Development and Pilot Testing of a Childhood Obesity Treatment Program

NCT ID: NCT03513510

Last Updated: 2023-12-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 101 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-01-01
• Study Completion Date: 2016-11-30

Brief Summary

The primary aims were to assess community capacity to develop, implement, and sustain a childhood obesity reduction initiative in the health-disparate Dan River Region as well as to pilot test iChoose to determine the potential reach (i.e., proportion of target population & representativeness), effectiveness (i.e., changes in child BMI z-scores over a 6 month period), feasibility (i.e., the degree to which the intervention can be adopted, implemented, and sustained as intended) and cost (i.e., resource and staffing costs) of the newly developed intervention.

Detailed Description

The Dan River Region (DRR) is a federally designated medically under-served area/population with high rates of obesity. In response to 3 comprehensive community needs assessments The Dan River Partnership for a Healthy Community (DRPHC) was established in 2010 'to foster community partnership to combat obesity in the Dan River Region through healthy lifestyle initiatives' (DRPHC mission statement). To date the DRPHC (1) tested a successful adult weight control intervention, (2) initiated youth-focus community garden and instant recess initiatives, and (3) continues to complete a comprehensive audit of the food and physical activity environment across the DRR. This RFA provided an opportunity to address an additional and complimentary area of need for the DRPHC-childhood obesity. A newly formed subcommittee and community advisory board (CAB) of the DRPHC, Partnering for Obesity Planning and Sustainability (POPS), met in preparation of this proposal and discussed the need to engage systems where high need families received services and could participate in childhood obesity treatment. The POPS-CAB came to consensus that using a systems-based approach, within the existing CBPR partnership would allow for the development of a contextually relevant intervention with the potential for long-term sustainability. Systems-based approaches include, but also move beyond, a focus on initiative effectiveness and address broader contextual issues such as initiative adoption, implementation, and maintenance across settings and delivery staff as well as reach and maintenance of effects at the individual level. The general goal of this proposal is to engage multiple systems through the DRPHC POPS-CAB and design and test prototype childhood obesity interventions. The current membership of the POPS-CAB include Danville Pittsylvania Health District, Children's Healthcare Center, Danville Parks Recreation & Tourism, and Boys & Girls Club, along with an interdisciplinary team of academic investigators. The first aim is to assess community capacity to develop, implement, and sustain a childhood obesity reduction initiative in the DRR. To accomplish this aim a concurrent mixed-method study design will be used and guided dimensions of community capacity and organizational level dimensions of the RE-AIM framework (i.e., adoption, implementation, and maintenance). The second aim is to determine the potential reach, effectiveness, feasibility and cost of the newly developed interventions. Three stages of iterative intervention testing/formative feedback loops in a public health and healthcare system will be used to achieve this aim. The partnership members will meet in an ongoing basis to discuss the qualitative & quantitative results and make adaptations to improve the strategies. Indicators of success include reduced child BMI z-scores, the engagement of multiple systems, and regional capacity to evaluate research evidence and integrate this evidence into sustainable practices. The end goal is a childhood obesity intervention that is ready for large scale testing across these systems in the DRR.

Conditions

Childhood Obesity

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

iChoose

6 biweekly family sessions, 6 biweekly telephone support calls to parents, 6 biweekly newsletters for children, and 3 supervised exercise sessions per week/3 months; delivers intervention to parents and children only

Group Type: EXPERIMENTAL

iChoose

Intervention Type: BEHAVIORAL

Interventions

iChoose

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• Parent/child dyads were eligible for participation if they resided in the Dan River Region
• English speaking
• child with a BMI percentile ranking of 85 or higher

Exclusion Criteria

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

• Minimum Eligible Age: 8 Years
• Maximum Eligible Age: 12 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Pittsylvania/Danville Health District

UNKNOWN

Sponsor Role: collaborator

National Institute on Minority Health and Health Disparities (NIMHD)

NIH

Sponsor Role: collaborator

Children's Healthcare Center

UNKNOWN

Sponsor Role: collaborator

Boys and Girls Club of Danville

UNKNOWN

Sponsor Role: collaborator

Danville Parks and Recreation

UNKNOWN

Sponsor Role: collaborator

Virginia Polytechnic Institute and State University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Paul A Estabrooks, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Nebraska

Other Identifiers

R24MD008005

Identifier Type: NIH

Identifier Source: secondary_id

View Link

VT IRB 12-977

Identifier Type: -

Identifier Source: org_study_id