Actively Recruiting

Phase Not Applicable
Age: 13Years - 65Years
All Genders
ID04036331

Effectiveness and Feasibility of a Coordinated Parent/Child Dyad Weight Loss Intervention with Brenner FIT and By Design Essentials Programs

Led by Wake Forest University Health Sciences · Updated on 2026-04-28

90

Participants Needed

1

Research Sites

N/A

Total Duration

On this page

Sponsors

W

Wake Forest University Health Sciences

Lead Sponsor

N

National Institutes of Health (NIH)

Collaborating Sponsor

AI-Summary

What this Trial Is About

Researchers are evaluating the effectiveness of a coordinated program called Dyad Plus designed to help families engage in self-monitoring, positive communication, joint problem solving, and social support to increase physical activity, healthy eating, and weight loss. The study involves participants from the Brenner FIT pediatric weight management program who are youth aged 2 to 18 years old referred for overweight or obesity, along with their parent or guardian. The goal is to improve weight loss outcomes by involving both adolescents and their caregivers in related weight loss programs. Participants are randomly assigned to one of three groups: Brenner FIT standard care, Brenner FIT plus By Design Essentials for caregivers, or Dyad Plus which combines both programs with added strategies like group sessions, one-on-one communication, joint goal setting, tracking, and home environment assessments. Brenner FIT includes orientation, monthly visits with a pediatrician and specialists, group classes, and behavioral counseling over 6 months. By Design Essentials provides tailored diet and exercise plans with behavioral counseling for adults, delivered in 20 group sessions over 6 months. Dyad Plus adds extra parent-child interaction and support sessions. During the study, youth and caregivers attend various sessions, classes, and counseling appointments to support lifestyle changes. Researchers will assess body mass index (BMI) z-scores at baseline and after 6 months, along with physical activity levels, dietary habits, fasting glucose, insulin, liver enzymes, cholesterol, and economic costs. Feasibility and acceptability of the programs will be evaluated at 6 months. The study lasts 6 months with multiple assessments to monitor progress and outcomes related to weight management and healthy behaviors.

CONDITIONS

Brief Title

Dyad Plus Effectiveness/Feasibility

Who Can Participate

Age: 13Years - 65Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Eligible for enrollment in Brenner FIT and/or By Design Essentials
  • Caregiver who lives in the house with a BMI > 30
  • No contraindication for physical activity or caloric restriction
  • Must be able to read and write English
Not Eligible

You will not qualify if you...

  • BMI < 30
  • Contraindication for physical activity or caloric restriction
  • Cannot read or write English

AI-Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Treatment

Duration - 6 months

Participants receive one of three weight loss interventions including Brenner FIT standard care, By Design Essentials, or the combined Dyad Plus program, which involves dietary, physical activity, behavioral counseling, and group sessions.

Monthly visits for 6 months plus multiple group sessions depending on the assigned intervention

Trial Site Locations

Total: 1 location

1

Wake Forest Baptist Medical Center

Winston-Salem, North Carolina, United States, 27127

Actively Recruiting

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Research Team

C

Camelia R Singletary, MPH

J

Justin Moore, PhD

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

3

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Published Research Related To This Trial

Trends in Obesity Prevalence Among Children and Adolescents in the United States, 1988-1994 Through 2013-2014.

Cynthia L Ogden, Margaret D Carroll, Hannah G Lawman...

https://pubmed.ncbi.nlm.nih.gov/27272581

Clinical review: behavioral interventions to prevent childhood obesity: a systematic review and metaanalyses of randomized trials.

Celia C Kamath, Kristin S Vickers, Angela Ehrlich...

https://pubmed.ncbi.nlm.nih.gov/18782880

Expert committee recommendations regarding the prevention, assessment, and treatment of child and adolescent overweight and obesity: summary report.

Sarah E Barlow, Expert Committee

https://pubmed.ncbi.nlm.nih.gov/18055651