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A Trial of Two Family-based Childhood Obesity Treatment Programs

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03245775
Recruitment Status : Unknown
Verified August 2017 by Jamie Zoellner, PhD RD, University of Virginia.
Recruitment status was:  Recruiting
First Posted : August 10, 2017
Last Update Posted : August 11, 2017
Sponsor:
Collaborators:
University of Nebraska
Virginia Polytechnic Institute and State University
Information provided by (Responsible Party):
Jamie Zoellner, PhD RD, University of Virginia

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.

Condition or disease Intervention/treatment Phase
Obesity, Childhood Behavioral: iChoose Behavioral: Family Connections Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 348 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : June 1, 2017
Estimated Primary Completion Date : November 30, 2019
Estimated Study Completion Date : May 29, 2020

Arm Intervention/treatment
Experimental: iChoose
12 bi-weekly sessions & 24 IVR calls/12 months, 24 physical activity sessions over 6 months; delivers intervention to parents and children only
Behavioral: iChoose
12 bi-weekly sessions & 24 IVR calls/12 months, 24 physical activity sessions over 6 months; delivers intervention to parents and children only

Experimental: Family Connections
2 in-person sessions spaced one week apart & 10 IVR calls/6 months, promotes physical activity but does not include structured exercise sessions; delivers intervention to parents only
Behavioral: Family Connections
2 in-person sessions spaced one week apart & 10 IVR calls/6 months, promotes physical activity but does not include structured exercise sessions; delivers intervention to parents only




Primary Outcome Measures :
  1. child BMI z-score [ Time Frame: 6-months ]

Secondary Outcome Measures :
  1. parent BMI [ Time Frame: 6-month ]
  2. child self-reported diet, physical activity, quality of life, health literacy [ Time Frame: 6-months ]
  3. child self-reported diet, physical activity, quality of life, health literacy, home environment [ Time Frame: 6-months ]


Information from the National Library of Medicine

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Ages Eligible for Study:   8 Years to 12 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Exclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03245775


Contacts
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Contact: Jamie M Zoellner, PhD, RD 434-962-4488 jz9q@virginia.edu
Contact: Paul A Estabrooks, PhD 402.559.4325 Paul.estabrooks@unmc.edu

Locations
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United States, Virginia
University of Virginia Recruiting
Charlottesville, Virginia, United States, 22908-0717
Contact: Jamie M Zoellner, PhD    434-962-4488    jz9q@virginia.edu   
Sponsors and Collaborators
University of Virginia
University of Nebraska
Virginia Polytechnic Institute and State University
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Jamie Zoellner, PhD RD, Associate Professor, University of Virginia
ClinicalTrials.gov Identifier: NCT03245775    
Other Study ID Numbers: 19748
First Posted: August 10, 2017    Key Record Dates
Last Update Posted: August 11, 2017
Last Verified: August 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Jamie Zoellner, PhD RD, University of Virginia:
health disparities
community-based participatory research
Additional relevant MeSH terms:
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Obesity
Pediatric Obesity
Overnutrition
Nutrition Disorders
Overweight
Body Weight