Community Outreach - Obesity Prevention Trial (CO-OPT)

NCT02024360 | Completed

• 1 other identifier: AHRQ 1P01HS021138-01-03
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Obesity; Overweight; Children

Keywords

obesity; overweight; children; prevention

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

patient navigation

EXPERIMENTAL

Patient navigator visits home to encourage health eating, active living and parental skill building

Behavioral: Patient navigation

Interventions

Patient navigation BEHAVIORAL

16 session (25 hour) home-based intervention with patient navigators encouraging families to adopt healthy eating, active living and parental skill building

patient navigation

Eligibility Criteria

• Age: 2 Years - 6 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• years old with a BMI above the 85 %ile

You may not qualify if:

• non-English and non-Spanish speaking, any chronic conditions

Sponsors & Collaborators

• Denver Health and Hospital Authority: lead
• University of Colorado, Denver: collaborator

Study Sites (1)

Denver Health

Denver, Colorado, 80204, United States

Location

Related Publications (1)

• 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.

  PMID: 26002612 DERIVED

MeSH Terms

Conditions

Obesity; Overweight

Interventions

Patient Navigation

Condition Hierarchy (Ancestors)

Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Patient-Centered Care; Primary Health Care; Comprehensive Health Care; Patient Care Management; Health Services Administration

Study Officials

• Arthur Davidson, MD, MSPH

  Denver Health

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director, Public Health Informatics and Epidemiiology

Study Record Dates

• First Submitted: December 21, 2013
• First Posted: December 31, 2013
• Study Start: March 1, 2012
• Primary Completion: October 1, 2017
• Study Completion: October 1, 2017
• Last Updated: November 25, 2025

Record last verified: 2022-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)