Delivering Health: Addressing Diabetes and Food Insecurity

Not Applicable

Completed

Conditions: Food Insecurity
Diabetes Mellitus, Type 2

Interventions: Behavioral: Type 2 Diabetes Appropriate Food Boxes + Diabetes Education

Registration Number: NCT04831216

Lead Sponsor: University of Arkansas

Brief Summary: The goal of this study was to develop, implement, and evaluate the effectiveness of an intervention to use home-delivery of Type 2 diabetes (T2D)-appropriate food boxes with plain language adapted education materials to improve the nutritional health, physical activity, and health outcomes of low-income food insecure people with T2D in northwest Arkansas.

Detailed Description: Background and Rationale

Decades of increasing incidence of type 2 diabetes (T2D) present a multifaceted challenge to the health of a growing number of Americans, affecting their diets and how they live life. Approximately 30 million (\~9%) of all people in the US have T2D, and this number is expected to continue to rise. At the same time, 15 million (11.8%) US households experience food insecurity, which is associated with risk for T2D and other chronic diseases. Both T2D and food insecurity are even more prevalent in Arkansas, with rates of T2D and food insecurity at 12.2% and 17.3%, respectively.

Approximately 46 million Americans per year turn to food pantries and related programs to help meet household nutritional needs. However, food pantries are not a long-term solution to improve health for food insecure people with T2D. Most food pantries do not provide food of sufficient dietary quality to support a healthy lifestyle.

Diabetes self-management education (DSME) is an approach with documented efficacy in helping people manage T2D. DSME supports informed decision-making, encourages goal setting and problem solving, and improves self-care behaviors. Recent studies have shown promise for DSME among food pantry clients with T2D. However, studies have suffered from problems with attendance and retention.

We designed a study to develop and evaluate the efficacy of a plain-language DSME curriculum to improve the nutritional health, physical activity, and health outcomes of low-income food insecure people with T2D. We home-delivered this curriculum along with T2D-appropriate healthy food boxes to mitigate difficulties associated with access to healthy food and attendance at DSME sessions outside of the home. We hypothesized that this approach will lead to improvements in participants' glycemic control, diet quality, and other outcomes.

Study Population Up to 110 study participants will be recruited from food pantries located in Benton and Washington Counties in northwest Arkansas.

Inclusion Criteria:

* 18 years of age or older

* Food insecure (confirmed with adapted 10-item screener)

* HbA1c levels of ≥7%

Exclusion Criteria:

* Conditions making it unlikely the participant will be able to follow the protocol, such as terminal illness, non-ambulatory, severe mental illness, severely impaired vision or hearing, eating disorder, or plans to move out of the geographic region

* Pregnant

* Only one adult per household will be enrolled

Study Design and Procedures For each participant, participation took place over 22 weeks (Weeks 1-4: Pre-intervention data collection; Weeks 5-16: Intervention; Weeks 17-22: Post-intervention data collection). Data collection took place at pre-intervention and post-intervention for each participant. At enrollment (i.e., pre-intervention) and one week after the 12th food box delivery (i.e. post-intervention), participants provided data on glycemic control (measured by HbA1c), physical activity, body mass index (BMI), T2D self-management behaviors, T2D knowledge, T2D self-efficacy, and food security. To enhance the study's significance in characterizing the diet patterns and fruit and vegetable consumption of low-income food insecure people with T2D, we collected extensive diet quality data measures pre-intervention and post-intervention.

Data Analysis To examine the intervention's effect on the primary outcomes of glycemic control as measured by HbA1c and diet quality as measured by Healthy Eating Index-2015 (HEI) scores, we used mixed effects regression models for repeated measures. These analyses focused on testing for a statistically significant difference between pre-intervention versus post-intervention measures. Analyses included relevant covariates such as sex or age.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 101

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

Study Type: INTERVENTIONAL

Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Type 2 Diabetes Appropriate Food Boxes + Diabetes Education	Type 2 Diabetes Appropriate Food Boxes + Diabetes Education	All participants will be assigned to a single intervention arm. The intervention includes weekly delivery of type 2 diabetes-appropriate food boxes that include diabetes self-management education materials.

Primary Outcome Measures

Name	Time	Method
Hemoglobin A1c (HbA1c), %	Baseline; immediate post-intervention (approx. 20 weeks)	A Siemens analyzer was utilized to measure HbA1c (%) via finger stick blood collection.

Secondary Outcome Measures

Name	Time	Method
Type 2 Diabetes Self-Management Behaviors - Medication Adherence	Baseline; immediate post-intervention (approx. 20 weeks)	The Summary of Diabetes Self-Care Activities (SDSCA) was used to assess self-management behaviors. The SDSCA is used to assess how well individuals with diabetes manage their condition by measuring the frequency (number of days) of their self-care practices like diet, exercise, blood glucose monitoring, and foot care over the past seven days. The Medication Adherence subscale is 2 items assessing how many days participants adhered to taking recommended diabetes medications (0-7 days per week).
Diet Quality	Baseline; immediate post-intervention (approx. 20 weeks)	Total skin carotenoid level was measured using a Veggie Meter optical skin scanner using Raman Spectroscopy. The Veggie Meter produces a score from 0 to 800, with higher scores indicating greater skin carotenoid levels, which suggest a greater intake of fruits and vegetables.
Diet Quality (2)	Baseline; immediate post-intervention (approx. 20 weeks)	24 hour dietary recalls was collected using the Nutrition Data System for Research (NDSR). NDSR was used to calculate Healthy Eating Index-2015 (HEI) scores. HEI is a metric used to assess the quality of a person's diet by comparing their food intake to the Dietary Guidelines for Americans, with a higher score indicating a diet that more closely aligns with recommended nutritional guidelines. HEI scores range from 0 to 100, where a higher score is better.
Body Mass Index (BMI)	Baseline; immediate post-intervention (approx. 20 weeks)	Weight and height was used to compute a continuous measure of BMI (kilograms per square meter).
Chronic Diseases	Baseline; immediate post-intervention (approx. 20 weeks)	Self-report items from the Behavioral Risk Factor Surveillance System (BRFSS) survey assessed lifetime prevalence of chronic diseases.
Type 2 Diabetes Self-Management Self-Efficacy	Baseline; immediate post-intervention (approx. 20 weeks)	Self-efficacy for self-management of type 2 diabetes was assessed using the eight item Diabetes Self-Efficacy Scale (DSES). The DSES assesses confidence in a person's perceived capability to perform necessary type 2 diabetes self-care activities including, maintaining healthy diet, engaging in exercise, and performing blood sugar monitoring (0, Not at all confident to 10, Totally confident). The score for the scale is the mean of the eight items, producing a range of scores of 0-10, with higher scores indicating higher levels of confidence to perform diabetes self-management activities.
Oral Health	Baseline; immediate post-intervention (approx. 20 weeks)	Oral health was assessed by a single self-report item from the BRFSS, asking length of time since a dental cleaning ("Within the past year=1; Within the past 2 years=2; Within the past 5 years=3; 5 or more years ago=4; Never=5"). A lower score indicates a better outcome (more recent dental cleaning).
Type 2 Diabetes-related Distress	Baseline; immediate post-intervention (approx. 20 weeks)	Psychological distress related to type 2 diabetes was assessed using the Problem Areas in Diabetes 5-item scale (PAID-5) scale. The PAID-5 is used to assess the emotional distress related to living with type 2 diabetes, consisting of five questions that focus on feelings like fear, depression, worry about future complications, feeling overwhelmed by diabetes management, and coping with diabetes complications; essentially measuring the psychological impact of managing diabetes on a person's daily life (0, Not a problem to 4, Serious problem). The sum of the items produces a total score that ranges from 0-20, with lower scores indicating less distress.
Food Security	Baseline	Food security was assessed using the Hunger Vital Sign two-question screening tool. Food security was not assessed at post-intervention, therefore no data can be reported for this measure.
Food Pantry Utilization	Baseline; immediate post-intervention (approx. 20 weeks)	Food pantry utilization was assessed through a single survey item adapted from Feeding America's Hunger in America survey. The item asked how many times the participant got food from a food pantry in the past 30 days.
Medication Adherence	Baseline; immediate post-intervention (approx. 20 weeks)	Type 2 diabetes medication adherence was collected using responses to six items (0, No; 1, Yes) from the National Health Interview Survey (NHIS). The survey items assess how well individuals with diabetes adhered to their prescribed medication regimen, specifically by measuring whether they are taking medications correctly and refilling prescriptions as directed versus using non-adherence strategies to lower the cost of their medications (e.g., skipping doses, taking less medicine than prescribed, delaying filling prescriptions). Scores ranged from 0-6, with lower scores on the scale indicating a better outcome (e.g., better adherence to medication regimens).
Cooking Skills and Knowledge (1)	Baseline	Cooking skills and knowledge were assessed using two items. The first item asks "How confident do you feel being able to cook from raw or basic ingredients?" Response options include "Not confident at all; Somewhat confident; and Completely confident". Cooking skills and knowledge were not assessed at post-intervention, therefore no data can be reported for this measure.
Cooking Skills and Knowledge (2)	Baseline	Cooking skills and knowledge were assessed using two items. The second item asks "How confident do you feel about following a simple recipe?" Response options include "Not confident at all; Somewhat confident; and Completely confident". Cooking skills and knowledge were not assessed at post-intervention, therefore no data can be reported for this measure.
Type 2 Diabetes Self-Management Behaviors - General Diet	Baseline; immediate post-intervention (approx. 20 weeks)	The Summary of Diabetes Self-Care Activities (SDSCA) was used to assess self-management behaviors. The SDSCA is used to assess how well individuals with diabetes manage their condition by measuring the frequency (number of days) of their self-care practices like diet, exercise, blood glucose monitoring, and foot care over the past seven days. The General Diet subscale is 2 items assessing how many days participants adhered to a diet plan (0-7 days per week).
Type 2 Diabetes Self-Management Behaviors - Specific Diet	Baseline; immediate post-intervention (approx. 20 weeks)	The Summary of Diabetes Self-Care Activities (SDSCA) was used to assess self-management behaviors. The SDSCA is used to assess how well individuals with diabetes manage their condition by measuring the frequency (number of days) of their self-care practices like diet, exercise, blood glucose monitoring, and foot care over the past seven days. The Specific Diet subscale is 2 items assessing how many days participants ate certain types of foods (0-7 days per week).
Type 2 Diabetes Self-Management Behaviors - Exercise	Baseline; immediate post-intervention (approx. 20 weeks)	The Summary of Diabetes Self-Care Activities (SDSCA) was used to assess self-management behaviors. The SDSCA is used to assess how well individuals with diabetes manage their condition by measuring the frequency (number of days) of their self-care practices like diet, exercise, blood glucose monitoring, and foot care over the past seven days. The Exercise subscale is 2 items assessing how many days participants engaged in exercise (0-7 days per week).
Type 2 Diabetes Self-Management Behaviors - Blood Glucose Testing	Baseline; immediate post-intervention (approx. 20 weeks)	The Summary of Diabetes Self-Care Activities (SDSCA) was used to assess self-management behaviors. The SDSCA is used to assess how well individuals with diabetes manage their condition by measuring the frequency (number of days) of their self-care practices like diet, exercise, blood glucose monitoring, and foot care over the past seven days. The Blood Glucose Testing subscale is 2 items assessing how many days participants tested their blood sugar (0-7 days per week).
Type 2 Diabetes Self-Management Behaviors - Foot Care	Baseline; immediate post-intervention (approx. 20 weeks)	The Summary of Diabetes Self-Care Activities (SDSCA) was used to assess self-management behaviors. The SDSCA is used to assess how well individuals with diabetes manage their condition by measuring the frequency (number of days) of their self-care practices like diet, exercise, blood glucose monitoring, and foot care over the past seven days. The Foot Care subscale is 2 items assessing how many days participants performed a foot check and inspected the inside of their shoes (0-7 days per week).
Type 2 Diabetes Self-Management Behaviors - Smoking	Baseline; immediate post-intervention (approx. 20 weeks)	The Summary of Diabetes Self-Care Activities (SDSCA) was used to assess self-management behaviors. The SDSCA is used to assess how well individuals with diabetes manage their condition by measuring the frequency (number of days) of their self-care practices like diet, exercise, blood glucose monitoring, and foot care over the past seven days. Smoking was assessed using a single yes/no item.