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

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.

Study Overview

• Status: Recruiting
• Conditions: Weight Management; Obesity & Overweight
• Intervention / Treatment: Behavioral: Shared Medical Appointments; Behavioral: Culinary medicine classes; Behavioral: Medically Tailored Groceries

• Study Type: Interventional
• Enrollment (Estimated): 60
• Phase: Not Applicable

Contacts and Locations

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

Study Locations

• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02111
      • Recruiting
      • Tufts Medical Center
      • Contact: Erin Mauney, MD; Phone Number: (617) 636-3266; Email: Erin.Mauney@tuftsmedicine.org
      • Principal Investigator: Erin Mauney, MD
    • Boston, Massachusetts, United States, 02111
      • Recruiting
      • Tufts University
      • Principal Investigator: Kelseanna Hollis-Hansen, PhD, MPH
      • Contact: NICHE Lab Team; Phone Number: ‪(469) 240-9112‬; Email: niche@tufts.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Cohort 1: SMA only; SMA group visits only	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.
Experimental: Cohort 2: SMA, MTG, and Culinary medicine; SMA group visits + MTG + culinary medicine classes embedded within SMAs.	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.; 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.; Other Names: Culinary medicine; 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.; Other Names: MTG
Experimental: Cohort 3: SMA and MTG; SMA group visits + MTG only.	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.; 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.; Other Names: MTG

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)	Baseline to 12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in absolute BMI and waist circumference	Collected from EHR, weight and height will be combined to report BMI in kg/m^2.	Baseline to 12 months and 18 months (6-month post-program follow-up).
Laboratory measures (ALT)	Collected from EHR, venipuncture for blood collection through Tufts Medical Center (LabCorp)	Baseline to 12 months
Laboratory measures (hemoglobin A1C)	Collected from EHR, venipuncture for blood collection through Tufts Medical Center (LabCorp)	Baseline to 12 months
Laboratory measures (lipid panel)	Collected from EHR, venipuncture for blood collection through Tufts Medical Center (LabCorp)	Baseline to 12 months
Change in physical activity	Measured by questions adapted from: - Physical Activity Questionnaire for Adolescents 7-day recall, 1-5 scale Kowalski, K. C., Crocker, P. R. E., & Faulkner, R. A. (2004). The Physical Activity Questionnaire for Older Children (PAQ-C) and Adolescents (PAQ-A) Manual. College of Kinesiology, University of Saskatchewan	Baseline to 12 months
Change in media use	Measured by questions adapted from: - Cumulative Media Use Index Higher cumulative score on this index has been heavily associated with negative outcomes Score of 0: Low media exposure across all environments. Score of 1-2: Moderate or isolated media risk. Score of 3-4: High-risk, "media-heavy ecology" Linebarger, D. L., et al. (2014). Associations between parenting, media use, cumulative risk, and children's executive functioning. Journal of Developmental & Behavioral Pediatrics, 35(6), 367-377	Baseline to 12 months
Change in sleep	Measured by questions adapted from: - Short Form Children's Sleep Habits questionnaire Each question is rated on a 3-point scale based on how often the behavior occurs, total Score greater than 30 on the SF-CSHQ indicates behavioral sleep issues. Owens, J. A., Spirito, A., & McGuinn, M. (2000). The Children's Sleep Habits Questionnaire (CSHQ): psychometric properties of a survey instrument for school-aged children. Journal of American Academy of Child & Adolescent Psychiatry, 39(12), 1546-1553.	Baseline to 12 months
Change in health-related quality of life	Based on PedsQL child and parent reports	Baseline to 12 months

Collaborators and Investigators

• Sponsor: Tufts University
• Collaborators: Tufts Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): February 5, 2025
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): December 1, 2027

Study Registration Dates

• First Submitted: July 10, 2026
• First Submitted That Met QC Criteria: July 16, 2026
• First Posted (Actual): July 21, 2026

Study Record Updates

• Last Update Posted (Actual): July 21, 2026
• Last Update Submitted That Met QC Criteria: July 16, 2026
• Last Verified: July 1, 2026

More Information

Terms related to this study

• Keywords: weight management; culinary medicine; medically tailored groceries
• Additional Relevant MeSH Terms: Nutrition Disorders; Overnutrition; Body Weight; Pathological Conditions, Signs and Symptoms; Nutritional and Metabolic Diseases; Signs and Symptoms; Overweight; Obesity; Professional Practice; Organization and Administration; Health Services Administration; Therapeutics; Patient Care; Appointments and Schedules; Practice Management; Practice Management, Medical; Shared Medical Appointments
• Other Study ID Numbers: STUDY00006548; 1267-Spring 2026 (Other Grant/Funding Number: Ardmore Institute)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No