Teaching Appropriate Gestational Weight Gain (TAGG)

Geisinger Health

Status: Completed

Conditions: Obesity

Treatments: Behavioral: Enhanced Care

Study type: Interventional

Funder types: Other

Identifiers

NCT02963428

2016-0205

Details and patient eligibility

About

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.

Full 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.

Enrollment: 218 patients

Sex: Female

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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218 participants in 2 patient groups

Standard of Care (SOC)

No Intervention group

Description:

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)

Experimental group

Description:

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.

Treatment:

Behavioral: Enhanced Care