Teaching Appropriate Gestational Weight Gain
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Geisinger Clinic
- Enrollment
- 218
- Locations
- 2
- Primary Endpoint
- Gestational weight gain, adjusting for time in the study
Study 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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- Single (Outcomes Assessor)
Eligibility Criteria
- Sex
- Female
- Accepts Healthy Volunteers
- Yes
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
Arms & Interventions
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.
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.
Intervention: Enhanced Care (Behavioral)
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)