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NCT Number: NCT04036331

Dyad Plus Effectiveness/Feasibility

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.

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Key information

Age range

13 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Brenner FIT Standard

Behavioral

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

Behavioral

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

Behavioral

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 outcomes

  1. BMI z-score

    Time frame: Baseline

    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.

  2. BMI z-score

    Time frame: 6 months

    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. Feasibility and Acceptability of Implementation

    Time frame: Month 6

    We will examine screening, recruitment, retention, adherence, and overall perception of Brenner FIT and By Design components

Secondary outcomes

  1. Physical Activity Assessment Tool (PAAT)-Adult

    Time frame: Baseline

    Physical activity data will be collected using the Physical Activity Assessment Tool (PAAT). The PAAT measures type, frequency, and duration of moderate and vigorous physical activity from all four domains of physical activity-leisure, occupational, household, and transportation-in the last 7 days, and asks if this is "more, less, or about the same as usual" activity

  2. Physical Activity Assessment Tool (PAAT)-Adult

    Time frame: 6 Months

    Physical activity data will be collected using the Physical Activity Assessment Tool (PAAT). The PAAT measures type, frequency, and duration of moderate and vigorous physical activity from all four domains of physical activity-leisure, occupational, household, and transportation-in the last 7 days, and asks if this is "more, less, or about the same as usual" activity

  3. Physical Activity Assessed with Youth Physical Activity Questionnaire (YPAQ)

    Time frame: Baseline

    Physical activity data will be collected using the Youth Physical Activity Questionnaire (YPAQ which contains 47 different activities broken into contextual settings/domains: sporting, leisure, school, and free-time activities and aims to measures frequency, duration, intensity, and mode, over the past 7 days of both PA and sedentary activities. The questionnaire will be self-administered via a REDCap survey. Study staff will be available to answer any questions that participants have during the process.

  4. Physical Activity Assessed with Youth Physical Activity Questionnaire (YPAQ)

    Time frame: 6 months

    Physical activity data will be collected using the Youth Physical Activity Questionnaire (YPAQ which contains 47 different activities broken into contextual settings/domains: sporting, leisure, school, and free-time activities and aims to measures frequency, duration, intensity, and mode, over the past 7 days of both PA and sedentary activities. The questionnaire will be self-administered via a REDCap survey. Study staff will be available to answer any questions that participants have during the process.

  5. Physical Activity Assessed Using Fitbit (Youth)

    Time frame: Baseline

    In addition to using the YPAQ, physical activity data will be collected using Fitbit Inspire 2 (Model Number: FB418BKBK). Participating children will be instructed to wear the Fitbit device for 7 days continuously during the two data collection timepoints (baseline and 6 months).

  6. Physical Activity Assessed Using Fitbit (Youth)

    Time frame: 6 Months

    In addition to using the YPAQ, physical activity data will be collected using Fitbit Inspire 2 (Model Number: FB418BKBK). Participating children will be instructed to wear the Fitbit device for 7 days continuously during the two data collection timepoints (baseline and 6 months).

  7. Concentration of fasting glucose for all participants, mg/dL

    Time frame: Baseline

    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. ONLY if routinely collected as a part of regular clinical care.

  8. Concentration of fasting glucose for all participants, mg/dL

    Time frame: 6 months

    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. ONLY if routinely collected as a part of regular clinical care.

  9. Aspartate Aminotransferase -Levels of AST for all participants, measured in units per liter (IU/L)

    Time frame: Baseline

    AST a useful test for detecting or monitoring liver damage. ONLY if routinely collected as a part of regular clinical care.

  10. Concentration of fasting Insulin for all participants, mg/dL

    Time frame: Baseline

    Fasting insulin levels will be gathered from all participants. ONLY if routinely collected as a part of regular clinical care.

  11. Concentration of fasting Insulin for all participants, mg/dL

    Time frame: 6 months

    Fasting insulin levels will be gathered from all participants. ONLY if routinely collected as a part of regular clinical care.

  12. Hemoglobin A1c concentration for all participants, measured in percentage

    Time frame: Baseline

    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. ONLY if routinely collected as a part of regular clinical care.

  13. Hemoglobin A1c concentration for all participants, measured in percentage

    Time frame: 6 months

    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. ONLY if routinely collected as a part of regular clinical care.

  14. Aspartate Aminotransferase -Levels of AST for all participants, measured in units per liter (IU/L)

    Time frame: 6 months

    AST a useful test for detecting or monitoring liver damage. ONLY if routinely collected as a part of regular clinical care.

  15. Alanine Aminotransferase-Levels of ALT for all participants, measured in units per liter

    Time frame: Baseline

    A low level of ALT in the blood is expected and is normal. ONLY if routinely collected as a part of regular clinical care.

  16. Alanine Aminotransferase-Levels of ALT for all participants, measured in units per liter

    Time frame: 6 months

    A low level of ALT in the blood is expected and is normal. ONLY if routinely collected as a part of regular clinical care.

  17. Concentration of total cholesterol (mg/dL)

    Time frame: Baseline

    total cholesterol: less than 200 mg/dL.ONLY if routinely collected as a part of regular clinical care.

  18. Concentration of total cholesterol (mg/dL)

    Time frame: 6 months

    total cholesterol: less than 200 mg/dL. ONLY if routinely collected as a part of regular clinical care.

  19. Economic costs of the three intervention arms over duration of program (USD)

    Time frame: Month 6

    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. ONLY if routinely collected as a part of regular clinical care.

  20. Diet for Parent and Youth

    Time frame: Baseline and 6 Months

    To assess diet in participant, we will use the NCI's NHANES Food Frequency Questionnaire which aims to obtain frequency and, in some cases, portion size information about food and beverage consumption over a specified period of time, typically the past month or year. A food frequency questionnaire (FFQ) consists of a finite list of foods and beverages with response categories to indicate usual frequency of consumption over the time period queried. To assess the total diet, the number of foods and beverages queried typically ranges from 80 to 120. The questionnaire will be self-administered via a REDCap survey. Study staff will be available to answer any questions that participants have during the process.

Study contacts

Contact information is provided by the study sponsor or research team.

Camelia R Singletary, MPH

CONTACT

[email protected]

13369992469

Justin Moore, PhD

CONTACT

[email protected]

336-716-3702

Sponsors and collaborators

Lead sponsor

Wake Forest University Health Sciences

Other

Collaborators

  • National Institutes of Health (NIH)

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2026
Study completion
2026
First posted
Jul 29, 2019
Registry last updated
Apr 28, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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