ClinicalTrials.gg
RecruitingNCT07717658Updated Jul 21, 2026

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

An interventional study of Culinary medicine classes and Medically Tailored Groceries in Obesity & Overweight and Weight Management, sponsored by Tufts University. Recruiting at 2 sites in United States. Open to participants aged 12 Years to 17 Years. Per ClinicalTrials.gov, last updated 2026-07-21.

Sponsored by Tufts University · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Registered 1 year 5 months after the study started (first participant enrolled Feb 2025, registered Jul 2026).
  • Started Feb 2025; still recruiting 1 year 9 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
60
Allocation
Non-randomized
Ages
12 Years to 17 Years
Sex
All
01

Study summary

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.

02

Conditions studied

  • Obesity & Overweight
  • Weight Management

Keywords

  • culinary medicine
  • medically tailored groceries
  • weight management
03

In context

Obesity

11,522 studies on the registry are indexed under Obesity; 2,033 are open to participants now.

This study's planned enrollment of 60 is below the median of 67 across 9,006 interventional studies indexed under Obesity.

Browse Obesity studies →

Lead sponsor

Tufts University is the lead sponsor of 228 studies on the registry; 23 are open to participants now.

Of its 11 completed or terminated interventional studies of FDA-regulated products, 8 (73%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
12 Years to 17 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

For children:

  • Child aged 12-17 years at time of enrollment (inclusive)
  • ≥ 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

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.
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

BMI (body mass index)

Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.

What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
60 participants (estimated)

Study arms

  • Active comparator
    Cohort 1: SMA only

    SMA group visits only

    Behavioral: Shared Medical Appointments

  • Experimental
    Cohort 2: SMA, MTG, and Culinary medicine

    SMA group visits + MTG + culinary medicine classes embedded within SMAs.

    Behavioral: Culinary medicine classes · Behavioral: Medically Tailored Groceries · Behavioral: Shared Medical Appointments

  • Experimental
    Cohort 3: SMA and MTG

    SMA group visits + MTG only.

    Behavioral: Medically Tailored Groceries · Behavioral: Shared Medical Appointments

Interventions

  • BehavioralCulinary 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.

    Also known as: Culinary medicine

  • BehavioralMedically 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.

    Also known as: MTG

  • BehavioralShared 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.

06

What researchers measure

Primary outcomes

  1. 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)

    Time frame: Baseline to 12 months

Secondary outcomes

  1. Change in absolute BMI and waist circumference

    Collected from EHR, weight and height will be combined to report BMI in kg/m\^2.

    Time frame: Baseline to 12 months and 18 months (6-month post-program follow-up).

  2. Laboratory measures (ALT)

    Collected from EHR, venipuncture for blood collection through Tufts Medical Center (LabCorp)

    Time frame: Baseline to 12 months

  3. Laboratory measures (hemoglobin A1C)

    Collected from EHR, venipuncture for blood collection through Tufts Medical Center (LabCorp)

    Time frame: Baseline to 12 months

  4. Laboratory measures (lipid panel)

    Collected from EHR, venipuncture for blood collection through Tufts Medical Center (LabCorp)

    Time frame: Baseline to 12 months

  5. 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

    Time frame: Baseline to 12 months

  6. 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

    Time frame: Baseline to 12 months

  7. 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.

    Time frame: Baseline to 12 months

  8. Change in health-related quality of life

    Based on PedsQL child and parent reports

    Time frame: Baseline to 12 months

07

Study locations

2 of 2 sites recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 21, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07717658
Lead sponsor
Tufts University
Responsible party
Sponsor
First posted
Jul 21, 2026
Start date
Feb 5, 2025
Primary completion
Dec 2027 (estimated)
Completion
Dec 2027 (estimated)
Last update
Jul 21, 2026

Study contacts

Kelseanna Hollis-Hansen, PhD
Contact
niche@tufts.edu
(469) 240-9112‬

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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