Clinical Trial Details
— Status: Active, not recruiting
Administrative data
| NCT number |
NCT02024360 |
| Other study ID # |
AHRQ 1P01HS021138-01-03 |
| Secondary ID |
|
| Status |
Active, not recruiting |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
March 2012 |
| Est. completion date |
October 2023 |
Study information
| Verified date |
April 2022 |
| Source |
Denver Health and Hospital Authority |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial 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.
Description:
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?
