A Coordinated Parent/Child Dyad Weight Loss Intervention: Dyad Plus (Feasibility)

NCT03811743 | Completed

• 1 other identifier: IRB00055004
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

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.

Conditions

Weight Loss; Pediatric Obesity

Keywords

Youth; Parents; Overweight; Families

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.

  3 Months

• 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

Secondary Outcomes (21)

• Physical Activity Assessed by Accelerometry

  Baseline

• Physical Activity Assessed by Accelerometry

  6 months

• Physical Activity Assessed by PAQ-A

  Baseline

• Physical Activity Assessed by PAQ-A

  6 months

• Physical Activity Assessed by IPAQ

  Baseline

Study Arms (2)

Adolescents Participants

EXPERIMENTAL

Adolescents will participate in the Dyad Plus program along with their caregivers. The Dyad plus program consist of the combination of two existing programs (Brenner FIT for adolescents and By Design for the adult caregivers) with a new, novel coordination component

Behavioral: Brenner FIT; Behavioral: Coordination

Caregivers of adolescents participants

EXPERIMENTAL

Adult caregivers will participate in the Dyad Plus program along with their youth participants. The Dyad plus program consist of the combination of two existing programs (Brenner FIT for adolescents and By Design for the adult caregivers) with a new, novel coordination component

Behavioral: By Design; Behavioral: Coordination

Interventions

Brenner FIT BEHAVIORAL

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.

Adolescents Participants

By Design BEHAVIORAL

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.

Caregivers of adolescents participants

Coordination BEHAVIORAL

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. Essentials (adults), with four additional components: dyad group sessions, one-on-one parent/child communication sessions, joint goal setting/tracking, and home environment assessment

Adolescents Participants; Caregivers of adolescents participants

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:

• Over the age of 65
• BMI \< 30
• Contraindication for physical activity or caloric restriction
• Cannot read or write English

Sponsors & Collaborators

• Wake Forest University Health Sciences: lead

Study Sites (1)

Wake Forest Baptist Medical Center

Winston-Salem, North Carolina, 27157, United States

Location

Related Publications (1)

• 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.

  PMID: 20880126 BACKGROUND

MeSH Terms

Conditions

Weight Loss; Pediatric Obesity; Overweight

Condition Hierarchy (Ancestors)

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

Study Officials

• Justin Moore, PhD

  Wake Forest University Health Sciences

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: January 10, 2019
• First Posted: January 22, 2019
• Study Start: February 25, 2020
• Primary Completion: June 16, 2020
• Study Completion: June 16, 2020
• Last Updated: March 22, 2023

Record last verified: 2021-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)