Family-Based Weight Wellness Treatment Through Food is Medicine and Group Medical Visits in Pediatric and Adult Primary Care
Recruiting · NCT07717658 · Interventional (participants receive a specific treatment) · Lead sponsor: Tufts University
View the official record on ClinicalTrials.gov →Interventions studied
What this trial 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. 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.
Who can take part
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 it is running
2 locations listed across 1 US state.
- Tufts Medical Center - Boston, Massachusetts, United States
- Tufts University - Boston, Massachusetts, United States