Couple-Based Lifestyle Intervention to Prevent Type 2 Diabetes

January 19, 2023 updated by: Katherine Baucom, University of Utah

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:

  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.

Study Overview

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.

Study Type

Interventional

Enrollment (Anticipated)

24

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United States
    • Utah
      • Salt Lake City, Utah, United States, 84112
        • Recruiting
        • University of Utah
        • Contact:
          • Katherine J Baucom, PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

      A. DPP Inclusion Criteria:

    1) BMI of ≥ 25 kg/m2 (≥ 23kg/m2 if Asian) AND 2) High risk for type 2 diabetes, based on 1+ of the following three:

    1. CDC/American Diabetes Association Prediabetes Risk Test score ≥ 5
    2. 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%)
    3. Previous diagnosis of gestational diabetes (among women)

      B. DPP Exclusion Criteria:

      1. Diagnosis of type 1 diabetes or type 2 diabetes
      2. Currently pregnant

      AND

      2. Eligible for Study (Additional Criteria).

      A. Study Inclusion Criteria:

      1. Living together for 1+ year
      2. Report being in a romantic relationship
      3. Conversational fluency in English
      4. Age 18 or older
      5. Interested in participating

      B. Study Exclusion Criteria

      1. Diagnosis of another chronic disease (unless stable or with no major events/changes for 3+ months);
      2. Current medication for prediabetes or obesity;
      3. Current participation in lifestyle intervention for prediabetes or obesity;
      4. Past participation in the National DPP;
      5. Not comfortable participating in intervention together with partner.
  • Eligibility criteria for "supporting partners":

A. Study Inclusion Criteria:

  1. Partner meets "target individual" eligibility criteria (per above)
  2. Living together for 1+ year
  3. Report being in a romantic relationship
  4. Conversational fluency in English
  5. Age 18 or older
  6. Interested in participating

B. Study Exclusion Criterion

1) Not comfortable participating in intervention together with partner.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Individual intervention condition
"PreventT2" individual lifestyle intervention curriculum (2021 revised National DPP curriculum, freely available from the CDC)
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 DPP, which has "full" recognition from the CDC based on outcome data over the course of a number of years.
Experimental: Couple-based intervention condition
"PreventT2 Together" (couple-based adaptation of PreventT2; approved by the CDC in November 2022 as an Alternate Curriculum for use in the National DPP)
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Couple-based intervention feasibility
Time Frame: 1.5 years

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).

1.5 years
Study protocol feasibility
Time Frame: 1.5 years

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.

1.5 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Physical activity.
Time Frame: 1.5 years

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.

1.5 years
Diet.
Time Frame: 1.5 years

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.

1.5 years
Sleep.
Time Frame: 1.5 years

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).

1.5 years
BMI
Time Frame: 1.5 years
Weight in kilograms and height in meters will be measured pre/post-intervention by Clinical Research Unit staff in order to calculate BMI.
1.5 years
Waist circumference
Time Frame: 1.5 years
Waist circumference in inches will be measured pre/post-intervention by Clinical Research Unit staff.
1.5 years
Weight
Time Frame: 1.5 years
Weight in kilograms will be assessed pre/post-intervention by Clinical Research Unit staff and weight in kilograms will also be collected before each intervention class by Lifestyle Coaches.
1.5 years
Blood glucose.
Time Frame: 1.5 years
Assessed pre/post-intervention by Clinical Research Unit medical staff: fasting blood glucose, HbA1c, 2-hr post glucose load (following 75 g OGTT).
1.5 years
Anxiety.
Time Frame: 1.5 years
Assessed pre/post-intervention and monthly with the PROMIS Anxiety 8a item scale. This 8-item measure includes statements such as "I felt fearful."
1.5 years
Depression.
Time Frame: 1.5 years
Assessed pre/post-intervention and monthly with the PROMIS Depression 8a item scale, which includes 8 statements such as "I felt worthless."
1.5 years
Affect.
Time Frame: 1.5 years
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.
1.5 years
Relationship satisfaction.
Time Frame: 1.5 years
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.
1.5 years
Intimacy.
Time Frame: 1.5 years
Assessed pre/post-intervention and at months 3, 6, 9 during the intervention, participants will complete the 6-item sexual intimacy subscale of the Personal Assessment for Intimacy in Relationships (PAIR).
1.5 years
Partner support.
Time Frame: 1.5 years

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.

1.5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 14, 2022

Primary Completion (Anticipated)

April 30, 2024

Study Completion (Anticipated)

April 30, 2024

Study Registration Dates

First Submitted

December 28, 2022

First Submitted That Met QC Criteria

January 19, 2023

First Posted (Actual)

January 23, 2023

Study Record Updates

Last Update Posted (Actual)

January 23, 2023

Last Update Submitted That Met QC Criteria

January 19, 2023

Last Verified

January 1, 2023

More Information

Terms related to this study

Other Study ID Numbers

  • 143079
  • K23DK115820 (U.S. NIH Grant/Contract)
  • 3K23DK115820-05S1 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact [email protected]. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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