Lifestyle Intervention for Preventing Type 2 Diabetes

(PT2T Trial)

Overseen By Elizabeth Z Beaulieu, B.S.

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Utah

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 12 months

324 Participants Needed

Trial Summary

What is the purpose of this trial?

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

Research Team

Katherine JW Baucom, PhD

Principal Investigator

University of Utah

Eligibility Criteria

This trial is for adults at risk of type 2 diabetes, including those with prediabetes, obesity, or polycystic ovary syndrome. Couples where one partner meets these conditions can join to test if support from a romantic partner helps in preventing diabetes through lifestyle changes.

Inclusion Criteria

My partner and I are both 18 years old or older.

My partner and I are both willing to participate in the study.

Target partner is eligible for the National DPP per CDC eligibility requirements

Exclusion Criteria

Target partner have previously participated in the National DPP

Either partner have a low level of relationship commitment

My partner or I feel uncomfortable participating in treatments together.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants engage in a couple-based lifestyle intervention to prevent type 2 diabetes, focusing on lifestyle changes and perceived partner support.

12 months

Monthly visits (in-person or virtual)

Follow-up

Participants are monitored for safety and effectiveness after treatment, with assessments of lifestyle factors, health outcomes, and relationship functioning.

2 months

Extension

Participants may continue to engage in lifestyle interventions to maintain and enhance health outcomes.

Long-term

Treatment Details

Interventions

• PreventT2 Together

Trial Overview The study tests two programs: 'PreventT2', an individual lifestyle intervention, and 'PreventT2 Together', a couple-based version. It aims to see if having a partner's support improves the effectiveness of the program in preventing type 2 diabetes.

Participant Groups

Group I: Couple-based intervention condition Experimental Treatment 1 Intervention

"PreventT2 Together" (couple-based adaptation of PreventT2; approved by the CDC in November 2022 as an Alternate Curriculum for use in the National DPP)

Group II: Individual intervention condition Active Control 1 Intervention

"PreventT2" individual lifestyle intervention curriculum (2021 revised National DPP curriculum, freely available from the CDC)

Who Is Running the Clinical Trial?

University of Utah

Lead Sponsor

Trials

1,169

Recruited

1,623,000+

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Collaborator

Trials

2,513

Recruited

4,366,000+