Clinical trial NCT05695170: Couple-Based Lifestyle Intervention to Prevent Type 2 Diabetes
Official title: Couple-Based Lifestyle Intervention to Prevent Type 2 Diabetes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: PreDiabetes
Prediabetic State
Overweight and Obesity
Keywords: Lifestyle Intervention
Prevention
Social Support
Couple Relationships
Lead sponsor: University of Utah
Sponsor class: OTHER
Collaborators: name: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
First posted: 2023-01-23
Enrollment: 28
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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:

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.

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.

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":

  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.

Primary outcomes:
measure: Couple-based intervention feasibility
timeFrame: 1.5 years
measure: Study protocol feasibility
timeFrame: 1.5 years
Secondary outcomes:
measure: Physical activity.
timeFrame: 1.5 years
measure: Diet.
timeFrame: 1.5 years
measure: Sleep.
timeFrame: 1.5 years
measure: BMI
timeFrame: 1.5 years
measure: Waist circumference
timeFrame: 1.5 years
measure: Weight
timeFrame: 1.5 years
measure: Blood glucose.
timeFrame: 1.5 years
measure: Anxiety.
timeFrame: 1.5 years
measure: Depression.
timeFrame: 1.5 years
measure: Affect.
timeFrame: 1.5 years
measure: Relationship satisfaction.
timeFrame: 1.5 years
measure: Partner support.
timeFrame: 1.5 years
Other outcomes:
Locations:
city: Salt Lake City
country: United States
facility: University of Utah
state: Utah
Study officials:
affiliation: University of Utah
name: Katherine JW Baucom, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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.
citation: Whitaker M, Aguirre MC, Gutierrez Chavez M, Beaulieu E, Arones YB, Gershenoff D, Hinton K, Klein N, Munezerou Uwizeye J, Napia E, Ramos C, Tavake-Pasi OF, Villalta J, Wolfsfeld C, Witte B, Maxfield E, Raphael K, Simmons DL, Clark L, Sher T, Smith TW, Baucom KJ. Couple-based lifestyle intervention to prevent type 2 diabetes: protocol for a randomised pilot trial. BMJ Open. 2023 Feb 16;13(2):e068623. doi: 10.1136/bmjopen-2022-068623.