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Rationale and design of "Hearts & Parks": study protocol for a pragmatic randomized clinical trial of an integrated clinic-community intervention to treat pediatric obesity.

ABSTRACT: BACKGROUND:The prevalence of child and adolescent obesity and severe obesity continues to increase despite decades of policy and research aimed at prevention. Obesity strongly predicts cardiovascular and metabolic disease risk; both begin in childhood. Children who receive intensive behavioral interventions can reduce body mass index (BMI) and reverse disease risk. However, delivering these interventions with fidelity at scale remains a challenge. Clinic-community partnerships offer a promising strategy to provide high-quality clinical care and deliver behavioral treatment in local park and recreation settings. The Hearts & Parks study has three broad objectives: (1) evaluate the effectiveness of the clinic-community model for the treatment of child obesity, (2) define microbiome and metabolomic signatures of obesity and response to lifestyle change, and (3) inform the implementation of similar models in clinical systems. METHODS:Methods are designed for a pragmatic randomized, controlled clinical trial (n?=?270) to test the effectiveness of an integrated clinic-community child obesity intervention as compared with usual care. We are powered to detect a difference in body mass index (BMI) between groups at 6?months, with follow up to 12?months. Secondary outcomes include changes in biomarkers for cardiovascular disease, psychosocial risk, and quality of life. Through collection of biospecimens (serum and stool), additional exploratory outcomes include microbiome and metabolomics biomarkers of response to lifestyle modification. DISCUSSION:We present the study design, enrollment strategy, and intervention details for a randomized clinical trial to measure the effectiveness of a clinic-community child obesity treatment intervention. This study will inform a critical area in child obesity and cardiovascular risk research-defining outcomes, implementation feasibility, and identifying potential molecular mechanisms of treatment response. CLINICAL TRIAL REGISTRATION:NCT03339440 .

SUBMITTER: Armstrong SC

PROVIDER: S-EPMC7318397 | biostudies-literature | 2020 Jun

REPOSITORIES: biostudies-literature

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Rationale and design of "Hearts & Parks": study protocol for a pragmatic randomized clinical trial of an integrated clinic-community intervention to treat pediatric obesity.

Armstrong Sarah C SC Windom McAllister M Bihlmeyer Nathan A NA Li Jennifer S JS Shah Svati H SH Story Mary M Zucker Nancy N Kraus William E WE Pagidipati Neha N Peterson Eric E Wong Charlene C Wiedemeier Manuela M Sibley Lauren L Berchuck Samuel I SI Merrill Peter P Zizzi Alexandra A Sarria Charles C Dressman Holly K HK Rawls John F JF Skinner Asheley C AC

BMC pediatrics 20200626 1

<h4>Background</h4>The prevalence of child and adolescent obesity and severe obesity continues to increase despite decades of policy and research aimed at prevention. Obesity strongly predicts cardiovascular and metabolic disease risk; both begin in childhood. Children who receive intensive behavioral interventions can reduce body mass index (BMI) and reverse disease risk. However, delivering these interventions with fidelity at scale remains a challenge. Clinic-community partnerships offer a pr ...[more]

PMID: 32590958

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Project description:PurposeFew evidence-based strategies are specifically tailored for disparity populations such as rural adults. Two-way video-conferencing using telemedicine can potentially surmount geographic barriers that impede participation in high-intensity treatment programs offering frequent visits to clinic facilities. We aimed to understand barriers and facilitators of implementing a telemedicine-delivered tertiary-care, rural academic weight-loss program for the management of obesity.MethodsA single-arm study of a 16-week, weight-loss pilot evaluated barriers and facilitators to program participation and exploratory measures of program adoption and staff confidence in implementation and intervention delivery. A program was delivered using video-conferencing within an existing clinical infrastructure. Elements of Consolidated Framework for Implementation Research (CFIR) provided a basis for assessing intervention characteristics, inner and outer settings, and individual characteristics using surveys and semi-structured interviews. We evaluated elements of the RE-AIM model (reach, adoption) to assess staff barriers to success for future scalability.FindingsThere were 27 patients and 8 staff completing measures. Using CFIR, the intervention was valuable from a patient participant standpoint; staff equally had positive feelings about using telemedicine as useful for patient care. The RE-AIM framework demonstrated limited reach but willingness to adopt was above average. A significant barrier limiting sustainability was physical space for intervention delivery and privacy and dedicated resources for staff. Scheduling stressors were also a challenge in its implementation.ConclusionsThe need to engage staff, enhance organizational culture, and increase reach are major factors for rural health obesity clinics to enhance sustainability of using telemedicine for the management of obesity.Trial registrationClinicaltrials.gov NCT03309787. Registered on 16 October 2017.

Dataset Information

Rationale and design of "Hearts & Parks": study protocol for a pragmatic randomized clinical trial of an integrated clinic-community intervention to treat pediatric obesity.

Publications

Rationale and design of "Hearts & Parks": study protocol for a pragmatic randomized clinical trial of an integrated clinic-community intervention to treat pediatric obesity.

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