Dyad Plus Effectiveness/Feasibility

Part of paid clinical trials in Winston-Salem, North Carolina.

Sponsor
Wake Forest University Health Sciences
Study ID
NCT04036331
Status
Recruiting
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Conditions

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

Eligibility Criteria

Sex
ALL
Age
13 Years - 65 Years
Healthy Volunteers
Not accepted

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.
  • 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).
  • 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.

Study Details

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.

Key Dates

Start date
Jul 30, 2021
Status verified
Jan 2026
Primary completion
Jul 31, 2026
Completion
Jul 31, 2026

Study Design

Enrollment
90 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: Adolescent Participants
    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.
  • Experimental: Caregivers of Adolescent Participants
    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.
  • Experimental: Co-enrollment
    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.

Primary Outcome Measure

BMI z-score [ Time Frame: Baseline ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Wake Forest Baptist Medical CenterWinston-SalemNorth Carolina27127
Justin Moore
[email protected]
336-716-3702
Camelia R Singletary
[email protected]
13369992469

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By research site
Wake Forest Baptist Medical Center· Winston-Salem, NC

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