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Behavioural Intervention

NDPP-NextGen for Diabetes Risk Reduction

N/A

Recruiting

Led By Katherine Sauder, PhD

Research Sponsored by University of Colorado, Denver

Eligibility Criteria Checklist

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

Must have

Be between 18 and 65 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up through study completion, an average of 2 years

Awards & highlights

Study Summary

This trial will test if an adapted NDPP can help young women improve health and reduce risk of diabetes before and during pregnancy.

Who is the study for?

This trial is for women aged 18-39 at Denver Health who are overweight or obese, not currently pregnant but considering pregnancy within the next two years. It's open to those who may become pregnant soon, including those not actively trying but open to it. Women with non-gestational diabetes, certain medical conditions or procedures preventing pregnancy, current participation in NDPP, or long-term contraception use aren't eligible.Check my eligibility

What is being tested?

The NDPP-NextGen program is being tested against usual care in young women at risk of obesity and diabetes before and during pregnancy. The study will compare pre-pregnancy blood sugar control and BMI changes as well as weight gain during pregnancy between the group receiving online classes on health management and a control group given health information packets.See study design

What are the potential side effects?

Since this intervention involves educational classes rather than medication, typical drug side effects are not expected. However, participants may experience stress or discomfort related to lifestyle changes encouraged by the program such as diet modification or increased physical activity.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ through study completion, an average of 2 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~through study completion, an average of 2 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and through study completion, an average of 2 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

BMI in early pregnancy

Secondary outcome measures

Glycemia in early pregnancy

Other outcome measures

A1C in early pregnancy

Diet quality

Glycemic status in early pregnancy

+27 more

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Healthy LifestyleExperimental Treatment1 Intervention

Women in the Healthy Lifestyle group will be invited to attend the online NDPP-NextGen class which will cover how to eat healthy, be active, and lose weight before getting pregnant. The classes will be led by a trained Lifestyle Coach. Each class lasts about 1 hour. Classes initially meet about once a week (for the first 6 months), then twice a month (for the next 3 months), and then once a month (for the last 3 months). Classes will meet virtually through video-conference. Lifestyle coaches will also call participants in between classes to discuss how participants are doing, answer questions, and provide reminders for upcoming classes. Prior to the first class, women will also participate in a "pre-session" designed to increase NDPP engagement via discussion of diabetes risks and treatment options (i.e., clarify relevance) and motivational interviewing to resolve barriers.

Group II: Healthy WomenActive Control1 Intervention

Women in the Healthy Women group get a packet of information standardly given in OB clinics about how to be healthy before, during and after pregnancy.

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

University of Colorado, DenverLead Sponsor

1,738 Previous Clinical Trials

2,149,123 Total Patients Enrolled

100 Trials studying Obesity

213,306 Patients Enrolled for Obesity

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)NIH

2,359 Previous Clinical Trials

4,314,189 Total Patients Enrolled

446 Trials studying Obesity

588,535 Patients Enrolled for Obesity

Wake Forest University Health SciencesLead Sponsor

1,243 Previous Clinical Trials

1,004,323 Total Patients Enrolled

37 Trials studying Obesity

5,344 Patients Enrolled for Obesity

Media Library

NDPP-NextGen (Behavioural Intervention) Clinical Trial Eligibility Overview. Trial Name: NCT05674799 — N/A

Obesity Research Study Groups: Healthy Lifestyle, Healthy Women

Obesity Clinical Trial 2023: NDPP-NextGen Highlights & Side Effects. Trial Name: NCT05674799 — N/A

NDPP-NextGen (Behavioural Intervention) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05674799 — N/A

Frequently Asked Questions

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

Does this clinical trial extend its recruitment to seniors above the age of seventy?

"Enrolment for this experiment is limited to those aged between 18 and 39 years old. Simultaneously, there are additional trials available to individuals under the age of 18 (213 studies) and those over 65 (666 studies)."

Answered by AI

Are there any open slots available for enrollment in this experiment?

"Data hosted on clinicaltrials.gov suggests that this medical trial is not currently open to recruitment and was last updated on April 1st, 2023. Although the study has concluded its enrolment phase, there are more than a thousand other trials actively seeking participants at present."

Answered by AI

To whom is enrollment in this research project available?

"This medical trial is looking for 360 participants between the tender ages of 18 and 39 who have overweight or obesity. Furthermore, they need to demonstrate a high level of interest in conceiving (actively trying), general curiosity regarding pregnancy (not actively attempting but keen on doing so soon) neutrality around procreation (no plans nor using contraception due to religious reasons), established at Denver Health, female gender identity (regardless of expression/identification), English-speaking or Spanish-speaking, BMI no less than 25 kg/m2for non-Asian race and 23kg/m2 if Asian race and evidence that activities which can lead to conception were"

Answered by AI

Recent research and studies

clinicaltrials.govStudy

NDPP-NextGen: A Clinical Trial to Reduce Intergenerational Obesity and Diabetes Risks

2023. "NDPP-NextGen: A Clinical Trial to Reduce Intergenerational Obesity and Diabetes Risks". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05674799.