deltatrials
Recruiting INTERVENTIONAL NCT04036331

Dyad Plus Effectiveness/Feasibility

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

Sponsor: National Institutes of Health (NIH)

Updated 29 times since 2019 Last updated: Apr 27, 2026 Started: Jul 30, 2021 Primary completion: Jul 1, 2026 Completion: Jul 1, 2026
This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

Listed as NCT04036331, this observational or N/A phase trial focuses on Family and Household and Overweight Adolescents and remains actively recruiting participants. Sponsored by National Institutes of Health (NIH), it has been updated 29 times since 2021, reflecting substantial change activity. This study adds to the evidence base for this therapeutic area through structured, versioned documentation.

Study Description(click to expand)

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...

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.

Status Flow

~Aug 2019 – ~Jan 2020 · 5 months · monthly snapshot~Jan 2020 – ~Feb 2020 · 31 days · monthly snapshot~Feb 2020 – ~Aug 2020 · 6 months · monthly snapshot~Aug 2020 – ~Nov 2020 · 3 months · monthly snapshot~Nov 2020 – ~Jan 2021 · 2 months · monthly snapshot~Jan 2021 – ~Feb 2021 · 31 days · monthly snapshot~Feb 2021 – ~Mar 2021 · 28 days · monthly snapshot~Mar 2021 – ~Apr 2021 · 31 days · monthly snapshot~Apr 2021 – ~May 2021 · 30 days · monthly snapshot~May 2021 – ~Jun 2021 · 31 days · monthly snapshot~Jun 2021 – ~Sep 2021 · 3 months · monthly snapshot~Sep 2021 – ~May 2022 · 8 months · monthly snapshot~May 2022 – ~Jun 2022 · 31 days · monthly snapshot~Jun 2022 – ~May 2023 · 11 months · monthly snapshot~May 2023 – ~Nov 2023 · 6 months · monthly snapshot~Nov 2023 – ~Feb 2024 · 3 months · monthly snapshot~Feb 2024 – ~Apr 2024 · 2 months · monthly snapshot~Apr 2024 – ~May 2024 · 30 days · monthly snapshot~May 2024 – ~Jul 2024 · 2 months · monthly snapshot~Jul 2024 – ~Aug 2024 · 31 days · monthly snapshot~Aug 2024 – ~Sep 2024 · 31 days · monthly snapshot~Sep 2024 – ~Oct 2024 · 30 days · monthly snapshot~Oct 2024 – ~Dec 2024 · 2 months · monthly snapshot~Dec 2024 – ~Feb 2025 · 2 months · monthly snapshot~Feb 2025 – ~Apr 2025 · 59 days · monthly snapshot~Apr 2025 – ~Oct 2025 · 6 months · monthly snapshot~Oct 2025 – ~Feb 2026 · 4 months · monthly snapshot~Feb 2026 – ~May 2026 · 3 months · monthly snapshotMay 4, 2026 – present · 56 days · daily API

Change History

29 versions recorded
  1. May 4, 2026 — Present [daily]

    Recruiting

    Phase: NANone

  2. Feb 2026 — May 2026 [monthly]

    Recruiting NA

  3. Oct 2025 — Feb 2026 [monthly]

    Recruiting NA

  4. Apr 2025 — Oct 2025 [monthly]

    Recruiting NA

  5. Feb 2025 — Apr 2025 [monthly]

    Recruiting NA

Show 24 earlier versions
  1. Dec 2024 — Feb 2025 [monthly]

    Recruiting NA

  2. Oct 2024 — Dec 2024 [monthly]

    Recruiting NA

  3. Sep 2024 — Oct 2024 [monthly]

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  4. Aug 2024 — Sep 2024 [monthly]

    Recruiting NA

  5. Jul 2024 — Aug 2024 [monthly]

    Recruiting NA

  6. May 2024 — Jul 2024 [monthly]

    Recruiting NA

  7. Apr 2024 — May 2024 [monthly]

    Recruiting NA

  8. Feb 2024 — Apr 2024 [monthly]

    Recruiting NA

  9. Nov 2023 — Feb 2024 [monthly]

    Recruiting NA

  10. May 2023 — Nov 2023 [monthly]

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  11. Jun 2022 — May 2023 [monthly]

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  12. May 2022 — Jun 2022 [monthly]

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  13. Sep 2021 — May 2022 [monthly]

    Recruiting NA

    Status: Not Yet RecruitingRecruiting

  14. Jun 2021 — Sep 2021 [monthly]

    Not Yet Recruiting NA

  15. May 2021 — Jun 2021 [monthly]

    Not Yet Recruiting NA

  16. Apr 2021 — May 2021 [monthly]

    Not Yet Recruiting NA

  17. Mar 2021 — Apr 2021 [monthly]

    Not Yet Recruiting NA

  18. Feb 2021 — Mar 2021 [monthly]

    Not Yet Recruiting NA

  19. Jan 2021 — Feb 2021 [monthly]

    Not Yet Recruiting NA

  20. Nov 2020 — Jan 2021 [monthly]

    Not Yet Recruiting NA

  21. Aug 2020 — Nov 2020 [monthly]

    Not Yet Recruiting NA

  22. Feb 2020 — Aug 2020 [monthly]

    Not Yet Recruiting NA

  23. Jan 2020 — Feb 2020 [monthly]

    Not Yet Recruiting NA

  24. Aug 2019 — Jan 2020 [monthly]

    Not Yet Recruiting NA

    First recorded

Eligibility 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.

Contact Information

Sponsor contact:
  • National Institutes of Health (NIH)
  • Wake Forest University Health Sciences
Data source: ClinicalTrials.gov

For direct contact, visit the study record on ClinicalTrials.gov .

Study Locations