NCT05695170

Couple-Based Lifestyle Intervention to Prevent Type 2 Diabetes

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 28 (actual)
• Sponsor: University of Utah · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• PreDiabetes
• Prediabetic State
• Overweight and Obesity

Interventions

Type	Name	Description
BEHAVIORAL	PreventT2 (Individual intervention)	PreventT2 will be delivered by a team of trained CDC Lifestyle Coaches to adults at high risk for diabetes. The 2021 version of the curriculum that will be used is freely available from the CDC. The intervention will be delivered in the context of the University of Utah National Diabetes Prevention Program (DPP), which has "full" recognition from the CDC based on outcome data over the course of a number of years.
BEHAVIORAL	PreventT2 Together (Couple-based intervention)	PreventT2 Together will be delivered by a team of trained CDC Lifestyle Coaches to adults at high risk for diabetes and their partners. The curriculum was developed with the input of a community advisory board and was approved by the CDC for use in the National DPP (i.e., meets CDC Diabetes Prevention Recognition Program Standards, including 22+ classes delivered over the course of 12 months and targeting lifestyle changes to prevention type 2 diabetes). In contrast to PreventT2, the intervention includes content specific to couples with prompts encouraging partners to consider and discuss how they can best support one another, information about lifestyle intervention in a relationship context, and examples demonstrating how couples collaborated to make healthy lifestyle changes.

Timeline

• Start date: 2022-12-14
• Primary completion: 2024-03-26
• Completion: 2024-04-02
• First posted: 2023-01-23
• Last updated: 2024-08-15

Locations

1 site across 1 country: United States