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Leveraging Interactive Digital Technology to Increase Access to Family-Based Behavioral Treatment for Childhood Obesity

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
6 Years and older
Sex
All sexes
Healthy volunteers
Accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study is developing FBT 2.0, an online program to help children and families manage weight. It includes personalized lessons for families, plus training and tools for staff who guide them. It is for children ages 6 to 17 with a high body mass index (BMI) and a caregiver who also meets the BMI requirement.

The primary goal of this SBIR Direct to Phase II is to expand upon the existing training platform to create an "all-in-one" digital product, FBT 2.0, that offers an integrated suite of intervention components, including (a) dynamic, personalized, self-paced program for children and parent/caregivers; (b) e-training and ongoing support for interventionists; and (c) family engagement and monitoring tools for interventionists. Investigators will create a comprehensive, e-learning digital intervention with engaging, interactive, and personalized online tools for youth and their parents/caregivers that are integrated into the broader interventionist platform.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • The child must be 6 to 17 years old.
  • The child's BMI must be at or above the 85th percentile for their age and sex. BMI is a measure based on height and weight; this means it is as high as or higher than that of 85 out of 100 children of the same age and sex.
  • One caregiver must take part, be at least 18, and live with the child at least half the time.
  • The caregiver must have a BMI of 25 or higher.
  • The child and caregiver must be able to use English well.
  • The family must have reliable internet access and a working scale at home.

Who can't join

  • The child has a health condition that makes weight loss unsafe, such as an eating disorder.
  • The caregiver has a medical or mental health condition that makes weight loss unsafe, or is pregnant.
  • The child cannot give assent, meaning they cannot agree to take part in the study.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

Inclusion Criteria: * must be youth between the ages of 6 and 17 * must have a body mass index (BMI) percentile greater than or equal to the 85th BMI percentile for age and sex * must have one caregiver participate, who is at least 18 years of age and lives with the child at least 50% of the time. * the participating caregiver must have a body mass index (BMI) of 25 or greater * youth and caregiver must be English proficient * family must have reliable internet access and a working scale in the home Exclusion Criteria: * co-morbid disorders that contraindicate weight loss (e.g., eating disorder). * caregiver has a medical or psychiatric condition in which weight loss is contraindicated (e.g., pregnancy) * youth is unable to provide assent

Study sites (1)

NC

  • 3C Institute · Durham, NC 27713Melissa DeRosier, PhD · Study contactMelissa DeRosier, PhD · Principal investigatorMore trials in Durham