Accepted for/Published in: JMIR Research Protocols
Date Submitted: Feb 3, 2020
Date Accepted: Feb 29, 2020
Date Submitted to PubMed: Apr 29, 2020
Design of a clinical trial to increase self-monitoring of physical activity and eating behaviors among adolescents: The ImPACT Feasibility Study
ABSTRACT
Background:
Severe obesity in youth (BMI for age ≥120th percentile) has been steadily increasing. The home environment and parental behavioral modeling are two of the strongest predictors of child weight loss during weight loss interventions, which highlights that a family-based treatment approach is warranted. This strategy has been successful in our existing, evidence-based pediatric weight management program [Brenner Families in Trailing (Brenner FIT®)], but this program relies on face-to-face encounters, which are limited by the time constraints of the families enrolled in treatment.
Objective:
Therefore, the purpose of this study is to refine and pilot a tailored suite of mobile (mHealth) components to augment an existing, evidence-based pediatric weight management program
Methods:
Study outcomes will include acceptability from a patient and clinical staff perspective, feasibility, and economic costs relative to the established weight management protocol alone [i.e., Brenner FIT vs. Brenner FIT + mHealth (Brenner mFIT)]. The Brenner mFIT intervention will consist of six mHealth components designed to increase patient/caregiver exposure to Brenner FIT programmatic content: 1) a mobile-enabled website, 2) dietary and physical activity tracking, 3) caregiver podcasts (n=12), 4) animated videos (n=6) for adolescent patients, 5) interactive messaging, and 6) in-person tailored clinical feedback facilitated by an online dashboard. For the study, 80 youth with obesity (13 – 18yrs) and a caregiver (dyads) will be randomized to Brenner FIT or Brenner mFIT. All participants will complete baseline measures prior to randomization, and at three and six months.
Results:
The results of the study are expected in fall of 2021.
Conclusions:
Results of the present study will be used to inform a large-scale implementation-effectiveness clinical trial. Clinical Trial: This study is registered in ClinicalTrials.gov as NCT03961061.
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