Teaching Appropriate Gestational Weight Gain (TAGG)

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.

Study Overview

• Status: Completed
• Conditions: Obesity
• Intervention / Treatment: Behavioral: Enhanced Care

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 Type: Interventional
• Enrollment (Actual): 218
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Pennsylvania
    • Danville, Pennsylvania, United States, 17822
      • Geisinger Health System

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: 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.
Experimental: 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.	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.; Other Names: EC

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Gestational weight gain, adjusting for time in the study	at delivery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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
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
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
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
Neonatal intensive care unit (NICU) admissions		At Delivery
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
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
Rate of gestational weight gain		Baseline through 4-12 weeks postpartum
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
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

Collaborators and Investigators

• Sponsor: Geisinger Clinic
• Collaborators: Penn State University
• Investigators: Principal Investigator: Awathif D Mackeen, MD, MPH, Geisinger Clinic

Study record dates

Study Major Dates

• Study Start: November 1, 2016
• Primary Completion (Actual): July 1, 2018
• Study Completion (Actual): July 1, 2019

Study Registration Dates

• First Submitted: October 12, 2016
• First Submitted That Met QC Criteria: November 10, 2016
• First Posted (Estimate): November 15, 2016

Study Record Updates

• Last Update Posted (Actual): August 14, 2019
• Last Update Submitted That Met QC Criteria: August 13, 2019
• Last Verified: August 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Body Weight; Body Weight Changes; Weight Gain; Gestational Weight Gain
• Other Study ID Numbers: 2016-0205

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED