Community Outreach - Obesity Prevention Trial (CO-OPT)
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 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.
Primary Aim:

 Design, conduct and evaluate a pilot community health worker (CHW) feasibility study in
 families with at least one overweight/obese child, targeting change in primary obesity
 outcomes (i.e., zBMI and health behaviors using the "5-2-1-0" targets).

 1. To determine the effect of a community health worker mediated childhood obesity
 prevention program with families on BMI in overweight and obese (O/O) children aged 2-6
 years The study sample size is selected for power to evaluate specific aim 1.a.

 1. Hypothesis: Compared to children receiving delayed-intervention, a higher
 proportion of O/O children in the intervention group will experience a >0.1 zBMI
 decrease in zBMI by -age/gender over the same 12 month period.

 2. Hypothesis: Within individual subjects, compared to their own zBMI measurements
 12-24 months prior, O/O children on average will experience a decrease in the slope
 of their BMI trajectory of >0.1 zBMI per year after starting the intervention.

 2. To determine the effect of the intervention on physical activity and eating behaviors of
 the index patient and their family members as summarized in "5-2-1-0" daily targets
 (i.e., 5 fruits and vegetables, less than 2 hours screen time, 1 hour of exercise and 0
 sweetened drinks).

 a. Hypothesis: Compared to baseline measures in children receiving delayed-intervention,
 a higher proportion of O/O children in the intervention group will experience an
 improvement in "5-2-1-0" measures over the same 12 month period.

 3. To determine the effect of the intervention in change in parenting skills and to
 evaluate the effects of the intervention on weight-related quality of life measures in
 the parents of O/O children 2-6 years.

 1. Hypothesis: Compared to baseline measurements, scores on a validated parenting
 style questionnaire will be higher at the end and 6 months after the intervention.

 Secondary Aims:

 1. Design and implement obesity registry functionality within an integrated safety-net
 healthcare system to measure primary obesity outcomes in a low-income population.

 a. What was the experience of the clinicians and administrators who used the registry
 program? Was it feasible and acceptable in its implementation and operations? What are
 areas for improvement or barriers to effective use?

 2. Design, deploy and evaluate technologies (e.g., text messaging and patient relationship
 manager [PRM]) as an aid to CHW working with an obese child and his/her family.

 1. What was the experience of the families and patients who used the text messaging
 and patient relationship manager program? Was it feasible and acceptable in its
 implementation and operations? What are areas for improvement or barriers to
 effective use?

 2. What was the experience of the CHW in using the text messaging and patient
 relationship manager program? Was it feasible and acceptable in its implementation
 and operations? What are areas for improvement or barriers to effective use?

 3. What was the experience of the providers and clinicians who received and used
 summaries of the text messaging and patient relationship manager program? Was it
 feasible and acceptable in its implementation and operations? What are areas for
 improvement or barriers to effective use?

 4. What was the experience of the CHW in using the hand-held device for recording
 information in the field? Was it feasible and acceptable in its implementation and
 operations? What are areas for improvement or barriers to effective use?

 3. Design, deliver and evaluate targeted training for clients, providers and CHW to enhance
 obesity clinical prevention strategies, including motivational interviewing.

 1. What was the experience of the clients, providers and CHW who were trained in
 obesity clinical prevention strategies? Was it feasible and acceptable in its
 implementation and operations? What are areas for improvement or barriers to
 effective use?
Inclusion Criteria:

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

 Exclusion Criteria:

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