Family-Based Weight Wellness Treatment Through Food is Medicine and Group Medical Visits in Pediatric and Adult Primary Care
Who can join
As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.
- Age
- 12 Years to 17 Years
- Sex
- All sexes
- Healthy volunteers
- Not accepted
- Compensation
- Travel or expenses covered
Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.
What to expect
No one can promise a trial will help you personally — that is what the research is trying to find out.
What participation involves
Not stated in the study description — ask the study team about visits and procedures.
- Compensation
- Travel or expenses covered
- Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
- Participants are monitored closely by the research team throughout the study.
- Some participants may receive access to an investigational treatment, which is still being studied.
- Your participation helps researchers learn whether this approach could help future patients.
About this study
In plain language
This study tests a family weight wellness program for teens ages 12–17 with a high BMI and their parents or guardians. It combines monthly group medical visits, groceries chosen for health needs for 12 months, and cooking and food education for 6 months.
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.
Compensation is read from the study's own description and may be missing — always confirm with the study team.
Eligibility
Who can join
- Teens must be ages 12–17 and current patients at Tufts Medical Center.
- Teens must have a BMI at or above the 95th percentile for their age and sex on CDC growth charts. BMI is a measure of weight compared with height.
- Teens must agree to join and be willing and able to take part for 18 months, including scheduled visits in person or online.
- Parents or guardians must be at least 18 years old.
- The main caregiver must be the teen’s legal guardian.
- Parents or guardians must give permission to join and be willing and able to take part for 12 months, including scheduled visits in person or online.
- Both teens and parents or guardians must be comfortable speaking and reading English.
- Both must have access to an internet-connected computer, tablet, or smartphone.
Who can't join
- Teens cannot join if a health or development condition makes participation unsuitable. Examples include severe problems with learning or thinking, an eating disorder or concerning eating habits, major limits on movement, or a serious mental health condition that is not managed.
- Teens cannot plan weight-loss surgery or another weight-loss procedure during the 12-month study period.
- Teens cannot be pregnant or plan to become pregnant in the next 12 months.
- Teens or parents cannot plan to move away or change to a different clinic during the 12-month study period.
- Teens cannot be in another weight management trial that could affect this study’s results or activities.
- Teens cannot join if their parent is unwilling or unable to take part. Parents also cannot join if severe problems with learning or thinking prevent participation.
- Teens cannot have a child of their own, be in the armed forces, or live independently and legally manage their own affairs.
- Teens cannot be in foster care or state custody, or have an open case with the Department of Children and Families (DCF).
Simplified for readability. The official criteria below are what the study team uses.
Official eligibility criteria
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.
Study sites (2)
MA
- Tufts Medical Center · Boston, MA 02111Erin Mauney, MD · Study contact · (617) 636-3266 · Erin.Mauney@tuftsmedicine.orgErin Mauney, MD · Principal investigatorMore trials in Boston
- Tufts University · Boston, MA 02111NICHE Lab Team · Study contact · (469) 240-9112 · niche@tufts.eduKelseanna Hollis-Hansen, PhD, MPH · Principal investigatorMore trials in Boston