Clinical trial NCT03245775: A Trial of Two Family-based Childhood Obesity Treatment Programs
Official title: A Randomized-controlled Trial to Compare the Reach, Effectiveness and Maintenance of Two Family-based Childhood Obesity Treatment Programs in a Medically Underserved Region
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity, Childhood
Keywords: health disparities
community-based participatory research
Lead sponsor: University of Virginia
Sponsor class: OTHER
Collaborators: name: University of Nebraska
name: Virginia Polytechnic Institute and State University
First posted: 2017-08-10
Enrollment: 267
Sex: ALL
Minimum age (years): 5
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The primary aim is to determine the relative effectiveness in child BMI z-scores at 3, 6, and 12-months post baseline of iChoose+ versus Family Connections. Secondary aims are to determine (1) ongoing reach, fidelity, and implementation costs, (2) community capacity for implementation and sustainability, (3) relative impact on family eating/physical activity and parental weight, and (4) relative adherence and potential dose response relationships.

Detailed description: In partnership with the Community Advisory Board and Parent Advisory Team, with a goal to improve the magnitude of weight reductions and increase the likelihood of iChoose sustainability in the community, the investigators propose to test iChoose+ that will (1) extend iChoose to a 6-month program, followed by 12 bi-weekly maintenance telephone calls, congruent with the 12-month Bright Bodies program duration, (2) formalize a Parent Health Advisory model of previous iChoose families to serve as a 'peer support safety net' for new program participants, and (3) deliver support calls using interactive voice response (IVR) automation to reduce the burden on community stakeholder implementation. When reflecting on and interpreting the outcomes of the previous planning grant, the Community Advisory Board and Parent Advisory Team also identified the need to use a study design that allowed all participants the opportunity to benefit and, with this in mind, to test alternative family-based childhood obesity program options that improve reach within the broad Dan River Region population of minority, low-income, and geographically dispersed families. Thus, the Community Advisory Board and Parent Advisory Team returned to a potential option for delivery that was considered earlier in the planning grant process and was rated highly for scalability- Family Connections, an adaptation of Golan's Home Environmental Change model that focuses exclusively on parents as the agents of change. When compared to iChoose+ (12 bi-weekly sessions \& 24 IVR calls/12 months), Family Connections has fewer sessions and fewer IVR support calls over a shorter period of time (2 in-person sessions spaced one week apart \& 10 IVR calls/6 months), delivers intervention to parents only, and promotes physical activity, but does not include structured exercise sessions. Still, in previous studies Family Connections led to significant reductions in child weight status, though smaller in magnitude than Bright Bodies, that were sustained 6-month post intervention completion. Committed to the goal of allowing all participating families an opportunity to benefit from study participation and the need for a sustainable family-based childhood obesity option, the Community Advisory Board and Parent Advisory Team propose a comparative effectiveness trial where eligible families will be randomly assigned to: (1) iChoose+ (n=87) or to (2) Family Connections (n=87). Given the need to optimize program enrollment, participation, and retention in each program, both iChoose+ and Family Connections will include Parent Health Advisor support63-68 as refined by the Parent Advisory Team. The primary aim is to determine the relative changes in child BMI z-scores at 6 months post baseline of iChoose+ versus Family Connections, though additional assessments will occur at 3 and 12 months post baseline. Secondary aims include (1) determine ongoing reach, fidelity, and costs of implementation, (2) assess community capacity to implement and sustain childhood obesity programs, (3) determine impact on family eating and physical activity and parental weight by intervention, and (4) assess the adherence by intervention and potential dose response relationships. The primary study hypotheses are: (a) children in both conditions will reduce BMI-z scores significantly, when compared to baseline at 3, 6 and 12 months, but iChoose+ reductions will be significantly larger than Family Connections, (b) reach-the sample will be representative of the eligible regional population on demographic and behavioral factors, (c) implementation-the intervention components will be delivered with high fidelity in both conditions, but costs will be lower for Family Connections, (d) maintenance-a sustainability action plan will be completed to include strategies for continued delivery of iChoose+ and/or Family Connections (outcome dependent), (e) parent weight, parent/child behaviors, \& tertiary outcomes that follow the same patterns as BMI z-scores, and (f), community capacity for implementing and sustaining a locally relevant FBCO treatment and maintenance program will remain high over time.

Eligibility criteria: Inclusion Criteria:

* Parent/child dyads will be eligible for participation if they reside in the Dan River Region

  * English speaking
  * child with a BMI percentile ranking of 85 or higher

    * Cohort 3 age eligibility changed from 8-12 to 5-15

Exclusion Criteria:

* children with a major cognitive impairment and parents or children with a medical contraindication for moderate physical activity.

Primary outcomes:
measure: Change From Baseline in Child Body Mass Index (BMI) Z-score at 6 Months
timeFrame: Baseline and 6-months
Secondary outcomes:
measure: Change From Baseline of Parent Body Mass Index (BMI) at 6 Months
timeFrame: Baseline and 6-months
measure: Change From Baseline in the Pediatric Quality of Life Inventory for Children Score at 6 Months
timeFrame: Baseline and 6-months
measure: Change From Baseline in the Healthy Days Core Module for Parents at 6 Months
timeFrame: Baseline and 6-months
Other outcomes:
Locations:
city: Charlottesville
country: United States
facility: University of Virginia
state: Virginia
Study officials:
References:
citation: Zoellner JM, You W, Hill JL, Brock DP, Yuhas M, Alexander RC, Price B, Estabrooks PA. A comparative effectiveness trial of two family-based childhood obesity treatment programs in a medically underserved region: Rationale, design & methods. Contemp Clin Trials. 2019 Sep;84:105801. doi: 10.1016/j.cct.2019.06.015. Epub 2019 Jun 28.