Couple-Based Lifestyle Intervention to Prevent Type 2 Diabetes

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

28 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-12-14

Study Completion Date

2024-04-02

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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PreDiabetes Prediabetic State Overweight and Obesity

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Outcome Assessors

Nurses who assess health markers and behaviors pre programs will be masked to group assignment.

Study Groups

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Individual intervention condition

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

Group Type ACTIVE_COMPARATOR

PreventT2 (Individual intervention)

Intervention Type BEHAVIORAL

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.

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)

Group Type EXPERIMENTAL

PreventT2 Together (Couple-based intervention)

Intervention Type BEHAVIORAL

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.

Interventions

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PreventT2 (Individual intervention)

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.

Intervention Type BEHAVIORAL

PreventT2 Together (Couple-based intervention)

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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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)

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

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.

Exclusion Criteria

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

AND

2\. Eligible for Study (Additional 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":

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No