Packaging Building Healthy Families for Community Implementation

NCT04719442 | Withdrawn

• 2 other identifiers: 121919-11U18DP006431
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

There is a large body of literature regarding efficacious intervention strategies for treating childhood obesity. Unfortunately, the degree to which efficacious programs have been packaged for translation in micropolitan and surrounding rural areas is unclear-an important issue when considering the prevalence of obesity is higher in rural areas when compared to urban areas. Epstein's Traffic Light Diet (TLD) is likely the most studied pediatric weight management intervention (PWMI) and has demonstrated efficacy across a wide range of randomized controlled trials in children 6-12 years of age. Building Healthy Families (BHF) is an adaptation of the TLD and has been implemented in a micropolitan city and achieved clinically and statistically significant reductions in child BMI z-score (-0.27±0.22)-a similar magnitude of effect relative to previous efficacy trials. The investigators have created online resources for organizations interested in delivering PWMIs, training modules for related interventions, and participant-facing program materials that could be combined into a 'turn-key' approach for communities interested in reducing childhood obesity to adopt, adapt and sustain it in other micropolitan/rural communities. The primary aim is to collaboratively refine and develop an intervention package for the BHF that includes materials necessary for others to implement the intervention in new metropolitan/rural locations. The second aim is to perform a rigorous, mixed-methods pilot implementation study using an innovative community application process to identify 4 to 8 new communities to pilot test the utility of the packaged PWMI and training materials while determining factors that predict adoption, implementation and sustainability. The investigators will also use a learning collaborative implementation strategy to improve implementation fidelity and local context and facilitation capacity in communities interested in delivering BHF. The third aim is to use the pilot evaluation data and results of the sustainability action plan to refine program and training materials and develop a dissemination plan to move the program to other communities. The approach will use an implementation research explanatory process and outcome model to test hypotheses related to implementation and sustainability, engaging community/ clinical partners in the implementation and sustainability process, and evaluate outcomes at both the individual and organizational level.

Conditions

Pediatric Obesity

Keywords

Obesity; Type III Hybrid Effectiveness Implementation; Rural

Outcome Measures

Primary Outcomes (1)

• Program Implementation

  % of objectives met during intervention sessions

  up to 12 weeks

Secondary Outcomes (7)

• Body Mass Index percentile ranking

  Calculated four times, baseline, 3-months, 6-months and 12 months

• Reach

  measured once at enrollment

• Height in Meters

  Measured once at baseline

• Weight in Kilograms

  Measured 4 times; baseline, 3 months, 6-months and 12 months.

• Body Mass Index

  Calculated 4 times; baseline, 3-months, 6-months and 12 months

Other Outcomes (1)

• Cost

  up to 24 months

Study Arms (2)

BHF-LC

EXPERIMENTAL

To test an innovative implementation strategy, four communities will be assigned to pilot test the packaged PWMI and training materials when coupled with a learning collaborative facilitation strategy and sustainability action planning process to support PWMI adoption, implementation, and sustainability (BHF-LC).

Behavioral: Building Healthy Families

BHF-Program Only

ACTIVE COMPARATOR

Four other communities will be assigned to receive the packaged PWMI and training program only.

Behavioral: Building Healthy Families

Interventions

Building Healthy Families BEHAVIORAL

Building Healthy Families (BHF) is a family based obesity treatment program which includes key behavior change strategies including goal setting for both behavior change and weight loss, self-monitoring, rewards/contingency management, role modeling, and stimulus control/ modifying the environment. BHF includes a minimum of 32 contact hours consisting of three main program components: nutrition education, behavior modification, and physical activity. Participants and parents are expected to attend 12 continuous weeks of education (2 hours/session) followed by 12 weeks of relapse prevention refresher courses. Relapse prevention refresher sessions are every three weeks for one hour to re-evaluate goals, discuss rewards/contingency management and changes in stimulus control with seasonal changes and holidays. A final follow-up check-in session is conducted at 12 months for approximately 1 hour.

Also known as: Building Healthy Families-Program Only

BHF-LC; BHF-Program Only

Eligibility Criteria

• Age: 6 Years - 12 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Child 6 to 12 years of age
• Child with BMI percentile at or above the 95th percentile

You may not qualify if:

• Child with major cognitive or physical impairments
• Child or parents/guardians with a contraindication for physical activity
• Families participating in a concurrent pediatric weight management intervention

Sponsors & Collaborators

• University of Nebraska: lead
• Centers for Disease Control and Prevention: collaborator

Related Publications (2)

• Michaud TL, Hill JL, Heelan KA, Bartee RT, Abbey BM, Malmkar A, Masker J, Golden C, Porter G, Glasgow RE, Estabrooks PA. Understanding implementation costs of a pediatric weight management intervention: an economic evaluation protocol. Implement Sci Commun. 2022 Apr 5;3(1):37. doi: 10.1186/s43058-022-00287-1.

  PMID: 35382891 DERIVED

• Hill JL, Heelan KA, Bartee RT, Wichman C, Michaud T, Abbey BM, Porter G, Golden C, Estabrooks PA. A Type III Hybrid Effectiveness-Implementation Pilot Trial Testing Dissemination and Implementation Strategies for a Pediatric Weight Management Intervention: The Nebraska Childhood Obesity Research Demonstration Project. Child Obes. 2021 Sep;17(S1):S70-S78. doi: 10.1089/chi.2021.0170.

  PMID: 34569848 DERIVED

MeSH Terms

Conditions

Pediatric Obesity; Obesity

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Jennie Hill, PhD

  University of Nebraska

  PRINCIPAL INVESTIGATOR

• Kate Heelan, PhD

  University of Nebraska at Kearney

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 2, 2020
• First Posted: January 22, 2021
• Study Start: June 1, 2021
• Primary Completion: June 1, 2021
• Study Completion: June 1, 2021
• Last Updated: September 3, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, ANALYTIC CODE
• Time Frame: Data will be available Jan 1, 2026 upon request.
• Access Criteria: proposals should be sent to bhf@nebraska.edu. To gain access, data requestors will need to sign a data access agreement.