelines, Daily healthful snack with fruit/vegetables, Weekly nutrition and physical activity education based on social cognitive theory. | Behavioural | HOP'N After-School Program |
Primary outcome
Body Mass Index Z-Score
Time frame: Fall 2005, Spring 2006, Fall 2006, Spring 2007, Fall 2007, Spring 2008
1 secondary outcome
physical activity
Time frame: Six times yearly
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Apr 2010.
- Background: PubMed 19178647Geller KS, Dzewaltowski DA. Longitudinal and cross-sectional influences on youth fruit and vegetable consumption. Nutr Rev. 2009 Feb;67(2):65-76. doi: 10.1111/j.1753-4887.2008.00142.x.
- Results publication: PubMed 19858314Geller KS, Dzewaltowski DA. Examining elementary school--aged children's self-efficacy and proxy efficacy for fruit and vegetable consumption. Health Educ Behav. 2010 Aug;37(4):465-78. doi: 10.1177/1090198109347067. Epub 2009 Oct 26.
- Results publication: PubMed 19187083Geller KS, Dzewaltowski DA, Rosenkranz RR, Karteroliotis K. Measuring children's self-efficacy and proxy efficacy related to fruit and vegetable consumption. J Sch Health. 2009 Feb;79(2):51-7. doi: 10.1111/j.1746-1561.2008.00376.x.
- Results publication: PubMed 19000239Coleman KJ, Geller KS, Rosenkranz RR, Dzewaltowski DA. Physical activity and healthy eating in the after-school environment. J Sch Health. 2008 Dec;78(12):633-40. doi: 10.1111/j.1746-1561.2008.00359.x.
- Results publication: PubMed 18317385Trost SG, Rosenkranz RR, Dzewaltowski D. Physical activity levels among children attending after-school programs. Med Sci Sports Exerc. 2008 Apr;40(4):622-9. doi: 10.1249/MSS.0b013e318161eaa5.
- Derived from this study: PubMed 34694005Virgara R, Phillips A, Lewis LK, Baldock K, Wolfenden L, Ferguson T, Richardson M, Okely A, Beets M, Maher C. Interventions in outside-school hours childcare settings for promoting physical activity amongst schoolchildren aged 4 to 12 years. Cochrane Database Syst Rev. 2021 Sep 27;9(9):CD013380. doi: 10.1002/14651858.CD013380.pub2.
- Derived from this study: PubMed 21918235Rosenkranz RR, Welk GJ, Dzewaltowski DA. Environmental correlates of objectively measured physical activity and sedentary behavior in after-school recreation sessions. J Phys Act Health. 2011 Sep;8 Suppl 2:S214-21.
- Derived from this study: PubMed 21144055Dzewaltowski DA, Rosenkranz RR, Geller KS, Coleman KJ, Welk GJ, Hastmann TJ, Milliken GA. HOP'N after-school project: an obesity prevention randomized controlled trial. Int J Behav Nutr Phys Act. 2010 Dec 13;7:90. doi: 10.1186/1479-5868-7-90.
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Healthy Volunteers
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.
David A Dzewaltowski, Ph.D. principal investigator
Kansas State University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing HOP'N After-school Program in people with Obesity Prevention, run by Kansas 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 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: status not confirmed, as of the sponsor's last update on 30 Apr 2010. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
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?
Body Mass Index Z-Score (time frame: Fall 2005, Spring 2006, Fall 2006, Spring 2007, Fall 2007, Spring 2008). 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 NCT01015599, which also lists 8 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 30 Apr 2010.