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

2026年7月16日 更新者: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.

調査の概要

研究の種類

介入

入学 (推定)

60

段階

  • 適用できない

連絡先と場所

このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。

研究連絡先

  • 名前:Kelseanna Hollis-Hansen, PhD
  • 電話番号:(469) 240-9112‬
  • メール:niche@tufts.edu

研究場所

    • Massachusetts
      • Boston、Massachusetts、アメリカ、02111
        • 募集
        • Tufts Medical Center
        • コンタクト:
        • 主任研究者:
          • Erin Mauney, MD
      • Boston、Massachusetts、アメリカ、02111
        • 募集
        • Tufts University
        • 主任研究者:
          • Kelseanna Hollis-Hansen, PhD, MPH
        • コンタクト:
          • NICHE Lab Team
          • 電話番号:‪(469) 240-9112‬
          • メール:niche@tufts.edu

参加基準

研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。

適格基準

就学可能な年齢

  • 子

健康ボランティアの受け入れ

いいえ

説明

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.

研究計画

このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。

研究はどのように設計されていますか?

デザインの詳細

  • 主な目的:処理
  • 割り当て:非ランダム化
  • 介入モデル:並列代入
  • マスキング:独身

武器と介入

参加者グループ / アーム
介入・治療
アクティブコンパレータ:Cohort 1: SMA only
SMA group visits only
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.
実験的:Cohort 2: SMA, MTG, and Culinary medicine
SMA group visits + MTG + culinary medicine classes embedded within SMAs.
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.
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.
他の名前:
  • Culinary medicine
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.
他の名前:
  • MTG
実験的:Cohort 3: SMA and MTG
SMA group visits + MTG only.
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.
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.
他の名前:
  • MTG

この研究は何を測定していますか?

主要な結果の測定

結果測定
メジャーの説明
時間枠
Change in BMI z-score
時間枠: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

二次結果の測定

結果測定
メジャーの説明
時間枠
Change in absolute BMI and waist circumference
時間枠: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)
時間枠:Baseline to 12 months
Collected from EHR, venipuncture for blood collection through Tufts Medical Center (LabCorp)
Baseline to 12 months
Laboratory measures (hemoglobin A1C)
時間枠:Baseline to 12 months
Collected from EHR, venipuncture for blood collection through Tufts Medical Center (LabCorp)
Baseline to 12 months
Laboratory measures (lipid panel)
時間枠:Baseline to 12 months
Collected from EHR, venipuncture for blood collection through Tufts Medical Center (LabCorp)
Baseline to 12 months
Change in physical activity
時間枠: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
時間枠: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
時間枠: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
時間枠:Baseline to 12 months
Based on PedsQL child and parent reports
Baseline to 12 months

協力者と研究者

ここでは、この調査に関係する人々や組織を見つけることができます。

スポンサー

研究記録日

これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。

主要日程の研究

研究開始 (実際)

2025年2月5日

一次修了 (推定)

2027年12月1日

研究の完了 (推定)

2027年12月1日

試験登録日

最初に提出

2026年7月10日

QC基準を満たした最初の提出物

2026年7月16日

最初の投稿 (実際)

2026年7月21日

学習記録の更新

投稿された最後の更新 (実際)

2026年7月21日

QC基準を満たした最後の更新が送信されました

2026年7月16日

最終確認日

2026年7月1日

詳しくは

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