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| Name | Class |
|---|---|
| Denver Health and Hospital Authority | OTHER |
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This study will pilot and assess feasibility of a prenatal intervention for obese pregnant women based on the Diabetes Prevention Program (DPP). Intervention group participants will meet with a clinic dietitian for 15 minutes at every prenatal appointment to complete a DPP-based curriculum and receive breastfeeding education. Control group participants will receive usual prenatal care. Outcomes include reach and dose of the intervention, gestational weight gain, dietary intake, physical activity, and breastfeeding in the first 6 weeks postpartum.
This study will pilot and test feasibility of a prenatal lifestyle intervention designed to limit gestational weight gain and prevent gestational diabetes. The intervention is based on the Diabetes Prevention Program lifestyle intervention, will include prenatal breastfeeding education and online peer group support, and will be integrated into the participants' regular prenatal appointments. Women (n=24) will be enrolled in early pregnancy. After baseline assessments (demographics, maternal diet, physical activity, mental health), women randomized equally to the intervention or usual care conditions. Further data collection will occur at approximately 24 weeks gestation, 36 weeks gestation, and 6 weeks postpartum, and clinical data (weight, pregnancy and obstetric complications) will be abstracted from medical records at the end of the study. Outcomes include reach and dose of the intervention, gestational weight gain, dietary intake, physical activity, and breastfeeding in the first 6 weeks postpartum. The investigators hypothesize that the intervention will reduce gestational weight gain, improve maternal dietary intake, increase total energy expenditure, and increase breastfeeding exclusivity in the first 6 weeks postpartum.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Dietary and Lifestyle Counseling | Experimental | Women randomized to the intervention group will meet with a dietary counselor for 15 minutes at every prenatal appointment. They will receive a dietary and lifestyle curriculum based on the Diabetes Prevention Program curriculum (11 lessons) with one additional lesson providing prenatal breastfeeding education. They will also have access to a private online Facebook page for additional education and peer group support. |
|
| Standard of Care | No Intervention | Usual prenatal care consists of regular clinical appointments, pregnancy ultrasounds, and recommendations to use prenatal multivitamins, eat a balanced diet, and remain physically active. Women with a pre-pregnant body mass index > 30 complete early glucose screening (as early as possible after presentation at the clinic) to detect pre-existing diabetes, and all women undergo routine gestational diabetes screening at 24-28 weeks. Women who test positive for pre-existing diabetes or gestational diabetes are referred to a registered dietitian. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dietary and Lifestyle Counseling | Behavioral | Dietary and lifestyle education; Peer group support. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Gestational weight gain | Weight change from pre-pregnancy to time of delivery | 40 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Maternal fruit intake | Change in daily servings of fruit from early pregnancy to mid-pregnancy, late pregnancy, and postpartum | Assessed from 12 weeks gestation through 6 weeks postpartum |
| Maternal vegetable intake |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Katherine A Sauder, PhD | University of Colorado, Denver | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Denver Health Eastside Family Health Center | Denver | Colorado | 80205 | United States |
Individual participant data will not be made available for this small pilot and feasibility study
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| ID | Term |
|---|---|
| D000078064 | Gestational Weight Gain |
| ID | Term |
|---|---|
| D015430 | Weight Gain |
| D001836 | Body Weight Changes |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
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| ID | Term |
|---|---|
| D004032 | Diet |
| ID | Term |
|---|---|
| D009747 | Nutritional Physiological Phenomena |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |
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Change in daily servings of vegetables from early pregnancy to mid-pregnancy, late pregnancy, and postpartum
| Assessed from 12 weeks gestation through 6 weeks postpartum |
| Maternal whole grains intake | Change in daily servings of whole grains from early pregnancy to mid-pregnancy, late pregnancy, and postpartum | Assessed from 12 weeks gestation through 6 weeks postpartum |
| Maternal solid fats intake | Change in daily servings of solid fats from early pregnancy to mid-pregnancy, late pregnancy, and postpartum | Assessed from 12 weeks gestation through 6 weeks postpartum |
| Maternal added sugars intake | Change in daily servings of added sugars from early pregnancy to mid-pregnancy, late pregnancy, and postpartum | Assessed from 12 weeks gestation through 6 weeks postpartum |
| Maternal physical activity | Change in total estimated energy expenditure from early pregnancy to mid-pregnancy, late pregnancy, and postpartum | Assessed from 12 weeks gestation through 6 weeks postpartum |
| Exclusive breastfeeding | Measured as exclusive breastfeeding (no formula, no complementary foods) in the first 6 weeks postpartum | Assessed at 6 weeks postpartum |
| D013568 |
| Pathological Conditions, Signs and Symptoms |