Family-Based Weight Wellness Treatment Through Food is Medicine and Group Medical Visits in Pediatric and Adult Primary Care
調査の概要
状態
研究の種類
入学 (推定)
段階
- 適用できない
連絡先と場所
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:
- Erin Mauney, MD
- 電話番号:(617) 636-3266
- メール:Erin.Mauney@tuftsmedicine.org
-
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
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
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
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:
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:
|
|
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:
|
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
スポンサー
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (推定)
研究の完了 (推定)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
追加の関連 MeSH 用語
その他の研究ID番号
- STUDY00006548
- 1267-Spring 2026 (その他の助成金/資金番号:Ardmore Institute)
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
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