search
Back to results

Maternal Health Diabetes Prevention Study

Primary Purpose

Gestational Diabetes, PreDiabetes, Hyperglycemia

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Lifestyle Intervention
Sponsored by
Tulane University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Gestational Diabetes focused on measuring Diabetes Prevention Program, Behavioral Intervention, Diet, Physical Activity, Special Supplemental Nutrition Program for Women, Infants, and Children (WIC)

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleAccepts Healthy Volunteers

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

Sites / Locations

  • Tulane Office of Health Research

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Lifestyle Intervention

Arm Description

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.

Outcomes

Primary Outcome Measures

Fidelity - sessions attended
Number of sessions attended throughout the 8 week intervention

Secondary Outcome Measures

Fidelity - sessions held
Number of sessions held throughout the 8 week intervention
Fidelity - session content
Assessment of whether key concepts were covered during sessions
Intervention feasibility
Feasibility questionnaire delivered to participants and staff delivering the intervention
Intervention appropriateness
Appropriateness questionnaire delivered to participants and staff delivering the intervention
Intervention acceptability
Acceptability questionnaire delivered to participants and staff delivering the intervention

Full Information

First Posted
April 4, 2022
Last Updated
November 29, 2022
Sponsor
Tulane University
Collaborators
Westat, National Heart, Lung, and Blood Institute (NHLBI)
search

1. Study Identification

Unique Protocol Identification Number
NCT05343494
Brief Title
Maternal Health Diabetes Prevention Study
Official Title
Maternal Health Diabetes Prevention Project Pilot Study
Study Type
Interventional

2. Study Status

Record Verification Date
April 2022
Overall Recruitment Status
Completed
Study Start Date
April 4, 2022 (Actual)
Primary Completion Date
October 5, 2022 (Actual)
Study Completion Date
October 5, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Tulane University
Collaborators
Westat, National Heart, Lung, and Blood Institute (NHLBI)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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.
Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gestational Diabetes, PreDiabetes, Hyperglycemia, Glucose Intolerance During Pregnancy
Keywords
Diabetes Prevention Program, Behavioral Intervention, Diet, Physical Activity, Special Supplemental Nutrition Program for Women, Infants, and Children (WIC)

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Lifestyle Intervention
Arm Type
Experimental
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Lifestyle Intervention
Intervention Description
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.
Primary Outcome Measure Information:
Title
Fidelity - sessions attended
Description
Number of sessions attended throughout the 8 week intervention
Time Frame
8-week intervention
Secondary Outcome Measure Information:
Title
Fidelity - sessions held
Description
Number of sessions held throughout the 8 week intervention
Time Frame
8-week intervention
Title
Fidelity - session content
Description
Assessment of whether key concepts were covered during sessions
Time Frame
8-week intervention
Title
Intervention feasibility
Description
Feasibility questionnaire delivered to participants and staff delivering the intervention
Time Frame
2-month data collection visit
Title
Intervention appropriateness
Description
Appropriateness questionnaire delivered to participants and staff delivering the intervention
Time Frame
2-month data collection visit
Title
Intervention acceptability
Description
Acceptability questionnaire delivered to participants and staff delivering the intervention
Time Frame
2-month data collection visit
Other Pre-specified Outcome Measures:
Title
Diet
Description
2-month change in self-reported dietary intake assessed by Dietary Screener Questionnaire
Time Frame
2 months
Title
Physical activity
Description
2-month change in self-reported physical activity (metabolic equivalents) assessed by International Physical Activity Questionnaire
Time Frame
2 months
Title
Weight
Description
Change in weight from baseline to 2-month visit
Time Frame
2 months
Title
Hemoglobin A1c
Description
Change in hemoglobin A1c from baseline to 2-month visit
Time Frame
2 months
Title
Fasting plasma glucose
Description
Change in fasting plasma glucose from baseline to 2-month visit
Time Frame
2 months
Title
Recruitment yield
Description
Yield of participants recruited (out of number of prescreening calls, screening visits)
Time Frame
Pre-enrollment (before enrollment into the study)
Title
Retention
Description
Proportion of participants retained to end of 2-month study
Time Frame
Through 2-month study period
Title
Staff time involved in intervention delivery
Time Frame
Through 2-month study period
Title
Staff time involved in recruitment
Time Frame
Pre-enrollment (before enrollment into the study)
Title
Staff time involved in data collection
Time Frame
Through 2-month study period
Title
Qualitative interviews
Description
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,
Time Frame
2 months

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Facility Information:
Facility Name
Tulane Office of Health Research
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70112
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Maternal Health Diabetes Prevention Study

We'll reach out to this number within 24 hrs