TY - JOUR
T1 - Implementing family-based behavioral treatment in the pediatric primary care setting
T2 - Design of the PLAN study
AU - Epstein, Leonard H.
AU - Schechtman, Kenneth B.
AU - Kilanowski, Colleen
AU - Ramel, Melissa
AU - Moursi, Nasreen A.
AU - Quattrin, Teresa
AU - Cook, Steven R.
AU - Eneli, Ihouma U.
AU - Pratt, Charlotte
AU - Geller, Nancy
AU - Campo, Rebecca
AU - Lew, Daphne
AU - Wilfley, Denise E.
N1 - Funding Information:
The proposed study reported is supported by the National Institute of Health under award number U01HL131552 . The funder had no role in any aspects of study design or manuscript preparation and submission.
Funding Information:
Families are randomized 1:1 to one of two groups; FBT + UC or UC and are followed for a 2-year period. The FBT + UC intervention has an inherently nested structure that is implemented within each site by newly trained interventionists called coaches, who are responsible for multiple families. Because this basic feature of the design implies clustering in one arm of the trial but not in the other, the study is an Individually Randomized Group Treatment (IRGT) trial [ 28 ], also known as a partially clustered trial. The trial is funded by the National Heart, Lung, and Blood Institute (U01HL131552) and is registered at clinicaltrials.gov ( NCT02873715 ). The study is approved by the University at Buffalo (UB) Institutional Review Board (IRB). A single IRB is used with the participating sites at the University of Rochester, Nationwide Children's Hospital in Columbus, Ohio, and Washington University in St. Louis, Missouri establishing reliance agreements with UB's IRB. Each of the four sites include a variety of primary pediatric care practices from which families are recruited. Data Coordinating Center (U01 HL131639) is located at Washington University in St. Louis.
Publisher Copyright:
© 2021 Elsevier Inc.
PY - 2021/10
Y1 - 2021/10
N2 - Family-based behavioral treatment (FBT) is an evidence-based treatment for pediatric obesity. FBT has primarily been implemented in specialty clinics, with highly trained interventionists. The goal of this study is to assess effectiveness of FBT implemented in pediatric primary care settings using newly trained interventionists who might implement FBT in pediatric practices. The goal is to randomize 528 families with a child with overweight/obesity (≥85th BMI percentile) and parent with overweight/obesity (BMI ≥ 25) across four sites (Buffalo and Rochester, New York; Columbus, Ohio; St. Louis, Missouri) to FBT or usual care and obtain assessments at 6-month intervals over 24 months of treatment. FBT is implemented using a mastery model, which provides quantity of treatment tailored to family progress and following the United States Preventive Services Task Force recommendations for effective dose and duration of treatment. The primary outcome of the trial is change in relative weight for children, and secondarily, for parents and siblings who are overweight/obese. Between group differences in the tendency to prefer small immediate rewards over larger, delayed rewards (delay discounting) and how this is related to treatment outcome is also evaluated. Challenges in translation of group-based interventions to individualized treatments in primary care settings, and in study implementation that arose due to the COVID-19 pandemic are discussed. It is hypothesized that the FBT intervention will be associated with better changes in relative weight for children, parents, and siblings than usual care. The results of this study can inform future dissemination and implementation of FBT into primary care settings.
AB - Family-based behavioral treatment (FBT) is an evidence-based treatment for pediatric obesity. FBT has primarily been implemented in specialty clinics, with highly trained interventionists. The goal of this study is to assess effectiveness of FBT implemented in pediatric primary care settings using newly trained interventionists who might implement FBT in pediatric practices. The goal is to randomize 528 families with a child with overweight/obesity (≥85th BMI percentile) and parent with overweight/obesity (BMI ≥ 25) across four sites (Buffalo and Rochester, New York; Columbus, Ohio; St. Louis, Missouri) to FBT or usual care and obtain assessments at 6-month intervals over 24 months of treatment. FBT is implemented using a mastery model, which provides quantity of treatment tailored to family progress and following the United States Preventive Services Task Force recommendations for effective dose and duration of treatment. The primary outcome of the trial is change in relative weight for children, and secondarily, for parents and siblings who are overweight/obese. Between group differences in the tendency to prefer small immediate rewards over larger, delayed rewards (delay discounting) and how this is related to treatment outcome is also evaluated. Challenges in translation of group-based interventions to individualized treatments in primary care settings, and in study implementation that arose due to the COVID-19 pandemic are discussed. It is hypothesized that the FBT intervention will be associated with better changes in relative weight for children, parents, and siblings than usual care. The results of this study can inform future dissemination and implementation of FBT into primary care settings.
KW - Behavioral intervention in primary care setting
KW - Childhood obesity
KW - Dissemination of evidence-based treatment
KW - Effectiveness trial
KW - Family-based obesity treatment
KW - Generalization of treatment to siblings
UR - http://www.scopus.com/inward/record.url?scp=85113371485&partnerID=8YFLogxK
U2 - 10.1016/j.cct.2021.106497
DO - 10.1016/j.cct.2021.106497
M3 - Article
C2 - 34389519
AN - SCOPUS:85113371485
SN - 1551-7144
VL - 109
JO - Contemporary Clinical Trials
JF - Contemporary Clinical Trials
M1 - 106497
ER -