Teaching Appropriate Gestational Weight Gain

Obesity Clinical Trial

— TAGG  

Official title:

Teaching Appropriate Gestational Weight Gain

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02963428
• Other study ID #: 2016-0205
• Status: Completed
• Phase: N/A
• Start date: November 2016
• Est. completion date: July 2019

Study information

• Verified date: August 2019
• Source: Geisinger Clinic
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 218
• Est. completion date: July 2019
• Est. primary completion date: July 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Gestational Weight Gain
• Obesity
• Weight Gain

Intervention

Behavioral:
• 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.

Locations

Country	Name	City	State
United States	Geisinger Health System	Danville	Pennsylvania

Sponsors (2)

Lead Sponsor	Collaborator
Geisinger Clinic	Penn State University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Gestational weight gain, adjusting for time in the study		at delivery
Secondary	Patient knowledge and expectations factors	Participants will be enrolled at baseline (Less than 16 6/7 weeks gestation) and be given a self-report survey tool developed using validated instruments to complete assessing these constructs. This survey tool will then be administered at 32-34 weeks gestation and 4-12 postpartum assessing end of pregnancy and post-intervention patient knowledge and expectations factors.	Baseline, 32-34 Weeks Gestation, and 4-12 Weeks Postpartum
Secondary	Attitude on pregnancy weight gain	Participants will be enrolled at baseline (Less than 16 6/7 weeks gestation) and be given a self-report survey tool developed using validated instruments to complete assessing these constructs. This survey tool will then be administered at 32-34 weeks gestation and 4-12 postpartum assessing end of pregnancy and post-intervention patient attitudes on pregnancy weight gain.	Baseline, 32-34 Weeks Gestation, and 4-12 Weeks Postpartum
Secondary	Self-efficacy of healthy eating	Participants will be enrolled at baseline (Less than 16 6/7 weeks gestation) and be given a self-report survey tool developed using validated instruments to complete assessing these constructs. This survey tool will then be administered at 32-34 weeks gestation and 4-12 postpartum assessing end of pregnancy and post-intervention patient self-efficacy of healthy eating.	Baseline, 32-34 Weeks Gestation, and 4-12 Weeks Postpartum
Secondary	Eating, sleeping and physical activity behavior	Participants will be enrolled at baseline (Less than 16 6/7 weeks gestation) and be given a self-report survey tool developed using validated instruments to complete assessing these constructs. This survey tool will then be administered at 32-34 weeks gestation and 4-12 postpartum assessing end of pregnancy and post-intervention patient eating, sleeping and physical activity behaviors.	Baseline, 32-34 Weeks Gestation, and 4-12 Weeks Postpartum
Secondary	Patient-experience and involvement in care	Participants will be enrolled at baseline (Less than 16 6/7 weeks gestation) and be given a self-report survey tool developed using validated instruments to complete assessing these constructs. This survey tool will then be administered at 32-34 weeks gestation and 4-12 postpartum assessing end of pregnancy and post-intervention patient experience and involvement in their care.	Baseline, 32-34 Weeks Gestation, and 4-12 Weeks Postpartum
Secondary	Delivery of large for gestational age infants	This measure will be obtained using electronic health record data and analyzed utilizing clinic data points as well as information gathered from patients through self-report survey data.	At Delivery
Secondary	Diagnosis of gestational diabetes mellitus	This measure will be obtained using EHR data and analyzed utilizing clinic data points.	Baseline through 4-12 Weeks Postpartum
Secondary	Neonatal intensive care unit (NICU) admissions		At Delivery
Secondary	Cost of Treatment	Participant cost of treatment will be assessed utilizing claims data obtained from Geisinger Health Plan to compare the effectiveness of the intervention in reducing cost.	Baseline through 4-12 Weeks Postpartum
Secondary	Mode of delivery	Clinical electronic health record data in regards to the participant mode of delivery will be utilized in statistical analyses to determine whether mode of delivery has an impact on other outcomes of interest.	At Delivery
Secondary	Rate of gestational weight gain		Baseline through 4-12 weeks postpartum
Secondary	Perceived stress measured via Perceived Stress Scale	Perceived Stress will be measured using the Perceived Stress Scale by Cohen et. al.	Baseline through 4-12 weeks postpartum
Secondary	Psychological factors measured via Pregnancy Weight Gain Attitude Scale	Psychological factors will be assessed using the Pregnancy Weight Gain Attitude Scale by Palmer et. al.	Baseline through 4-12 Weeks postpartum