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Dyad Plus Effectiveness

Primary Purpose

Weight Loss, Pediatric Obesity, Overweight Adolescents

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Brenner FIT Standard
By Design Essentials
Dyad Plus
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

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:

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

Sites / Locations

  • Wake Forest Baptist Medical CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Experimental

Experimental

Arm Label

Adolescent Participants

Caregivers of Adolescent Participants

Co-enrollment

Arm 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.

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.

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.

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.

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
July 25, 2019
Last Updated
October 24, 2023
Sponsor
Wake Forest University Health Sciences
Collaborators
National Institutes of Health (NIH)
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1. Study Identification

Unique Protocol Identification Number
NCT04036331
Brief Title
Dyad Plus Effectiveness
Official Title
Effectiveness of A Coordinated Parent/Child Dyad Weight Loss Intervention:
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Recruiting
Study Start Date
July 30, 2021 (Actual)
Primary Completion Date
January 2024 (Anticipated)
Study Completion Date
January 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Wake Forest University Health Sciences
Collaborators
National Institutes of Health (NIH)

4. Oversight

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

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Weight Loss, Pediatric Obesity, Overweight Adolescents, Parent-Child Relations, Family and Household

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
90 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Adolescent Participants
Arm Type
Active Comparator
Arm 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.
Arm Title
Caregivers of Adolescent Participants
Arm Type
Experimental
Arm 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.
Arm Title
Co-enrollment
Arm Type
Experimental
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Brenner FIT Standard
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
By Design Essentials
Intervention Description
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).
Intervention Type
Behavioral
Intervention Name(s)
Dyad Plus
Intervention Description
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.
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
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
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: BMI < 30 Contraindication for physical activity or caloric restriction Cannot read or write English
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Camelia R Singletary, MPH
Phone
13369992469
Email
crsingle@wakehealth.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Justin Moore, PhD
Phone
336-716-3702
Email
jusmoore@wakehealth.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Justin Moore
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
27127
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Justin Moore
Phone
336-716-3702
Email
jusmoore@wakehealth.edu
First Name & Middle Initial & Last Name & Degree
Camelia R Singletary
Phone
13369992469
Email
crsingle@wakehealth.edu

12. IPD Sharing Statement

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