Community Outreach - Obesity Prevention Trial (CO-OPT) (CO-OPT)

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?