Prediabetic StatePT2TNCT06690788
PreventT2 Together: Examining the Efficacy of Couple-based Lifestyle Intervention to Prevent Type 2 Diabetes
A study testing Individual intervention condition (PreventT2) and 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) in people with Prediabetic State and Life Style, run by University of Utah at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Prediabetic State, Life Style, Intervention Study
- What is being tested?
- Individual intervention condition (PreventT2) and 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)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 324 participants
- Where
- 1 siteUnited States
- Study dates
- 6 Mar 2025to Nov 2028
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- "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.
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- Both partners are willing to participate in the research.
- Both partners are at least 18 years old.
- Both partners are fluent in English.
Who cannot join
- "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).
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Katherine JW Baucom, PhD contact
United States1 site, 1 recruiting
- Recruiting
University of Utah
Salt Lake City, Utah, 84112
Elizabeth Z Beaulieu, BS, 801-696-3757, heartlab@psych.utah.edu
Katherine JW Baucom, PhD
About this study
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
Read the detailed description
Nearly half of U.S. adults have or are at risk of developing type 2 diabetes. Lifestyle intervention is efficacious and the first line of prevention among adults at high risk for type 2 diabetes. Unfortunately, outcomes in real-world settings do not approach the initial efficacy trial findings, in part due to low rates of retention in the intervention. Real-world programs have particularly struggled to retain participants who identify as members of racial/ethnic groups that are disproportionately affected by type 2 diabetes, potentially exacerbating health disparities. Given the strong influence romantic partners have on one another and the shared environment, in which couples typically live, lifestyle interventions that systematically include romantic partners have the potential to address the research-practice gap. The purpose of this project is to examine the efficacy of PreventT2 Together, a couple-based lifestyle intervention our team developed. The specific aims of the research are: (1) to determine the efficacy of PreventT2 Together in a single-center, randomized clinical trial,(2) to examine baseline relationship satisfaction as a moderator and perceived partner support as a mechanism of lifestyle change, and (3) to quantify intervention retention and describe reach across recruitment methods. The investigators will recruit 162 couples (i.e., adults at high risk for type 2 diabetes and their romantic partners)from community and healthcare settings, over-sampling members of racial/ethnic minority groups. The investigators will randomize participating couples to individual (PreventT2; delivered only to partners at high risk) or couple-based (PreventT2 Together; delivered to couples) lifestyle intervention conditions. HbA1c and objectively measured moderate to vigorous physical activity (MVPA) will be collected from all participants at baseline (Pre)and at the end of the 1-year intervention (Post). Participants will also report on lifestyle factors, health outcomes, and relationship functioning at each of 13-time points (Pre, monthly, during the intervention, and post). The investigators focus on the patient-centered minimum clinically important difference (MCID) in outcomes, including objectively-measured MVPA (primary outcome), as well as other aspects of lifestyle (nutrition, sleep), health outcomes (HbA1c, weight loss, stress), and relationship functioning (perceived partner support) (secondary outcomes). Situating lifestyle intervention within the romantic relationship context in which lifestyle change occurs is likely to increase reach and improve retention and lifestyle change outcomes in real-world settings. Our community-engaged approach to the development of the intervention and design of the proposed project will ensure broad applicability and dissemination of results across communities, including racial/ethnic minority groups that have not been effectively reached and retained. CDC review and approval of PreventT2 Together for use as an alternate curriculum in the National Diabetes Prevention Program (National DPP) delivered across the U.S. underscores the scalability of the intervention. If efficacious, PreventT2 Together has the potential to impact individuals and their romantic partners' quality of life and ultimately improve real-world outcomes of lifestyle intervention to prevent type 2 diabetes.
- Conditions
- Prediabetic State, Life Style, Intervention Study, Social Support, Physical Activity, Obesity
- Being tested
- Individual intervention condition (PreventT2), 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)
- Keywords
- Lifestyle Intervention, Prevention, Social Support, Couple Relationships
- Medical subject headings
- Prediabetic State, Motor Activity, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Individual intervention condition (PreventT2)Behavioural
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)Behavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Individual intervention condition | Active comparator | "PreventT2" individual lifestyle intervention curriculum (2021 revised National DPP curriculum, freely available from the CDC) Receives: Behavioral: Individual intervention condition (PreventT2) |
| 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) Receives: Behavioral: 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) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 14 months
Secondary outcomes (6)
HbA1c
Assessed by the research team using the A1c Now Point of Care System.
Measured: 14 months
Weight
Weight in pounds will be assessed by the research team at both the Pre and Post time points using a medical grade scale. Among participants attending intervention classes, weight in pounds will be privately measured by Lifestyle Coaches before each class.
Measured: 14 months
Stress
Assessed with the Perceived Stress Scale measure (Possible score range: 0-24, with higher scores representing higher levels of perceived stress).
Measured: 14 months
Nutrition
Assessed with the Automated self-administered 24-hr recall (ASA24) (Pre, Post). We will examine the following outcomes: Healthy Eating Index (HEI), total vegetable, added sugars, fiber, whole grains, refined grains, and total KiloCalorie. (HEI Score Range: 0-100, with higher scores representing sets of foods that more closely align with key dietary recommendations and patterns.)(Total Vegetable expressed in cups, added sugars expressed in teaspoon equivalents, fiber expressed in grams, whole grains expressed in ounce equivalents, refined grains expressed in ounce equivalents, and total KCal expressed in kilocalories.)
Assessed with the Rapid Eating and Activity Assessment for Participants (REAP-S; Composite Score Range 13-39, with higher scores representing higher diet quality) (Monthly).
Measured: 14 months
Sleep
Assessed with the Patient-Reported Outcomes Measurement Information System (PROMIS) Short Form Version 1.0 Sleep-Related Impairment 8a (T-score range: 30-80.1, with higher scores indicating higher levels of sleep-related impairment) and the PROMIS Short Form Version 1.0 Sleep Disturbance 8a (T-score range: 30.5-77.5, with higher scores indicating higher levels of sleep disturbance).
Measured: 14 months
Perceived Partner Support
Assessed with the Multidimensional Scale of Perceived Social Support "special person" subscale, with the language updated to "romantic partners," consistent with prior work. This subscale assesses the amount of support individuals perceive from their romantic partners (Score range: 4-28, with higher scores indicating more perceived support from romantic partners).
Measured: 14 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Nov 2024
- Study start6 Mar 2025
- Primary completionNov 2028 (estimated)
- Study completionNov 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Prediabetic StateStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 324 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Utah
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Katherine Baucom, University of Utah
- Investigators
- Katherine JW Baucom, PhD, Principal investigator, University of Utah
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06690788
- Sponsor's protocol ID
- 166946
- Other IDs
- 1R01DK140177-01
- Acronym
- PT2T
- Status last verified
- Oct 2026
- First submitted
- 12 Aug 2024
- Last updated
- 16 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: We will only include in the repository data from study participants who agree to their information being saved for future diabetes prevention research. This will be discussed in the informed consent process and all participants will be asked to initial alongside their choice (yes, no) on the consent document. Data shared from those study participants who explicitly agree to be included are: de-identified demographic and other survey data (.csv); results from HbA1c tests (.csv); and objectively measured physical activity data (.csv).
Publications
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.
PubMed 33536698Whitaker 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.
PubMed 36797025