Weight GainNCT03455712
Impact of GWG Tool on Patient Knowledge
A study testing Gestational Weight Gain Card in people with Weight Gain and Pregnancy Related, run by MetroHealth Medical Center.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Weight Gain, Pregnancy Related
- What is being tested?
- Gestational Weight Gain Card
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 140 participants
- Where
- No sites listed yet
- Study dates
- 27 Jun 2016to 7 Sep 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Singleton gestation
- Primary prenatal care at MetroHealth Medical Center
- Planning to deliver at MetroHealth Medical Center
Who cannot join
- Any inclusion criteria not met
- Prior diagnosis of eating disorder
- Inadequate knowledge of English language
About this study
Official title: Impact of a Patient Education Intervention on Maternal Knowledge of Gestational Weight Gain Recommendations
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
- Being tested
- Gestational Weight Gain Card
- Keywords
- Pregnancy, Gestational weight gain, Weight gain, Patient education, Patient knowledge, Institute of Medicine
- Medical subject headings
- Weight Gain, Gestational Weight Gain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Gestational Weight Gain CardBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | Subjects to receive the Gestational Weight Gain Card at enrollment in addition to standard prenatal care. Receives: Behavioral: Gestational Weight Gain Card |
| Standard-of-Care | No intervention | No intervention to be delivered. Subjects to receive standard prenatal care. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Outcome assessed up to 23 weeks gestation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Mar 2018
- Study start27 Jun 2016
- Primary completion1 Nov 2016
- Study completion7 Sep 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Weight GainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- 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)
- Enrolment
- 140 participants (actual)
Sponsor and investigators
- Lead sponsor
- MetroHealth Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Allie Reid, MetroHealth Medical Center
- Investigators
- Erica Berggren, MD, MSCR, Principal investigator, Case Western Reserve University School of Medicine, MetroHealth Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03455712
- Sponsor's protocol ID
- IRB16-00295
- Status last verified
- Apr 2024
- First submitted
- 27 Feb 2018
- Last updated
- 25 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of a Patient Education Intervention on Maternal Knowledge of Gestational Weight Gain Recommendations
- ClinicalTrials.gov ID
- NCT03455712
- Acronym / sponsor ID
- IRB16-00295
- Conditions
- Weight Gain, Pregnancy Related
- Keywords
- Pregnancy, Gestational weight gain, Weight gain, Patient education, Patient knowledge, Institute of Medicine
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 140 participants (actual)
- Lead sponsor
- MetroHealth Medical CenterUniversity, hospital or other
- Study start
- 27 Jun 2016 (actual)
- Primary completion
- 1 Nov 2016 (actual)
- Study completion
- 7 Sep 2017 (actual)
- First posted
- 6 Mar 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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'.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Behavioral: Gestational Weight Gain CardSubjects to receive the Gestational Weight Gain Card at enrollment in addition to standard prenatal care. |
| Standard-of-Care | No intervention | –No intervention to be delivered. Subjects to receive standard prenatal care. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Singleton gestation
- Primary prenatal care at MetroHealth Medical Center
- Planning to deliver at MetroHealth Medical Center
Key exclusion criteria (3 listed)
- Any inclusion criteria not met
- Prior diagnosis of eating disorder
- Inadequate knowledge of English language
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Gestational Weight Gain CardThe 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. | Behavioural | Intervention |
Primary outcome
Pregnancy-specific topic/guideline questionnaire responses
Time frame: Outcome assessed up to 23 weeks gestation
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.
1 secondary outcome
Pregnancy-specific topic/guideline questionnaire responses
Time frame: Outcome assessed up to 23 weeks gestation
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Apr 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Erica Berggren, MD, MSCR principal investigator
Case Western Reserve University School of Medicine, MetroHealth Medical Center
Questions about this trial
What is this clinical trial studying?
A study testing Gestational Weight Gain Card in people with Weight Gain and Pregnancy Related, run by MetroHealth Medical Center.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pregnancy-specific topic/guideline questionnaire responses (time frame: Outcome assessed up to 23 weeks gestation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Apr 2024.