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CompletedNCT03455712Updated Apr 25, 2024

Impact of GWG Tool on Patient Knowledge

An interventional study of Gestational Weight Gain Card in Weight Gain and Pregnancy Related, sponsored by MetroHealth Medical Center. Completed. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-04-25.

Sponsored by MetroHealth Medical Center · Not applicable, Interventional, and Other

Phase
Not applicable
Study type
Interventional
Enrollment
140
Allocation
Non-randomized
Ages
18 Years and older
Sex
Female
01

Study summary

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'.

02

Conditions studied

  • Weight Gain
  • Pregnancy Related

Keywords

  • Pregnancy
  • Gestational weight gain
  • Weight gain
  • Patient education
  • Patient knowledge
  • Institute of Medicine
03

Who can participate

Ages eligible
18 Years and older
Sexes eligible
Female
Accepts healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • Any inclusion criteria not met
  • Prior diagnosis of eating disorder
  • Inadequate knowledge of English language
04

Study design

Phase
Not applicable
Primary purpose
Other
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
140 participants (actual)

Study arms

  • Experimental
    Intervention

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

    Behavioral: Gestational Weight Gain Card

  • No intervention
    Standard-of-Care

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

Interventions

  • BehavioralGestational 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.

05

What researchers measure

Primary outcomes

  1. Pregnancy-specific topic/guideline questionnaire responses

    Comparison of number of participants in control vs. intervention groups who correctly answer multiple choice and free response questions related to pregnancy-specific topics and guidelines following intervention.

    Time frame: Outcome assessed up to 23 weeks gestation

Secondary outcomes

  1. Pregnancy-specific topic/guideline questionnaire responses

    Description of general patient population knowledge of pregnancy-specific topics and guidelines from number of participants who correctly answer multiple choice and free response questions related to pregnancy-specific topics and guidelines prior to intervention.

    Time frame: Outcome assessed up to 23 weeks gestation

06

Study locations

No study locations are listed for this record.

07

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT03455712
Lead sponsor
MetroHealth Medical Center
Responsible party
Allie Reid (Principal Investigator, MetroHealth Medical Center) — Principal investigator
First posted
Mar 6, 2018
Start date
Jun 27, 2016
Primary completion
Nov 1, 2016
Completion
Sep 7, 2017
Last update
Apr 25, 2024

Study contacts

Erica Berggren, MD, MSCR
principal investigator · Case Western Reserve University School of Medicine, MetroHealth Medical Center

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Apr 2024. You cannot join it, but the record below documents what was studied.

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