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Behavioral Intervention

Lifestyle Intervention for Prediabetes

N/A
Waitlist Available
Research Sponsored by Tulane University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2 months
Awards & highlights

Study Summary

The aim of this project is to use the Exploration, Preparation, Implementation, Sustainment (EPIS) framework to collect pilot data on the implementation of a Diabetes Prevention Program-like intervention in the Women, Infants, and Children (WIC) program.

Eligible Conditions
  • Prediabetes
  • Gestational Diabetes
  • High Blood Sugar

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 2 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
Fidelity - sessions attended
Secondary outcome measures
Fidelity - session content
Fidelity - sessions held
Intervention acceptability
+2 more
Other outcome measures
Diet
Fasting plasma glucose
Hemoglobin A1c
+8 more

Side effects data

From 2008 Phase 2 trial • 114 Patients • NCT00151411
35%
Diarrhea
22%
headache/migraine
22%
common cold/respiratory tract infection
16%
nausea and/or vomiting
15%
flu
13%
dysmenorrhea/cramps
11%
stomach/abdominal pain or discomfort
9%
musculoskeletal
5%
vaginal infection
5%
dizziness
5%
hair loss
5%
dental issues
4%
fatigue
4%
flatulence
2%
bladder infection
100%
80%
60%
40%
20%
0%
Study treatment Arm
Placebo
Metformin

Trial Design

1Treatment groups
Experimental Treatment
Group I: Lifestyle InterventionExperimental Treatment1 Intervention
The intervention has been modified from a subset of sessions from the National DPP Prevent T2 Curriculum (an adapted DPP for community settings that improves cardiometabolic outcomes and is implemented nationwide). The intervention will consist of 8 weekly sessions. The first session will be one-on-one and subsequent sessions will be in small groups. Sessions 1, 2, and 6 will be in-person and other sessions will be held by Zoom.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Lifestyle Intervention
2001
Completed Phase 2
~8880

Find a Location

Who is running the clinical trial?

Tulane UniversityLead Sponsor
115 Previous Clinical Trials
226,482 Total Patients Enrolled
WestatOTHER
43 Previous Clinical Trials
37,154 Total Patients Enrolled
National Heart, Lung, and Blood Institute (NHLBI)NIH
3,837 Previous Clinical Trials
47,851,607 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
clinicaltrials.govStudy
Maternal Health Diabetes Prevention Study
2022. "Maternal Health Diabetes Prevention Study". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05343494.
~7 spots leftby Apr 2025
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