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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.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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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)
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
Are there results?
Not yet: the study is under way

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.
Show all 9Show fewer
  • 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.

Elizabeth Z Beaulieu, B.S. contact

801-696-3757

elizabeth.beaulieu@psych.utah.edu

Katherine JW Baucom, PhD contact

katherine.baucom@psych.utah.ed

United States1 site, 1 recruiting

  • University of Utah

    Salt Lake City, Utah, 84112

    Elizabeth Z Beaulieu, BS, 801-696-3757, heartlab@psych.utah.edu

    Katherine JW Baucom, PhD

    Recruiting

Other trials in United States

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.

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 groups in NCT06690788
Study groupRoleWhat they receive
Individual intervention conditionActive 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 conditionExperimental"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.

  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.

    Measured: 14 months

Secondary outcomes (6)

  1. HbA1c

    Assessed by the research team using the A1c Now Point of Care System.

    Measured: 14 months

  2. 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

  3. 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

  4. 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

  5. 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

  6. 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.

  1. First posted15 Nov 2024
  2. Study start6 Mar 2025
  3. Primary completionNov 2028 (estimated)
  4. Study completionNov 2028 (estimated)

Resources

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)
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 33536698

  • Whitaker 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

Questions about this trial

What is this clinical trial studying?

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.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 16 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Elizabeth Z Beaulieu, B.S. (801-696-3757, elizabeth.beaulieu@psych.utah.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percent of target partners achieving clinically meaningful increases in Moderate to Vigorous Physical Activity (MVPA) (time frame: 14 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06690788, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Oct 2026.

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