Clinical trial

PreventT2 Together: Examining the Efficacy of Couple-based Lifestyle Intervention to Prevent Type 2 Diabetes

Recruiting now · Not applicable · 1 countries · Registry ID NCT06690788

Recruiting nowNot applicableInterventional

What this study 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

A promising-looking record is not the same as confirmed eligibility. The study team must review the full criteria and current recruitment status.

Basic eligibility

Age18 Years to Not listed

SexAll

Healthy volunteersAccepted

ConditionPrediabetic State, Life Style, Intervention Study, Social Support, Physical Activity, Obesity

Full registry criteria

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).

Treatments and study arms

Individual intervention condition (PreventT2)

Behavioral

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)

Behavioral

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 outcomes

Percent of target partners achieving clinically meaningful increases in Moderate to Vigorous Physical Activity (MVPA)14 months

International Physical Activity Questionnaire (IPAQ)-7 day (Pre-Intervention, Post-Intervention) and a 7-day At-Home accelerometer assessment (Pre-Intervention, Post-Intervention). International Physical Activity Questionnaire (IPAQ)-7 day (Monthly during Intervention). Among participants attending intervention classes, starting at the fourth class minutes of moderate-to-vigorous physical activity (MVPA) over the past week will be reported to Lifestyle Coaches. International Physical Activity Questionnaire (IPAQ) questionnaires assess self-reported walking, moderate intensity, and vigorous intensity physical activity as well as overall sedentary time. Accelerometers provide objective assessments of these constructs. Intervention class participants self-report the total number of Moderate to Vigorous Physical Activity (MVPA) minutes over the previous week.

Study locations

1 locations were listed when this page was built. The first 40 are shown.

University of Utah🇺🇸 Salt Lake City, Utah, United States

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Elizabeth Z Beaulieu, BSContact

Email · Call 801-696-3757

Katherine JW Baucom, PhDContact