Impact of GWG Tool on Patient Knowledge

NCT03455712 | Completed

• 1 other identifier: IRB16-00295
• Study Type: interventional
• Target: 140
• Locations: 0 countries
• Sites: N/A

Brief 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'.

Conditions

Weight Gain; Pregnancy Related

Keywords

Pregnancy; Gestational weight gain; Weight gain; Patient education; Patient knowledge; Institute of Medicine

Outcome Measures

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.

  Outcome assessed up to 23 weeks gestation

Secondary Outcomes (1)

• Pregnancy-specific topic/guideline questionnaire responses

  Outcome assessed up to 23 weeks gestation

Study Arms (2)

Intervention

EXPERIMENTAL

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

Behavioral: Gestational Weight Gain Card

Standard-of-Care

NO INTERVENTION

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

Interventions

Gestational Weight Gain Card 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.

Intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Prior diagnosis of eating disorder
• Inadequate knowledge of English language

Sponsors & Collaborators

• MetroHealth Medical Center: lead

MeSH Terms

Conditions

Weight Gain; Gestational Weight Gain

Condition Hierarchy (Ancestors)

Body Weight Changes; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Erica Berggren, MD, MSCR

  Case Western Reserve University School of Medicine, MetroHealth Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: 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.

Study Record Dates

• First Submitted: February 27, 2018
• First Posted: March 6, 2018
• Study Start: June 27, 2016
• Primary Completion: November 1, 2016
• Study Completion: September 7, 2017
• Last Updated: April 25, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share