CompletedNot Applicable

Reinforced Enhanced - Families Responsibility Education Support and Health

United States140 participantsStarted 2017-04-17

Plain-language summary

The purpose of this application is to evaluate whether a pediatric weight control program that incorporates comprehensive parenting training with behavioral therapy can increase weight loss in children compared to traditional family-based behavioral therapy programs. Since certain parenting styles are associated with greater weight loss during interventions and appear to enhance the impact of key behavioral strategies, adding parenting training to these interventions may increase the overall effectiveness of these programs and increase our ability to help children obtain a healthy weight. This project could result in identifying an improved method of pediatric obesity treatment that provides additional benefits to the growth and development of children via improved self-regulatory behaviors.

Who can participate

Age range

7 Years – 12 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. Children between the ages of 7 and 12 years old;
. BMI ≥85th percentile but \<100% overweight, so as to limit those children who are morbidly obese and are in need of more intense medical treatment;
. Children with mothers who are willing to attend 20 weekly group sessions and be randomized to either treatment arm;
. Have at least one parent who is overweight or obese (BMI≥25); and
. Parents who speak English at a 5th grade level.

Exclusion criteria

. Children with serious medical conditions that affect their weight;

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Change in BMI percentile

Timeframe: 6 months and 18 months

Trial details

NCT IDNCT02976636

SponsorUniversity of California, San Diego

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2022-11-02

View on ClinicalTrials.gov More Pediatric Obesity trials