Teaching Appropriate Gestational Weight Gain - Clinical Trial for Obesity | NCT02963428

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Primary Purpose

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Enhanced Care

About this trial

This is an interventional prevention trial for Obesity

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)FemaleAccepts 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

Sites / Locations

Geisinger Health System

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Standard of Care (SOC)

Enhanced Care (EC)

Arm Description

Participants will receive the usual standard of care which includes written educational materials as well as counseling by their obstetric care provider.

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.

Outcomes

Primary Outcome Measures

Gestational weight gain, adjusting for time in the study

Secondary Outcome Measures

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.

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.

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.

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.

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.

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.

Diagnosis of gestational diabetes mellitus

This measure will be obtained using EHR data and analyzed utilizing clinic data points.

Neonatal intensive care unit (NICU) admissions

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.

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.

Rate of gestational weight gain

Perceived stress measured via Perceived Stress Scale

Perceived Stress will be measured using the Perceived Stress Scale by Cohen et. al.

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.

Full Information

NCT ID

NCT02963428

First Posted

October 12, 2016

Last Updated

August 13, 2019

Sponsor

Geisinger Clinic

Collaborators

Penn State University

1. Study Identification

Unique Protocol Identification Number

NCT02963428

Brief Title

Teaching Appropriate Gestational Weight Gain

Acronym

TAGG

Official Title

Teaching Appropriate Gestational Weight Gain

Study Type

Interventional

2. Study Status

Record Verification Date

August 2019

Overall Recruitment Status

Completed

Study Start Date

November 2016 (undefined)

Primary Completion Date

July 2018 (Actual)

Study Completion Date

July 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Geisinger Clinic

Collaborators

Penn State University

4. Oversight

Data Monitoring Committee

No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Obesity

7. Study Design

Primary Purpose

Prevention

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

Outcomes Assessor

Allocation

Randomized

Enrollment

218 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Standard of Care (SOC)

Arm Type

No Intervention

Arm Description

Participants will receive the usual standard of care which includes written educational materials as well as counseling by their obstetric care provider.

Arm Title

Enhanced Care (EC)

Arm Type

Experimental

Arm 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.

Intervention Type

Behavioral

Intervention Name(s)

Enhanced Care

Other Intervention Name(s)

EC

Intervention 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.

Primary Outcome Measure Information:

Title

Gestational weight gain, adjusting for time in the study

Time Frame

at delivery

Secondary Outcome Measure Information:

Title

Patient knowledge and expectations factors

Description

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.

Time Frame