PreventT2 Together: Examining the Efficacy of Couple-based Lifestyle Intervention to Prevent Type 2 Diabetes

Part of paid clinical trials in Salt Lake City, Utah.

Sponsor
University of Utah
Study ID
NCT06690788
Status
Recruiting

Conditions

  • Intervention Study
  • Life Style
  • Obesity
  • Physical Activity
  • Prediabetic State
  • Social Support

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Accepted

Interventions

  • Individual intervention condition (PreventT2) — BEHAVIORAL
    PreventT2 will be delivered by a team of trained CDC National Diabetes Prevention Program (NDPP) Lifestyle Coaches to adults at high risk for diabetes. The 2021 version of the lifestyle intervention curriculum to be used is freely available from the CDC. The intervention will be delivered in the context of the University of Utah National DPP, which has Full recognition from the CDC based on outcome data over the course of a number of years.
  • Couple-based intervention condition (PreventT2 Together; couple-based adaptation of 2021 PreventT2; approved by the CDC in November 2022 as an Alternate Curriculum for use in the NDPP) — BEHAVIORAL
    PreventT2 Together will be delivered by a team of trained CDC National DPP Lifestyle Coaches to adults at high risk for diabetes and their partners. The lifestyle intervention curriculum was developed with the input of a community advisory board and was approved by the CDC for use in the National DPP (Diabetes Prevention Program) (i.e., meets CDC Diabetes Prevention Recognition Program Standards, including 22+ classes delivered over the course of 12 months and targeting lifestyle changes to prevent 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.

Study Details

Nearly half of adults in the United States have or are at risk of developing type 2 diabetes. The overall goal of this community-engaged research is to examine the efficacy of an innovative couple-based lifestyle intervention to prevent type 2 diabetes that is applicable to a broad range of partnered adults in the United States. By simultaneously targeting lifestyle and perceived support from romantic partners, there is a high likelihood of creating lasting changes in both

Key Dates

Start date
Mar 6, 2025
Status verified
May 2025
Primary completion
Nov 30, 2028
Completion
Nov 30, 2028

Study Design

Enrollment
324 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION

Arms

  • Active Comparator: Individual intervention condition
    "PreventT2" individual lifestyle intervention curriculum (2021 revised National DPP curriculum, freely available from the CDC)
  • Experimental: Couple-based intervention condition
    "PreventT2 Together" (couple-based adaptation of PreventT2; approved by the CDC in November 2022 as an Alternate Curriculum for use in the National DPP)

Primary Outcome Measure

Percent of target partners achieving clinically meaningful increases in Moderate to Vigorous Physical Activity (MVPA) [ Time Frame: 14 months ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of UtahSalt Lake CityUtah84112
Elizabeth Z Beaulieu, BS
801-696-3757
Katherine JW Baucom, PhD

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