Couple-Based Lifestyle Intervention to Prevent Type 2 Diabetes

NCT05695170 | Completed

• 3 other identifiers: 143079K23DK1158203K23DK115820-05S1
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 1

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. 1.To describe the feasibility of the couple-based intervention.
2. 2.To describe the feasibility of the study protocol for use in a definitive trial.

Conditions

PreDiabetes; Prediabetic State; Overweight and Obesity

Keywords

Lifestyle Intervention; Prevention; Social Support; Couple Relationships

Outcome Measures

Primary Outcomes (2)

• 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).

  1.5 years

• 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.

  1.5 years

Secondary Outcomes (12)

• Physical activity.

  1.5 years

• Diet.

  1.5 years

• Sleep.

  1.5 years

• BMI

  1.5 years

• Waist circumference

  1.5 years

Study Arms (2)

Individual intervention condition

ACTIVE COMPARATOR

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

Behavioral: PreventT2 (Individual intervention)

Couple-based intervention condition

EXPERIMENTAL

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

Behavioral: PreventT2 Together (Couple-based intervention)

Interventions

PreventT2 (Individual intervention) 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.

Individual intervention condition

PreventT2 Together (Couple-based intervention) 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.

Couple-based intervention condition

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \) 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)

You may not qualify if:

• Diagnosis of type 1 diabetes or type 2 diabetes
• Currently pregnant
• AND
• \. Eligible for Study (Additional Criteria).
• Living together for 1+ year
• Report being in a romantic relationship
• Conversational fluency in English
• Age 18 or older
• Interested in participating
• 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":

Sponsors & Collaborators

• University of Utah: lead
• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK): collaborator

Study Sites (1)

University of Utah

Salt Lake City, Utah, 84112, United States

Location

Related Publications (2)

• 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.

  PMID: 33536698 BACKGROUND

• 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.

  PMID: 36797025 BACKGROUND

MeSH Terms

Conditions

Prediabetic State; Overweight; Obesity

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Overnutrition; Nutrition Disorders; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Katherine JW Baucom, PhD

  University of Utah

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Nurses who assess health markers and behaviors pre programs will be masked to group assignment.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: December 28, 2022
• First Posted: January 23, 2023
• Study Start: December 14, 2022
• Primary Completion: March 26, 2024
• Study Completion: April 2, 2024
• Last Updated: August 15, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)