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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04036331
Other study ID # IRB00059569
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
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
Health authority
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

Study Design


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, 

References & Publications (37)

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Thompson FE, Dixit-Joshi S, Potischman N, Dodd KW, Kirkpatrick SI, Kushi LH, Alexander GL, Coleman LA, Zimmerman TP, Sundaram ME, Clancy HA, Groesbeck M, Douglass D, George SM, Schap TE, Subar AF. Comparison of Interviewer-Administered and Automated Self-Administered 24-Hour Dietary Recalls in 3 Diverse Integrated Health Systems. Am J Epidemiol. 2015 Jun 15;181(12):970-8. doi: 10.1093/aje/kwu467. Epub 2015 May 10. — View Citation

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* Note: There are 37 references in allClick 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
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