Obesity & OverweightNCT07717658
Family-Based Weight Wellness Treatment Through Food is Medicine and Group Medical Visits in Pediatric and Adult Primary Care
A study testing Culinary medicine classes, Medically Tailored Groceries and Shared Medical Appointments in people with Obesity & Overweight and Weight Management, run by Tufts University at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 12 to 17 years
- Conditions the study is for
- Obesity & Overweight, Weight Management
- What is being tested?
- Culinary medicine classes, Medically Tailored Groceries and Shared Medical Appointments
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 2 sitesUnited States
- Study dates
- 5 Feb 2025to Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
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- 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.
Who cannot join
- 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
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- 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.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States2 sites, 2 recruiting
- Recruiting
Tufts Medical Center
Boston, Massachusetts, 02111
Erin Mauney, MD, (617) 636-3266, Erin.Mauney@tuftsmedicine.org
Erin Mauney, MD
- Recruiting
Tufts University
Boston, Massachusetts, 02111
NICHE Lab Team, (469) 240-9112, niche@tufts.edu
Kelseanna Hollis-Hansen, PhD, MPH
About this study
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.
- Conditions
- Obesity & Overweight, Weight Management
- Being tested
- Culinary medicine classes, Medically Tailored Groceries, Shared Medical Appointments
- Keywords
- culinary medicine, medically tailored groceries, weight management
- Medical subject headings
- Obesity, Overweight
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Culinary medicine classesBehavioural
Also called Culinary medicine
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.
Medically Tailored GroceriesBehavioural
Also called MTG
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.
Shared Medical AppointmentsBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1: SMA only | Active comparator | SMA group visits only Receives: Behavioral: Shared Medical Appointments |
| Cohort 2: SMA, MTG, and Culinary medicine | Experimental | SMA group visits + MTG + culinary medicine classes embedded within SMAs. Receives: Behavioral: Culinary medicine classes; Behavioral: Medically Tailored Groceries; Behavioral: Shared Medical Appointments |
| Cohort 3: SMA and MTG | Experimental | SMA group visits + MTG only. Receives: Behavioral: Medically Tailored Groceries; Behavioral: Shared Medical Appointments |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: Baseline to 12 months
Secondary outcomes (8)
Change in absolute BMI and waist circumference
Collected from EHR, weight and height will be combined to report BMI in kg/m^2.
Measured: 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)
Measured: Baseline to 12 months
Laboratory measures (hemoglobin A1C)
Collected from EHR, venipuncture for blood collection through Tufts Medical Center (LabCorp)
Measured: Baseline to 12 months
Laboratory measures (lipid panel)
Collected from EHR, venipuncture for blood collection through Tufts Medical Center (LabCorp)
Measured: 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
Measured: 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
Measured: 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.
Measured: Baseline to 12 months
Change in health-related quality of life
Based on PedsQL child and parent reports
Measured: Baseline to 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jul 2026
- Study start5 Feb 2025
- Primary completionDec 2027 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Obesity & OverweightStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- This is a quasi-experimental cohort study whereby Cohort 1 receives shared medical appointments only, Cohort 2 receives shared medical appointments (SMA) + culinary medicine classes, and medically tailored groceries (MTG), and Cohort 3 receives shared medical appointments and medically tailored groceries.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tufts University
- Sponsor type
- University, hospital or other
- Collaborators
- Tufts Medical Center
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07717658
- Sponsor's protocol ID
- STUDY00006548
- Other IDs
- 1267-Spring 2026
- Status last verified
- Jul 2026
- First submitted
- 10 Jul 2026
- Last updated
- 21 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Family-Based Weight Wellness Treatment Through Food is Medicine and Group Medical Visits in Pediatric and Adult Primary Care
- ClinicalTrials.gov ID
- NCT07717658
- Acronym / sponsor ID
- STUDY00006548
- Conditions
- Obesity & Overweight, Weight Management
- Keywords
- culinary medicine, medically tailored groceries, weight management
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Tufts UniversityUniversity, hospital or other
- Collaborators
- Tufts Medical Center
- Study start
- 5 Feb 2025 (actual)
- Primary completion
- Dec 2027 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 21 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
- Model description
- This is a quasi-experimental cohort study whereby Cohort 1 receives shared medical appointments only, Cohort 2 receives shared medical appointments (SMA) + culinary medicine classes, and medically tailored groceries (MTG), and Cohort 3 receives shared medical appointments and medically tailored groceries.
| Arm | Type | Receives |
|---|---|---|
| Cohort 1: SMA only | Active comparator | Behavioral: Shared Medical AppointmentsSMA group visits only |
| Cohort 2: SMA, MTG, and Culinary medicine | Experimental | Behavioral: Culinary medicine classes, Behavioral: Medically Tailored Groceries, Behavioral: Shared Medical AppointmentsSMA group visits + MTG + culinary medicine classes embedded within SMAs. |
| Cohort 3: SMA and MTG | Experimental | Behavioral: Medically Tailored Groceries, Behavioral: Shared Medical AppointmentsSMA group visits + MTG only. |
Who may qualify
- Ages
- 12 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (13 listed)
- 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
Key exclusion criteria (13 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Culinary medicine classesAlso: Culinary medicineCulinary 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. | Behavioural | Cohort 2: SMA, MTG, and Culinary medicine |
| Medically Tailored GroceriesAlso: MTGMedically 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. | Behavioural | Cohort 2: SMA, MTG, and Culinary medicine, Cohort 3: SMA and MTG |
| Shared Medical AppointmentsShared 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. | Behavioural | Cohort 1: SMA only, Cohort 2: SMA, MTG, and Culinary medicine, Cohort 3: SMA and MTG |
Primary outcome
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)
8 secondary outcomes
Change in absolute BMI and waist circumference
Time frame: Baseline to 12 months and 18 months (6-month post-program follow-up).
Laboratory measures (ALT)
Time frame: Baseline to 12 months
Laboratory measures (hemoglobin A1C)
Time frame: Baseline to 12 months
Laboratory measures (lipid panel)
Time frame: Baseline to 12 months
Change in physical activity
Time frame: Baseline to 12 months
Change in media use
Time frame: Baseline to 12 months
Change in sleep
Time frame: Baseline to 12 months
Change in health-related quality of life
Time frame: Baseline to 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jul 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Culinary medicine classes, Medically Tailored Groceries and Shared Medical Appointments in people with Obesity & Overweight and Weight Management, run by Tufts University at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 21 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Kelseanna Hollis-Hansen, PhD ((469) 240-9112, niche@tufts.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in BMI z-score (time frame: Baseline to 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Jul 2026.