Clinical trial NCT06077162: Diabetes Nutrition Education and Healthy Food Resource for AIANs With T2D
Official title: Diabetes Nutrition Education (What Can I Eat? [WCIE]) and Healthy Food Resource for American Indians and Alaska Natives With T2D
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Type 2 Diabetes
Lead sponsor: Colorado State University
Sponsor class: OTHER
Collaborators: name: American Diabetes Association
name: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
name: University of Colorado, Denver
name: Washington State University
name: Oklahoma City Indian Clinic
name: Gretchen Swanson Center for Nutrition
name: University of North Carolina, Chapel Hill
name: University of California, Irvine
First posted: 2023-10-11
Enrollment: 67
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 3 arm RCT (nutrition education classes only, nutrition education classes + healthy food resource, healthy food resource only) - randomized at pt level, no stratification
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: Healthy nutrition habits are key to managing type 2 diabetes (T2D). However, American Indian and Alaska Natives (AI/ANs) often lack access to culturally relevant nutrition education and they disproportionately experience food insecurity. Food insecurity, defined as lack of consistent access to enough food for an active, healthy life, negatively impacts one's ability to engage in diabetes self-management and care. The purpose of this study is to evaluate if diabetes nutrition education and an added food security resource, such as farmers market vouchers for fruits and vegetables, can improve diabetes self-management for AI/ANs with T2D. Researchers will work with collaborators at the Oklahoma City Indian Clinic in Oklahoma City, OK, and an American Indian community advisory board (CAB) throughout the study to ensure the nutrition education and food security resources are designed to meet the needs of the community and clinic. With the guidance of the CAB, researchers will recruit adults with T2D to participate in a 3-month intervention. Participants will be randomized into one of 3 groups. Some people will have diabetes nutrition education and the food security resource, some will have only the diabetes nutrition education, and some will receive only the food security resource. Outcomes such as food security status and clinical diabetes health indicators will be measured at 5 timepoints. This intervention is significant to diabetes because AI/ANs experience diabetes health disparities and the combination of diabetes nutrition education plus an added food security resource could help decrease T2D complications and improve quality of life for AI/ANs.

Detailed description: Background: Healthy nutrition is key to T2D self-care and management. Culturally relevant nutrition education for American Indian and Alaska Natives (AI/Ans) is limited, contributing to diabetes health disparities, and disproportionate rates of food insecurity exacerbates these disparities.

Hypothesis: AI/ANs with T2D who receive both culturally relevant diabetes nutrition education and food security resources will have more improved outcomes (e.g., dietary intake, HbA1c) than AI/ANs with T2D who receive only diabetes nutrition education or a food security resource.

Supporting Rationale: Nutrition education improves T2D outcomes and reducing food insecurity can decrease diabetes health disparities.

Specific Aims: Aim #1: Engage an AI/AN community advisory board to support rigorous and equitable community based participatory research; Aim #2: Implement and evaluate a diabetes nutrition education and food security resource intervention in collaboration with the Oklahoma City Indian Clinic in Oklahoma City, OK.

Research Design: Three arm randomized controlled trial with: intervention group (diabetes nutrition education + food security resource); diabetes nutrition education group only; food security resource group only. Three month intervention with diabetes nutrition education and food security resource with 5 data collection timepoints: baseline, 1, 3, 6, 9 months. Outcomes include: HbA1c, blood pressure, dietary intake, diabetes distress, and food security.

Relevance to a cure, prevention and/or treatment of diabetes: Treatment of T2D among AI/ANs requires multi-level approaches to decrease health disparities related to social determinants of health such as lack of access to healthful foods. Providing both nutrition education and a food security resource could synergistically improve T2D self-management for AI/ANs

Eligibility criteria: Inclusion Criteria:

* Dx type 2 diabetes; American Indian or Alaska Native; fluent in English

Exclusion Criteria:

* Planned move within the study period

Primary outcomes:
measure: Hemoglobin A1c
timeFrame: 0, 3, 6, 9 months
Secondary outcomes:
measure: Blood pressure
timeFrame: 0, 3, 6, 9 months
measure: Body weight
timeFrame: 0, 3, 6, 9 months
measure: Food insecurity
timeFrame: 0, 3, 6, 9 months
measure: Diabetes distress
timeFrame: 0, 3, 6, 9 months
measure: Economic Quality of Life
timeFrame: 0, 3, 6, 9 months
measure: Perceived Diabetes Self Management Scale (PDSMS)
timeFrame: 0, 3, 6, 9 months
measure: What Can I Eat? Impact Survey
timeFrame: 0, 3, 6, 9 months
measure: Dietary intake - 24 hour recall
timeFrame: 0, 3 months (2 * 24 hour recalls at each timepoint = 4 * 24 hour recalls per participant)
Other outcomes:
Locations:
city: Oklahoma City
country: United States
facility: Oklahoma City Indian Clinic
state: Oklahoma
Study officials:
affiliation: Colorado State University
name: Sarah Stotz, PhD
role: PRINCIPAL_INVESTIGATOR
References: