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- Klinische proef NCT02963428
Teaching Appropriate Gestational Weight Gain (TAGG)
Studie Overzicht
Gedetailleerde beschrijving
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.
Studietype
Inschrijving (Werkelijk)
Fase
- Niet toepasbaar
Contacten en locaties
Studie Locaties
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Pennsylvania
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Danville, Pennsylvania, Verenigde Staten, 17822
- Geisinger Health System
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Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
- Kind
- Volwassen
- Oudere volwassene
Accepteert gezonde vrijwilligers
Geslachten die in aanmerking komen voor studie
Beschrijving
Inclusion Criteria:
- Pre-pregnancy body mass index of at least 30 kg/m2 (per patient report of weight)
- Less than 16 weeks gestation
- Gestational weight gain (GWG) less than < 11 pounds from their pre-pregnancy weight to time of potential study enrollment
- Singleton gestation
- Access to a phone
Exclusion Criteria:
- BMI less than 30 kg/m2
- Gestational age greater than or equal to 16 weeks
- Active diagnosis of cancer on their electronic health record problem list
- Acquired immunodeficiency syndrome (AIDS)
- Palliative medicine patients
- Multiple gestations
- GWG in excess of 11 pounds prior to study enrollment
- Patients with Non-Geisinger prenatal care providers
- Vegan diet
- Malabsorptive conditions
- Previously enrolled in TAGG during prior pregnancy. Patient will be excluded from re-randomization
- Non-English Speaking
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Preventie
- Toewijzing: Gerandomiseerd
- Interventioneel model: Parallelle opdracht
- Masker: Enkel
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
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Geen tussenkomst: Standard of Care (SOC)
Participants will receive the usual standard of care which includes written educational materials as well as counseling by their obstetric care provider.
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Experimenteel: Enhanced Care (EC)
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. |
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.
Andere namen:
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Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Tijdsspanne |
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Gestational weight gain, adjusting for time in the study
Tijdsspanne: at delivery
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at delivery
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Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
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Patient knowledge and expectations factors
Tijdsspanne: Baseline, 32-34 Weeks Gestation, and 4-12 Weeks Postpartum
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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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Baseline, 32-34 Weeks Gestation, and 4-12 Weeks Postpartum
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Attitude on pregnancy weight gain
Tijdsspanne: Baseline, 32-34 Weeks Gestation, and 4-12 Weeks Postpartum
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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.
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Baseline, 32-34 Weeks Gestation, and 4-12 Weeks Postpartum
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Self-efficacy of healthy eating
Tijdsspanne: Baseline, 32-34 Weeks Gestation, and 4-12 Weeks Postpartum
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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.
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Baseline, 32-34 Weeks Gestation, and 4-12 Weeks Postpartum
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Eating, sleeping and physical activity behavior
Tijdsspanne: Baseline, 32-34 Weeks Gestation, and 4-12 Weeks Postpartum
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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.
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Baseline, 32-34 Weeks Gestation, and 4-12 Weeks Postpartum
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Patient-experience and involvement in care
Tijdsspanne: Baseline, 32-34 Weeks Gestation, and 4-12 Weeks Postpartum
|
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.
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Baseline, 32-34 Weeks Gestation, and 4-12 Weeks Postpartum
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Delivery of large for gestational age infants
Tijdsspanne: At Delivery
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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.
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At Delivery
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Diagnosis of gestational diabetes mellitus
Tijdsspanne: Baseline through 4-12 Weeks Postpartum
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This measure will be obtained using EHR data and analyzed utilizing clinic data points.
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Baseline through 4-12 Weeks Postpartum
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Neonatal intensive care unit (NICU) admissions
Tijdsspanne: At Delivery
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At Delivery
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Cost of Treatment
Tijdsspanne: Baseline through 4-12 Weeks Postpartum
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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.
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Baseline through 4-12 Weeks Postpartum
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Mode of delivery
Tijdsspanne: At Delivery
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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.
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At Delivery
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Rate of gestational weight gain
Tijdsspanne: Baseline through 4-12 weeks postpartum
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Baseline through 4-12 weeks postpartum
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Perceived stress measured via Perceived Stress Scale
Tijdsspanne: Baseline through 4-12 weeks postpartum
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Perceived Stress will be measured using the Perceived Stress Scale by Cohen et.
al.
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Baseline through 4-12 weeks postpartum
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Psychological factors measured via Pregnancy Weight Gain Attitude Scale
Tijdsspanne: Baseline through 4-12 Weeks postpartum
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Psychological factors will be assessed using the Pregnancy Weight Gain Attitude Scale by Palmer et.
al.
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Baseline through 4-12 Weeks postpartum
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Medewerkers en onderzoekers
Sponsor
Medewerkers
Onderzoekers
- Hoofdonderzoeker: Awathif D Mackeen, MD, MPH, Geisinger Clinic
Studie record data
Bestudeer belangrijke data
Studie start
Primaire voltooiing (Werkelijk)
Studie voltooiing (Werkelijk)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Schatting)
Updates van studierecords
Laatste update geplaatst (Werkelijk)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- 2016-0205
Plan Individuele Deelnemersgegevens (IPD)
Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?
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