Increased Monitoring of Physical Activity and Calories With Technology (IMPACT)

Wake Forest University (WFU)

Status: Completed

Conditions: Obesity, Childhood; Parent-Child Relations; Behavior, Health; Weight Change, Body

Treatments: Behavioral: Brenner mFIT (standard care); Behavioral: Brenner mFIT (standard care plus mobile health components)

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT03961061

R34DK119815 (U.S. NIH Grant/Contract)

IRB00058207

Details and patient eligibility

About

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.

Full description

For this project, we will randomize 80 youth with obesity (13 - 18yrs) and a caregiver (dyads) to the Brenner Families in Training (FIT) group or the Brenner Families in Training Mobile (mFIT) group. All youth participants will receive a commercially available activity monitor. Caregivers will receive podcasts with a story about a caregiver supporting weight loss in a child by providing healthy foods/activities for his/her family, including healthy eating and physical activity information. Children will receive animated videos that contain healthy eating and physical activity messaging, with an engaging story of a child losing weight. All participants will have access to a website and mobile apps where they will track weight, diet, and physical activity for themselves (youth) or their child (parents). Based on their reports of weight, eating, and physical activity, the messaging received from clinical staff by the families will be individually tailored to promote healthy behaviors and overcome perceived barriers. The proposed research is innovative in that it explicitly incorporates theory into the intervention and evaluation components of the project and builds upon an existing literature on mobile health interventions that use mobile technology.

Enrollment: 28 patients

Sex: All

Ages: 13 to 18 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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28 participants in 2 patient groups

Brenner FIT (Standard Care)

Active Comparator group

Description:

Adolescents will participate in Brenner Families in Training along with their caregiver. They will receive all components of standard Brenner FIT treatments.

Treatment:

Behavioral: Brenner mFIT (standard care)

Brenner mFIT (standard care plus mobile health components)

Experimental group

Description:

Adolescents will participate in Brenner Families in Training along with their caregiver. Brenner mFIT (Families in Training + mobile health) includes all components of the standard Brenner FIT

Treatment:

Behavioral: Brenner mFIT (standard care plus mobile health components)