Health TrialsbyHealthPanel

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

ConditionsObesity & OverweightWeight Management
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age12-17
SponsorTufts University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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.

Treatment groups

60 Participants
are divided into 3 treatment groups
Group A: Cohort 1: SMA onlyActive comparator 1 intervention
Group B: Cohort 2: SMA, MTG, and Culinary medicineExperimental treatment 3 interventions
Group C: Cohort 3: SMA and MTGExperimental treatment 2 interventions

Trial outcomes

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)

Time frame
Baseline to 12 months

Secondary outcomes

1

Change in absolute BMI and waist circumference

Collected from EHR, weight and height will be combined to report BMI in kg/m\^2.

Time frame
Baseline to 12 months and 18 months (6-month post-program follow-up).
2

Laboratory measures (ALT)

Collected from EHR, venipuncture for blood collection through Tufts Medical Center (LabCorp)

Time frame
Baseline to 12 months
3

Laboratory measures (hemoglobin A1C)

Collected from EHR, venipuncture for blood collection through Tufts Medical Center (LabCorp)

Time frame
Baseline to 12 months
4

Laboratory measures (lipid panel)

Collected from EHR, venipuncture for blood collection through Tufts Medical Center (LabCorp)

Time frame
Baseline to 12 months

Other outcomes

Sponsors and contacts

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Tufts University

Lead sponsor

Tufts Medical Center

Collaborator

Source ClinicalTrials.gov
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