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Clinical Trials/NCT02963428
NCT02963428
Completed
Not Applicable

Teaching Appropriate Gestational Weight Gain

Geisinger Clinic1 site in 1 country218 target enrollmentNovember 2016
ConditionsObesity

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Obesity
Sponsor
Geisinger Clinic
Enrollment
218
Locations
1
Primary Endpoint
Gestational weight gain, adjusting for time in the study
Status
Completed
Last Updated
6 years ago

Overview

Brief Summary

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.

Detailed Description

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.

Registry
clinicaltrials.gov
Start Date
November 2016
End Date
July 2019
Last Updated
6 years ago
Study Type
Interventional
Study Design
Parallel
Sex
Female

Investigators

Responsible Party
Sponsor

Eligibility Criteria

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

Outcomes

Primary Outcomes

Gestational weight gain, adjusting for time in the study

Time Frame: at delivery

Secondary Outcomes

  • Perceived stress measured via Perceived Stress Scale(Baseline through 4-12 weeks postpartum)
  • Patient knowledge and expectations factors(Baseline, 32-34 Weeks Gestation, and 4-12 Weeks Postpartum)
  • Attitude on pregnancy weight gain(Baseline, 32-34 Weeks Gestation, and 4-12 Weeks Postpartum)
  • Neonatal intensive care unit (NICU) admissions(At Delivery)
  • Rate of gestational weight gain(Baseline through 4-12 weeks postpartum)
  • Patient-experience and involvement in care(Baseline, 32-34 Weeks Gestation, and 4-12 Weeks Postpartum)
  • Cost of Treatment(Baseline through 4-12 Weeks Postpartum)
  • Self-efficacy of healthy eating(Baseline, 32-34 Weeks Gestation, and 4-12 Weeks Postpartum)
  • Eating, sleeping and physical activity behavior(Baseline, 32-34 Weeks Gestation, and 4-12 Weeks Postpartum)
  • Diagnosis of gestational diabetes mellitus(Baseline through 4-12 Weeks Postpartum)
  • Delivery of large for gestational age infants(At Delivery)
  • Mode of delivery(At Delivery)
  • Psychological factors measured via Pregnancy Weight Gain Attitude Scale(Baseline through 4-12 Weeks postpartum)

Study Sites (1)

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