Clinical trial NCT04036331: Dyad Plus Effectiveness/Feasibility
Official title: Effectiveness/Feasibility of A Coordinated Parent/Child Dyad Weight Loss Intervention:
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Weight Loss
Pediatric Obesity
Overweight Adolescents
Parent-Child Relations
Family and Household
Lead sponsor: Wake Forest University Health Sciences
Sponsor class: OTHER
Collaborators: name: National Institutes of Health (NIH)
First posted: 2019-07-29
Enrollment: 90
Sex: ALL
Minimum age (years): 13
Maximum age (years): 65
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Detailed description: Brenner FIT is a family-based pediatric weight management clinic for youth 2-18 years old referred by a physician for overweight or obesity. By Design is an adult (\>18yrs) weight loss clinic that includes tailored dietary and physical activity behavioral counseling. The preliminary data suggest that most adolescent youth who enroll in Brenner FIT have at least one adult caregiver who is eligible and would benefit from enrollment in By Design Essentials.

Participants will be randomized into 1 of 3 groups. This include Brenner FIT standard care, Brenner FIT standard care+ By Design Essentials, or Dyad Plus.

Brenner 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.

By 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).

Dyad Plus (combination of Brenner FIT and By Design Essentials):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.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

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

Primary outcomes:
measure: BMI z-score
timeFrame: Baseline
measure: BMI z-score
timeFrame: 6 months
measure: Feasibility and Acceptability of Implementation
timeFrame: Month 6
Secondary outcomes:
measure: Physical Activity Assessment Tool (PAAT)-Adult
timeFrame: Baseline
measure: Physical Activity Assessment Tool (PAAT)-Adult
timeFrame: 6 Months
measure: Physical Activity Assessed with Youth Physical Activity Questionnaire (YPAQ)
timeFrame: Baseline
measure: Physical Activity Assessed with Youth Physical Activity Questionnaire (YPAQ)
timeFrame: 6 months
measure: Physical Activity Assessed Using Fitbit (Youth)
timeFrame: Baseline
measure: Physical Activity Assessed Using Fitbit (Youth)
timeFrame: 6 Months
measure: Concentration of fasting glucose for all participants, mg/dL
timeFrame: Baseline
measure: Concentration of fasting glucose for all participants, mg/dL
timeFrame: 6 months
measure: Aspartate Aminotransferase -Levels of AST for all participants, measured in units per liter (IU/L)
timeFrame: Baseline
measure: Concentration of fasting Insulin for all participants, mg/dL
timeFrame: Baseline
measure: Concentration of fasting Insulin for all participants, mg/dL
timeFrame: 6 months
measure: Hemoglobin A1c concentration for all participants, measured in percentage
timeFrame: Baseline
measure: Hemoglobin A1c concentration for all participants, measured in percentage
timeFrame: 6 months
measure: Aspartate Aminotransferase -Levels of AST for all participants, measured in units per liter (IU/L)
timeFrame: 6 months
measure: Alanine Aminotransferase-Levels of ALT for all participants, measured in units per liter
timeFrame: Baseline
measure: Alanine Aminotransferase-Levels of ALT for all participants, measured in units per liter
timeFrame: 6 months
measure: Concentration of total cholesterol (mg/dL)
timeFrame: Baseline
measure: Concentration of total cholesterol (mg/dL)
timeFrame: 6 months
measure: Economic costs of the three intervention arms over duration of program (USD)
timeFrame: Month 6
measure: Diet for Parent and Youth
timeFrame: Baseline and 6 Months
Other outcomes:
Locations:
city: Winston-Salem
country: United States
facility: Wake Forest Baptist Medical Center
state: North Carolina
Study officials:
affiliation: Wake Forest University Health Sciences
name: Justin Moore
role: PRINCIPAL_INVESTIGATOR
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