Family-Based Weight Wellness Treatment Through Food is Medicine and Group Medical Visits in Pediatric and Adult Primary Care
研究概览
地位
研究类型
注册 (估计的)
阶段
- 不适用
联系人和位置
学习联系方式
- 姓名:Kelseanna Hollis-Hansen, PhD
- 电话号码:(469) 240-9112
- 邮箱:niche@tufts.edu
学习地点
-
-
Massachusetts
-
Boston、Massachusetts、美国、02111
- 招聘中
- Tufts Medical Center
-
接触:
- Erin Mauney, MD
- 电话号码:(617) 636-3266
- 邮箱:Erin.Mauney@tuftsmedicine.org
-
首席研究员:
- Erin Mauney, MD
-
Boston、Massachusetts、美国、02111
- 招聘中
- Tufts University
-
首席研究员:
- Kelseanna Hollis-Hansen, PhD, MPH
-
接触:
- NICHE Lab Team
- 电话号码:(469) 240-9112
- 邮箱:niche@tufts.edu
-
-
参与标准
资格标准
适合学习的年龄
- 孩子
接受健康志愿者
描述
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.
学习计划
研究是如何设计的?
设计细节
- 主要用途:治疗
- 分配:非随机化
- 介入模型:并行分配
- 屏蔽:单身的
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
有源比较器: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.
|
|
实验性的: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.
其他名称:
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.
其他名称:
|
|
实验性的: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.
其他名称:
|
研究衡量的是什么?
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Change in BMI z-score
大体时间: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
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Change in absolute BMI and waist circumference
大体时间: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)
大体时间:Baseline to 12 months
|
Collected from EHR, venipuncture for blood collection through Tufts Medical Center (LabCorp)
|
Baseline to 12 months
|
|
Laboratory measures (hemoglobin A1C)
大体时间:Baseline to 12 months
|
Collected from EHR, venipuncture for blood collection through Tufts Medical Center (LabCorp)
|
Baseline to 12 months
|
|
Laboratory measures (lipid panel)
大体时间:Baseline to 12 months
|
Collected from EHR, venipuncture for blood collection through Tufts Medical Center (LabCorp)
|
Baseline to 12 months
|
|
Change in physical activity
大体时间: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
大体时间: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
大体时间: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
大体时间:Baseline to 12 months
|
Based on PedsQL child and parent reports
|
Baseline to 12 months
|
合作者和调查者
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (估计的)
研究完成 (估计的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
与本研究相关的术语
其他相关的 MeSH 术语
其他研究编号
- STUDY00006548
- 1267-Spring 2026 (其他赠款/资助编号:Ardmore Institute)
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)?
药物和器械信息、研究文件
研究美国 FDA 监管的药品
研究美国 FDA 监管的设备产品
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