Development and Pilot Testing of a Childhood Obesity Treatment Program
Primary Purpose
Childhood Obesity
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
iChoose
Sponsored by
About this trial
This is an interventional treatment trial for Childhood Obesity focused on measuring evidence-based programs, community-based participatory research, program adoption
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
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
iChoose
Arm Description
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
Outcomes
Primary Outcome Measures
Community capacity to identify, adapt, and implement a childhood obesity program.
qualitative interviews
Secondary Outcome Measures
child BMI z-score
This is a age and gender normed standardization of child weight status.
reach
the proportion of eligible families that enroll in the trial and their representativeness to the larger population of eligible families.
cost
cost of intervention delivery.
Full Information
NCT ID
NCT03513510
First Posted
April 19, 2018
Last Updated
February 28, 2019
Sponsor
University of Nebraska
Collaborators
Virginia Polytechnic Institute and State University, Pittsylvania/Danville Health District, National Institute on Minority Health and Health Disparities (NIMHD), Children's Healthcare Center, Boys and Girls Club of Danville, Danville Parks and Recreation
1. Study Identification
Unique Protocol Identification Number
NCT03513510
Brief Title
Development and Pilot Testing of a Childhood Obesity Treatment Program
Official Title
Participatory Development and Pilot Testing of iChoose: An Adaptation of an Evidence-Based Pediatric Weight Management Program for Community Implementation
Study Type
Interventional
2. Study Status
Record Verification Date
February 2019
Overall Recruitment Status
Completed
Study Start Date
January 1, 2013 (Actual)
Primary Completion Date
June 27, 2015 (Actual)
Study Completion Date
November 30, 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Nebraska
Collaborators
Virginia Polytechnic Institute and State University, Pittsylvania/Danville Health District, National Institute on Minority Health and Health Disparities (NIMHD), Children's Healthcare Center, Boys and Girls Club of Danville, Danville Parks and Recreation
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Childhood Obesity
Keywords
evidence-based programs, community-based participatory research, program adoption
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
101 (Actual)
8. Arms, Groups, and Interventions
Arm Title
iChoose
Arm Type
Experimental
Arm Description
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
Intervention Type
Behavioral
Intervention Name(s)
iChoose
Primary Outcome Measure Information:
Title
Community capacity to identify, adapt, and implement a childhood obesity program.
Description
qualitative interviews
Time Frame
2 years
Secondary Outcome Measure Information:
Title
child BMI z-score
Description
This is a age and gender normed standardization of child weight status.
Time Frame
6-months
Title
reach
Description
the proportion of eligible families that enroll in the trial and their representativeness to the larger population of eligible families.
Time Frame
6-months
Title
cost
Description
cost of intervention delivery.
Time Frame
6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
8 Years
Maximum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Paul A Estabrooks, PhD
Organizational Affiliation
University of Nebraska
Official's Role
Principal Investigator
12. IPD Sharing Statement
Plan to Share IPD
Undecided
IPD Sharing Plan Description
There is no current plan. Though we will comply with requests consistent with NIH data sharing policies.
Learn more about this trial
Development and Pilot Testing of a Childhood Obesity Treatment Program
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