Impact of GWG Tool on Patient Knowledge

Study Overview
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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'.

Official Title
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Impact of a Patient Education Intervention on Maternal Knowledge of Gestational Weight Gain Recommendations

Conditions
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Weight Gain, Pregnancy Related

Intervention / Treatment
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* Behavioral: Gestational Weight Gain Card


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Singleton gestation Primary prenatal care at MetroHealth Medical Center Planning to deliver at MetroHealth Medical Center Exclusion Criteria: Any inclusion criteria not met Prior diagnosis of eating disorder Inadequate knowledge of English language

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: 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.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention<br>Subjects to receive the Gestational Weight Gain Card at enrollment in addition to standard prenatal care. | Behavioral: Gestational Weight Gain Card<br>* 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.<br>|
| No Intervention: Standard-of-Care<br>No intervention to be delivered. Subjects to receive standard prenatal care. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Outcome assessed up to 23 weeks gestation | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Pregnancy, Gestational weight gain, Weight gain, Patient education, Patient knowledge, Institute of Medicine