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NDPP-Flex for Prediabetes (NDPP-Flex Trial)

N/A
Recruiting
Led By Natalie Ritchie
Research Sponsored by Denver Health and Hospital Authority
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Age ≥18 years
English- or Spanish-speaking
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 months
Awards & highlights

NDPP-Flex Trial Summary

This trial is testing a new diabetes prevention program (NDPP-Flex) to see if it's better than the standard program at improving blood sugar levels, reducing diabetes risk, and helping people lose weight. The study will enroll 200 adults with prediabetes who are normal weight or overweight/obese.

Who is the study for?
This trial is for adults over 18 with prediabetes, indicated by an A1C level of 5.7-6.4%, who are patients at Denver Health and have a BMI ≥20 kg/m2 (or ≥18.5 kg/m2 if Asian). It's not open to those who've done NDPP before, take diabetes medication like metformin, are pregnant, or have been diagnosed with diabetes.Check my eligibility
What is being tested?
The study compares NDPP-Flex—a modified version of the National Diabetes Prevention Program—with the standard program to see which is better at improving blood sugar levels and helping more people reach normal blood sugar levels.See study design
What are the potential side effects?
Since this trial involves lifestyle interventions rather than medications, typical drug side effects aren't expected. However, participants may experience fatigue or muscle soreness from increased physical activity.

NDPP-Flex Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am 18 years old or older.
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I speak English or Spanish.

NDPP-Flex Trial Timeline

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
A1C
Secondary outcome measures
return to normoglycemia

NDPP-Flex Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: NDPP-FlexExperimental Treatment1 Intervention
NDPP-Flex. The primary difference between NDPP-Flex and the standard NDPP is the approach to goal setting. In NDPP-Flex, coaches use the latest CDC-published curriculum, but adapted such that participants are encouraged to 1) set attainable, individually-tailored goals for risk-reduction, 2) adjust goals over time as needed, and 3) avoid all-or-nothing assessments of goal attainment. At each session, coaches provide a goal setting worksheet (see excerpt) with a simple, fillable format to better accommodate low literacy (e.g., "I will limit my soda and sugary drinks to __ per day").
Group II: National Diabetes Prevention ProgramActive Control1 Intervention
The Diabetes Prevention Program was a successful clinical trial demonstrating that intensive lifestyle support for weight loss reduced diabetes incidence by 58%. The intervention was translated into the National Diabetes Prevention Program (NDPP) and disseminated by the Centers for Disease Control and Prevention as a yearlong group-based program since 2012.

Find a Location

Who is running the clinical trial?

Denver Health and Hospital AuthorityLead Sponsor
101 Previous Clinical Trials
400,197 Total Patients Enrolled
University of Colorado, DenverOTHER
1,738 Previous Clinical Trials
2,149,326 Total Patients Enrolled
Natalie RitchiePrincipal InvestigatorDenver Health

Media Library

NDPP Clinical Trial Eligibility Overview. Trial Name: NCT05559515 — N/A
Prediabetes Research Study Groups: National Diabetes Prevention Program, NDPP-Flex
Prediabetes Clinical Trial 2023: NDPP Highlights & Side Effects. Trial Name: NCT05559515 — N/A
NDPP 2023 Treatment Timeline for Medical Study. Trial Name: NCT05559515 — N/A

Frequently Asked Questions

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

Is this study currently searching for participants?

"According to clinicaltrials.gov, this trial is no longer accepting new recruits as it was last updated on September 26th 2022, following its initial listing date of December 10th 2022. However there are 198 other available studies searching for volunteers at the present moment."

Answered by AI

To which demographic is enrollment in this research endeavor open?

"To join this trial, recruits should have a prediabetic A1C reading of 5.7-6.4%, BMI over 20 kg/m2 (or 18.5 for Asian individuals), be affiliated with Denver Health and possess either English or Spanish language proficiency; the age range is from 18 to 85 years old and 200 participants are currently sought after."

Answered by AI

Is it possible for individuals over fifty years of age to participate in this research?

"The minimal age of admittance for this particular trial is 18, while the maximum age allowed to enroll is 85."

Answered by AI

Who else is applying?

What state do they live in?
Oregon
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
What site did they apply to?
Jayna DeRoeck
Recent research and studies
clinicaltrials.govStudy
Patient-centered Goal Setting in the National Diabetes Prevention Program
2023. "Patient-centered Goal Setting in the National Diabetes Prevention Program". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05559515.
~73 spots leftby Dec 2024
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