Clinical trial NCT05343494: Maternal Health Diabetes Prevention Study
Official title: Maternal Health Diabetes Prevention Project Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: 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)
Lead sponsor: Tulane University
Sponsor class: OTHER
Collaborators: name: Westat
name: National Heart, Lung, and Blood Institute (NHLBI)
First posted: 2022-04-25
Enrollment: 20
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

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.

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

Primary outcomes:
measure: Fidelity - sessions attended
timeFrame: 8-week intervention
Secondary outcomes:
measure: Fidelity - sessions held
timeFrame: 8-week intervention
measure: Fidelity - session content
timeFrame: 8-week intervention
measure: Intervention feasibility
timeFrame: 2-month data collection visit
measure: Intervention appropriateness
timeFrame: 2-month data collection visit
measure: Intervention acceptability
timeFrame: 2-month data collection visit
Other outcomes:
measure: Diet
timeFrame: 2 months
measure: Physical activity
timeFrame: 2 months
measure: Weight
timeFrame: 2 months
measure: Hemoglobin A1c
timeFrame: 2 months
measure: Fasting plasma glucose
timeFrame: 2 months
measure: Recruitment yield
timeFrame: Pre-enrollment (before enrollment into the study)
measure: Retention
timeFrame: Through 2-month study period
measure: Staff time involved in intervention delivery
timeFrame: Through 2-month study period
measure: Staff time involved in recruitment
timeFrame: Pre-enrollment (before enrollment into the study)
measure: Staff time involved in data collection
timeFrame: Through 2-month study period
measure: Qualitative interviews
timeFrame: 2 months
Locations:
city: New Orleans
country: United States
facility: Tulane Office of Health Research
state: Louisiana
Study officials:
References: