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NCT02024360 · ClinicalTrials.gov registry record · NA
Community Outreach - Obesity Prevention Trial (CO-OPT)
A NA study, sponsored by Denver Health and Hospital Authority.
- Completed
- Registry status
- NA
- Development phase
- 300
- Enrollment target
NCT02024360 is a NA study that has completed, run by Denver Health and Hospital Authority. The registered enrollment target is 300 participants.
The verdict
NCT02024360, a NA study, has completed, sponsored by Denver Health and Hospital Authority.
- COMPLETED
- Registry status
- NA
- Development phase
- 300 participants
- Enrollment target
Study Summary
The purpose of this research is to investigate the effectiveness of a community health worker-based program as an adjunct to clinical services regarding childhood obesity management. This family-centered program will be delivered in the community and homes of enrolled families. The primary outcome will compare change in age-gender specific body-mass-index (BMI) z-score (zBMI) over time. All Denver Health children and families will be enrolled at study inception and receive the intervention in 1 of 5 defined 6-month stepped wedge engagements. The intervention lasts for 6 months and the time prior to engagement in the intervention will serve as the control period. Intervention construct validity will be evaluated using data on diet, activity, and fitness. The primary goal is to examine the effect of the intervention in reducing the zBMI in the index patient and secondarily on any participating family members. We will test effectiveness among demographic groups under-represented in prior studies, including very young children and Latinos. Results from this study will inform future intervention modifications and permit effect size estimation and power calculations for future randomized trials that include a community health worker-based obesity prevention and treatment program. During the course of the study, an obesity registry will be designed and implemented within an integrated safety-net healthcare system to measure primary obesity outcomes in a low-income population and conduct analyses. The community health worker will be using several new technologies (e.g., text messaging and patient relationship manager \[PRM\]) as an adjunct when working with an obese child and his/her family. Targeted training for clients, providers and CHW will be part of the prevention strategies implemented during the grant period, these will include motivational interviewing. All of these (i.e., obesity registry, technologies and training) will have an evaluative component.
Interventions
- BEHAVIORAL Patient navigation
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 300 participants |
| Start Date | 2012-03 |
| Est. Completion | 2017-10 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02024360
The ClinicalTrials.gov registry entry for NCT02024360 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 300 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Denver Health and Hospital Authority, which has 73 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Patient navigation is the first listed.
NCT02024360 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT02024360 about?
NCT02024360 is a clinical study titled "Community Outreach - Obesity Prevention Trial (CO-OPT)". The purpose of this research is to investigate the effectiveness of a community health worker-based program as an adjunct to clinical services regarding childhood obesity management. This family-centered program will be delivered in the community and homes of enrolled families. The primary outcome w...
What is the current status of trial NCT02024360?
This trial is currently completed. It is a NA study. The enrollment target is 300 participants. The study started on 2012-03. Estimated completion is 2017-10.
What interventions are being tested in trial NCT02024360?
The interventions under investigation include: Patient navigation (BEHAVIORAL).
Who is sponsoring clinical trial NCT02024360?
This trial is sponsored by Denver Health and Hospital Authority, which has 73 total clinical trials registered on ClinicalTrials.gov.
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