- ICH GCP
- US-Register für klinische Studien
- Klinische Studie NCT02963428
Teaching Appropriate Gestational Weight Gain (TAGG)
Studienübersicht
Detaillierte Beschreibung
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.
Studientyp
Einschreibung (Tatsächlich)
Phase
- Unzutreffend
Kontakte und Standorte
Studienorte
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Pennsylvania
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Danville, Pennsylvania, Vereinigte Staaten, 17822
- Geisinger Health System
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Teilnahmekriterien
Zulassungskriterien
Studienberechtigtes Alter
- Kind
- Erwachsene
- Älterer Erwachsener
Akzeptiert gesunde Freiwillige
Studienberechtigte Geschlechter
Beschreibung
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
Studienplan
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Verhütung
- Zuteilung: Zufällig
- Interventionsmodell: Parallele Zuordnung
- Maskierung: Single
Waffen und Interventionen
Teilnehmergruppe / Arm |
Intervention / Behandlung |
---|---|
Kein Eingriff: 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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Experimental: 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:
|
Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Zeitfenster |
---|---|
Gestational weight gain, adjusting for time in the study
Zeitfenster: at delivery
|
at delivery
|
Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
---|---|---|
Patient knowledge and expectations factors
Zeitfenster: 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 knowledge and expectations factors.
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Baseline, 32-34 Weeks Gestation, and 4-12 Weeks Postpartum
|
Attitude on pregnancy weight gain
Zeitfenster: 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 attitudes on pregnancy weight gain.
|
Baseline, 32-34 Weeks Gestation, and 4-12 Weeks Postpartum
|
Self-efficacy of healthy eating
Zeitfenster: 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 self-efficacy of healthy eating.
|
Baseline, 32-34 Weeks Gestation, and 4-12 Weeks Postpartum
|
Eating, sleeping and physical activity behavior
Zeitfenster: 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 eating, sleeping and physical activity behaviors.
|
Baseline, 32-34 Weeks Gestation, and 4-12 Weeks Postpartum
|
Patient-experience and involvement in care
Zeitfenster: 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.
|
Baseline, 32-34 Weeks Gestation, and 4-12 Weeks Postpartum
|
Delivery of large for gestational age infants
Zeitfenster: At Delivery
|
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
Zeitfenster: 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
Zeitfenster: At Delivery
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At Delivery
|
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Cost of Treatment
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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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Mitarbeiter und Ermittler
Sponsor
Mitarbeiter
Ermittler
- Hauptermittler: Awathif D Mackeen, MD, MPH, Geisinger Clinic
Studienaufzeichnungsdaten
Haupttermine studieren
Studienbeginn
Primärer Abschluss (Tatsächlich)
Studienabschluss (Tatsächlich)
Studienanmeldedaten
Zuerst eingereicht
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
Zuerst gepostet (Schätzen)
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
Zuletzt verifiziert
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Zusätzliche relevante MeSH-Bedingungen
Andere Studien-ID-Nummern
- 2016-0205
Plan für individuelle Teilnehmerdaten (IPD)
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