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临床试验/NCT04725630
NCT04725630已完成不适用

A Healthy Food Prescription Incentive Program for Adults With Type 2 Diabetes Who Are Experiencing Food Insecurity

University of Calgary2 个研究点 分布在 1 个国家目标入组 597 人开始时间: 2021年5月29日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
597
试验地点
2
主要终点
Blood glucose levels via hemoglobin A1C

研究概览

简要总结

It is important for individuals with type 2 diabetes (T2DM) to adhere to a healthy dietary pattern to maintain optimal blood glucose levels and overall health. The increasing costs of healthy foods, however, is a barrier to maintaining healthful dietary patterns, particularly for individuals with T2DM who are experiencing food insecurity (i.e., inadequate or insecure access to food due to financial constraints). Lower diet quality may result in difficulties maintaining optimal blood glucose levels, leading to higher rates of diabetes complications, and increased acute care usage and costs.

Effective strategies to address this issue are lacking despite the well-known impact of food insecurity on maintaining optimal blood glucose levels. One way to address this problem is to provide incentives to purchase healthy foods through healthy food prescription programs. These programs may help to reduce food insecurity and improve diet quality, thereby improving blood glucose control and reducing diabetes complications over time.

This study will investigate the reach, effectiveness, adoption, implementation, and maintenance (RE-AIM) of a healthy food prescription incentive program among adults who are experiencing food insecurity and persistent hyperglycemia through three concurrent studies; a randomized controlled trial, an implementation study, and a modelling study.

The randomized controlled trial will examine the effectiveness of a healthy food prescription incentive program compared to a healthy food prescription alone in reducing blood glucose levels among adults who are experiencing food insecurity and persistent hyperglycemia.

详细描述

It is vital for individuals with type 2 diabetes (T2DM) to adhere to a healthy dietary pattern to maintain optimal blood glucose levels and overall health. However, the increasing costs of healthy foods is a barrier to maintaining healthful dietary patterns, particularly for individuals with T2DM who are experiencing food insecurity (i.e., inadequate or insecure access to food due to financial constraints). Lower diet quality may result in difficulties maintaining optimal blood glucose levels, leading to higher rates of diabetes complications, and increased acute care usage and costs.

Although the adverse impact of food insecurity on maintaining optimal blood glucose levels is well documented, effective strategies to address food insecurity among individuals with T2DM are lacking. One approach to address this problem is to provide incentives for individuals to purchase healthy foods through healthy food prescription programs. These programs may help to reduce food insecurity and improve diet quality, thereby improving blood glucose levels and reducing diabetes complications over time.

Using a type 2 hybrid effectiveness-implementation design, we will conduct three concurrent studies (i.e. randomized controlled trial, implementation study, modelling study) to examine the reach, effectiveness, adoption, implementation, and maintenance (RE-AIM) of a healthy food prescription incentive program among adults who are experiencing food insecurity and persistent hyperglycemia. The randomized controlled trial will examine the effectiveness of a healthy food prescription incentive program compared to a healthy food prescription alone in improving blood glucose levels, quantified via hemoglobin A1C, among adults who are experiencing food insecurity and persistent hyperglycemia. Secondary outcomes include blood glucose levels quantified via fructosamine, the proportion of patients with elevated hemoglobin A1C (i.e. ≥ 8.5%), diet quality and skin carotenoid levels, intermediate clinical outcomes (blood lipids, blood pressure, BMI, waist circumference, need for anti-hyperglycemic medication/insulin) and patient-reported outcomes (psychosocial well-being, self-rated health, diabetes self-efficacy, diabetes self-management, diabetes distress, diabetes competing demands, perceived financial barriers to chronic disease care, hypoglycemic episodes, household food insecurity).

Methods: 594 adults who are experiencing food insecurity and persistent hyperglycemia (i.e., hemoglobin A1C 6.5-12%) from urban and rural primary care clinics will be randomized to a 12 month healthy food prescription incentive (n=297) or a healthy food prescription comparison group (n=297).

The healthy food prescription incentive program consists of the following two core elements: 1) The one-time healthy food prescription pamphlet is a low literacy resource comprised of a pre-printed healthy food prescription that outlines an evidence-based healthy dietary pattern; 2) The healthy food incentive provides a weekly incentive of $10.50/household member to purchase healthy foods in participating supermarkets for 12 months. The intervention will be delivered over 12 months to allow sufficient time for dietary changes to be reflected in several A1c cycles.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Single (Investigator)

盲法说明

Investigators will be blinded to group allocation during data collection.

入排标准

年龄范围
18 Years 至 85 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Adults (18-85 years) with type 2 diabetes (or diabetes of unknown etiology)
  • Persistent hyperglycemia (i.e. hemoglobin A1C 6.5-12%)
  • Are currently experiencing food insecurity and/or report that it is difficult/very difficult to make ends meet
  • Can communicate in English or have someone to translate

排除标准

  • A1c <6.5% or > 12% given the recommendation for anti-hyperglycemic treatment escalation for those with A1c>12%
  • Reside in a facility that provides meals (e.g., shelter, long-term care, prison)
  • Exhibit signs/symptoms of metabolic decompensation (weight loss, polyuria, polydipsia)
  • Diagnosis of eating disorder(s) (e.g., anorexia nervosa, bulimia)
  • Have experienced diabetic ketoacidosis or a hyperglycemic hyperosmolar emergency in the past year
  • Experienced a hypoglycemic event in the past 3 months
  • Are trying to conceive, pregnant and/or breastfeeding
  • Are currently participating in other clinical trials
  • A household member is currently or has previously participated in this trial
  • Unwilling/unable to shop in study-affiliated supermarkets for the next 12 months
  • Plan to leave for Canada for more than 2 weeks in the next 12 months
  • Unable to complete data collection at follow-up (e.g., due to moving)

研究组 & 干预措施

Subsidized Healthy Food Prescription Incentive

Experimental

Participants will receive a one-time healthy food prescription pamphlet from their healthcare provider and a weekly incentive of $10.50/household member to purchase healthy foods in supermarkets for 12 months. The list of incentive-eligible foods includes whole, minimally processed foods with little to no added fat, sugar or salt from all food groups.

干预措施: Healthy food incentive (Behavioral)

Healthy Food Prescription Comparison

Active Comparator

Participants will receive a one-time healthy food prescription pamphlet from their healthcare provider. The pamphlet closely mimics current standard of care for patients with diabetes in Alberta (i.e., nutrition counselling).

干预措施: Healthy food prescription (Behavioral)

Subsidized Healthy Food Prescription Incentive

Experimental

Participants will receive a one-time healthy food prescription pamphlet from their healthcare provider and a weekly incentive of $10.50/household member to purchase healthy foods in supermarkets for 12 months. The list of incentive-eligible foods includes whole, minimally processed foods with little to no added fat, sugar or salt from all food groups.

干预措施: Healthy food prescription (Behavioral)

结局指标

主要结局

Blood glucose levels via hemoglobin A1C

时间窗: Assessed at Baseline (0 months) and Follow-up (6 months, 12 months, 18 months)

Difference between intervention and comparison groups in blood glucose levels measured by hemoglobin A1C

次要结局

  • Blood glucose levels via elevated hemoglobin A1C(Assessed at Baseline (0 months) and Follow-up (6 months, 12 months, 18 months))
  • Blood glucose levels via fructosamine(Assessed at Baseline (0 months) and Follow-up (6 months, 12 months, 18 months))
  • Overall diet quality by Healthy Eating Index-2015 and by Healthy Eating Food Index-2019(Assessed twice at Baseline (0 months) and twice at Follow-up (6 months, 12 months, 18 months))
  • Diet quality sub-scores by Healthy Eating Index-2015 and by Healthy Eating Food Index-2019(Assessed twice at Baseline (0 months) and twice at Follow-up (6 months, 12 months, 18 months))
  • Fruit and vegetable intake via skin carotenoids(Assessed at Baseline (0 months) and Follow-up (12 months))
  • Blood Lipids(Assessed at Baseline (0 months) and Follow-up (12 months))
  • Waist Circumference(Assessed at Baseline (0 months) and Follow-up (12 months))
  • Blood Pressure(Assessed at Baseline (0 months) and Follow-up (12 months))
  • Anti-hyperglycemic Medication/Insulin(Assessed at Baseline (0 months) and Follow-up (12 months))
  • Problem Areas in Diabetes Scale scores(Assessed at Baseline (0 months) and Follow-up (12 months))
  • EQ-5D-5L scores(Assessed at Baseline (0 months) and Follow-up (12 months))
  • Barriers to Care for People with Chronic Health Conditions scores(Assessed at Baseline (0 months) and Follow-up (12 months))
  • Health Canada's Household Food Security Survey Module scores(Assessed at Baseline (0 months) and Follow-up (6 months, 12 months, 18 months))
  • Body Mass Index(Assessed at Baseline (0 months) and Follow-up (12 months))
  • World Health Organization-5 Well-Being Scale scores(Assessed at Baseline (0 months) and Follow-up (12 months))
  • Stanford Diabetes Self-efficacy Scale scores(Assessed at Baseline (0 months) and Follow-up (12 months))
  • Diabetes Self-Management Questionnaire scores(Assessed at Baseline (0 months) and Follow-up (12 months))
  • Hypoglycemic Episodes(Assessed at Baseline (0 months) and Follow-up (12 months))
  • Diabetes Competing Demands scores(Assessed at Baseline (0 months) and Follow-up (12 months))
  • Dose-response analyses(0-12 months)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Dana Lee Olstad

Associate Professor

University of Calgary

研究点 (2)

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