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NCT Number: NCT07717658

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.

Recruiting

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Key information

Age range

12 year–17 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Tufts Medical Center, Boston, Massachusetts, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Culinary medicine classes

Behavioral

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

Medically Tailored Groceries

Behavioral

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

Shared Medical Appointments

Behavioral

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.

Primary outcomes

  1. Change in BMI z-score

    Time frame: Baseline to 12 months

    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)

Secondary outcomes

  1. Change in absolute BMI and waist circumference

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

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

  2. Laboratory measures (ALT)

    Time frame: Baseline to 12 months

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

  3. Laboratory measures (hemoglobin A1C)

    Time frame: Baseline to 12 months

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

  4. Laboratory measures (lipid panel)

    Time frame: Baseline to 12 months

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

  5. Change in physical activity

    Time frame: Baseline to 12 months

    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
  6. Change in media use

    Time frame: Baseline to 12 months

    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
  7. Change in sleep

    Time frame: Baseline to 12 months

    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.

  8. Change in health-related quality of life

    Time frame: Baseline to 12 months

    Based on PedsQL child and parent reports

Study contacts

Contact information is provided by the study sponsor or research team.

Kelseanna Hollis-Hansen, PhD

CONTACT

[email protected]

(469) 240-9112‬

Sponsors and collaborators

Lead sponsor

Tufts University

Other

Collaborators

  • Tufts Medical Center

Registry information

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Jul 21, 2026
Registry last updated
Jul 21, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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