Couple-Based Lifestyle Intervention to Prevent Type 2 Diabetes
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- University of Utah
- Enrollment
- 28
- Locations
- 1
- Primary Endpoint
- Study protocol feasibility
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- Single (Outcomes Assessor)
Masking Description
Nurses who assess health markers and behaviors pre programs will be masked to group assignment.
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion 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)
Exclusion Criteria
- •Diagnosis of type 1 diabetes or type 2 diabetes
- •Currently pregnant
- •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.
Arms & Interventions
Individual intervention condition
"PreventT2" individual lifestyle intervention curriculum (2021 revised National DPP curriculum, freely available from the CDC)
Intervention: PreventT2 (Individual intervention) (Behavioral)
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)
Intervention: PreventT2 Together (Couple-based intervention) (Behavioral)
Outcomes
Primary Outcomes
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.
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).
Secondary Outcomes
- Blood glucose.(1.5 years)
- Depression.(1.5 years)
- Relationship satisfaction.(1.5 years)
- Physical activity.(1.5 years)
- Diet.(1.5 years)
- BMI(1.5 years)
- Anxiety.(1.5 years)
- Affect.(1.5 years)
- Partner support.(1.5 years)
- Weight(1.5 years)
- Sleep.(1.5 years)
- Waist circumference(1.5 years)
Investigators
Katherine Baucom
Assistant Professor
University of Utah