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CO-OPT
Center for Research in Implementation Science and Prevention (CRISP) - Community Outreach - Obesity Prevention Trial (CO-OPT)
Sponsor study identifier
interventional
300
1 country
1
Study Start
March 2012
Actual (reported)Primary Completion
October 2017
Actual (reported)Study Completion
October 2017
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
October 2017
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
March 2012
Actual (reported)December 21, 2013
Actual (reported)December 31, 2013
Actual (reported)October 2017
Actual (reported)October 2017
Actual (reported)Change in BMI z-score
BMI z-score will be calculated for each child at the indicated times
Baseline, post intervention, 6 months post intervention
Patient navigator visits home to encourage health eating, active living and parental skill building
16 session (25 hour) home-based intervention with patient navigators encouraging families to adopt healthy eating, active living and parental skill building
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Denver Health
Denver, Colorado, 80204, United States
Yun L, Boles RE, Haemer MA, Knierim S, Dickinson LM, Mancinas H, Hambidge SJ, Davidson AJ. A randomized, home-based, childhood obesity intervention delivered by patient navigators. BMC Public Health. 2015 May 23;15:506. doi: 10.1186/s12889-015-1833-z.
Arthur Davidson, MD, MSPH
Denver Health
First Submitted
December 21, 2013
First Posted
December 31, 2013
Study Start
March 2012
Actual (reported)Primary Completion
October 2017
Actual (reported)Contact the study team to confirm eligibility.
Study Completion
October 2017
Actual (reported)Last Updated
November 25, 2025
Record last verified: 2022-04
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Source: ClinicalTrials.gov.
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