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Completed

NCT Number: NCT02963428

Teaching Appropriate Gestational Weight Gain

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.

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Key information

Conditions

Obesity Body Weight Nutrition Disorders Nutritional and Metabolic Diseases Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Geisinger Health System

Danville, Pennsylvania, 17822, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Enhanced Care

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.

Other names: EC

Primary outcomes

  1. Gestational weight gain, adjusting for time in the study

    Time frame: at delivery

Secondary outcomes

  1. Patient knowledge and expectations factors

    Time frame: Baseline, 32-34 Weeks Gestation, and 4-12 Weeks Postpartum

    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.

  2. Attitude on pregnancy weight gain

    Time frame: Baseline, 32-34 Weeks Gestation, and 4-12 Weeks Postpartum

    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.

  3. Self-efficacy of healthy eating

    Time frame: Baseline, 32-34 Weeks Gestation, and 4-12 Weeks Postpartum

    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.

  4. Eating, sleeping and physical activity behavior

    Time frame: Baseline, 32-34 Weeks Gestation, and 4-12 Weeks Postpartum

    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.

  5. Patient-experience and involvement in care

    Time frame: Baseline, 32-34 Weeks Gestation, and 4-12 Weeks Postpartum

    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.

  6. Delivery of large for gestational age infants

    Time frame: At Delivery

    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.

  7. Diagnosis of gestational diabetes mellitus

    Time frame: Baseline through 4-12 Weeks Postpartum

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

  8. Neonatal intensive care unit (NICU) admissions

    Time frame: At Delivery

  9. Cost of Treatment

    Time frame: Baseline through 4-12 Weeks Postpartum

    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.

  10. Mode of delivery

    Time frame: At 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.

  11. Rate of gestational weight gain

    Time frame: Baseline through 4-12 weeks postpartum

  12. Perceived stress measured via Perceived Stress Scale

    Time frame: Baseline through 4-12 weeks postpartum

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

  13. Psychological factors measured via Pregnancy Weight Gain Attitude Scale

    Time frame: Baseline through 4-12 Weeks postpartum

    Psychological factors will be assessed using the Pregnancy Weight Gain Attitude Scale by Palmer et. al.

Sponsors and collaborators

Lead sponsor

Geisinger Clinic

Other

Collaborators

  • Penn State University

Registry information

Acronym: TAGG

Important dates

Study start
2016
Primary completion
2018
Study completion
2019
First posted
Nov 15, 2016
Registry last updated
Aug 14, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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