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

16 de julho de 2026 atualizado por: 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.

Visão geral do estudo

Status

Recrutamento

Condições

Intervenção / Tratamento

Tipo de estudo

Intervencional

Inscrição (Estimado)

60

Estágio

  • Não aplicável

Contactos e Locais

Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.

Contato de estudo

  • Nome: Kelseanna Hollis-Hansen, PhD
  • Número de telefone: (469) 240-9112‬
  • E-mail: niche@tufts.edu

Locais de estudo

  • Estados Unidos
    • Massachusetts
      • Boston, Massachusetts, Estados Unidos, 02111
        • Recrutamento
        • Tufts Medical Center
        • Contato:
        • Investigador principal:
          • Erin Mauney, MD
      • Boston, Massachusetts, Estados Unidos, 02111
        • Recrutamento
        • Tufts University
        • Investigador principal:
          • Kelseanna Hollis-Hansen, PhD, MPH
        • Contato:
          • NICHE Lab Team
          • Número de telefone: ‪(469) 240-9112‬
          • E-mail: niche@tufts.edu

Critérios de participação

Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.

Critérios de elegibilidade

Idades elegíveis para estudo

  • Filho

Aceita Voluntários Saudáveis

Não

Descrição

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.

Plano de estudo

Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.

Como o estudo é projetado?

Detalhes do projeto

  • Finalidade Principal: Tratamento
  • Alocação: Não randomizado
  • Modelo Intervencional: Atribuição Paralela
  • Mascaramento: Solteiro

Armas e Intervenções

Grupo de Participantes / Braço
Intervenção / Tratamento
Comparador Ativo: Cohort 1: SMA only
SMA group visits only
Comportamental: 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.
Comportamental: 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.
Comportamental: 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.
Outros nomes:
  • Culinary medicine
Comportamental: 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.
Outros nomes:
  • MTG
Experimental: Cohort 3: SMA and MTG
SMA group visits + MTG only.
Comportamental: 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.
Comportamental: 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.
Outros nomes:
  • MTG

O que o estudo está medindo?

Medidas de resultados primários

Medida de resultado
Descrição da medida
Prazo
Change in BMI z-score
Prazo: 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

Medidas de resultados secundários

Medida de resultado
Descrição da medida
Prazo
Change in absolute BMI and waist circumference
Prazo: 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)
Prazo: Baseline to 12 months
Collected from EHR, venipuncture for blood collection through Tufts Medical Center (LabCorp)
Baseline to 12 months
Laboratory measures (hemoglobin A1C)
Prazo: Baseline to 12 months
Collected from EHR, venipuncture for blood collection through Tufts Medical Center (LabCorp)
Baseline to 12 months
Laboratory measures (lipid panel)
Prazo: Baseline to 12 months
Collected from EHR, venipuncture for blood collection through Tufts Medical Center (LabCorp)
Baseline to 12 months
Change in physical activity
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: Baseline to 12 months
Based on PedsQL child and parent reports
Baseline to 12 months

Colaboradores e Investigadores

É aqui que você encontrará pessoas e organizações envolvidas com este estudo.

Patrocinador

Tufts University

Colaboradores

Tufts Medical Center

Datas de registro do estudo

Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados ​​pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.

Datas Principais do Estudo

Início do estudo (Real)

5 de fevereiro de 2025

Conclusão Primária (Estimado)

1 de dezembro de 2027

Conclusão do estudo (Estimado)

1 de dezembro de 2027

Datas de inscrição no estudo

Enviado pela primeira vez

10 de julho de 2026

Enviado pela primeira vez que atendeu aos critérios de CQ

16 de julho de 2026

Primeira postagem (Real)

21 de julho de 2026

Atualizações de registro de estudo

Última Atualização Postada (Real)

21 de julho de 2026

Última atualização enviada que atendeu aos critérios de controle de qualidade

16 de julho de 2026

Última verificação

1 de julho de 2026

Mais Informações

Termos relacionados a este estudo

Palavras-chave

Termos MeSH relevantes adicionais

Outros números de identificação do estudo

  • STUDY00006548
  • 1267-Spring 2026 (Número de outro subsídio/financiamento: Ardmore Institute)

Plano para dados de participantes individuais (IPD)

Planeja compartilhar dados de participantes individuais (IPD)?

NÃO

Informações sobre medicamentos e dispositivos, documentos de estudo

Estuda um medicamento regulamentado pela FDA dos EUA

Não

Estuda um produto de dispositivo regulamentado pela FDA dos EUA

Não

Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .

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