NCT07717658 · Tufts University
Family-Based Weight Wellness Treatment Through Food is Medicine and Group Medical Visits in Pediatric and Adult Primary Care
What this study is about
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.
View original scientific description
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.
Interventions
BEHAVIORAL
Culinary medicine classes
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.
BEHAVIORAL
Medically Tailored Groceries
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.
BEHAVIORAL
Shared Medical Appointments
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.
Primary outcome measures
Change in BMI z-score
Time frame: Baseline to 12 months
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)
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- 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.
Exclusion criteria
- 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.
Where
- Boston, Massachusetts
Collaborators
Tufts Medical Center
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jul 21, 2026 · Source of record for eligibility and locations