Food Delivery, Remote Monitoring, and Coaching-Enhanced Education for Optimized Diabetes Management (FREEDOM)
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 304
- 试验地点
- 2
- 主要终点
- Primary Outcome for the HIV Cohort: Change in HbA1c level between baseline and 6 months
研究概览
简要总结
Brief Summary:
The FREEDOM study aims to develop a scalable intervention to improve type 2 diabetes mellitus control in low-income Black adults in the Deep South. The intervention targets social determinants of health (SDoH) such as reduced healthcare access, poverty, transportation barriers, and food insecurity.
详细描述
Detailed Description:
- FREEDOM Study (Type 2 Diabetes Mellitus):
The FREEDOM study is a 12-month clinical trial enrolling 304 Black adults with Type 2 Diabetes Mellitus across three healthcare systems in Alabama and Mississippi. Participants are randomly assigned to one of eight combinations of three intervention components:
- Digital Health Coaching: Participants receive one-on-one phone-based coaching for optimized diabetes management.
- Food Box Delivery: Food boxes are delivered every two weeks to participants' homes,
- Remote Patient Monitoring (RPM): Participants receive essential supplies, including glucometers, for remote blood glucose measurement. Data is monitored remotely for timely interventions.
The study involves three in-person visits at baseline, month 6, and month 12, as well as two telephone study check-ins at month 3 and 9. Survey packets are administered at each time point. 2. FREEDOM-HIV Study (Type 2 Diabetes Mellitus and HIV Cohort):
Additionally, a cohort within the study, known as the FREEDOM-HIV study, will enroll additional 80 adults who have both Type 2 Diabetes Mellitus and HIV. This cohort will be observed over a 6-month period and will also consist of the same three intervention components.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Supportive Care
- 盲法
- Single (Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Self-identified as Black/African American
- •ICD diagnosis of T2DM
- •≥18 years of age
- •Ongoing insulin treatment
- •HbA1c ≥8% within 6 weeks of study screening
- •has the ability to converse in and read English
- •must provide written informed consent prior to enrollment
排除标准
- •Current enrollment in any diabetes-related interventional study
- •Cognitive impairment
- •End-stage kidney disease (CKD-5)
- •Pregnant or plans to become pregnant within 12 months
- •Currently enrolled in a structured lifestyle change program
- •Enrolled in remote patient monitoring or health coaching within 60 days of the study or intervention
- •HIV Cohort Criteria
- •Inclusion Criteria
- •≥ 18 years of age
- •ICD diagnosis of T2DM
- •Confirmed HIV+ diagnosis
- •Prescribed HIV ART therapy as part of care
- •Exclusion Criteria
- •Current enrollment in any diabetes-related interventional study or structured lifestyle change program
- •Enrolled in RPM or health coaching (except for coaching on smoking cessation) within 60 days of the intervention
- •Cognitive impairment
- •End-stage kidney disease (CKD-5)
- •Pregnant or plans to become pregnant within 12 months
研究组 & 干预措施
Arm 5
Food delivery+ RPM
干预措施: Diabetes Education Class (Behavioral)
Arm 1
Digital coaching+ Food delivery+ RPM
干预措施: Digital Health Coaching (Behavioral)
Arm 5
Food delivery+ RPM
干预措施: Food Box Delivery (Dietary Supplement)
Arm 5
Food delivery+ RPM
干预措施: Remote Patient Monitoring (RPM) (Behavioral)
Arm 7
Food delivery
干预措施: Food Box Delivery (Dietary Supplement)
Arm 7
Food delivery
干预措施: Diabetes Education Class (Behavioral)
Arm 8
RPM
干预措施: Remote Patient Monitoring (RPM) (Behavioral)
Arm 3
Digital coaching+ Food delivery
干预措施: Food Box Delivery (Dietary Supplement)
Arm 3
Digital coaching+ Food delivery
干预措施: Diabetes Education Class (Behavioral)
Arm 8
RPM
干预措施: Diabetes Education Class (Behavioral)
Arm 6
The participant's will not receive any Intervention
干预措施: Diabetes Education Class (Behavioral)
Arm 1
Digital coaching+ Food delivery+ RPM
干预措施: Remote Patient Monitoring (RPM) (Behavioral)
Arm 1
Digital coaching+ Food delivery+ RPM
干预措施: Food Box Delivery (Dietary Supplement)
Arm 4
Digital coaching+ RPM
干预措施: Digital Health Coaching (Behavioral)
Arm 4
Digital coaching+ RPM
干预措施: Remote Patient Monitoring (RPM) (Behavioral)
Arm 4
Digital coaching+ RPM
干预措施: Diabetes Education Class (Behavioral)
Arm 2
Digital coaching
干预措施: Diabetes Education Class (Behavioral)
Arm 2
Digital coaching
干预措施: Digital Health Coaching (Behavioral)
Arm 3
Digital coaching+ Food delivery
干预措施: Digital Health Coaching (Behavioral)
Arm 1
Digital coaching+ Food delivery+ RPM
干预措施: Diabetes Education Class (Behavioral)
结局指标
主要结局
Primary Outcome for the HIV Cohort: Change in HbA1c level between baseline and 6 months
时间窗: 6 months
The primary outcome of the study is to track change in the HbA1c between baseline and 6 months (endpoint of the study). The HbA1C will be tested at baseline and 6 months.
FREEDOM Study: Change in HbA1c level between baseline and 12 month
时间窗: 12 months
The primary outcome of the study is to track change in the HbA1c between baseline and 12 months (endpoint of the study). The HbA1C will be tested at baseline, 6 and 12 months.
次要结局
未报告次要终点
研究者
Tapan Shirish Mehta
Professor, Director of Research
University of Alabama at Birmingham