Impact of GWG Tool on Patient Knowledge

NCT ID: NCT03455712

Last Updated: 2024-04-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

140 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-06-27

Study Completion Date

2017-09-07

Brief Summary

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Women with singleton pregnancies at one outpatient clinic to be recruited for controlled clinical trial. Over eight weeks, women 15 0/7--22 6/7 weeks' with at least one prior prenatal visit to be enrolled in the control group. Women 6 0/7--14 6/7 weeks' to be enrolled in the intervention group at their first prenatal visit and to receive a pregnancy-specific gestational weight gain card. Women to be encouraged to record their weight at each prenatal care visit. All women to complete a GWG knowledge--based questionnaire at 15 0/7-22 6/7 weeks'.

Detailed Description

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Conditions

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Weight Gain Pregnancy Related

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Subjects to be enrolled into the intervention and standard-of-care groups depending on their gestational age at the time of consent during the expected 2 month period of enrollment. Any subject who is between 6 weeks 0 days and 14 weeks 6 days of pregnancy at the time of consent and who has had no prior prenatal visits will be enrolled in the intervention group. Any subject who is between 15 weeks 0 days to 22 weeks 6 days of pregnancy at the time of consent and who has had at least one prior prenatal visit will be enrolled in the control group.
Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Intervention

Subjects to receive the Gestational Weight Gain Card at enrollment in addition to standard prenatal care.

Group Type EXPERIMENTAL

Gestational Weight Gain Card

Intervention Type BEHAVIORAL

The Gestational Weight Gain Card is designed to be an educational and weight gain tracking tool. Study subjects will be highly encouraged to use the GWG card to gain both important clinical information and to document weight measurements throughout their pregnancy.

Standard-of-Care

No intervention to be delivered. Subjects to receive standard prenatal care.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Gestational Weight Gain Card

The Gestational Weight Gain Card is designed to be an educational and weight gain tracking tool. Study subjects will be highly encouraged to use the GWG card to gain both important clinical information and to document weight measurements throughout their pregnancy.

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* Singleton gestation
* Primary prenatal care at MetroHealth Medical Center
* Planning to deliver at MetroHealth Medical Center

* Prior diagnosis of eating disorder
* Inadequate knowledge of English language
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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MetroHealth Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Allie Reid

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Erica Berggren, MD, MSCR

Role: PRINCIPAL_INVESTIGATOR

Case Western Reserve University School of Medicine, MetroHealth Medical Center

Other Identifiers

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IRB16-00295

Identifier Type: -

Identifier Source: org_study_id

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