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Trial record 1 of 1 for:    nct02024360
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Community Outreach - Obesity Prevention Trial (CO-OPT) (CO-OPT)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02024360
Recruitment Status : Active, not recruiting
First Posted : December 31, 2013
Last Update Posted : February 17, 2020
University of Colorado, Denver
Information provided by (Responsible Party):
Arthur Davidson, Denver Health and Hospital Authority

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.

Condition or disease Intervention/treatment Phase
Obesity Overweight Children Behavioral: Patient navigation Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 300 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Center for Research in Implementation Science and Prevention (CRISP) - Community Outreach - Obesity Prevention Trial (CO-OPT)
Study Start Date : March 2012
Estimated Primary Completion Date : October 2020
Estimated Study Completion Date : October 2020

Arm Intervention/treatment
Experimental: patient navigation
Patient navigator visits home to encourage health eating, active living and parental skill building
Behavioral: Patient navigation
16 session (25 hour) home-based intervention with patient navigators encouraging families to adopt healthy eating, active living and parental skill building

Primary Outcome Measures :
  1. Change in BMI z-score [ Time Frame: Baseline, post intervention, 6 months post intervention ]
    BMI z-score will be calculated for each child at the indicated times

Information from the National Library of Medicine

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Ages Eligible for Study:   2 Years to 6 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  • 2-6 years old with a BMI above the 85 %ile

Exclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02024360

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United States, Colorado
Denver Health
Denver, Colorado, United States, 80204
Sponsors and Collaborators
Denver Health and Hospital Authority
University of Colorado, Denver
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Principal Investigator: Arthur Davidson, MD, MSPH Denver Health

Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Arthur Davidson, Director, Public Health Informatics and Epidemiiology, Denver Health and Hospital Authority Identifier: NCT02024360    
Other Study ID Numbers: AHRQ 1P01HS021138-01-03
First Posted: December 31, 2013    Key Record Dates
Last Update Posted: February 17, 2020
Last Verified: February 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Arthur Davidson, Denver Health and Hospital Authority:
Additional relevant MeSH terms:
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Nutrition Disorders
Body Weight
Signs and Symptoms