The Effect of a Novel Food is Medicine Program on Outcomes in Pediatric Patients With Diabetes: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Difference in nutrition-related clinical outcomes
研究概览
简要总结
The objective of this randomized controlled trial is to evaluate the effect of novel Food is Medicine Programming in the form of medically tailored pre-packaged meals for pediatric patients with Type 1 Diabetes. The provision of medically-tailored meals to children and adolescents with diabetes that have potential food security or access concerns in addition to nutrition counseling will improve clinical outcomes, decrease healthcare utilization, and improve health-related quality of life (HRQOL). Consulting with a Registered Dietician is the established multidisciplinary standard of care for pediatric patients with diabetes at UMass. Community Servings provides a medically-tailored pre-packaged meal plan designed for pediatric patients with Type 1 Diabetes. The addition of Community Servings to the current standard of care in pediatric patients with potential food security or access concerns will further improve clinical, decrease healthcare utilization, and improve HRQOL outcomes in pediatric patients with Type 1 Diabetes.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 5 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Current patients of the UMMMC Pediatric Endocrinology Clinic
- •Children and Adolescents less than or equal to 17 years of age at the time of enrollment
- •Diagnosed with Type 1 Diabetes at least 3 months ago
- •Public (MassHealth or Medicaid) Health Insurance
排除标准
- •Celiac disease or severe gluten allergy
- •Congenital, genetic, or chronic comorbidities
- •DCF Custody
- •Pregnant women
- •Prisoners
- •Non-English speaking subjects
研究组 & 干预措施
Community Servings
The treatment group will receive six months of medically-tailored meals for pediatric Type I Diabetes through Community Servings non-profit organization in addition to standard-of-care treatment from UMass Pediatric Endocrinology and nutrition counseling. Participants will have a six-month follow-up period following completion of the medically tailored meals programming. Subjects will complete the PedsQL quality of life surveys, program-specific surveys on medically-tailored meals with Community Servings, and social drivers of health risk surveys while participating in the study. Subjects will attend all clinically indicated appointments with their endocrinologist and/or registered dietician on a quarterly basis with no additional appointments for research purposes. Demographics, health information, and continuous glucose monitoring (CGM) data (if the participant uses a CGM device) will be collected throughout the duration of the study.
干预措施: Community Servings (Other)
Community Servings
The treatment group will receive six months of medically-tailored meals for pediatric Type I Diabetes through Community Servings non-profit organization in addition to standard-of-care treatment from UMass Pediatric Endocrinology and nutrition counseling. Participants will have a six-month follow-up period following completion of the medically tailored meals programming. Subjects will complete the PedsQL quality of life surveys, program-specific surveys on medically-tailored meals with Community Servings, and social drivers of health risk surveys while participating in the study. Subjects will attend all clinically indicated appointments with their endocrinologist and/or registered dietician on a quarterly basis with no additional appointments for research purposes. Demographics, health information, and continuous glucose monitoring (CGM) data (if the participant uses a CGM device) will be collected throughout the duration of the study.
干预措施: PedsQL Survey (Other)
Community Servings
The treatment group will receive six months of medically-tailored meals for pediatric Type I Diabetes through Community Servings non-profit organization in addition to standard-of-care treatment from UMass Pediatric Endocrinology and nutrition counseling. Participants will have a six-month follow-up period following completion of the medically tailored meals programming. Subjects will complete the PedsQL quality of life surveys, program-specific surveys on medically-tailored meals with Community Servings, and social drivers of health risk surveys while participating in the study. Subjects will attend all clinically indicated appointments with their endocrinologist and/or registered dietician on a quarterly basis with no additional appointments for research purposes. Demographics, health information, and continuous glucose monitoring (CGM) data (if the participant uses a CGM device) will be collected throughout the duration of the study.
干预措施: Nutrition Counseling (Other)
Community Servings
The treatment group will receive six months of medically-tailored meals for pediatric Type I Diabetes through Community Servings non-profit organization in addition to standard-of-care treatment from UMass Pediatric Endocrinology and nutrition counseling. Participants will have a six-month follow-up period following completion of the medically tailored meals programming. Subjects will complete the PedsQL quality of life surveys, program-specific surveys on medically-tailored meals with Community Servings, and social drivers of health risk surveys while participating in the study. Subjects will attend all clinically indicated appointments with their endocrinologist and/or registered dietician on a quarterly basis with no additional appointments for research purposes. Demographics, health information, and continuous glucose monitoring (CGM) data (if the participant uses a CGM device) will be collected throughout the duration of the study.
干预措施: SDOH Survey (Other)
Standard of Care Pediatric Type I Diabetes
The control group will receive twelve months of standard-of-care treatment from UMass Pediatric Endocrinology and nutrition counseling. Subjects will complete the PedsQL quality of life surveys and social drivers of health risk surveys while participating in the study. Subjects will attend all clinically indicated appointments with their endocrinologist and/or registered dietician on a quarterly basis with no additional appointments for research purposes. Demographics, health information, and continuous glucose monitoring (CGM) data (if the participant uses a CGM device) will be collected throughout the duration of the study. If the subject completes all study procedures, they will have the option to access six months of Community Servings medically-tailored meals provided by the research institution upon completion of the study.
干预措施: PedsQL Survey (Other)
Standard of Care Pediatric Type I Diabetes
The control group will receive twelve months of standard-of-care treatment from UMass Pediatric Endocrinology and nutrition counseling. Subjects will complete the PedsQL quality of life surveys and social drivers of health risk surveys while participating in the study. Subjects will attend all clinically indicated appointments with their endocrinologist and/or registered dietician on a quarterly basis with no additional appointments for research purposes. Demographics, health information, and continuous glucose monitoring (CGM) data (if the participant uses a CGM device) will be collected throughout the duration of the study. If the subject completes all study procedures, they will have the option to access six months of Community Servings medically-tailored meals provided by the research institution upon completion of the study.
干预措施: Nutrition Counseling (Other)
Standard of Care Pediatric Type I Diabetes
The control group will receive twelve months of standard-of-care treatment from UMass Pediatric Endocrinology and nutrition counseling. Subjects will complete the PedsQL quality of life surveys and social drivers of health risk surveys while participating in the study. Subjects will attend all clinically indicated appointments with their endocrinologist and/or registered dietician on a quarterly basis with no additional appointments for research purposes. Demographics, health information, and continuous glucose monitoring (CGM) data (if the participant uses a CGM device) will be collected throughout the duration of the study. If the subject completes all study procedures, they will have the option to access six months of Community Servings medically-tailored meals provided by the research institution upon completion of the study.
干预措施: SDOH Survey (Other)
结局指标
主要结局
Difference in nutrition-related clinical outcomes
时间窗: 12 months
The primary outcome measure is the difference in clinical outcomes between the control and intervention groups. Nutrition-related outcomes will include growth metrics (Z-score and percentile rank), and height and weight will be combined to report Body Mass Index (BMI) in kg/m\^2 metrics.
Difference in Diabetes-related clinical outcomes
时间窗: 12 months
One primary outcome measure is the difference in clinical outcomes between the control and intervention groups. Diabetes outcomes will include changes in insulin dosage (units/mL/day), continuous glucose monitoring metrics (glucose in mg/dL, time spent at range intervals and variability as percentages), and Hemoglobin A1c (percentage).
次要结局
- Healthcare Utilization(12 months)
- HRQOL Outcomes(12 months)
- Medically-tailored Meals Sustainability(12 months)
研究者
Lawrence Rhein
Neonatologist and Pediatric Pulmonologist; Chair, Department of Pediatrics and Associate Professor, UMass Chan Medical School
University of Massachusetts, Worcester