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Behavioral Nudges for Prediabetes (BEGIN Trial)

N/A

Waitlist Available

Led By Matthew J O'Brien, MD

Research Sponsored by Northwestern University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Adult patients (aged 18-80 years) with prediabetes and overweight/obesity (BMI ≥25kg/m2)

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 12 months

Awards & highlights

BEGIN Trial Summary

This trial will test two low-touch interventions designed to motivate the adoption of treatments to prevent diabetes, which has the potential for large public health impact.

Who is the study for?

The BEGIN Trial is for English or Spanish-speaking adults aged 18-80 with prediabetes and overweight (BMI ≥25kg/m2). It's not for those with type 2 diabetes, dementia, current steroid use, pregnancy, no recent doctor visits, kidney issues indicated by high serum creatinine levels, past metformin use or very high blood pressure.Check my eligibility

What is being tested?

This trial tests two 'nudge' strategies to prevent diabetes in primary care: a text messaging intervention and a decision aid tool. Participants will either receive these interventions or continue with usual care without additional support.See study design

What are the potential side effects?

Since the interventions involve behavioral nudges like text messages and decision aids rather than medications or invasive procedures, there are minimal expected side effects. The main focus is on encouraging lifestyle changes and treatment adoption.

BEGIN Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I am 18-80 years old, overweight or obese, and have prediabetes.

BEGIN Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 12 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~12 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Weight

Secondary outcome measures

Metformin

BEGIN Trial Design

4Treatment groups

Experimental Treatment

Placebo Group

Group I: Text Messaging interventionExperimental Treatment1 Intervention

Participants will receive biweekly messages throughout the 12-month trial. Automated messages will be sent using an existing secure text messaging platform.

Group II: Decision Aid intervention + Text Messaging interventionExperimental Treatment2 Interventions

Health Educators (HEs) will meet briefly with eligible participants after each office visit to review a prediabetes decision aid. Additionally, participants will receive biweekly messages throughout the 12-month trial. Automated messages will be sent using an existing secure text messaging platform.

Group III: Decision Aid interventionExperimental Treatment1 Intervention

Health Educators (HEs) will meet briefly with eligible participants after each office visit to review a prediabetes decision aid which reviews information about the benefits and risks of intensive lifestyle intervention and metformin.

Group IV: Usual CarePlacebo Group1 Intervention

Usual care includes no additional intervention above the care routinely provided at the clinical partner site, Erie Family Health Center.

0 / 1Eligibility criteria met

Find a Location

Who is running the clinical trial?

Northwestern UniversityLead Sponsor

1,586 Previous Clinical Trials

916,291 Total Patients Enrolled

Matthew J O'Brien, MDPrincipal InvestigatorAssociate Professor

Media Library

Usual Care Clinical Trial Eligibility Overview. Trial Name: NCT04869917 — N/A

Prediabetes Research Study Groups: Decision Aid intervention + Text Messaging intervention, Usual Care, Decision Aid intervention, Text Messaging intervention

Prediabetes Clinical Trial 2023: Usual Care Highlights & Side Effects. Trial Name: NCT04869917 — N/A

Usual Care 2023 Treatment Timeline for Medical Study. Trial Name: NCT04869917 — N/A

Frequently Asked Questions

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

Are any volunteers being accepted for this experiment at the moment?

"As indicated on clinicaltrials.gov, the initial posting for this trial occurred on March 21st 2022 and was last modified on May 4th 2022. Unfortunately, there is no current patient recruitment; however, 198 other trials are welcoming applicants at this moment in time."

Answered by AI

Could I be a suitable subject for this medical experiment?

"In order to participate in this trial, applicants must be prediabetic and between 18-80 years old. As of now, plans are underway to bring on nearly a thousand individuals."

Answered by AI

Does this medical trial include participants of at least twenty years of age?

"This trial is open to individuals aged 18-80. If a patient falls outside of this range, there are 11 trials for those younger than 18 and 160 studies available for patients 65 or older."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Behavioral Nudges for Diabetes Prevention (BEGIN) Trial in Primary Care

Matthew J O'Brien 2022. "Behavioral Nudges for Diabetes Prevention (BEGIN) Trial in Primary Care". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04869917.

All > Prediabetes