Dyad Plus Effectiveness

Weight Loss Clinical Trial

Official title:

Effectiveness of A Coordinated Parent/Child Dyad Weight Loss Intervention:

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04036331
• Other study ID #: IRB00059569
• Status: Recruiting
• Phase: N/A
• Start date: July 30, 2021
• Est. completion date: June 2024

Study information

• Verified date: March 2024
• Source: Wake Forest University Health Sciences
• Contact: Camelia R Singletary, MPH
• Phone: 13369992469
• Email: crsingle[@]wakehealth.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 90
• Est. completion date: June 2024
• Est. primary completion date: June 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 13 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Family and Household
• Overweight
• Overweight Adolescents
• Parent-Child Relations
• Pediatric Obesity
• Weight Loss

Intervention

Behavioral:
• 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
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.

Locations

Country	Name	City	State
United States	Wake Forest Baptist Medical Center	Winston-Salem	North Carolina

Sponsors (2)

Lead Sponsor	Collaborator
Wake Forest University Health Sciences	National Institutes of Health (NIH)

Country where clinical trial is conducted

United States, 

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* Note: There are 37 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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.	Baseline
Secondary	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.	6 months
Secondary	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.	Baseline
Secondary	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.	6 months
Secondary	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.	Baseline
Secondary	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.	6 months
Secondary	Caloric intake expressed in kcals	Diet will be assessed by the Automated Self-Administered 24-hour (ASA24) dietary assessment tool.	Baseline
Secondary	Caloric intake expressed in kcals	Diet will be assessed by the Automated Self-Administered 24-hour (ASA24) dietary assessment tool.	6 months
Secondary	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.	Baseline
Secondary	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.	6 months
Secondary	Concentration of fasting Insulin for all participants, mg/dL	Fasting insulin levels will be gathered from all participants.	Baseline
Secondary	Concentration of fasting Insulin for all participants, mg/dL	Fasting insulin levels will be gathered from all participants.	6 months
Secondary	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.	Baseline
Secondary	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.	6 months
Secondary	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.	Baseline
Secondary	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.	6 months
Secondary	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.	Baseline
Secondary	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.	6 months
Secondary	Concentration of total cholesterol (mg/dL)	total cholesterol: less than 200 mg/dL	Baseline
Secondary	Concentration of total cholesterol (mg/dL)	total cholesterol: less than 200 mg/dL	6 months
Secondary	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.	6 months