NCT07717658

Brief Summary

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
16mo left

Started Feb 2025

Typical duration for not_applicable

Geographic Reach
1 country

2 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress53%
Feb 2025Dec 2027

Study Start

First participant enrolled

February 5, 2025

Completed
1.4 years until next milestone

First Submitted

Initial submission to the registry

July 10, 2026

Completed
11 days until next milestone

First Posted

Study publicly available on registry

July 21, 2026

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2027

Last Updated

July 21, 2026

Status Verified

July 1, 2026

Enrollment Period

2.8 years

First QC Date

July 10, 2026

Last Update Submit

July 16, 2026

Conditions

Obesity & OverweightWeight Management

Keywords

culinary medicinemedically tailored groceriesweight management

Outcome Measures

Primary Outcomes (1)

  • Change in BMI z-score

    Measured using standardized CDC growth charts, obtained from EMR-recorded height and weight at in-person visits. Weight and height will be combined to report BMI in kg/m\^2)

    Baseline to 12 months

Secondary Outcomes (8)

  • Change in absolute BMI and waist circumference

    Baseline to 12 months and 18 months (6-month post-program follow-up).

  • Laboratory measures (ALT)

    Baseline to 12 months

  • Laboratory measures (hemoglobin A1C)

    Baseline to 12 months

  • Laboratory measures (lipid panel)

    Baseline to 12 months

  • Change in physical activity

    Baseline to 12 months

  • +3 more secondary outcomes

Study Arms (3)

Cohort 1: SMA only

ACTIVE COMPARATOR

SMA group visits only

Behavioral: Shared Medical Appointments

Cohort 2: SMA, MTG, and Culinary medicine

EXPERIMENTAL

SMA group visits + MTG + culinary medicine classes embedded within SMAs.

Behavioral: Culinary medicine classesBehavioral: Medically Tailored GroceriesBehavioral: Shared Medical Appointments

Cohort 3: SMA and MTG

EXPERIMENTAL

SMA group visits + MTG only.

Behavioral: Medically Tailored GroceriesBehavioral: Shared Medical Appointments

Interventions

Culinary medicine classesBEHAVIORAL

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.

Also known as: Culinary medicine
Cohort 2: SMA, MTG, and Culinary medicine
Shared Medical AppointmentsBEHAVIORAL

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.

Cohort 1: SMA onlyCohort 2: SMA, MTG, and Culinary medicineCohort 3: SMA and MTG
Medically Tailored GroceriesBEHAVIORAL

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.

Also known as: MTG
Cohort 2: SMA, MTG, and Culinary medicineCohort 3: SMA and MTG

Eligibility Criteria

Age12 Years - 17 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • For children:
  • Child aged 12-17 years at time of enrollment (inclusive)
  • BMI ≥ 95% for age and sex based on CDC growth charts
  • Comfortable speaking and reading English (due to limitations in intervention materials and qualitative data collection tools)
  • Child is an active patient at Tufts Medical Center
  • Child can provide assent, Willing and able to participate in the 18-month study, including attendance at scheduled in-person or telehealth sessions
  • Access to a device with internet capability (e.g., computer, tablet, or smartphone) to engage with online intervention
  • For parents or guardians:
  • Age 18+ at time of enrollment
  • Primary caregiver is the legal guardian of the child
  • Comfortable speaking and reading English (due to limitations in intervention materials and qualitative data collection tools)
  • Can provide consent, Willing and able to participate in the 12-month study, including attendance at scheduled in-person or telehealth sessions
  • Access to a device with internet capability (e.g., computer, tablet, or smartphone) to engage with online intervention components.

You may not qualify if:

  • For Children:
  • Participation is medically or developmentally inappropriate, including but not limited to: Severe intellectual disability or cognitive impairment preventing meaningful participation, Active eating disorder diagnosis or concerning disordered eating behaviors, Severe physical limitations or mobility impairments that would limit participation in lifestyle activities, Active unmanaged psychiatric condition (e.g., acute suicidality or psychosis) that may interfere with participation or consent
  • Planned bariatric surgery or other weight loss procedures during the 12-month study period
  • Child is currently pregnant or plans to become so in the next 12 months
  • Plans to relocate or transfer care away from the participating clinic during the 12-month study period
  • Concurrent participation in another weight management clinical trial that could confound results or interfere with study activities
  • Parent is unwilling or unable to participate in the study
  • Child is a parent (has their own child), is in the armed forces, or lives independently and manages their own affairs (emancipated)
  • Child is a foster child, in state custody, or has an open DCF case pending as identified in the electronic medical record or disclosed verbally by child or guardian.
  • For parent:
  • Severe intellectual disability or cognitive impairment preventing meaningful participation
  • Plans to relocate or transfer care away from the participating clinic during the 12-month study period
  • Unwilling or unable to participate in the study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Tufts Medical Center

Boston, Massachusetts, 02111, United States

RECRUITING

Tufts University

Boston, Massachusetts, 02111, United States

RECRUITING

MeSH Terms

Conditions

ObesityOverweight

Interventions

Shared Medical Appointments

Condition Hierarchy (Ancestors)

OvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Patient CareTherapeuticsAppointments and SchedulesOrganization and AdministrationHealth Services AdministrationPractice Management, MedicalPractice ManagementProfessional Practice

Central Study Contacts

Kelseanna Hollis-Hansen, PhD

CONTACT

(469) 240-9112‬niche@tufts.edu

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: This is a quasi-experimental cohort study whereby Cohort 1 receives shared medical appointments only, Cohort 2 receives shared medical appointments (SMA) + culinary medicine classes, and medically tailored groceries (MTG), and Cohort 3 receives shared medical appointments and medically tailored groceries.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 10, 2026

First Posted

July 21, 2026

Study Start

February 5, 2025

Primary Completion (Estimated)

December 1, 2027

Study Completion (Estimated)

December 1, 2027

Last Updated

July 21, 2026

Record last verified: 2026-07

Data Sharing

IPD Sharing
Will not share

Locations

US(2)