RecruitingNot ApplicableNCT04036331

Dyad Plus Effectiveness/Feasibility

Effectiveness/Feasibility of A Coordinated Parent/Child Dyad Weight Loss Intervention:

Sponsor

Wake Forest University Health Sciences

Enrollment

90 participants

Start Date

Jul 30, 2021

Study Type

INTERVENTIONAL

Conditions

Weight Loss Pediatric Obesity Family and Household Parent-Child Relations Overweight Adolescents

Summary

The purpose of this research is to determine the effectiveness of a coordinated program (Dyad Plus) that would help to facilitate self-monitoring, positive communication, joint problem solving, and social support to increase physical activity, healthy eating, and weight loss. Participants of the Brenner FIT (Families In Training) pediatric weight management program and their parent/guardian will co-enroll in weight loss programs. Parents/guardians will receive the components of By Design Essentials.

Eligibility

Min Age: 13 YearsMax Age: 65 Years

Plain Language Summary

Simplified for easier understanding

This study, called Dyad Plus, tests a weight management program that involves both children/adolescents and a parent or caregiver who also has obesity. The idea is that family-based interventions — where both parent and child work on healthy habits together — may be more effective than child-only programs. Eligible participants are already enrolled in a weight management program (Brenner FIT or By Design Essentials). The study adds extra support for the caregiver-child 'dyad' (pair) to see if involving the family unit improves outcomes. You may be eligible if: - You (the caregiver) live with the child and have a BMI greater than 30 - You are between 13 and 65 years old - You have no medical contraindication for physical activity or caloric restriction - You are able to read and write in English You may NOT be eligible if: - Your BMI is below 30 - You have a medical reason that prevents physical activity or dietary changes - You cannot read or write in English Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

BEHAVIORALBrenner FIT Standard

After referral, families attend an orientation, in which they are then scheduled for an initial introductory 2-hour intake group session and cooking class; these occur within 2-4 weeks of the orientation. Monthly 1-hour long visits with the dietitian, counselor, and physical activity specialist are held for 6 months, in which the child and caregiver see the pediatrician. During the 6 months of treatment, they attend 4 group classes, choosing from topics such as meal planning, physical activity, and parenting. Specialized visits with the physical activity specialist or dietician are scheduled as pertinent issues arise. Clinic visits include individualized goal setting (for behaviors family/clinician have agreed to address), healthy eating and physical activity education, and behavioral counseling to implement changes at home.

BEHAVIORALBy Design Essentials

A dietitian provides each participant with a detailed program manual that describes the prescribed diet. The dietitian utilizes standard behavioral techniques to promote lifestyle behavior changes that enable participants to implement and maintain behaviors necessary to adhere to the dietary prescription. Participants also receive a standard exercise program designed to promote exercise energy expenditure of approximately 600 kilocalories\*/week. The exercise prescription includes resistance training for 2 days per week and aerobic training for 3 days per week, to meet a 600 kilocalories\*/week expenditure goal. Behaviorists meet with participants to provide individual and group-based counseling to learn the skills necessary to adopt the prescribed dietary pattern and exercise plans. Group sessions will be delivered consecutively over 6 months (20 total; 1.5 hours each).

BEHAVIORALDyad Plus

This will include all components of the standard Brenner FIT program and By Design Essentials. In addition, group sessions, one-on-one parent/child communication sessions, joint goal setting/tracking, and home environment assessment. Dyads will attend 6 meetings that will last approximately 1 hour each.