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Behavioural Intervention

Lifestyle Intervention for Preventing Type 2 Diabetes (PT2T Trial)

N/A

Waitlist Available

Led By Katherine JW Baucom, PhD

Research Sponsored by University of Utah

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Both partners are fluent in English

Both partners are at least 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 14 months

Awards & highlights

No Placebo-Only Group

Summary

This trial aims to study a new program to prevent type 2 diabetes in adults in the US. The program focuses on lifestyle changes and support from romantic partners to create long-lasting effects.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Since this trial focuses on lifestyle interventions like diet and exercise rather than medication, side effects are minimal but may include muscle soreness or injury from physical activity.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

My partner and I both speak English fluently.

Select...

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

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 14 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~14 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 14 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Percent of target partners achieving clinically meaningful increases in Moderate to Vigorous Physical Activity (MVPA)

Secondary study objectives

HbA1c

Nutrition

Perceived Partner Support

+3 more

Other study objectives

Additional lifestyle intervention engagement

Anxiety

Communal Coping

+14 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Couple-based intervention conditionExperimental Treatment1 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 conditionActive Control1 Intervention

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

0 / 2Eligibility criteria met