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Gestational Weight GainNCT01803698

Management of Gestational Weight Gain by Family Physicians: Seeking Congruence With Guidelines

A study testing Training in the use of IOM charts in people with Gestational Weight Gain, run by Helena Piccinini at 1 site in Canada.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
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Trial summary

Background The Institute of Medicine (IOM) published guidelines in 2009 for optimal gestational weight gain (GWG) during pregnancy. These guidelines include trajectories for optimal GWG, based on a woman's pre-pregnancy body mass index (BMI), to be used throughout the duration of a pregnancy. Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for
Gestational Weight Gain
What is being tested?
Training in the use of IOM charts
Could I receive a placebo?
No, everyone receives an active treatment
How many people
0 participants
Where
1 siteCanada
Study dates
Jan 2017to Jan 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
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • family physicians who provide prenatal care
  • pregnant women with low risk pregnancy

Who cannot join

  • pregnant women < 18 years old
  • pregnant women with multiple gestation
  • pregnant women with chronic disease
  • pregnant women initially presenting in second trimester or later.

Trial locations and contacts

1 site in 1 country.

Canada1 site
  • Halifax Regional Municipality

    Halifax, Nova Scotia

Other trials in Canada

About this study

Official title: MANAGEMENT OF GESTATIONAL WEIGHT GAIN BY FAMILY PHYSICIANS: SEEKING CONGRUENCE WITH GUIDELINES

Background The Institute of Medicine (IOM) published guidelines in 2009 for optimal gestational weight gain (GWG) during pregnancy. These guidelines include trajectories for optimal GWG, based on a woman's pre-pregnancy body mass index (BMI), to be used throughout the duration of a pregnancy. Although there is a significant association between the total GWG recommended by these guidelines and maternal and perinatal outcomes, research has demonstrated that only approximately one-third of pregnant women have total GWG within the recommended amounts. Factors known to influence GWG include maternal age, parity, being in a committed relationship and smoking. In addition, recommendations by primary care providers have been shown to influence actual GWG. Women appreciate advice from their primary care providers, however, despite this, there is evidence that many patients report not being advised at all about GWG by their primary care providers.

Relevance Excess weight gain in pregnancy has been shown to be a modifiable risk factor for excess weight in childhood, thus contributing to the intergenerational cycle of obesity. There is an opportunity to interfere with this cycle during the peri-pregnancy period, as women's motivation to engage in behaviour change is elevated and contact with their primary care providers is frequent.

Read more

Research Question and Hypothesis What impact does training family physicians to regularly refer to the IOM trajectories and provide feedback about GWG ("training in the use of IOM charts") during routine prenatal visits, compared to usual care, have on congruence of total GWG with IOM guidelines? Null Hypothesis: there is no difference in the congruence of total GWG with IOM guidelines between women whose family physicians were assigned to training in the use of the IOM charts and those whose family physicians were assigned to usual care.

Objectives

The following are the objectives for this study:

  1. To compare the congruence of total GWG with IOM guidelines between women whose family physicians were assigned to training in the use of IOM trajectories and those whose family physicians were assigned to usual care.
  2. To explore the relationship between other independent variables (maternal age, parity, committed relationship and smoking) and congruence of total GWG with IOM guidelines, for women whose family physicians were assigned to training in the use of IOM trajectories and for those whose family physicians were assigned to usual care.
Being tested
Training in the use of IOM charts
Keywords
Pregnancy, Gestational weight gain, Primary care, Guidelines
Medical subject headings
Gestational Weight Gain

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Training in the use of IOM chartsBehavioural

Study groups in NCT01803698
Study groupRoleWhat they receive
Training in the use of IOM chartsExperimentalTraining family physicians to regularly refer to the Institute of Medicine guideline trajectories and provide feedback about GWG ("training in the use of IOM charts") during routine prenatal visits.
Receives: Behavioral: Training in the use of IOM charts
Usual careNo interventionFamily physicians providing usual prenatal care.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Congruence with gestational weight gain guidelines

    The congruence of total gestational weight gain with Institute of Medicine guidelines based on pre-pregnancy body mass index.

    Measured: up to 38 weeks after enrolment

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted4 Mar 2013 (estimated)
  2. Study startJan 2017
  3. Primary completionJan 2017
  4. Study completionJan 2017

Why it stopped: never started

Resources

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
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Participant
Enrolment
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01803698
Sponsor's protocol ID
P20PiccVall
Status last verified
Jul 2018
First submitted
1 Mar 2013
Last updated
19 Jul 2018
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A study testing Training in the use of IOM charts in people with Gestational Weight Gain, run by Helena Piccinini at 1 site in Canada.

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 2 inclusion and 4 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: withdrawn, as of the sponsor's last update on 19 Jul 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

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 was withdrawn before enrolling participants, so there are no results.

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?

Congruence with gestational weight gain guidelines (time frame: up to 38 weeks after enrolment). 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 19 Jul 2018.

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