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Completed

NCT Number: NCT05343494

Maternal Health Diabetes Prevention 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.

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Key information

Conditions

Gestational Diabetes Behavior Diabetes Mellitus Diabetes, Gestational Endocrine System Diseases Female Urogenital Diseases and Pregnancy Complications Glucose Intolerance During Pregnancy Glucose Metabolism Disorders Hyperglycemia Metabolic Diseases Motor Activity Nutritional and Metabolic Diseases PreDiabetes Prediabetic State Pregnancy Complications Urogenital Diseases

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Tulane Office of Health Research

New Orleans, Louisiana, 70112, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Lifestyle Intervention

Behavioral

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 outcomes

  1. Fidelity - sessions attended

    Time frame: 8-week intervention

    Number of sessions attended throughout the 8 week intervention

Secondary outcomes

  1. Fidelity - sessions held

    Time frame: 8-week intervention

    Number of sessions held throughout the 8 week intervention

  2. Fidelity - session content

    Time frame: 8-week intervention

    Assessment of whether key concepts were covered during sessions

  3. Intervention feasibility

    Time frame: 2-month data collection visit

    Feasibility questionnaire delivered to participants and staff delivering the intervention

  4. Intervention appropriateness

    Time frame: 2-month data collection visit

    Appropriateness questionnaire delivered to participants and staff delivering the intervention

  5. Intervention acceptability

    Time frame: 2-month data collection visit

    Acceptability questionnaire delivered to participants and staff delivering the intervention

Other outcomes

  1. Diet

    Time frame: 2 months

    2-month change in self-reported dietary intake assessed by Dietary Screener Questionnaire

  2. Physical activity

    Time frame: 2 months

    2-month change in self-reported physical activity (metabolic equivalents) assessed by International Physical Activity Questionnaire

  3. Weight

    Time frame: 2 months

    Change in weight from baseline to 2-month visit

  4. Hemoglobin A1c

    Time frame: 2 months

    Change in hemoglobin A1c from baseline to 2-month visit

  5. Fasting plasma glucose

    Time frame: 2 months

    Change in fasting plasma glucose from baseline to 2-month visit

  6. Recruitment yield

    Time frame: Pre-enrollment (before enrollment into the study)

    Yield of participants recruited (out of number of prescreening calls, screening visits)

  7. Retention

    Time frame: Through 2-month study period

    Proportion of participants retained to end of 2-month study

  8. Staff time involved in intervention delivery

    Time frame: Through 2-month study period

  9. Staff time involved in recruitment

    Time frame: Pre-enrollment (before enrollment into the study)

  10. Staff time involved in data collection

    Time frame: Through 2-month study period

  11. Qualitative interviews

    Time frame: 2 months

    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,

Sponsors and collaborators

Lead sponsor

Tulane University

Other

Collaborators

  • National Heart, Lung, and Blood Institute (NHLBI)
  • Westat

Registry information

Official study title

Maternal Health Diabetes Prevention Project Pilot Study

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
Apr 25, 2022
Registry last updated
Nov 30, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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