CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 28 enrolled
Drug / intervention
Brenner mFIT (standard care) +1 morebehavioral
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03961061
NCT03961061N/ACompleted

Increased Monitoring of Physical Activity and Calories With Technology

Wake Forest University Health Sciences·interventional·Posted May 23, 2019·Updated Nov 8, 2024

In Brief

A clinical study evaluating Brenner mFIT (standard care) and Brenner mFIT (standard care plus mobile health components) for Weight Change, Body and 3 related conditions. Completed, enrolled 28 participants across 1 site.

Detailed Summary

Since severe obesity in youth has been steadily increasing. Specialized pediatric obesity clinics provide programs to aid in reducing obesity. Since the home environment and parental behavioral modeling are two of the strongest predictors of child weight loss during behavioral weight loss interventions, a family-based treatment approach is best. This strategy has been moderately successful in our existing, evidence-based pediatric weight management program, Brenner Families In Training (Brenner FIT). However, since programs such as Brenner Families in Training rely on face-to-face interactions and delivery, they are sometimes by the time constraints experienced by families. Therefore, the purpose of this study is to develop and pilot a tailored, mobile health component to potentially increase the benefits seen by Brenner FIT standard program components and similar pediatric weight management programs.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States

Timeline

N/ACompletedFinished
2020202120222023202420252026
First PostedMay 23, 2019
Enrollment StartNov 4, 2020
Primary CompletionDec 1, 2022
TodayJul 2, 2026
Enrollment to primary: 2.1 yearsPosted 7.1 years ago

Interventions

Brenner mFIT (standard care)behavioral

Families attend an orientation, in which they are then scheduled for an initial introductory 2-hour intake group session and cooking class; these occur within 2-4 weeks of the orientation. Monthly 1-hour long visits with the dietitian, counselor, and PA specialist are held for 6 months, in which the child and caregiver see the pediatrician. During the 6 months of treatment, they attend 4 group classes, choosing from topics such as meal planning, PA, and parenting. Specialized visits with the PA specialist or dietician are scheduled as pertinent issues arise. Motivational interviewing, modified by Brenner FIT for use with families, is the key to treatment; family counselors are trained in cognitive behavioral therapy, parenting support/mindfulness, and employ these approaches to assist families in developing healthy habits.

Brenner mFIT (standard care plus mobile health components)behavioral

Brenner mFIT includes all components of the standard Brenner FIT program in addition to six mobile health components. The six mHealth components that will be used in addition to standard Brenner Families in Training program include- 1. a mobile-enabled website, 2. diet and physical activity tracking apps and physical activity tracker 3. tailored self-monitoring feedback 4. caregiver podcasts 5. animated videos for adolescent patients 6. social support via social media.