Home Food Delivery for Diabetes Management in Patients of Rural Clinics
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 416
- 试验地点
- 13
- 主要终点
- HbA1c
研究概览
简要总结
The goal of this randomized controlled trial was to determine the effectiveness of a Healthy Food Delivery Intervention (HFDI) on the outcomes of rural food insecure patients with type 2 diabetes mellitus (T2DM). Our specific aims were to:
- Compare the effectiveness of the HFDI and CDCES Consultation Only to improve diabetes-related outcomes among rural food insecure patients with T2DM.
Hypotheses: Compared with CDCES Consultation Only, patients receiving the HFDI will demonstrate improved:
H1- glycemic control as measured by HbA1c; H2- cardio-metabolic risk factors: body mass index (BMI), blood pressure, total cholesterol, high-density lipoproteins (HDL), low-density lipoproteins (LDL), triglycerides, blood glucose; H3- diabetes management self-efficacy; H4- diabetes-related distress. 2. Compare the effectiveness of the HFDI and CDCES Consultation Only to improve diet quality among rural food insecure patients with T2DM.
Hypotheses: Compared with CDCES Consultation Only, patients receiving the HFDI will demonstrate improved:
H1- Healthy Eating Index 2015 (HEI-2015) scores; H2- fruit and vegetable consumption as measured by Veggie Meter scores. 3. Compare cost-effectiveness to understand HFDI costs in relationship to outcomes in relation to CDCES Consultation Only.
Hypothesis: The HFDI will be cost-effective based on traditional cost per additional quality-adjusted life year gained.
详细描述
Type 2 diabetes mellitus (T2DM) is a growing public health concern affecting 37.3 million people (11.3%) in the United States (US). At the same time, 13.5 million (10.2%) US households experience food insecurity. People living in rural areas are particularly challenged by the intersection of food insecurity and T2DM - both food insecurity and T2DM prevalence in rural areas are higher than metropolitan areas. Arkansas has the sixth highest proportion of rural population (44.5%) of all US states, with rates of food insecurity and T2DM of 14.7% and 12.5%, respectively. Rurality and food insecurity are associated with social determinants of health that impede diabetes management (e.g., limited transportation, longer distance to healthcare clinics, lack of access to healthy food options). People experiencing food insecurity have poor diet quality (e.g., high intake of sugar-sweetened beverages and red/processed meat, low intake of fruits and vegetables), which is a key risk factor for unmanaged T2DM. Unmanaged T2DM can lead to increased risk of serious complications. Improved diet quality is a crucial factor to enhance T2DM management. Millions of people with T2DM experiencing food insecurity turn to food pantries for food; however, food pantries are not a long-term solution to improve health for rural people with T2DM experiencing food insecurity. Certified Diabetes Care and Education Specialists (CDCES; i.e., diabetes educators) have expertise in working with patients to instill knowledge and skills necessary to live an active and healthy lifestyle with T2DM.
This study used a two-arm randomized controlled comparative effectiveness design to compare the effectiveness of a Healthy Food Delivery Intervention (HFDI) plus a consultation with a CDCES Consultation Only in improving diabetes-related outcomes among rural people with T2DM experiencing food insecurity. We hypothesized HFDI to be comparatively more effective in improving HbA1c and other outcomes for rural people with T2DM experiencing food insecurity.
The primary outcome was change in hemoglobin A1c (HbA1c) between baseline and post-intervention. Secondary outcomes included diet quality (Healthy Eating Index-2015 and Veggie meter scores), body mass index, blood pressure, lipids, glucose, diabetes management self-efficacy and diabetes-related distress. We also examined the duration of treatment effects by comparing outcomes at 6 months post-intervention and 12 months post-intervention.
Participants were randomly assigned to either the HFDI arm or the CDCES Consultation Only arm. Participants randomized to the CDCES Consultation Only study arm received the standard of care at the clinic from which they were recruited, plus a 60 minute healthy eating consultation with a CDCES and a food pantry resource guide specific to their community. In addition to standard of care and the CDCES consultation, participants randomized to the HFDI arm received weekly home delivery of type 2 diabetes-appropriate food boxes over 3 months (12 food boxes in total). Each food box included approximately 9000 calories of food. Food boxes were designed by a Registered Dietician. Food boxes also included recipes and cooking tips specific to foods included in that week's box.
Participants were initially recruited only from family medicine clinics within the University of Arkansas for Medical Sciences (UAMS) network that serve the highest percentage of rural patients with T2DM. Additional clinics and Federally Qualified Health Centers were added as recruitment sites in order to meet study recruitment goals.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Double (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •18 years of age or older
- •HbA1c equal to or greater than 6.5
- •Speak English or Spanish
排除标准
- •conditions making it unlikely the participant will be able to follow the protocol, such as terminal illness, severe mental illness, severely impaired vision or hearing, eating disorder, or plans to move out of the geographic region
- •Only one adult with T2DM per household will be enrolled
研究组 & 干预措施
CDCES Consultation Only
Participants randomized to this study arm receive the standard of care at the clinic from which they were recruited, plus a 60 minute healthy eating consultation with a Certified Diabetes Care and Education Specialist and a food pantry resource guide specific to their community.
干预措施: CDCES Consultation Only (Behavioral)
Healthy Food Delivery Intervention
In addition to standard of care and the CDCES consultation, participants randomized to the Healthy Food Delivery arm receive weekly home delivery of type 2 diabetes-appropriate food boxes over 3 months (12 food boxes in total).
干预措施: Healthy Food Delivery Intervention (Behavioral)
结局指标
主要结局
HbA1c
时间窗: Baseline to immediate post-intervention (approx. 18 weeks)
Finger stick blood collection will be used to test HbA1c using a Siemens DCA Vantage.
Hemoglobin A1c (HbA1c)
时间窗: Baseline; Immediate post-intervention; 6 months post-intervention; 12 months post-intervention
Finger stick blood collection will be used to test HbA1c using a Siemens DCA Vantage analyzer.
Hemoglobin A1c (HbA1c)
时间窗: Baseline; Immediate post-intervention (approx. 12 weeks); 6 months post-intervention; 12 months post-intervention
Finger stick blood collection will be used to test HbA1c using a Siemens DCA Vantage analyzer.
次要结局
- Diet Quality: Healthy Eating Index-2015 Score(Baseline; Immediate post-intervention)
- Diet Quality: Veggie Meter Score(Baseline; Immediate post-intervention; 6 months post-intervention; 12 months post-intervention)
- Body Mass Index (BMI)(Baseline; Immediate post-intervention; 6 months post-intervention; 12 months post-intervention)
- Systolic Blood Pressure (SBP)(Baseline; Immediate post-intervention; 6 months post-intervention; 12 months post-intervention)
- Diastolic Blood Pressure (DBP)(Baseline; Immediate post-intervention; 6 months post-intervention; 12 months post-intervention)
- Total Cholesterol(Baseline; Immediate post-intervention; 6 months post-intervention; 12 months post-intervention)
- High-Density Lipoproteins (HDL)(Baseline; Immediate post-intervention; 6 months post-intervention; 12 months post-intervention)
- Low-Density Lipoproteins (LDL)(Baseline; Immediate post-intervention; 6 months post-intervention; 12 months post-intervention)
- Triglycerides(Baseline; Immediate post-intervention; 6 months post-intervention; 12 months post-intervention)
- Glucose(Baseline; Immediate post-intervention; 6 months post-intervention; 12 months post-intervention)
- Diabetes Self-Efficacy (DMSES)(Baseline; Immediate post-intervention; 6 months post-intervention; 12 months post-intervention)
- Diabetes-Related Distress (PAID-5)(Baseline; Immediate post-intervention; 6 months post-intervention; 12 months post-intervention)
- Food Insecurity(Baseline; Immediate post-intervention; 6 months post-intervention; 12 months post-intervention)
- Diet Quality: Healthy Eating Index-2015 Score(Baseline; Immediate post-intervention (approx. 12 weeks))
- Diet Quality: Veggie Meter Score(Baseline; Immediate post-intervention (approx. 12 weeks); 6 months post-intervention; 12 months post-intervention)
- Body Mass Index (BMI)(Baseline; Immediate post-intervention (approx. 12 weeks); 6 months post-intervention; 12 months post-intervention)
- Systolic Blood Pressure (SBP)(Baseline; Immediate post-intervention (approx. 12 weeks); 6 months post-intervention; 12 months post-intervention)
- Diastolic Blood Pressure (DBP)(Baseline; Immediate post-intervention (approx. 12 weeks); 6 months post-intervention; 12 months post-intervention)
- Total Cholesterol(Baseline; Immediate post-intervention (approx. 12 weeks); 6 months post-intervention; 12 months post-intervention)
- High-Density Lipoproteins (HDL)(Baseline; Immediate post-intervention (approx. 12 weeks); 6 months post-intervention; 12 months post-intervention)
- Low-Density Lipoproteins (LDL)(Baseline; Immediate post-intervention (approx. 12 weeks); 6 months post-intervention; 12 months post-intervention)
- Triglycerides(Baseline; Immediate post-intervention (approx. 12 weeks); 6 months post-intervention; 12 months post-intervention)
- Glucose(Baseline; Immediate post-intervention (approx. 12 weeks); 6 months post-intervention; 12 months post-intervention)
- Diabetes Self-Efficacy (DMSES)(Baseline; Immediate post-intervention (approx. 12 weeks); 6 months post-intervention; 12 months post-intervention)
- Diabetes-Related Distress (PAID-5)(Baseline; Immediate post-intervention (approx. 12 weeks); 6 months post-intervention; 12 months post-intervention)
- Food Insecurity(Baseline; Immediate post-intervention (approx. 12 weeks); 6 months post-intervention; 12 months post-intervention)
