Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Brown University | OTHER |
Not provided
Not provided
Not provided
Not provided
The overall purpose of this study is to determine the efficacy of a pre-pregnancy lifestyle intervention to reduce the recurrence of gestational diabetes mellitus in multiethnic women with overweight or obesity.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Lifestyle Intervention | Experimental | Intervention group will receive a comprehensive, multicomponent weight loss intervention targeting diet, physical activity, and behavioral strategies. |
|
| Health Promotion | Active Comparator | Health promotion group will receive education on healthy eating and activity before pregnancy. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lifestyle intervention | Behavioral | Intervention group will receive comprehensive behavioral weight loss program. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of Gestational Diabetes Mellitus | 26 weeks gestation |
| Measure | Description | Time Frame |
|---|---|---|
| Changes in maternal levels of fasting glucose | study entry, 16 weeks, 26 weeks gestation | |
| Changes in maternal levels of fasting insulin | study entry, 16 weeks, 26 weeks gestation | |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Suzanne Phelan, PhD | California Polytechnic State University-San Luis Obispo | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| California Polytechnic State University | San Luis Obispo | California | 93401 | United States | ||
| Miriam Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36758710 | Derived | Phelan S, Jelalian E, Coustan D, Caughey AB, Castorino K, Hagobian T, Munoz-Christian K, Schaffner A, Shields L, Heaney C, McHugh A, Wing RR. Randomized controlled trial of prepregnancy lifestyle intervention to reduce recurrence of gestational diabetes mellitus. Am J Obstet Gynecol. 2023 Aug;229(2):158.e1-158.e14. doi: 10.1016/j.ajog.2023.01.037. Epub 2023 Feb 8. | |
| 33827659 |
Not provided
Not provided
A de-identified dataset will be made available to outside investigators after the primary and secondary analyses are completed and in accordance with local institutional review board and NIH policies.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Health Promotion | Other | The health promotion group will receive education on healthy eating and activity |
|
| Changes in maternal levels of systolic and diastolic blood pressure |
| study entry, 16 weeks, 26 weeks gestation |
| Changes in maternal levels of C-reactive protein | study entry, 16 weeks, 26 weeks gestation |
| Incidence of preeclampsia | Delivery |
| Incidence of cesarean delivery | Delivery |
| Weight changes | study entry, 16 weeks, 26 weeks gestation |
| Daily caloric intake | study entry, 16 weeks, 26 weeks gestation |
| Minutes per week of moderate physical activity | study entry, 16 weeks, 26 weeks gestation |
| Providence |
| Rhode Island |
| 02906 |
| United States |
| Phelan S, Jelalian E, Coustan D, Caughey AB, Castorino K, Hagobian T, Munoz-Christian K, Schaffner A, Shields L, Heaney C, McHugh A, Wing RR. Protocol for a randomized controlled trial of pre-pregnancy lifestyle intervention to reduce recurrence of gestational diabetes: Gestational Diabetes Prevention/Prevencion de la Diabetes Gestacional. Trials. 2021 Apr 7;22(1):256. doi: 10.1186/s13063-021-05204-w. |
| ID | Term |
|---|---|
| D016640 | Diabetes, Gestational |
| ID | Term |
|---|---|
| D011248 | Pregnancy Complications |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D006293 | Health Promotion |
| ID | Term |
|---|---|
| D006266 | Health Education |
| D011314 | Preventive Health Services |
| D006296 | Health Services |
| D005159 | Health Care Facilities Workforce and Services |
Not provided
Not provided