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Teaching Appropriate Gestational Weight Gain (TAGG)

13 agosto 2019 aggiornato da: 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.

Panoramica dello studio

Stato

Completato

Condizioni

Intervento / Trattamento

Descrizione dettagliata

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.

Tipo di studio

Interventistico

Iscrizione (Effettivo)

218

Fase

  • Non applicabile

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Luoghi di studio

  • Stati Uniti
    • Pennsylvania
      • Danville, Pennsylvania, Stati Uniti, 17822
        • Geisinger Health System

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

  • Bambino
  • Adulto
  • Adulto più anziano

Accetta volontari sani

Sì

Sessi ammissibili allo studio

Femmina

Descrizione

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

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Prevenzione
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione parallela
  • Mascheramento: Separare

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Nessun intervento: 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.
Sperimentale: 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.
Comportamentale: 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.

Altri nomi:
  • CE

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Lasso di tempo
Gestational weight gain, adjusting for time in the study
Lasso di tempo: at delivery
at delivery

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Patient knowledge and expectations factors
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: At Delivery
At Delivery
Cost of Treatment
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: Baseline through 4-12 weeks postpartum
Baseline through 4-12 weeks postpartum
Perceived stress measured via Perceived Stress Scale
Lasso di tempo: 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
Lasso di tempo: 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

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

Geisinger Clinic

Collaboratori

Penn State University

Investigatori

  • Investigatore principale: Awathif D Mackeen, MD, MPH, Geisinger Clinic

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio

1 novembre 2016

Completamento primario (Effettivo)

1 luglio 2018

Completamento dello studio (Effettivo)

1 luglio 2019

Date di iscrizione allo studio

Primo inviato

12 ottobre 2016

Primo inviato che soddisfa i criteri di controllo qualità

10 novembre 2016

Primo Inserito (Stima)

15 novembre 2016

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

14 agosto 2019

Ultimo aggiornamento inviato che soddisfa i criteri QC

13 agosto 2019

Ultimo verificato

1 agosto 2019

Maggiori informazioni

Termini relativi a questo studio

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • 2016-0205

Piano per i dati dei singoli partecipanti (IPD)

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INDECISO

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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