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

Must not be taking: Prediabetes, Obesity medications

Disqualifiers: Type 2 diabetes, Chronic disease, others

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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to evaluate how well a lifestyle program, called PreventT2 Together, can prevent type 2 diabetes by encouraging couples to make healthy changes together. It explores whether support from a romantic partner can help sustain these changes. Participants are divided into two groups: one where couples work together on the program and another where individuals participate solo. This trial may suit couples who have lived together for over a year, with one partner at risk for type 2 diabetes but not yet diagnosed. As an unphased trial, it offers a unique opportunity for couples to proactively manage health together and potentially prevent type 2 diabetes.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but you cannot participate if you are currently on medication for prediabetes or obesity.

What prior data suggests that this lifestyle intervention is safe for preventing type 2 diabetes?

Research has shown that the PreventT2 Together program is based on a plan approved by the CDC to help prevent type 2 diabetes. Although specific safety data is not available, the CDC's approval suggests it is generally safe and well-tolerated. The program emphasizes lifestyle changes, such as healthier eating and increased exercise, which are typically safe for most people. Since it does not involve medication, there are often fewer safety concerns. Designed for couples, the program can enhance support and motivation between partners, improving the experience without adding risks. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the PreventT2 Together program because it offers a unique approach to preventing type 2 diabetes by focusing on couples working together. Unlike standard individual interventions like the PreventT2 program, this couple-based method leverages social support to encourage lifestyle changes, potentially enhancing motivation and adherence. This approach could lead to more effective and sustained lifestyle changes, offering a fresh angle compared to traditional individual-focused interventions.

What evidence suggests that this trial's treatments could be effective for preventing type 2 diabetes?

Research shows that lifestyle changes can greatly lower the risk of developing type 2 diabetes. In this trial, participants will join one of two treatment arms. The "PreventT2 Together" program, part of the couple-based intervention condition, encourages couples to make these changes together with partner support. Although specific results for this program are still being collected, similar programs have shown positive outcomes. These programs often help individuals become more active and eat healthier. By involving partners, "PreventT2 Together" aims to sustain these lifestyle changes by boosting motivation and support. ^{1 2 3 4 5}

Who Is on the Research Team?

Katherine JW Baucom, PhD

Principal Investigator

University of Utah

Are You a Good Fit for This Trial?

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

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

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

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT05695170

Couple-Based Lifestyle Intervention to Prevent Type 2 ... Data will be collected on: feasibility, background, health behaviors, physical and mental health, and relationship functioning. Detailed Description. The goal ...

2. our.utah.edu our.utah.edu/spur/preventt2-together-examining-the-efficacy-of-couple-based-lifestyle-intervention-to-prevent-type-2-diabetes/

PreventT2 Together: Examining the Efficacy of Couple-Based ... Our on-going 5-year project (2024-2029) examines the efficacy of PreventT2 Together in increasing physical activity among individuals at high risk for type 2 ...

3. trialx.com trialx.com/clinical-trials/listings/298344/preventt2-together-examining-the-efficacy-of-couple-based-lifestyle-intervention-to-prevent-type-2-diabetes/?&geo_lat=40.6668916&geo_lng=-111.8879909&radius=10&place=Murray&user_country=United%20States

PreventT2 Together: Examining the Efficacy of Couple ... If efficacious, PreventT2 Together has the potential to impact individuals and their romantic partners' quality of life and ultimately improve ...

4. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/36797025/

Couple-based lifestyle intervention to prevent type 2 diabetes The randomised pilot trial protocol described in this manuscript will evaluate a couple-based lifestyle intervention to prevent type 2 diabetes.

5. bmjopen.bmj.com bmjopen.bmj.com/content/13/2/e068623

Couple-based lifestyle intervention to prevent type 2 diabetes The randomised pilot trial protocol described in this manuscript will evaluate a couple-based lifestyle intervention to prevent type 2 diabetes.