Family-Based Weight Wellness Treatment Through Food is Medicine and Group Medical Visits in Pediatric and Adult Primary Care
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Change in BMI z-score
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 12 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
结局指标
主要结局
Change in BMI z-score
时间窗: 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)
次要结局
- Change in absolute BMI and waist circumference(Baseline to 12 months and 18 months (6-month post-program follow-up).)
- Laboratory measures (ALT)(Baseline to 12 months)
- Laboratory measures (hemoglobin A1C)(Baseline to 12 months)
- Laboratory measures (lipid panel)(Baseline to 12 months)
- Change in physical activity(Baseline to 12 months)
- Change in media use(Baseline to 12 months)
- Change in sleep(Baseline to 12 months)
- Change in health-related quality of life(Baseline to 12 months)