Recruiting

Lifestyle Intervention

Sponsor:

University of Utah

Code:

NCT06690788

Conditions

Prediabetic State

Life Style

Intervention Study

Social Support

Physical Activity

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Interventions

Individual intervention condition (PreventT2)

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)

Study Details

Brief summary:

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

Conditions

Prediabetic State

Life Style

Intervention Study

Social Support

Physical Activity

Study ID

NCT06690788

Start date

Mar 6, 2025

Status verified date

Oct, 2026

Completion date

Nov, 2028

Anticipated

Primary completion date

Nov, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Inclusion Criteria:

1. "Target partner" is eligible for the National DPP per CDC eligibility requirements:

  • BMI ≥ 25 kg/m² (≥ 23 kg/m² if Asian American), and
  • Do not have a diagnosis of type 1 or type 2 diabetes, and
  • Not currently pregnant, and
  • High risk for type 2 diabetes based on: (i) CDC Prediabetes Risk Test score ≥ 5, (ii) clinically diagnosed Gestational Diabetes during a previous pregnancy (for women), or (iii) a blood test result indicative of prediabetes in the past year (i.e., fasting blood glucose 100-125 mg/dl; plasma glucose 140-199 mg/dl measured 2 hours after a 75 g glucose load; or HbA1c 5.7%-6.4%).
2. The couple has lived together for 1+ years.
3. Both partners are willing to participate in the research.
4. Both partners are at least 18 years old.
5. Both partners are fluent in English.

EXCLUSION CRITERIA:

1. "Supporting partner" has a diagnosis of Type 2 Diabetes.
2. Either partner:

  • Has a diagnosis of another chronic disease (unless no major events/changes for 3+ months), or
  • Is currently on medication or engaged in lifestyle intervention for prediabetes or obesity, or
  • Has previously participated in the National DPP, or
  • Reports discomfort participating in a lifestyle program with their partner, or
  • Reports a low level of relationship commitment (i.e., "4" or lower on a scale from 1 (do not agree at all) to 7 (agree completely) on the item "I want this relationship to stay strong no matter what rough times we encounter."; Owen et al., 2011).

Study Design

Enrollment

324 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Prevention

Interventions and Outcome Measures

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)

Interventions

Individual intervention condition (PreventT2)

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)

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.

Primary outcome measure

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

Central Contacts and Locations

Central contacts

Elizabeth Z Beaulieu, B.S.

801-696-3757elizabeth.beaulieu@psych.utah.edu

Katherine JW Baucom, PhD

katherine.baucom@psych.utah.ed

Locations

University of Utah

Recruiting

Salt Lake City, Utah, United States, 84112

Contacts

Elizabeth Z Beaulieu, BS

801-696-3757heartlab@psych.utah.edu

More Information

Sponsor

University of Utah

Last update posted

Oct 16, 2026

Last verified

Oct, 2026

Keywords

  • Lifestyle Intervention
  • Prevention
  • Social Support
  • Couple Relationships

Trial information was received from ClinicalTrials.gov and was last updated on 2026-10-17. This information was provided to ClinicalTrials.gov by University of Utah on 2026-10-16. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.