Gestational Diabetes, Glucose Intolerance During Pregnancy, Hyperglycemia, PreDiabetes
Conditions
Keywords
Diabetes Prevention Program, Behavioral Intervention, Diet, Physical Activity, Special Supplemental Nutrition Program for Women, Infants, and Children (WIC)
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.
Interventions
BEHAVIORALLifestyle 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.
Sponsors
Westat
National Heart, Lung, and Blood Institute (NHLBI)
Tulane University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Fidelity - sessions attended | 8-week intervention | Number of sessions attended throughout the 8 week intervention |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Fidelity - sessions held | 8-week intervention | Number of sessions held throughout the 8 week intervention |
| Fidelity - session content | 8-week intervention | Assessment of whether key concepts were covered during sessions |
| Intervention feasibility | 2-month data collection visit | Feasibility questionnaire delivered to participants and staff delivering the intervention |
| Intervention appropriateness | 2-month data collection visit | Appropriateness questionnaire delivered to participants and staff delivering the intervention |
| Intervention acceptability | 2-month data collection visit | Acceptability questionnaire delivered to participants and staff delivering the intervention |
Other
| Measure | Time frame | Description |
|---|---|---|
| Retention | Through 2-month study period | Proportion of participants retained to end of 2-month study |
| Staff time involved in intervention delivery | Through 2-month study period | — |
| Diet | 2 months | 2-month change in self-reported dietary intake assessed by Dietary Screener Questionnaire |
| Staff time involved in data collection | Through 2-month study period | — |
| Qualitative interviews | 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, |
| Staff time involved in recruitment | Pre-enrollment (before enrollment into the study) | — |
| Physical activity | 2 months | 2-month change in self-reported physical activity (metabolic equivalents) assessed by International Physical Activity Questionnaire |
| Weight | 2 months | Change in weight from baseline to 2-month visit |
| Hemoglobin A1c | 2 months | Change in hemoglobin A1c from baseline to 2-month visit |
| Fasting plasma glucose | 2 months | Change in fasting plasma glucose from baseline to 2-month visit |
| Recruitment yield | Pre-enrollment (before enrollment into the study) | Yield of participants recruited (out of number of prescreening calls, screening visits) |
Countries
United States
Outcome results
None listed