NCT02963428

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
218

participants targeted

Target at P75+ for not_applicable obesity

Timeline
Completed

Started Nov 2016

Typical duration for not_applicable obesity

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 12, 2016

Completed
20 days until next milestone

Study Start

First participant enrolled

November 1, 2016

Completed
14 days until next milestone

First Posted

Study publicly available on registry

November 15, 2016

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2018

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2019

Completed
Last Updated

August 14, 2019

Status Verified

August 1, 2019

Enrollment Period

1.7 years

First QC Date

October 12, 2016

Last Update Submit

August 13, 2019

Conditions

Obesity

Outcome Measures

Primary Outcomes (1)

  • Gestational weight gain, adjusting for time in the study

    at delivery

Secondary Outcomes (13)

  • Patient knowledge and expectations factors

    Baseline, 32-34 Weeks Gestation, and 4-12 Weeks Postpartum

  • Attitude on pregnancy weight gain

    Baseline, 32-34 Weeks Gestation, and 4-12 Weeks Postpartum

  • Self-efficacy of healthy eating

    Baseline, 32-34 Weeks Gestation, and 4-12 Weeks Postpartum

  • Eating, sleeping and physical activity behavior

    Baseline, 32-34 Weeks Gestation, and 4-12 Weeks Postpartum

  • Patient-experience and involvement in care

    Baseline, 32-34 Weeks Gestation, and 4-12 Weeks Postpartum

  • +8 more secondary outcomes

Study Arms (2)

Standard of Care (SOC)

NO INTERVENTION

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

Enhanced Care (EC)

EXPERIMENTAL

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

Interventions

Enhanced CareBEHAVIORAL

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.

Also known as: EC
Enhanced Care (EC)

Eligibility Criteria

Sexfemale
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Geisinger Health System

Danville, Pennsylvania, 17822, United States

Location

MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Awathif D Mackeen, MD, MPH

    Geisinger Clinic

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 12, 2016

First Posted

November 15, 2016

Study Start

November 1, 2016

Primary Completion

July 1, 2018

Study Completion

July 1, 2019

Last Updated

August 14, 2019

Record last verified: 2019-08

Locations

US(1)