Teaching Appropriate Gestational Weight Gain

NCT ID: NCT02963428

Last Updated: 2019-08-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 218 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-11-30
• Study Completion Date: 2019-07-31

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.

Conditions

Obesity

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

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.

Group Type: EXPERIMENTAL

Enhanced Care

Intervention Type: BEHAVIORAL

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.

Interventions

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.

Intervention Type: BEHAVIORAL

Other Intervention Names

EC

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

• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Penn State University

OTHER

Sponsor Role: collaborator

Geisinger Clinic

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Awathif D Mackeen, MD, MPH

Role: PRINCIPAL_INVESTIGATOR

Geisinger Clinic

Locations

Geisinger Health System

Danville, Pennsylvania, United States

Countries

United States

Other Identifiers

2016-0205

Identifier Type: -

Identifier Source: org_study_id