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Teaching Appropriate Gestational Weight Gain (TAGG)

13. august 2019 oppdatert av: Geisinger Clinic
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.

Studieoversikt

Status

Fullført

Forhold

Intervensjon / Behandling

Detaljert beskrivelse

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

Intervensjonell

Registrering (Faktiske)

218

Fase

  • Ikke aktuelt

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

  • Forente stater
    • Pennsylvania
      • Danville, Pennsylvania, Forente stater, 17822
        • Geisinger Health System

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

  • Barn
  • Voksen
  • Eldre voksen

Tar imot friske frivillige

Ja

Kjønn som er kvalifisert for studier

Hunn

Beskrivelse

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

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Forebygging
  • Tildeling: Randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Enkelt

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Ingen inngripen: 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.
Eksperimentell: 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.
Atferdsmessig: Enhanced Care

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.

Andre navn:
  • EC

Hva måler studien?

Primære resultatmål

Resultatmål
Tidsramme
Gestational weight gain, adjusting for time in the study
Tidsramme: at delivery
at delivery

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Patient knowledge and expectations factors
Tidsramme: 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.
Baseline, 32-34 Weeks Gestation, and 4-12 Weeks Postpartum
Attitude on pregnancy weight gain
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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.
At Delivery
Diagnosis of gestational diabetes mellitus
Tidsramme: Baseline through 4-12 Weeks Postpartum
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
Tidsramme: At Delivery
At Delivery
Cost of Treatment
Tidsramme: Baseline through 4-12 Weeks Postpartum
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
Tidsramme: At 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
Tidsramme: Baseline through 4-12 weeks postpartum
Baseline through 4-12 weeks postpartum
Perceived stress measured via Perceived Stress Scale
Tidsramme: Baseline through 4-12 weeks postpartum
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
Tidsramme: Baseline through 4-12 Weeks postpartum
Psychological factors will be assessed using the Pregnancy Weight Gain Attitude Scale by Palmer et. al.
Baseline through 4-12 Weeks postpartum

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Geisinger Clinic

Samarbeidspartnere

Penn State University

Etterforskere

  • Hovedetterforsker: Awathif D Mackeen, MD, MPH, Geisinger Clinic

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart

1. november 2016

Primær fullføring (Faktiske)

1. juli 2018

Studiet fullført (Faktiske)

1. juli 2019

Datoer for studieregistrering

Først innsendt

12. oktober 2016

Først innsendt som oppfylte QC-kriteriene

10. november 2016

Først lagt ut (Anslag)

15. november 2016

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

14. august 2019

Siste oppdatering sendt inn som oppfylte QC-kriteriene

13. august 2019

Sist bekreftet

1. august 2019

Mer informasjon

Begreper knyttet til denne studien

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • 2016-0205

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

UBESLUTTE

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