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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
University of Nebraska
About
Eligibility
Locations
Arms
Outcomes
Full info

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

8 Years - 12 Years (Child)All SexesAccepts Healthy Volunteers

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

    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
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    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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