Family-Based Weight Wellness Treatment Through Food is Medicine and Group Medical Visits in Pediatric and Adult Primary Care

Part of paid clinical trials in Boston, Massachusetts.

Sponsor
Tufts University
Study ID
NCT07717658
Status
Recruiting
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Conditions

  • Obesity & Overweight
  • Weight Management

Eligibility Criteria

Sex
ALL
Age
12 Years - 17 Years
Healthy Volunteers
Not accepted

Interventions

  • Culinary medicine classes — BEHAVIORAL
    Culinary Education - Kids Test Kitchen: In Cohort 2, as part of the SMA, families will participate in six cooking classes. The curriculum emphasizes hands-on cooking, nutrition literacy, and family engagement.
  • Medically Tailored Groceries — BEHAVIORAL
    Medically Tailored Groceries (MTG): In Cohorts 2 and 3 families receive twelve months of MTG at $250 USD per month. Groceries are customized to clinical goals such as weight management, blood pressure control, and glycemic regulation.
  • Shared Medical Appointments — BEHAVIORAL
    Shared Medical Appointments (SMAs): Families will attend monthly 60-90-minute group visits. The SMAs will include separate parent and adolescent classes, followed by joint activities. Parent sessions will be led by Dr. Kane using the Ardmore Full Plate Living curriculum. Adolescent sessions will be led by Drs. Mauney and Bushard using the SPARK Wellness Program. Each SMA will integrate nutrition education, behavioral health support, and goal setting tailored to the patient and family needs.

Study Details

The proposed project aims to implement and evaluate a novel, family-based lifestyle medicine intervention integrating group Shared Medical Appointments (SMAs) for parents and adolescents with a twelve-month medically tailored groceries (MTG) and six-month culinary medicine Food is Medicine program. The intervention provides adolescent weight wellness treatment through a holistic, community engaged approach leveraging family connection, clinical care, and nutrition support. Monthly SMAs will include time for parents and adolescents to meet independently and conclude together. These visits will be co-led by physicians, dietitians, and health professionals. Parents will receive the Ardmore Institute's Full Plate Living program while adolescents receive Tufts Pediatrics Strong, Positive and Resilient Kids (SPARK) Weight Wellness program. The SMA format is reimbursable, fosters peer support, enhances patient-provider interaction, and allows efficient delivery of education and care. Each session will include nutrition and lifestyle education, review of individualized weight care plans, and proactive goal setting tailored to adults, adolescents, and families.

Key Dates

First listed
Jul 21, 2026
Start date
Feb 5, 2025
Status verified
Jul 2026
Primary completion
Dec 31, 2027
Completion
Dec 31, 2027

Study Design

Enrollment
60 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: Cohort 1: SMA only
    SMA group visits only
  • Experimental: Cohort 2: SMA, MTG, and Culinary medicine
    SMA group visits + MTG + culinary medicine classes embedded within SMAs.
  • Experimental: Cohort 3: SMA and MTG
    SMA group visits + MTG only.

Primary Outcome Measure

Change in BMI z-score [ Time Frame: Baseline to 12 months ]

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
Tufts Medical CenterBostonMassachusetts02111
Erin Mauney, MD
[email protected]
(617) 636-3266
Erin Mauney, MD (PRINCIPAL_INVESTIGATOR)
Tufts UniversityBostonMassachusetts02111
NICHE Lab Team
[email protected]
‪(469) 240-9112‬
Kelseanna Hollis-Hansen, PhD, MPH (PRINCIPAL_INVESTIGATOR)

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