N/A N=28 Randomized Single-blind Treatment

Increased Monitoring of Physical Activity and Calories With Technology

Weight Change, Body · Behavior, Health · Obesity, Childhood · Parent-Child Relations

Bottom Line

View on ClinicalTrials.gov: NCT03961061 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Nov 2024

Primary outcome: Primary: BMI Percentile — 98.46; 99.37 BMI percentile for age and sex

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: Brenner mFIT (standard care) (Behavioral); Brenner mFIT (standard care plus mobile health components) (Behavioral)
Age: Pediatric, Adult · 13+ yrs
Sex: All
Sponsor: Wake Forest University Health Sciences
Primary completion: Dec 2022

Outcome Measures

Outcome	Result	p-value
PRIMARY BMI Percentile	99; 99.9	—
PRIMARY BMI Percentile	99; 99.9	—
PRIMARY BMI Percentile	99; 99.9	—
SECONDARY Physical Activity Via Accelerometry (Bouts of Physical Activity)	13.5; 21.0	—
SECONDARY Physical Activity Via Accelerometry (Bouts of Physical Activity)	13.5; 21.0	—
SECONDARY Physical Activity Via Accelerometry (Bouts of Physical Activity)	13.5; 21.0	—
SECONDARY ASA24 Automated Self Administered 24 Hour Dietary Assessment Tool	1650.6	—
SECONDARY ASA24 Automated Self Administered 24 Hour Dietary Assessment Tool	1650.6	—
SECONDARY ASA24 Automated Self Administered 24 Hour Dietary Assessment Tool	1650.6	—
SECONDARY Economic Costs of the Two Intervention Arms	2616; 3482	—

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.

Eligibility Criteria

Inclusion Criteria

Youth with obesity, 13 - 18yrs, who are enrolled or eligible to enroll in Brenner Families in Training (FIT). Caregivers must live in the home with their youth participants. Obesity is defined a BMI (35.9 +/- 8.6). Participants must also have access to a smartphone or tablet

Exclusion Criteria

Adolescents under the age of 13 will be excluded. If participants do not have access to a smartphone or tablet, they will not be able to participate.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT03961061). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.