Recruitment

Recruitment Status
Not yet recruiting
Estimated Enrollment
Same as current

Summary

Conditions
Diabetes
Type
Interventional
Phase
Not Applicable
Design
Allocation: RandomizedIntervention Model: Parallel AssignmentIntervention Model Description: A randomized controlled trial of meal delivery services designed to improve diabetic blood sugar control.Masking: Single (Investigator)Masking Description: The research team member collecting data will be blinded to the participant randomization status.Primary Purpose: Health Services Research

Participation Requirements

Age
Between 50 years and 85 years
Gender
Both males and females

Description

We are partnering with Meals on Wheels (MoW) of Austin to provide the meals and delivery service for this study. Everything MoW does will be routine for the organization. UT research personnel will provide informed consent and collect all study measures. Participants must be willing to undergo the b...

We are partnering with Meals on Wheels (MoW) of Austin to provide the meals and delivery service for this study. Everything MoW does will be routine for the organization. UT research personnel will provide informed consent and collect all study measures. Participants must be willing to undergo the background check in order to participate, but they do not need to "pass" the background check to participate and receive services. MoW will call people on the "interested" list and ask their standard new client questions related to MoW services. One of these questions includes medical conditions. If an individual states that he or she has diabetes, the MoW caseworker will notify them of the research study (see script) and ask if they would be interested in participating. If the potential participant indicates that they would be interested, MoW will contact the UT research team to call and schedule a time to obtain consent and screen the individual for enrollment. If the participant meets enrollment qualifications they will be randomized to intervention (6 months of medically tailored meals delivered by a MoW volunteer/driver) or control (remain on the interest list and receive regular MoW services when they reach the top of the list). Participants in the treatment arm will receive 1 ready-to-eat and 1 frozen medically tailored meal delivered by MoW volunteers/drivers Monday through Friday. Individuals in the control arm will not initially receive MoW services but will remain on the MoW interest list and receive services based on the normal progression through this list. At the end of the 6-month study period, individuals in the intervention group will receive Meals on Wheels regular services or return to their position on the interest list (names will remain on the list and move up while on intervention allowing for no loss in "place" in the line). Main Outcome Measures - HbA1c level. We will collect HbA1c at five points in time: baseline, 3, 6, 9 and 12 months. Based on previous research we anticipate that the proposed sample size for this study will provide adequate power to detect a difference in measured HbA1c levels between 2 groups. Secondary Outcome Measures - healthcare utilization, self-efficacy, nutritional status and food security, depression, anxiety, loneliness, resilience, health status and quality of life, self-reported disability, and satisfaction.

Tracking Information

NCT #
NCT04277117
Collaborators
Not Provided
Investigators
Principal Investigator: Maninder K Kahlon, PhD University of Texas at Austin