PreventT2 Together: Examining the Efficacy of Couple-based Lifestyle Intervention to Prevent Type 2 Diabetes
Recruiting · NCT06690788 · Interventional (participants receive a specific treatment) · Lead sponsor: University of Utah
View the official record on ClinicalTrials.gov →Interventions studied
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)Individual intervention condition (PreventT2)
What this trial is about
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
Who can take part
Age range
18 Years and older
Sex
All (male and female)
Healthy volunteers
Yes - healthy volunteers may be accepted
Phase
Not applicable (e.g. observational or device study)
Study type
Interventional (participants receive a specific treatment)
Inclusion criteria
- "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%).
- The couple has lived together for 1+ years.
- Both partners are willing to participate in the research.
- Both partners are at least 18 years old.
- Both partners are fluent in English.
Exclusion criteria
- "Supporting partner" has a diagnosis of Type 2 Diabetes.
- 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).
Where it is running
1 location listed across 1 US state.
- University of Utah - Salt Lake City, Utah, United States