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| Name | Class |
|---|---|
| Mid-Atlantic Nutrition Obesity Research Center | UNKNOWN |
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Investigators conducted a pilot feasibility and acceptability randomized controlled trial of a remotely delivered behavioral health coaching program in pregnancy and postpartum.
Half of pregnant women are overweight or obese. Obesity disproportionately impacts low-income women and women of racial and ethnic minorities. Maternal obesity is linked with adverse perinatal outcomes, including gestational diabetes and preeclampsia, as well as longer-term health problems such as obesity in offspring and maternal cardiovascular disease. Pregnancy provides a unique opportunity to engage women in improving their health behaviors because women are motivated to protect the health of their babies and have frequent interactions with the healthcare system. Advances in behavioral weight management and obesity prevention have not yet been translated into real-world prenatal care settings. Our team was recently supported by the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)-funded Nutrition and Obesity Research Center Pilot and Feasibility program to adapt an evidence-based telephonic health coaching program for pregnant women. Investigators conducted 20 in-depth interviews with patients and providers to gain valuable feedback to inform the intervention design and delivery, and have put together a multi-disciplinary team to adapt the intervention. Investiagtors developed the intervention specific for pregnancy and postpartum based on this feedback and are testing the intervention, Healthy for Two / Healthy for You, to assess feasibility and acceptability.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Healthy for Two, Healthy for You | Experimental | Remotely delivered behavioral health coaching in pregnancy and postpartum |
|
| Pregnancy Health Education | Active Comparator | Single health education visit with study staff member |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Healthy for Two, Healthy for You | Behavioral | Remotely delivered health coaching in pregnancy and postpartum to promote healthy weight gain. |
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| Measure | Description | Time Frame |
|---|---|---|
| Gestational weight gain | Gestational weight gain is calculated as weight, in pounds recorded at 37 weeks gestation minus the baseline weight recorded by 14 weeks gestation. | At 37 weeks gestation |
| Measure | Description | Time Frame |
|---|---|---|
| Postpartum weight retention | Postpartum weight retention is calculated as weight, in pounds, recorded at 3 months after delivery minus the weight recorded at baseline (by 14 weeks gestation). | At 3 months after delivery |
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Inclusion Criteria:
Mothers:
Infants:
• Born during Mother's enrollment in study
Exclusion Criteria:
• Type 1 or type 2 diabetes, pre-pregnancy or gestational diabetes, diagnosed prior to start of intervention (14 weeks gestation)
Pregnancy condition
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| ID | Term |
|---|---|
| D015430 | Weight Gain |
| ID | Term |
|---|---|
| D001836 | Body Weight Changes |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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Parallel randomized controlled trial
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| Health Education | Behavioral |
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