Clinical trial NCT04831216: Delivering Health: Addressing Diabetes and Food Insecurity
Official title: Delivering Health: An Integrated Approach to Address Diabetes in the Context of Food Insecurity
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Food Insecurity
Diabetes Mellitus, Type 2
Keywords: Food insecurity
Type 2 diabetes mellitus
Nutrition
Food delivery
Lead sponsor: University of Arkansas
Sponsor class: OTHER
First posted: 2021-04-05
Enrollment: 101
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: All participants will be assigned to a single intervention arm.
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility criteria: 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

Primary outcomes:
measure: Hemoglobin A1c (HbA1c), %
timeFrame: Baseline; immediate post-intervention (approx. 20 weeks)
Secondary outcomes:
measure: Diet Quality
timeFrame: Baseline; immediate post-intervention (approx. 20 weeks)
measure: Diet Quality (2)
timeFrame: Baseline; immediate post-intervention (approx. 20 weeks)
measure: Body Mass Index (BMI)
timeFrame: Baseline; immediate post-intervention (approx. 20 weeks)
measure: Chronic Diseases
timeFrame: Baseline; immediate post-intervention (approx. 20 weeks)
measure: Type 2 Diabetes Self-Management Self-Efficacy
timeFrame: Baseline; immediate post-intervention (approx. 20 weeks)
measure: Oral Health
timeFrame: Baseline; immediate post-intervention (approx. 20 weeks)
measure: Type 2 Diabetes-related Distress
timeFrame: Baseline; immediate post-intervention (approx. 20 weeks)
measure: Food Security
timeFrame: Baseline
measure: Food Pantry Utilization
timeFrame: Baseline; immediate post-intervention (approx. 20 weeks)
measure: Medication Adherence
timeFrame: Baseline; immediate post-intervention (approx. 20 weeks)
measure: Cooking Skills and Knowledge (1)
timeFrame: Baseline
measure: Cooking Skills and Knowledge (2)
timeFrame: Baseline
measure: Type 2 Diabetes Self-Management Behaviors - General Diet
timeFrame: Baseline; immediate post-intervention (approx. 20 weeks)
measure: Type 2 Diabetes Self-Management Behaviors - Specific Diet
timeFrame: Baseline; immediate post-intervention (approx. 20 weeks)
measure: Type 2 Diabetes Self-Management Behaviors - Exercise
timeFrame: Baseline; immediate post-intervention (approx. 20 weeks)
measure: Type 2 Diabetes Self-Management Behaviors - Blood Glucose Testing
timeFrame: Baseline; immediate post-intervention (approx. 20 weeks)
measure: Type 2 Diabetes Self-Management Behaviors - Foot Care
timeFrame: Baseline; immediate post-intervention (approx. 20 weeks)
measure: Type 2 Diabetes Self-Management Behaviors - Smoking
timeFrame: Baseline; immediate post-intervention (approx. 20 weeks)
measure: Type 2 Diabetes Self-Management Behaviors - Medication Adherence
timeFrame: Baseline; immediate post-intervention (approx. 20 weeks)
Other outcomes:
Locations:
city: Fayetteville
country: United States
facility: University of Arkansas for Medical Sciences Northwest
state: Arkansas
Study officials:
affiliation: University of Arkansas
name: Krista N Langston, MBA
role: PRINCIPAL_INVESTIGATOR
References: