Dyad Plus Effectiveness/Feasibility

NCT04036331 | Recruiting DMC

• 2 other identifiers: IRB0005956940010565
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

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

Outcome Measures

Primary Outcomes (3)

• BMI z-score

  Weight status of caregivers and youth will be quantified through calculation of BMI derived from measurement of height and weight at the intake and follow-up visits. Both height (plus or minus 0.1 cm) and weight (plus or minus 0.5 kg) will be recorded twice and values will be averaged to produce the final value using a Tanita (registered trademark) digital scale and a Seca (registered trademark) Height Rod (respectively). BMI will be calculated as kg /m2. BMI z-score will be calculated using CDC growth charts.

  Baseline

• BMI z-score

  Weight status of caregivers and youth will be quantified through calculation of BMI derived from measurement of height and weight at the intake and follow-up visits. Both height (plus or minus 0.1 cm) and weight (plus or minus 0.5 kg) will be recorded twice and values will be averaged to produce the final value using a Tanita (registered trademark) digital scale and a Seca (registered trademark) Height Rod (respectively). BMI will be calculated as kg /m2. BMI z-score will be calculated using CDC growth charts.

  6 months

• Feasibility and Acceptability of Implementation

  We will examine screening, recruitment, retention, adherence, and overall perception of Brenner FIT and By Design components

  Month 6

Secondary Outcomes (20)

• Physical Activity Assessment Tool (PAAT)-Adult

  Baseline

• Physical Activity Assessment Tool (PAAT)-Adult

  6 Months

• Physical Activity Assessed with Youth Physical Activity Questionnaire (YPAQ)

  Baseline

• Physical Activity Assessed with Youth Physical Activity Questionnaire (YPAQ)

  6 months

• Physical Activity Assessed Using Fitbit (Youth)

  Baseline

Study Arms (3)

Adolescent Participants

ACTIVE COMPARATOR

Brenner FIT pediatric weight management program enrollment. an interdisciplinary, family-based pediatric weight management clinic based upon the Familial Approach to Treatment of Childhood Obesity. Patients are referred by a physician for obesity or overweight with a weight-related comorbidity. Treatment teams are comprised of a pediatrician, counselor, dietitian, and physical activity specialist, with others (e.g., social workers, physical therapists) as needed. The entire family is encouraged to attend all aspects of the treatment program, although only one attending caregiver is required.

Behavioral: Brenner FIT Standard

Caregivers of Adolescent Participants

EXPERIMENTAL

Weight loss program for adults/caregivers of those enrolled in Brenner FIT. Participants in the By Design condition (adult caregivers) will be prescribed the Essentials lifestyle intervention which includes tailored dietary and physical activity goals designed to achieve 1-2 lbs./week of weight loss, provided by a multidisciplinary team of medical providers, dietitians, behaviorists, and exercise specialists. A daily calorie restriction of 500 kcal/day is prescribed based on estimates of total energy expenditure (TEE) obtained from a measured resting metabolic rate (RMR) prior to enrollment.

Behavioral: By Design Essentials

Co-enrollment

EXPERIMENTAL

This condition is for dyads that are co-enrolled in This component adds four additional strategies: dyad group sessions, one-on-one parent/child communication sessions, joint goal setting/tracking, and home environment assessment. This innovative approach will seek to employ components of motivation and communication theories to increase self-monitoring, positive communication, problem solving, and social support to increase healthy physical activity and eating behaviors to increase the effectiveness of the weight loss programs beyond gains observed in matched controls.

Behavioral: Dyad Plus

Interventions

Brenner FIT Standard BEHAVIORAL

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.

Adolescent Participants

By Design Essentials BEHAVIORAL

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).

Caregivers of Adolescent Participants

Dyad Plus BEHAVIORAL

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.

Co-enrollment

Eligibility Criteria

• Age: 13 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Wake Forest University Health Sciences: lead
• National Institutes of Health (NIH): collaborator

Study Sites (1)

Wake Forest Baptist Medical Center

Winston-Salem, North Carolina, 27127, United States

RECRUITING

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MeSH Terms

Conditions

Weight Loss; Pediatric Obesity

Condition Hierarchy (Ancestors)

Body Weight Changes; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Obesity; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases

Study Officials

• Justin Moore

  Wake Forest University Health Sciences

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Camelia R Singletary, MPH

CONTACT

13369992469; camelia.singletary@advocatehealth.org

Justin Moore, PhD

CONTACT

336-716-3702; justin.b.moore@wfusm.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 25, 2019
• First Posted: July 29, 2019
• Study Start: July 30, 2021
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): July 1, 2026
• Last Updated: April 28, 2026

Record last verified: 2026-01

Locations

US (1)