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Couple-Based Lifestyle Intervention for Prediabetes Prevention

N/A
Waitlist Available
Research Sponsored by University of Utah
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Target individual: Eligible for National DPP, BMI of ≥ 25 kg/m2 (≥ 23kg/m2 if Asian) and high risk for type 2 diabetes, based on specific criteria, and eligible for study based on additional criteria
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1.5 years
Awards & highlights

Study Summary

This trial is researching if a couple-based lifestyle intervention is feasible to help reduce risk of type 2 diabetes. Couples will be assessed before, during, and after the year-long intervention.

Who is the study for?
This trial is for couples where one partner has a high risk of type 2 diabetes, with a BMI ≥25 kg/m2 (or ≥23kg/m2 if Asian), and both are over 18 years old, speak English fluently, and have been in a romantic relationship living together for at least one year. It's not for those already diagnosed with diabetes or on medication for prediabetes/obesity.Check my eligibility
What is being tested?
The study tests the effectiveness of two lifestyle interventions to prevent type 2 diabetes: PreventT2 Together (for couples) versus PreventT2 (for individuals). Couples will be randomly assigned to either group and participate in assessments throughout the year-long intervention.See study design
What are the potential side effects?
Since this is a lifestyle intervention focusing on diet and exercise rather than medication, typical drug side effects aren't expected. However, participants may experience changes in physical activity levels or dietary habits.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am at high risk for type 2 diabetes and meet the BMI criteria for the National DPP.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1.5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and 1.5 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Couple-based intervention feasibility
Study protocol feasibility
Secondary outcome measures
Affect.
Anxiety.
BMI
+9 more

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Couple-based intervention conditionExperimental Treatment1 Intervention
"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 II: Individual intervention conditionActive Control1 Intervention
"PreventT2" individual lifestyle intervention curriculum (2021 revised National DPP curriculum, freely available from the CDC)
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
PreventT2 Together (Couple-based intervention)
2022
N/A
~30

Find a Location

Who is running the clinical trial?

University of UtahLead Sponsor
1,098 Previous Clinical Trials
1,778,602 Total Patients Enrolled
16 Trials studying Obesity
2,400 Patients Enrolled for Obesity
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)NIH
2,357 Previous Clinical Trials
4,315,158 Total Patients Enrolled
447 Trials studying Obesity
588,938 Patients Enrolled for Obesity

Media Library

PreventT2 Clinical Trial Eligibility Overview. Trial Name: NCT05695170 — N/A
Obesity Research Study Groups: Individual intervention condition, Couple-based intervention condition
Obesity Clinical Trial 2023: PreventT2 Highlights & Side Effects. Trial Name: NCT05695170 — N/A
PreventT2 2023 Treatment Timeline for Medical Study. Trial Name: NCT05695170 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many participants are currently invited to join this clinical research?

"Affirmative. Information on clinicaltrials.gov confirms that this study, which was initially published on December 14th 2022, is actively recruiting for participants. They aim to enrol 24 patients from a single medical site."

Answered by AI

Are any additional participants being accepted for this experiment?

"Indeed, according to the data from clinicaltrials.gov, this study is presently recruiting patients. It was initially advertised on December 14th 2022 and updated most recently on January 19th 2023 - 24 participants are needed at 1 location."

Answered by AI

What tangible outcomes is this research endeavor hoping to accomplish?

"The primary objective of this 1.5-year study is to assess its feasibility, while secondary outcomes include diet quality evaluated with the Automated Self-Administered 24-hour (ASA) and Rapid Eating Assessment for Participants - Shortened Version (REAP-S), sleep disturbances assessed by Patient Reported Outcomes Measurement Information System (PROMIS) Sleep Disturbance 8a item scale and PROMIS Sleep Related Impairment 8a item scales, as well as Body Mass Index calculated from participant's weight in kilograms & height in meters."

Answered by AI

Who else is applying?

What site did they apply to?
University of Utah
What portion of applicants met pre-screening criteria?
Met criteria
Recent research and studies
clinicaltrials.govStudy
Couple-Based Lifestyle Intervention to Prevent Type 2 Diabetes
Katherine Baucom 2022. "Couple-Based Lifestyle Intervention to Prevent Type 2 Diabetes". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05695170.
~12 spots leftby Apr 2025
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