Couple-Based Lifestyle Intervention to Prevent Type 2 Diabetes

Utah System of Higher Education (USHE)

Status: Completed

Conditions: Prediabetic State; Overweight and Obesity; PreDiabetes

Treatments: Behavioral: PreventT2 (Individual intervention); Behavioral: PreventT2 Together (Couple-based intervention)

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT05695170

143079

K23DK115820 (U.S. NIH Grant/Contract)

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

Details and patient eligibility

About

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.

Full 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.

Enrollment: 28 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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":

  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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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28 participants in 2 patient groups

Individual intervention condition

Active Comparator group

Description:

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

Treatment:

Behavioral: PreventT2 (Individual intervention)

Couple-based intervention condition

Experimental group

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)

Treatment:

Behavioral: PreventT2 Together (Couple-based intervention)