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

16 juli 2026 uppdaterad av: Tufts University
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.

Studieöversikt

Status

Rekrytering

Betingelser

Intervention / Behandling

Studietyp

Interventionell

Inskrivning (Beräknad)

60

Fas

  • Inte tillämpbar

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studiekontakt

  • Namn: Kelseanna Hollis-Hansen, PhD
  • Telefonnummer: (469) 240-9112‬
  • E-post: niche@tufts.edu

Studieorter

  • Förenta staterna
    • Massachusetts
      • Boston, Massachusetts, Förenta staterna, 02111
        • Rekrytering
        • Tufts Medical Center
        • Kontakt:
        • Huvudutredare:
          • Erin Mauney, MD
      • Boston, Massachusetts, Förenta staterna, 02111
        • Rekrytering
        • Tufts University
        • Huvudutredare:
          • Kelseanna Hollis-Hansen, PhD, MPH
        • Kontakt:
          • NICHE Lab Team
          • Telefonnummer: ‪(469) 240-9112‬
          • E-post: niche@tufts.edu

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

  • Barn

Tar emot friska volontärer

Nej

Beskrivning

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.

Studieplan

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

  • Primärt syfte: Behandling
  • Tilldelning: Icke-randomiserad
  • Interventionsmodell: Parallellt uppdrag
  • Maskning: Enda

Vapen och interventioner

Deltagargrupp / Arm
Intervention / Behandling
Aktiv komparator: Cohort 1: SMA only
SMA group visits only
Beteende: 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.
Experimentell: Cohort 2: SMA, MTG, and Culinary medicine
SMA group visits + MTG + culinary medicine classes embedded within SMAs.
Beteende: 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.
Beteende: 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.
Andra namn:
  • Culinary medicine
Beteende: 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.
Andra namn:
  • MTG
Experimentell: Cohort 3: SMA and MTG
SMA group visits + MTG only.
Beteende: 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.
Beteende: 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.
Andra namn:
  • MTG

Vad mäter studien?

Primära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Change in BMI z-score
Tidsram: 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)
Baseline to 12 months

Sekundära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Change in absolute BMI and waist circumference
Tidsram: 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.
Baseline to 12 months and 18 months (6-month post-program follow-up).
Laboratory measures (ALT)
Tidsram: Baseline to 12 months
Collected from EHR, venipuncture for blood collection through Tufts Medical Center (LabCorp)
Baseline to 12 months
Laboratory measures (hemoglobin A1C)
Tidsram: Baseline to 12 months
Collected from EHR, venipuncture for blood collection through Tufts Medical Center (LabCorp)
Baseline to 12 months
Laboratory measures (lipid panel)
Tidsram: Baseline to 12 months
Collected from EHR, venipuncture for blood collection through Tufts Medical Center (LabCorp)
Baseline to 12 months
Change in physical activity
Tidsram: 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
Baseline to 12 months
Change in media use
Tidsram: 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
Baseline to 12 months
Change in sleep
Tidsram: 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.
Baseline to 12 months
Change in health-related quality of life
Tidsram: Baseline to 12 months
Based on PedsQL child and parent reports
Baseline to 12 months

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Sponsor

Tufts University

Samarbetspartners

Tufts Medical Center

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart (Faktisk)

5 februari 2025

Primärt slutförande (Beräknad)

1 december 2027

Avslutad studie (Beräknad)

1 december 2027

Studieregistreringsdatum

Först inskickad

10 juli 2026

Först inskickad som uppfyllde QC-kriterierna

16 juli 2026

Första postat (Faktisk)

21 juli 2026

Uppdateringar av studier

Senaste uppdatering publicerad (Faktisk)

21 juli 2026

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

16 juli 2026

Senast verifierad

1 juli 2026

Mer information

Termer relaterade till denna studie

Nyckelord

Ytterligare relevanta MeSH-villkor

Andra studie-ID-nummer

  • STUDY00006548
  • 1267-Spring 2026 (Annat bidrag/finansieringsnummer: Ardmore Institute)

Plan för individuella deltagardata (IPD)

Planerar du att dela individuella deltagardata (IPD)?

NEJ

Läkemedels- och apparatinformation, studiedokument

Studerar en amerikansk FDA-reglerad läkemedelsprodukt

Nej

Studerar en amerikansk FDA-reglerad produktprodukt

Nej

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