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