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

Primary Purpose

Weight Loss, Pediatric Obesity

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Brenner FIT
By Design
Coordination
Sponsored by
Wake Forest University Health Sciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Weight Loss focused on measuring Youth, Parents, Overweight, Families

Eligibility Criteria

13 Years - 65 Years (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Wake Forest Baptist Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Adolescents Participants

Caregivers of adolescents participants

Arm Description

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

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

Outcomes

Primary Outcome Measures

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.
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.
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.

Secondary Outcome Measures

Physical Activity Assessed by Accelerometry
Physical activity data will be collected using ActiGraph (trademark) accelerometers worn continuously over 7 days except during bathing and sleeping. Moderate to vigorous activity will be measured in minutes.
Physical Activity Assessed by Accelerometry
Physical activity data will be collected using ActiGraph (trademark) accelerometers worn continuously over 7 days except during bathing and sleeping. Moderate to vigorous activity will be measured in minutes.
Physical Activity Assessed by PAQ-A
The Physical Activity Questionnaire for Adolescents (PAQ-A) will be given to assess physical activity. The PAQ-A ranges from 1-7. Higher score denotes better outcome.
Physical Activity Assessed by PAQ-A
The Physical Activity Questionnaire for Adolescents (PAQ-A) will be given to assess physical activity. The PAQ-A ranges from 1-7. Higher score denotes better outcome.
Physical Activity Assessed by IPAQ
The International Physical Activity Questionnaire (IPAQ) will be given to assess physical activity in adults. The IPAQ ranges from 10-960 minutes/day of physical activity. Higher score denotes better outcome.
Physical Activity Assessed by IPAQ
The International Physical Activity Questionnaire (IPAQ) will be given to assess physical activity in adults. The IPAQ ranges from 10-960 minutes/day of physical activity. Higher score denotes better outcome.
Caloric intake expressed in kcals
Diet will be assessed by the Automated Self-Administered 24-hour (ASA24) dietary assessment tool.
Caloric intake expressed in kcals
Diet will be assessed by the Automated Self-Administered 24-hour (ASA24) dietary assessment tool.
Concentration of fasting glucose for all participants, mg/dL
Fasting blood glucose will be ascertained for each participant. A fasting blood sugar level less than 100 mg/dL (5.6 mmol/L) is optimal. A fasting blood sugar level from 100 to 125 mg/dL (5.6 to 6.9 mmol/L) is considered prediabetes.
Concentration of fasting glucose for all participants, mg/dL
Fasting blood glucose will be ascertained for each participant. A fasting blood sugar level less than 100 mg/dL (5.6 mmol/L) is optimal. A fasting blood sugar level from 100 to 125 mg/dL (5.6 to 6.9 mmol/L) is considered prediabetes.
Concentration of fasting Insulin for all participants, mg/dL
Fasting insulin levels will be gathered from all participants.
Concentration of fasting Insulin for all participants, mg/dL
Fasting insulin levels will be gathered from all participants.
Hemoglobin A1c concentration for all participants, measured in percentage
Normal range for the hemoglobin A1c level is between 4% and 5.6%. Hemoglobin A1c levels between 5.7% and 6.4% Values greater denote diabetes.
Hemoglobin A1c concentration for all participants, measured in percentage
Normal range for the hemoglobin A1c level is between 4% and 5.6%. Hemoglobin A1c levels between 5.7% and 6.4%. Values greater denote diabetes.
Aspartate Aminotransferase -Levels of AST for all participants, measured in units per liter (IU/L)
AST a useful test for detecting or monitoring liver damage.
Aspartate Aminotransferase -Levels of AST for all participants, measured in units per liter (IU/L)
AST a useful test for detecting or monitoring liver damage.
Alanine Aminotransferase-Levels of ALT for all participants, measured in units per liter
A low level of ALT in the blood is expected and is normal.
Alanine Aminotransferase-Levels of ALT for all participants, measured in units per liter
A low level of ALT in the blood is expected and is normal.
Concentration of total cholesterol (mg/dL)
total cholesterol: less than 200 mg/dL
Concentration of total cholesterol (mg/dL)
total cholesterol: less than 200 mg/dL
Economic costs of the three intervention arms over duration of program (USD)
Clinical and non-clinical costs of the interventions will be compiled over the duration of the program. All cost will be reported in the same unit.

Full Information

First Posted
January 10, 2019
Last Updated
March 17, 2023
Sponsor
Wake Forest University Health Sciences
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1. Study Identification

Unique Protocol Identification Number
NCT03811743
Brief Title
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

2. Study Status

Record Verification Date
May 2021
Overall Recruitment Status
Completed
Study Start Date
February 25, 2020 (Actual)
Primary Completion Date
June 16, 2020 (Actual)
Study Completion Date
June 16, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Wake Forest University Health Sciences

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Weight Loss, Pediatric Obesity
Keywords
Youth, Parents, Overweight, Families

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
16 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Adolescents Participants
Arm Type
Experimental
Arm Description
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
Arm Title
Caregivers of adolescents participants
Arm Type
Experimental
Arm Description
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
Intervention Type
Behavioral
Intervention Name(s)
Brenner FIT
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
By Design
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Coordination
Intervention Description
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
Primary Outcome Measure Information:
Title
BMI z-score
Description
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.
Time Frame
Baseline
Title
BMI z-score
Description
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.
Time Frame
3 Months
Title
BMI z-score
Description
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.
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Physical Activity Assessed by Accelerometry
Description
Physical activity data will be collected using ActiGraph (trademark) accelerometers worn continuously over 7 days except during bathing and sleeping. Moderate to vigorous activity will be measured in minutes.
Time Frame
Baseline
Title
Physical Activity Assessed by Accelerometry
Description
Physical activity data will be collected using ActiGraph (trademark) accelerometers worn continuously over 7 days except during bathing and sleeping. Moderate to vigorous activity will be measured in minutes.
Time Frame
6 months
Title
Physical Activity Assessed by PAQ-A
Description
The Physical Activity Questionnaire for Adolescents (PAQ-A) will be given to assess physical activity. The PAQ-A ranges from 1-7. Higher score denotes better outcome.
Time Frame
Baseline
Title
Physical Activity Assessed by PAQ-A
Description
The Physical Activity Questionnaire for Adolescents (PAQ-A) will be given to assess physical activity. The PAQ-A ranges from 1-7. Higher score denotes better outcome.
Time Frame
6 months
Title
Physical Activity Assessed by IPAQ
Description
The International Physical Activity Questionnaire (IPAQ) will be given to assess physical activity in adults. The IPAQ ranges from 10-960 minutes/day of physical activity. Higher score denotes better outcome.
Time Frame
Baseline
Title
Physical Activity Assessed by IPAQ
Description
The International Physical Activity Questionnaire (IPAQ) will be given to assess physical activity in adults. The IPAQ ranges from 10-960 minutes/day of physical activity. Higher score denotes better outcome.
Time Frame
6 months
Title
Caloric intake expressed in kcals
Description
Diet will be assessed by the Automated Self-Administered 24-hour (ASA24) dietary assessment tool.
Time Frame
Baseline
Title
Caloric intake expressed in kcals
Description
Diet will be assessed by the Automated Self-Administered 24-hour (ASA24) dietary assessment tool.
Time Frame
6 months
Title
Concentration of fasting glucose for all participants, mg/dL
Description
Fasting blood glucose will be ascertained for each participant. A fasting blood sugar level less than 100 mg/dL (5.6 mmol/L) is optimal. A fasting blood sugar level from 100 to 125 mg/dL (5.6 to 6.9 mmol/L) is considered prediabetes.
Time Frame
Baseline
Title
Concentration of fasting glucose for all participants, mg/dL
Description
Fasting blood glucose will be ascertained for each participant. A fasting blood sugar level less than 100 mg/dL (5.6 mmol/L) is optimal. A fasting blood sugar level from 100 to 125 mg/dL (5.6 to 6.9 mmol/L) is considered prediabetes.
Time Frame
6 months
Title
Concentration of fasting Insulin for all participants, mg/dL
Description
Fasting insulin levels will be gathered from all participants.
Time Frame
Baseline
Title
Concentration of fasting Insulin for all participants, mg/dL
Description
Fasting insulin levels will be gathered from all participants.
Time Frame
6 months
Title
Hemoglobin A1c concentration for all participants, measured in percentage
Description
Normal range for the hemoglobin A1c level is between 4% and 5.6%. Hemoglobin A1c levels between 5.7% and 6.4% Values greater denote diabetes.
Time Frame
Baseline
Title
Hemoglobin A1c concentration for all participants, measured in percentage
Description
Normal range for the hemoglobin A1c level is between 4% and 5.6%. Hemoglobin A1c levels between 5.7% and 6.4%. Values greater denote diabetes.
Time Frame
6 months
Title
Aspartate Aminotransferase -Levels of AST for all participants, measured in units per liter (IU/L)
Description
AST a useful test for detecting or monitoring liver damage.
Time Frame
Baseline
Title
Aspartate Aminotransferase -Levels of AST for all participants, measured in units per liter (IU/L)
Description
AST a useful test for detecting or monitoring liver damage.
Time Frame
6 months
Title
Alanine Aminotransferase-Levels of ALT for all participants, measured in units per liter
Description
A low level of ALT in the blood is expected and is normal.
Time Frame
Baseline
Title
Alanine Aminotransferase-Levels of ALT for all participants, measured in units per liter
Description
A low level of ALT in the blood is expected and is normal.
Time Frame
6 months
Title
Concentration of total cholesterol (mg/dL)
Description
total cholesterol: less than 200 mg/dL
Time Frame
Baseline
Title
Concentration of total cholesterol (mg/dL)
Description
total cholesterol: less than 200 mg/dL
Time Frame
6 months
Title
Economic costs of the three intervention arms over duration of program (USD)
Description
Clinical and non-clinical costs of the interventions will be compiled over the duration of the program. All cost will be reported in the same unit.
Time Frame
Baseline through 6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
13 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Justin Moore, PhD
Organizational Affiliation
Wake Forest University Health Sciences
Official's Role
Principal Investigator
Facility Information:
Facility Name
Wake Forest Baptist Medical Center
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27157
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
20880126
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.
Results Reference
background

Learn more about this trial

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

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