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| Name | Class |
|---|---|
| Penn State University | OTHER |
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The study aims to improve obstetrical care by managing gestational weight gain (GWG) among high risk women in an effort to reduce maternal and fetal complications.
The project is aimed at teaching women about the appropriate weight gain during pregnancy to optimize health outcomes for mothers and newborn babies. Obese gravida meeting inclusion criteria and none of the exclusion criteria will be offered enrollment in TAGG. Those that consent will be randomized to receive standard of care or enhanced care regarding gestational weight gain.
The primary outcome is the proportion of patients that gain less than 20 lbs over the course of the pregnancy. Secondary outcomes include patient knowledge and expectations, attitude about pregnancy weight gain, self-efficacy of ability to eat healthy, and eating, sleeping and physical activity behavior, perceived stress, psychological factors, patient-experience, involvement in care, and food security.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Standard of Care (SOC) | No Intervention | Participants will receive the usual standard of care which includes written educational materials as well as counseling by their obstetric care provider. | |
| Enhanced Care (EC) | Experimental | In addition to standard of care, the study participants will also receive: i. An initial consult with a licensed, Registered Dietician Nutritionist (RDN); ii. Regular tele-health check-ups (10-20 mins/check-up) with the RDN until delivery; iii. Exposure to personal GWG chart; iv. Letter from physician stating the recommendations for GWG over the course of the pregnancy. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Enhanced Care | Behavioral | In addition to standard of care, the study participants will also receive: i. An initial consult with a licensed, Registered Dietician Nutritionist (RDN); ii. Regular tele-health check-ups (10-20 mins/check-up) with the RDN until delivery; iii. Exposure to personal GWG chart; iv. Letter from physician stating the recommendations for GWG over the course of the pregnancy. |
| Measure | Description | Time Frame |
|---|---|---|
| Gestational weight gain, adjusting for time in the study | at delivery |
| Measure | Description | Time Frame |
|---|---|---|
| Patient knowledge and expectations factors | Participants will be enrolled at baseline (Less than 16 6/7 weeks gestation) and be given a self-report survey tool developed using validated instruments to complete assessing these constructs. This survey tool will then be administered at 32-34 weeks gestation and 4-12 postpartum assessing end of pregnancy and post-intervention patient knowledge and expectations factors. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Awathif D Mackeen, MD, MPH | Geisinger Clinic | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Geisinger Health System | Danville | Pennsylvania | 17822 | United States |
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| ID | Term |
|---|---|
| D009765 | Obesity |
| ID | Term |
|---|---|
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
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| Baseline, 32-34 Weeks Gestation, and 4-12 Weeks Postpartum |
| Attitude on pregnancy weight gain | Participants will be enrolled at baseline (Less than 16 6/7 weeks gestation) and be given a self-report survey tool developed using validated instruments to complete assessing these constructs. This survey tool will then be administered at 32-34 weeks gestation and 4-12 postpartum assessing end of pregnancy and post-intervention patient attitudes on pregnancy weight gain. | Baseline, 32-34 Weeks Gestation, and 4-12 Weeks Postpartum |
| Self-efficacy of healthy eating | Participants will be enrolled at baseline (Less than 16 6/7 weeks gestation) and be given a self-report survey tool developed using validated instruments to complete assessing these constructs. This survey tool will then be administered at 32-34 weeks gestation and 4-12 postpartum assessing end of pregnancy and post-intervention patient self-efficacy of healthy eating. | Baseline, 32-34 Weeks Gestation, and 4-12 Weeks Postpartum |
| Eating, sleeping and physical activity behavior | Participants will be enrolled at baseline (Less than 16 6/7 weeks gestation) and be given a self-report survey tool developed using validated instruments to complete assessing these constructs. This survey tool will then be administered at 32-34 weeks gestation and 4-12 postpartum assessing end of pregnancy and post-intervention patient eating, sleeping and physical activity behaviors. | Baseline, 32-34 Weeks Gestation, and 4-12 Weeks Postpartum |
| Patient-experience and involvement in care | Participants will be enrolled at baseline (Less than 16 6/7 weeks gestation) and be given a self-report survey tool developed using validated instruments to complete assessing these constructs. This survey tool will then be administered at 32-34 weeks gestation and 4-12 postpartum assessing end of pregnancy and post-intervention patient experience and involvement in their care. | Baseline, 32-34 Weeks Gestation, and 4-12 Weeks Postpartum |
| Delivery of large for gestational age infants | This measure will be obtained using electronic health record data and analyzed utilizing clinic data points as well as information gathered from patients through self-report survey data. | At Delivery |
| Diagnosis of gestational diabetes mellitus | This measure will be obtained using EHR data and analyzed utilizing clinic data points. | Baseline through 4-12 Weeks Postpartum |
| Neonatal intensive care unit (NICU) admissions | At Delivery |
| Cost of Treatment | Participant cost of treatment will be assessed utilizing claims data obtained from Geisinger Health Plan to compare the effectiveness of the intervention in reducing cost. | Baseline through 4-12 Weeks Postpartum |
| Mode of delivery | Clinical electronic health record data in regards to the participant mode of delivery will be utilized in statistical analyses to determine whether mode of delivery has an impact on other outcomes of interest. | At Delivery |
| Rate of gestational weight gain | Baseline through 4-12 weeks postpartum |
| Perceived stress measured via Perceived Stress Scale | Perceived Stress will be measured using the Perceived Stress Scale by Cohen et. al. | Baseline through 4-12 weeks postpartum |
| Psychological factors measured via Pregnancy Weight Gain Attitude Scale | Psychological factors will be assessed using the Pregnancy Weight Gain Attitude Scale by Palmer et. al. | Baseline through 4-12 Weeks postpartum |
| D001835 |
| Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |