Couple-Based Lifestyle Intervention to Prevent Type 2 Diabetes

Status Completed

Clinical Trial Summary

The goal of this randomized pilot clinical trial is to describe the feasibility of a couple-based lifestyle intervention and the study protocol in preparation for a future definitive randomized clinical trial. Participants include individuals at risk for type 2 diabetes and their romantic partners. The main objectives are: 1. To describe the feasibility of the couple-based intervention. 2. To describe the feasibility of the study protocol for use in a definitive trial. Participating couples will be randomized to one of two year-long lifestyle intervention conditions: an individual curriculum or a couple-based curriculum. Participants will complete assessments before and after the year-long intervention, as well as monthly during the intervention. Data will be collected on: feasibility, background, health behaviors, physical and mental health, and relationship functioning.

Clinical Trial Description

The goal of this randomized pilot clinical trial is to describe the feasibility of a couple-based lifestyle intervention and the study protocol in preparation for a future definitive randomized clinical trial. Participants include individuals at risk for type 2 diabetes and their romantic partners. Prior to all study procedures, eligible participants will be required to complete an informed consent process and electronically sign a consent document. 12 eligible couples will be randomly assigned to either an individual lifestyle intervention (PreventT2) or a couple-based adaptation designed with input from a community advisory board (PreventT2 Together) (1:1). Both curricula have CDC approval for use in the National DPP and are delivered to small groups of participants over the course of 12 months. Across conditions, participants will complete assessments before and after the year-long intervention, as well as monthly during the intervention. Data will be collected on: feasibility, background, health behaviors, physical and mental health, and relationship functioning. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT05695170
Study type	Interventional
Source	University of Utah
Contact
Status	Completed
Phase	N/A
Start date	December 14, 2022
Completion date	April 2, 2024

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