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| ID | Type | Description | Link |
|---|---|---|---|
| OT2HL158287 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| Westat | OTHER |
| National Heart, Lung, and Blood Institute (NHLBI) | NIH |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Lifestyle Intervention | Experimental | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Fidelity - sessions attended | Number of sessions attended throughout the 8 week intervention | 8-week intervention |
| 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 |
| 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 |
Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Tulane Office of Health Research | New Orleans | Louisiana | 70112 | United States |
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| ID | Term |
|---|---|
| D016640 | Diabetes, Gestational |
| D011236 | Prediabetic State |
| D006943 | Hyperglycemia |
| D009043 | Motor Activity |
| ID | Term |
|---|---|
| D011248 | Pregnancy Complications |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D003920 | Diabetes Mellitus |
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| 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 |
| 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 |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
| D001519 | Behavior |