Maternal Health Diabetes Prevention Study

PreDiabetes Clinical Trial

Official title:

Maternal Health Diabetes Prevention Project Pilot Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05343494
• Other study ID #: 2021-1234
• Secondary ID: OT2HL158287
• Status: Completed
• Phase: N/A
• Start date: April 4, 2022
• Est. completion date: October 5, 2022

Study information

• Verified date: April 2022
• Source: Tulane University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

In this study, investigators will pilot a 2-month Diabetes Prevention Program-like program (delivered by WIC staff) to 20 women with recent gestational diabetes (6 weeks to 12 months postpartum) who receive WIC services.

The goal of this pilot is to evaluate the feasibility, acceptability, appropriateness, fidelity of implementing this intervention in the setting of WIC clinics and feasibility of conducting a larger-scale study.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: October 5, 2022
• Est. primary completion date: October 5, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Age =18 years

• 6 weeks to 12 months postpartum

• Medical record documented diagnosis of GDM during most recent pregnancy

• Access to a device that can access the internet

• English speaking

Exclusion Criteria:

• Pregnant or planning to become pregnant in the next two months

• Planning to move out of the area in the next two months

• Self-report of diagnosed diabetes

• Use of glucose-lowering medications

• Plasma glucose >200 mg/dL and classic symptoms of hyperglycemia (thirst, polyuria, weight loss, blurry vision) or HbA1c >6.5% (based on screening visit blood draw)

• Unable or unwilling to provide informed consent

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes, Gestational
• Gestational Diabetes
• Glucose Intolerance
• Glucose Intolerance During Pregnancy
• Hyperglycemia
• PreDiabetes

Intervention

Behavioral:
• Lifestyle 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.

Locations

Country	Name	City	State
United States	Tulane Office of Health Research	New Orleans	Louisiana

Sponsors (3)

Lead Sponsor	Collaborator
Tulane University	National Heart, Lung, and Blood Institute (NHLBI), Westat

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Diet	2-month change in self-reported dietary intake assessed by Dietary Screener Questionnaire	2 months
Other	Physical activity	2-month change in self-reported physical activity (metabolic equivalents) assessed by International Physical Activity Questionnaire	2 months
Other	Weight	Change in weight from baseline to 2-month visit	2 months
Other	Hemoglobin A1c	Change in hemoglobin A1c from baseline to 2-month visit	2 months
Other	Fasting plasma glucose	Change in fasting plasma glucose from baseline to 2-month visit	2 months
Other	Recruitment yield	Yield of participants recruited (out of number of prescreening calls, screening visits)	Pre-enrollment (before enrollment into the study)
Other	Retention	Proportion of participants retained to end of 2-month study	Through 2-month study period
Other	Staff time involved in intervention delivery		Through 2-month study period
Other	Staff time involved in recruitment		Pre-enrollment (before enrollment into the study)
Other	Staff time involved in data collection		Through 2-month study period
Other	Qualitative interviews	Qualitative interviews with staff delivering intervention and WIC participants participating in the intervention. Topics covered: barriers and facilitators, intervention feasibility, appropriateness and acceptability, fidelity, potential for scalability and sustainability, usability of the technology and apps used in the intervention, recommendations to improve the intervention/implementation,	2 months
Primary	Fidelity - sessions attended	Number of sessions attended throughout the 8 week intervention	8-week intervention
Secondary	Fidelity - sessions held	Number of sessions held throughout the 8 week intervention	8-week intervention
Secondary	Fidelity - session content	Assessment of whether key concepts were covered during sessions	8-week intervention
Secondary	Intervention feasibility	Feasibility questionnaire delivered to participants and staff delivering the intervention	2-month data collection visit
Secondary	Intervention appropriateness	Appropriateness questionnaire delivered to participants and staff delivering the intervention	2-month data collection visit
Secondary	Intervention acceptability	Acceptability questionnaire delivered to participants and staff delivering the intervention	2-month data collection visit