Clinical trial NCT03811743: A Coordinated Parent/Child Dyad Weight Loss Intervention: Dyad Plus (Feasibility)
Official title: A Coordinated Parent/Child Dyad Weight Loss Intervention: Dyad Plus (Feasibility)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Weight Loss
Pediatric Obesity
Keywords: Youth
Parents
Overweight
Families
Lead sponsor: Wake Forest University Health Sciences
Sponsor class: OTHER
First posted: 2019-01-22
Enrollment: 16
Sex: ALL
Minimum age (years): 13
Maximum age (years): 65
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this research is to develop 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: Participation in this study will involve participation in six, one-hour sessions in addition to those required by your weight loss program. These sessions will work to facilitate an increase in 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. Joint goal setting and tracking will be enabled by commercially available devices and apps. Each caregiver and child will receive an activity monitor, activity app, and a food app (digital food diary) that allows self-monitoring of consumption and "social accountability," which will allow caregivers and the Brenner FIT team to monitor and encourage. Furthermore, two home visits will be conducted to evaluation the home food and activity environments to inform tailored feedback to families.

Brenner FIT is a family-based pediatric weight management clinic for youth 2-18 years old referred by a physician for overweight or obesity.11-14 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.

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:

* Over the age of 65
* 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: 3 Months
measure: BMI z-score
timeFrame: 6 months
Secondary outcomes:
measure: Physical Activity Assessed by Accelerometry
timeFrame: Baseline
measure: Physical Activity Assessed by Accelerometry
timeFrame: 6 months
measure: Physical Activity Assessed by PAQ-A
timeFrame: Baseline
measure: Physical Activity Assessed by PAQ-A
timeFrame: 6 months
measure: Physical Activity Assessed by IPAQ
timeFrame: Baseline
measure: Physical Activity Assessed by IPAQ
timeFrame: 6 months
measure: Caloric intake expressed in kcals
timeFrame: Baseline
measure: Caloric intake expressed in kcals
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: 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: Baseline
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: Baseline through 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, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Skelton JA, Beech BM. Attrition in paediatric weight management: a review of the literature and new directions. Obes Rev. 2011 May;12(5):e273-81. doi: 10.1111/j.1467-789X.2010.00803.x. Epub 2010 Sep 29.