Family-based weight wellness with medically tailored groceries and group visits

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This trial implements a family-centered lifestyle medicine approach combining monthly shared medical appointments with 12 months of medically tailored groceries and 6 months of culinary medicine. Adolescents participate in weight wellness activities alongside their parents, guided by clinicians and nutrition professionals. The program uses established family- and nutrition-focused curricula and aims to streamline care delivery through a reimbursable SMA format.

Why it matters

Who can join: the full rules

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's running

• Tufts Medical Center
  Boston, Massachusetts, United States Recruiting
• Tufts University
  Boston, Massachusetts, United States Recruiting

Study contacts

• Study coordinator: Kelseanna Hollis-Hansen, PhD
• Email: niche@tufts.edu
• Phone: (469) 240-9112‬

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.