AzTrials
AzTrials

PreDiabetesNCT05695170

Couple-Based Lifestyle Intervention to Prevent Type 2 Diabetes

A study testing PreventT2 (Individual intervention) and PreventT2 Together (Couple-based intervention) in people with PreDiabetes and Prediabetic State, run by University of Utah at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

The goal of this randomized pilot clinical trial is to describe the feasibility of a couple-based lifestyle intervention and the study protocol in preparation for a future definitive randomized clinical trial. Participants include individuals at risk for type 2 diabetes and their romantic partners. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
PreventT2 (Individual intervention) and PreventT2 Together (Couple-based intervention)
Could I receive a placebo?
No, everyone receives an active treatment
How many people
28 participants
Where
1 siteUnited States
Study dates
14 Dec 2022to 2 Apr 2024
Phase
Interventional
Are there results?
None posted in the registry

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
  • No healthy volunteers
  • Adult, Older adult

Both the "target individual" (i.e., individual at high risk for type 2 diabetes) and "supporting partner" (i.e., partner of target individual) must meet eligibility criteria in order for a couple to enroll in the study.

  • Eligibility criteria for "target individuals":
  1. Eligible for National DPP.
  2. DPP Inclusion Criteria:
  3. BMI of ≥ 25 kg/m2 (≥ 23kg/m2 if Asian) AND 2) High risk for type 2 diabetes, based on 1+ of the following three:
  4. CDC/American Diabetes Association Prediabetes Risk Test score ≥ 5
  5. Blood test results indicative of prediabetes in the past year (i.e., fasting blood glucose 100-125 mg/dl; blood glucose of 140-199 mg/dl 2 hours after a 75 g glucose load; OR 6.4% ≥ HbA1c ≥ 5.7%)
  6. Previous diagnosis of gestational diabetes (among women)
  7. DPP Exclusion Criteria:
  8. Diagnosis of type 1 diabetes or type 2 diabetes
  9. Currently pregnant AND
  10. Eligible for Study (Additional Criteria).
  11. Study Inclusion Criteria:
  12. Living together for 1+ year
  13. Report being in a romantic relationship
  14. Conversational fluency in English
  15. Age 18 or older
  16. Interested in participating
  17. Study Exclusion Criteria
  18. Diagnosis of another chronic disease (unless stable or with no major events/changes for 3+ months);
  19. Current medication for prediabetes or obesity;
  20. Current participation in lifestyle intervention for prediabetes or obesity;
  21. Past participation in the National DPP;
  22. Not comfortable participating in intervention together with partner.
  • Eligibility criteria for "supporting partners":
  1. Study Inclusion Criteria:
  2. Partner meets "target individual" eligibility criteria (per above)
  3. Living together for 1+ year
  4. Report being in a romantic relationship
  5. Conversational fluency in English
  6. Age 18 or older
  7. Interested in participating
  8. Study Exclusion Criterion
  9. Not comfortable participating in intervention together with partner.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • University of Utah

    Salt Lake City, Utah, 84112

Other trials in United States

About this study

The goal of this randomized pilot clinical trial is to describe the feasibility of a couple-based lifestyle intervention and the study protocol in preparation for a future definitive randomized clinical trial. Participants include individuals at risk for type 2 diabetes and their romantic partners.

The main objectives are:

Read more
  1. To describe the feasibility of the couple-based intervention.
  2. To describe the feasibility of the study protocol for use in a definitive trial.

Participating couples will be randomized to one of two year-long lifestyle intervention conditions: an individual curriculum or a couple-based curriculum.

Participants will complete assessments before and after the year-long intervention, as well as monthly during the intervention. Data will be collected on: feasibility, background, health behaviors, physical and mental health, and relationship functioning.

Read the detailed description

The goal of this randomized pilot clinical trial is to describe the feasibility of a couple-based lifestyle intervention and the study protocol in preparation for a future definitive randomized clinical trial. Participants include individuals at risk for type 2 diabetes and their romantic partners.

Prior to all study procedures, eligible participants will be required to complete an informed consent process and electronically sign a consent document. 12 eligible couples will be randomly assigned to either an individual lifestyle intervention (PreventT2) or a couple-based adaptation designed with input from a community advisory board (PreventT2 Together) (1:1). Both curricula have CDC approval for use in the National DPP and are delivered to small groups of participants over the course of 12 months.

Across conditions, participants will complete assessments before and after the year-long intervention, as well as monthly during the intervention. Data will be collected on: feasibility, background, health behaviors, physical and mental health, and relationship functioning.

Being tested
PreventT2 (Individual intervention), PreventT2 Together (Couple-based intervention)
Keywords
Lifestyle Intervention, Prevention, Social Support, Couple Relationships
Medical subject headings
Prediabetic State, Overweight, Obesity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • PreventT2 (Individual intervention)Behavioural

    PreventT2 will be delivered by a team of trained CDC Lifestyle Coaches to adults at high risk for diabetes. The 2021 version of the curriculum that will be used is freely available from the CDC. The intervention will be delivered in the context of the University of Utah National Diabetes Prevention Program (DPP), which has "full" recognition from the CDC based on outcome data over the course of a number of years.

  • PreventT2 Together (Couple-based intervention)Behavioural

    PreventT2 Together will be delivered by a team of trained CDC Lifestyle Coaches to adults at high risk for diabetes and their partners. The curriculum was developed with the input of a community advisory board and was approved by the CDC for use in the National DPP (i.e., meets CDC Diabetes Prevention Recognition Program Standards, including 22+ classes delivered over the course of 12 months and targeting lifestyle changes to prevention 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 NCT05695170
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: PreventT2 (Individual intervention)
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: PreventT2 Together (Couple-based intervention)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Couple-based intervention feasibility

    Participants will complete the Theoretical Framework of Acceptability-Based Questionnaire and two open-ended survey items developed by the research team monthly during the intervention and at post-intervention. Participants will also complete a post-intervention qualitative joint couple interview that utilizes a semi-structured couple interview guide. Lifestyle Coaches will also report on attendance, completion of weekly activity logs, and completion of make-up sessions.

    The team of Lifestyle Coaches delivering PreventT2 Together will also complete open-ended items developed by the research team following each class. Lifestyle Coaches will also complete a measure of barriers to participation and lifestyle change they observed among the participants, as well as several measures based on implementation outcomes (i.e., Acceptability of Intervention Measure, Intervention Appropriateness Measure, Feasibility of Intervention Measure).

    Measured: 1.5 years

  2. Study protocol feasibility

    Participants will report on perceptions of the study protocol in a post-intervention qualitative joint couple interview that utilizes a semi-structured couple interview guide. The guide includes specific prompts focused on recruitment, randomization, and assessments.

    In addition to these qualitative data collected from participants, data on recruitment feasibility will also be collected with an item on the contact form potential participants complete. Data on assessment feasibility will also be collected based on completion of measures and the length of time participants spend on these measures at each assessment.

    Measured: 1.5 years

Secondary outcomes (12)

  1. Physical activity.

    Assessed pre/post-intervention with the International Physical Activity Questionnaire (IPAQ)-Long and a 7-day accelerometer assessment. Assessed monthly with the IPAQ-7 day. Participants will also self-report minutes of moderate-to-vigorous physical activity over the past week at each attended intervention class.

    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.

    Measured: 1.5 years

  2. Diet.

    Assessed pre/post-intervention with the Automated Self-Administered 24-hr diet assessment from the NCI (ASA-24). The ASA is a detailed 24-hour recall of food including portion sizes and preparation.

    Assessed pre/post-intervention and monthly during the intervention with the Rapid Eating Assessment for Participants- Shortened Version (REAP-S), a brief measure of diet quality and content over an average week.

    Measured: 1.5 years

  3. Sleep.

    Assessed pre/post-intervention and monthly with the Patient-Reported Outcomes Measurement Information System (PROMIS) Sleep Disturbance 8a item scale (SD) and the PROMIS Sleep-Related Impairment 8a item scale (SRI). Participants will also self-report their daily sleep during the 7-day pre/post-intervention accelerometer wear.

    The SD assesses sleep quality with 8 statements including "my sleep was restless," and the SRI assesses the impact of poor sleep and sleepiness on daily behaviors with 8 statements including "I had problems during the day because of poor sleep." Item responses on both measures range from 1 (not at all) to 5 (very much).

    Measured: 1.5 years

  4. BMI

    Weight in kilograms and height in meters will be measured pre-intervention by Clinical Research Unit staff in order to calculate BMI.

    Measured: 1.5 years

  5. Waist circumference

    Waist circumference in inches will be measured pre-intervention by Clinical Research Unit staff.

    Measured: 1.5 years

  6. Weight

    Weight in kilograms will be assessed pre-intervention by Clinical Research Unit staff and weight in pounds will also be collected before each intervention class by Lifestyle Coaches.

    Weight in pounds will be collected post-intervention with a medical-grade scale.

    Measured: 1.5 years

  7. Blood glucose.

    Assessed at pre-intervention by Clinical Research Unit medical staff: fasting blood glucose, HbA1c, 2-hr post glucose load (following 75 g OGTT).

    Assessed at post-intervention by the A1c Now point-of-care system test: HbA1c.

    Measured: 1.5 years

  8. Anxiety.

    Assessed pre/post-intervention and monthly with the Patient-Reported Outcomes Measurement Information System (PROMIS) Anxiety 8a item scale. This 8-item measure includes statements such as "I felt fearful."

    Measured: 1.5 years

  9. Depression.

    Assessed pre/post-intervention and monthly with the PROMIS Depression 8a item scale, which includes 8 statements such as "I felt worthless."

    Measured: 1.5 years

  10. Affect.

    Participants will complete the Positive and Negative Affective Scale (PANAS) daily during the pre/post-intervention 7-day accelerometer wear. The PANAS assesses positive and negative affect over the last day with 20 items. Participants rate from 1 (very slightly to none at all) to 7 (extremely) the extent to which they experienced each item (e.g., "nervous") in the past day.

    Measured: 1.5 years

  11. Relationship satisfaction.

    Assessed pre/post-intervention and monthly with the 16-item Couples Satisfaction Index (CSI), a measure of overall relationship satisfaction. Assessed daily during the pre/post-intervention 7-day accelerometer wear using a brief 4-item version of the CSI.

    Measured: 1.5 years

  12. Partner support.

    Assessed pre/post-intervention and at months 3, 6, 9 during the intervention, with the Social support and Exercise Survey and the Social Support and Eating Habits Survey. These measures assess the amount of support individuals seeking to exercise regularly perceive from family members and the amount of support individuals seeking to improve their diet receive from family members.

    Participants will also report on daily emotional and instrumental support during the pre/post-intervention 7-day accelerometer wear.

    Measured: 1.5 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 Jan 2023
  2. Study start14 Dec 2022
  3. Primary completion26 Mar 2024
  4. Study completion2 Apr 2024

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
Single blind
Who is masked
Outcomes assessor
Enrolment
28 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05695170
Sponsor's protocol ID
143079
Other IDs
K23DK115820, 3K23DK115820-05S1
Status last verified
Aug 2024
First submitted
28 Dec 2022
Last updated
15 Aug 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

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 PreventT2 (Individual intervention) and PreventT2 Together (Couple-based intervention) in people with PreDiabetes and Prediabetic State, 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?

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: finished, as of the sponsor's last update on 15 Aug 2024. 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Couple-based intervention feasibility (time frame: 1.5 years). The study lists 2 primary outcomes in all. 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 NCT05695170, 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 15 Aug 2024.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in