Maternal Health Diabetes Prevention Study

Maternal Health Diabetes Prevention Project Pilot Study

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.

Study Overview

• Status: Completed
• Conditions: Hyperglycemia; PreDiabetes; Gestational Diabetes; Glucose Intolerance During Pregnancy
• Intervention / Treatment: Behavioral: Lifestyle Intervention

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.

• Study Type: Interventional
• Enrollment (Actual): 20
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Louisiana
    • New Orleans, Louisiana, United States, 70112
      • Tulane Office of Health Research

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: PREVENTION
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

EXPERIMENTAL: 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.

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Fidelity - sessions attended	Number of sessions attended throughout the 8 week intervention	8-week intervention

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Fidelity - sessions held	Number of sessions held throughout the 8 week intervention	8-week intervention
Fidelity - session content	Assessment of whether key concepts were covered during sessions	8-week intervention
Intervention feasibility	Feasibility questionnaire delivered to participants and staff delivering the intervention	2-month data collection visit
Intervention appropriateness	Appropriateness questionnaire delivered to participants and staff delivering the intervention	2-month data collection visit
Intervention acceptability	Acceptability questionnaire delivered to participants and staff delivering the intervention	2-month data collection visit

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Diet	2-month change in self-reported dietary intake assessed by Dietary Screener Questionnaire	2 months
Physical activity	2-month change in self-reported physical activity (metabolic equivalents) assessed by International Physical Activity Questionnaire	2 months
Weight	Change in weight from baseline to 2-month visit	2 months
Hemoglobin A1c	Change in hemoglobin A1c from baseline to 2-month visit	2 months
Fasting plasma glucose	Change in fasting plasma glucose from baseline to 2-month visit	2 months
Recruitment yield	Yield of participants recruited (out of number of prescreening calls, screening visits)	Pre-enrollment (before enrollment into the study)
Retention	Proportion of participants retained to end of 2-month study	Through 2-month study period
Staff time involved in intervention delivery		Through 2-month study period
Staff time involved in recruitment		Pre-enrollment (before enrollment into the study)
Staff time involved in data collection		Through 2-month study period
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

Collaborators and Investigators

• Sponsor: Tulane University
• Collaborators: National Heart, Lung, and Blood Institute (NHLBI); Westat

Study record dates

Study Major Dates

• Study Start (ACTUAL): April 4, 2022
• Primary Completion (ACTUAL): October 5, 2022
• Study Completion (ACTUAL): October 5, 2022

Study Registration Dates

• First Submitted: April 4, 2022
• First Submitted That Met QC Criteria: April 19, 2022
• First Posted (ACTUAL): April 25, 2022

Study Record Updates

• Last Update Posted (ACTUAL): November 30, 2022
• Last Update Submitted That Met QC Criteria: November 29, 2022
• Last Verified: April 1, 2022

More Information

Terms related to this study

• Keywords: Physical Activity; Diet; Behavioral Intervention; Diabetes Prevention Program; Special Supplemental Nutrition Program for Women, Infants, and Children (WIC)
• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Pregnancy Complications; Hyperglycemia; Diabetes Mellitus; Glucose Intolerance; Diabetes, Gestational
• Other Study ID Numbers: 2021-1234; OT2HL158287 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No