Clinical trial NCT02963428: Teaching Appropriate Gestational Weight Gain
Official title: Teaching Appropriate Gestational Weight Gain
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity
Lead sponsor: Geisinger Clinic
Sponsor class: OTHER
Collaborators: name: Penn State University
First posted: 2016-11-15
Enrollment: 218
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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
* Previously enrolled in TAGG during prior pregnancy. Patient will be excluded from re-randomization
* Non-English Speaking

Primary outcomes:
measure: Gestational weight gain, adjusting for time in the study
timeFrame: at delivery
Secondary outcomes:
measure: Patient knowledge and expectations factors
timeFrame: Baseline, 32-34 Weeks Gestation, and 4-12 Weeks Postpartum
measure: Attitude on pregnancy weight gain
timeFrame: Baseline, 32-34 Weeks Gestation, and 4-12 Weeks Postpartum
measure: Self-efficacy of healthy eating
timeFrame: Baseline, 32-34 Weeks Gestation, and 4-12 Weeks Postpartum
measure: Eating, sleeping and physical activity behavior
timeFrame: Baseline, 32-34 Weeks Gestation, and 4-12 Weeks Postpartum
measure: Patient-experience and involvement in care
timeFrame: Baseline, 32-34 Weeks Gestation, and 4-12 Weeks Postpartum
measure: Delivery of large for gestational age infants
timeFrame: At Delivery
measure: Diagnosis of gestational diabetes mellitus
timeFrame: Baseline through 4-12 Weeks Postpartum
measure: Neonatal intensive care unit (NICU) admissions
timeFrame: At Delivery
measure: Cost of Treatment
timeFrame: Baseline through 4-12 Weeks Postpartum
measure: Mode of delivery
timeFrame: At Delivery
measure: Rate of gestational weight gain
timeFrame: Baseline through 4-12 weeks postpartum
measure: Perceived stress measured via Perceived Stress Scale
timeFrame: Baseline through 4-12 weeks postpartum
measure: Psychological factors measured via Pregnancy Weight Gain Attitude Scale
timeFrame: Baseline through 4-12 Weeks postpartum
Other outcomes:
Locations:
city: Danville
country: United States
facility: Geisinger Health System
state: Pennsylvania
Study officials:
affiliation: Geisinger Clinic
name: Awathif D Mackeen, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References: