PreventT2 Together: Examining the Efficacy of Couple-based Lifestyle Intervention to Prevent Type 2 Diabetes
PT2T
2 other identifiers
interventional
324
1 country
1
Brief Summary
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Mar 2025
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 12, 2024
CompletedFirst Posted
Study publicly available on registry
November 15, 2024
CompletedStudy Start
First participant enrolled
March 6, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2028
ExpectedStudy Completion
Last participant's last visit for all outcomes
November 1, 2028
May 30, 2025
May 1, 2025
3.7 years
August 12, 2024
May 28, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Percent of target partners achieving clinically meaningful increases in Moderate to Vigorous Physical Activity (MVPA)
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.
14 months
Secondary Outcomes (6)
HbA1c
14 months
Weight
14 months
Stress
14 months
Nutrition
14 months
Sleep
14 months
- +1 more secondary outcomes
Other Outcomes (17)
Anxiety
14 months
Depression
14 months
Fatigue
14 months
- +14 more other outcomes
Study Arms (2)
Individual intervention condition
ACTIVE COMPARATOR"PreventT2" individual lifestyle intervention curriculum (2021 revised National DPP curriculum, freely available from the CDC)
Couple-based intervention condition
EXPERIMENTAL"PreventT2 Together" (couple-based adaptation of PreventT2; approved by the CDC in November 2022 as an Alternate Curriculum for use in the National DPP)
Interventions
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.
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.
Eligibility Criteria
You may qualify if:
- "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.
You may not qualify if:
- "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).
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of Utah
Salt Lake City, Utah, 84112, United States
Related Publications (2)
Aguirre MC, Brown H, Gershenoff D, Hinton KL, Huntzinger OM, Klein N, Ramos C, Tavake-Pasi OF, Witte B, Wolfsfeld M, Sher T, Simmons DL, Smith TW, Clark L, Baucom KJW. The Role of Advocacy in Adapting the Diabetes Prevention Program for Couple-Based Delivery That Reaches Marginalized Groups. Behav Ther (N Y N Y). 2020 Oct;43(7):261-265. No abstract available.
PMID: 33536698BACKGROUNDWhitaker M, Aguirre MC, Gutierrez Chavez M, Beaulieu E, Arones YB, Gershenoff D, Hinton K, Klein N, Munezerou Uwizeye J, Napia E, Ramos C, Tavake-Pasi OF, Villalta J, Wolfsfeld C, Witte B, Maxfield E, Raphael K, Simmons DL, Clark L, Sher T, Smith TW, Baucom KJ. Couple-based lifestyle intervention to prevent type 2 diabetes: protocol for a randomised pilot trial. BMJ Open. 2023 Feb 16;13(2):e068623. doi: 10.1136/bmjopen-2022-068623.
PMID: 36797025BACKGROUND
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Katherine JW Baucom, PhD
University of Utah
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Assistant Professor
Study Record Dates
First Submitted
August 12, 2024
First Posted
November 15, 2024
Study Start
March 6, 2025
Primary Completion (Estimated)
November 1, 2028
Study Completion (Estimated)
November 1, 2028
Last Updated
May 30, 2025
Record last verified: 2025-05
Data Sharing
- IPD Sharing
- Will not share