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Couple-Based Lifestyle Intervention to Prevent Type 2 Diabetes

Primary Purpose

PreDiabetes, Prediabetic State, Overweight and Obesity

Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
PreventT2 (Individual intervention)
PreventT2 Together (Couple-based intervention)
Sponsored by
University of Utah
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for PreDiabetes focused on measuring Lifestyle Intervention, Prevention, Social Support, Couple Relationships

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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": 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: CDC/American Diabetes Association Prediabetes Risk Test score ≥ 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%) Previous diagnosis of gestational diabetes (among women) B. DPP Exclusion Criteria: Diagnosis of type 1 diabetes or type 2 diabetes Currently pregnant AND 2. Eligible for Study (Additional Criteria). A. Study Inclusion Criteria: Living together for 1+ year Report being in a romantic relationship Conversational fluency in English Age 18 or older Interested in participating B. Study Exclusion Criteria Diagnosis of another chronic disease (unless stable or with no major events/changes for 3+ months); Current medication for prediabetes or obesity; Current participation in lifestyle intervention for prediabetes or obesity; Past participation in the National DPP; Not comfortable participating in intervention together with partner. Eligibility criteria for "supporting partners": A. Study Inclusion Criteria: Partner meets "target individual" eligibility criteria (per above) Living together for 1+ year Report being in a romantic relationship Conversational fluency in English Age 18 or older Interested in participating B. Study Exclusion Criterion 1) Not comfortable participating in intervention together with partner.

Sites / Locations

  • University of Utah

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Individual intervention condition

Couple-based intervention condition

Arm Description

"PreventT2" individual lifestyle intervention curriculum (2021 revised National DPP curriculum, freely available from the CDC)

"PreventT2 Together" (couple-based adaptation of PreventT2; approved by the CDC in November 2022 as an Alternate Curriculum for use in the National DPP)

Outcomes

Primary Outcome Measures

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).
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.

Secondary Outcome Measures

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.
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.
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).
BMI
Weight in kilograms and height in meters will be measured pre/post-intervention by Clinical Research Unit staff in order to calculate BMI.
Waist circumference
Waist circumference in inches will be measured pre/post-intervention by Clinical Research Unit staff.
Weight
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.
Blood glucose.
Assessed pre/post-intervention by Clinical Research Unit medical staff: fasting blood glucose, HbA1c, 2-hr post glucose load (following 75 g OGTT).
Anxiety.
Assessed pre/post-intervention and monthly with the PROMIS Anxiety 8a item scale. This 8-item measure includes statements such as "I felt fearful."
Depression.
Assessed pre/post-intervention and monthly with the PROMIS Depression 8a item scale, which includes 8 statements such as "I felt worthless."
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.
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.
Intimacy.
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).
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.

Full Information

First Posted
December 28, 2022
Last Updated
February 17, 2023
Sponsor
University of Utah
Collaborators
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
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1. Study Identification

Unique Protocol Identification Number
NCT05695170
Brief Title
Couple-Based Lifestyle Intervention to Prevent Type 2 Diabetes
Official Title
Couple-Based Lifestyle Intervention to Prevent Type 2 Diabetes
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
December 14, 2022 (Actual)
Primary Completion Date
April 30, 2024 (Anticipated)
Study Completion Date
April 30, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Utah
Collaborators
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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. The main objectives are: To describe the feasibility of the couple-based intervention. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
PreDiabetes, Prediabetic State, Overweight and Obesity
Keywords
Lifestyle Intervention, Prevention, Social Support, Couple Relationships

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Masking Description
Nurses who assess health markers and behaviors pre and post programs will be masked to group assignment.
Allocation
Randomized
Enrollment
28 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Individual intervention condition
Arm Type
Active Comparator
Arm Description
"PreventT2" individual lifestyle intervention curriculum (2021 revised National DPP curriculum, freely available from the CDC)
Arm Title
Couple-based intervention condition
Arm Type
Experimental
Arm Description
"PreventT2 Together" (couple-based adaptation of PreventT2; approved by the CDC in November 2022 as an Alternate Curriculum for use in the National DPP)
Intervention Type
Behavioral
Intervention Name(s)
PreventT2 (Individual intervention)
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
PreventT2 Together (Couple-based intervention)
Intervention Description
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.
Primary Outcome Measure Information:
Title
Couple-based intervention feasibility
Description
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).
Time Frame
1.5 years
Title
Study protocol feasibility
Description
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.
Time Frame
1.5 years
Secondary Outcome Measure Information:
Title
Physical activity.
Description
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.
Time Frame
1.5 years
Title
Diet.
Description
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.
Time Frame
1.5 years
Title
Sleep.
Description
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).
Time Frame
1.5 years
Title
BMI
Description
Weight in kilograms and height in meters will be measured pre/post-intervention by Clinical Research Unit staff in order to calculate BMI.
Time Frame
1.5 years
Title
Waist circumference
Description
Waist circumference in inches will be measured pre/post-intervention by Clinical Research Unit staff.
Time Frame
1.5 years
Title
Weight
Description
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.
Time Frame
1.5 years
Title
Blood glucose.
Description
Assessed pre/post-intervention by Clinical Research Unit medical staff: fasting blood glucose, HbA1c, 2-hr post glucose load (following 75 g OGTT).
Time Frame
1.5 years
Title
Anxiety.
Description
Assessed pre/post-intervention and monthly with the PROMIS Anxiety 8a item scale. This 8-item measure includes statements such as "I felt fearful."
Time Frame
1.5 years
Title
Depression.
Description
Assessed pre/post-intervention and monthly with the PROMIS Depression 8a item scale, which includes 8 statements such as "I felt worthless."
Time Frame
1.5 years
Title
Affect.
Description
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.
Time Frame
1.5 years
Title
Relationship satisfaction.
Description
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.
Time Frame
1.5 years
Title
Intimacy.
Description
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).
Time Frame
1.5 years
Title
Partner support.
Description
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.
Time Frame
1.5 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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": 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: CDC/American Diabetes Association Prediabetes Risk Test score ≥ 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%) Previous diagnosis of gestational diabetes (among women) B. DPP Exclusion Criteria: Diagnosis of type 1 diabetes or type 2 diabetes Currently pregnant AND 2. Eligible for Study (Additional Criteria). A. Study Inclusion Criteria: Living together for 1+ year Report being in a romantic relationship Conversational fluency in English Age 18 or older Interested in participating B. Study Exclusion Criteria Diagnosis of another chronic disease (unless stable or with no major events/changes for 3+ months); Current medication for prediabetes or obesity; Current participation in lifestyle intervention for prediabetes or obesity; Past participation in the National DPP; Not comfortable participating in intervention together with partner. Eligibility criteria for "supporting partners": A. Study Inclusion Criteria: Partner meets "target individual" eligibility criteria (per above) Living together for 1+ year Report being in a romantic relationship Conversational fluency in English Age 18 or older Interested in participating B. Study Exclusion Criterion 1) Not comfortable participating in intervention together with partner.
Facility Information:
Facility Name
University of Utah
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84112
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
33536698
Citation
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.
Results Reference
background

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Couple-Based Lifestyle Intervention to Prevent Type 2 Diabetes

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