Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| R01DK122087 | U.S. NIH Grant/Contract | View source |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Kaiser Foundation Research Institute | OTHER |
| National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) | NIH |
Not provided
Not provided
Not provided
Not provided
The aim of this trial is to test components of a digital health outreach intervention to promote uptake of postpartum screening and lifestyle programs for diabetes prevention among patients with gestational diabetes (GDM). The outreach intervention, designed to be interactive and delivered online, includes standard health information plus up to four theory-based components, targeting motivational and logistical barriers to engaging in diabetes preventive care during the postpartum period. The trial leverages the Multiphase Optimization Strategy (MOST) using a randomized factorial study design.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Condition 1 | Experimental | Standard health message + VA + TRI + MI+ AP |
|
| Condition 2 | Experimental | Standard health message + VA + TRI + MI |
|
| Condition 3 | Experimental | Standard health message + VA + TRI + AP |
|
| Condition 4 | Experimental | Standard health message + VA + TRI |
|
| Condition 5 | Experimental |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Standard Health Information | Behavioral | Standard health information about postpartum screening and lifestyle programs for diabetes prevention |
|
| Measure | Description | Time Frame |
|---|---|---|
| Completion of recommended postpartum diabetes screening. | Completion of a 75-gram, 2-hour oral glucose tolerance test (OGTT) | 4-12 weeks postpartum |
| Measure | Description | Time Frame |
|---|---|---|
| Completion of any recommended postpartum diabetes screening test. | Completion of any screening test (OGTT, fasting plasma glucose, or HbA1c) | 4-52 weeks postpartum |
| Completion of any recommended postpartum diabetes screening test. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Susan D Brown, PhD | University of California, Davis | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Kaiser Permanente Northern California | Pleasanton | California | 94588 | United States |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| ICF | No | No | Yes | Informed Consent Form | Jan 5, 2023 | Feb 16, 2023 |
Not provided
Not provided
Not provided
Not provided
Not provided
Standard health message + VA + MI+ AP
|
| Condition 6 | Experimental | Standard health message + VA + MI |
|
| Condition 7 | Experimental | Standard health message + VA + AP |
|
| Condition 8 | Experimental | Standard health message + VA |
|
| Condition 9 | Experimental | Standard health message + TRI + MI+ AP |
|
| Condition 10 | Experimental | Standard health message + TRI + MI |
|
| Condition 11 | Experimental | Standard health message + TRI + AP |
|
| Condition 12 | Experimental | Standard health message + TRI |
|
| Condition 13 | Experimental | Standard health message + MI+ AP |
|
| Condition 14 | Experimental | Standard health message + MI |
|
| Condition 15 | Experimental | Standard health message + AP |
|
| Condition 16 | Experimental | Standard health message |
|
| Values Affirmation (VA) | Behavioral | Interactive prompts to reflect on core personal values |
|
| Tailored Risk Information (TRI) | Behavioral | Interactive prompts to provide tailored information on risk factors for type 2 diabetes |
|
| Motivational Interviewing-based (MI) | Behavioral | Interactive prompts based on principles of motivational interviewing |
|
| Action planning (AP) | Behavioral | Interactive prompts to problem solve challenges |
|
Completion of any screening test (OGTT, fasting plasma glucose, or HbA1c)
| 4-12 weeks postpartum |
| Uptake of a lifestyle program for diabetes prevention. | Enrollment in a lifestyle program for diabetes prevention among women without type 2 diabetes mellitus according to any screening result | 4-52 weeks postpartum |
| ICF_000.pdf |
| ID | Term |
|---|---|
| D016640 | Diabetes, Gestational |
| D003924 | Diabetes Mellitus, Type 2 |
| D003920 | Diabetes Mellitus |
| ID | Term |
|---|---|
| D011248 | Pregnancy Complications |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
Not provided
Not provided