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Recruiting NCT05695170

Couple-Based Lifestyle Intervention to Prevent Type 2 Diabetes

Conditions: PreDiabetes, Prediabetic State, Overweight and Obesity

Sex: All
Ages: 18 Years – N/A
Phase: NA
Enrollment: 24
Sponsor: University of Utah

Location: United States

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.

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":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 ≥ 5Blood 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)B. DPP Exclusion Criteria:Diagnosis of type 1 diabetes or type 2 diabetesCurrently pregnantAND2. Eligible for Study (Additional Criteria).A. Study Inclusion Criteria:Living together for 1+ yearReport being in a romantic relationshipConversational fluency in EnglishAge 18 or olderInterested in participatingB. Study Exclusion CriteriaDiagnosis 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+ yearReport being in a romantic relationshipConversational fluency in EnglishAge 18 or olderInterested in participatingB. Study Exclusion Criterion1) Not comfortable participating in intervention together with partner.

Interested in this study? View the official listing for contact and enrollment details.

View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT05695170). StuddyBuddy aggregates publicly available trial information.