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.
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
- Type of treatment
- Lifestyle or therapy programme
- 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.
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:
- 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.
- 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.
- Conditions
- Gestational Weight Gain
- 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 group | Role | What they receive |
|---|---|---|
| Training in the use of IOM charts | Experimental | Training 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 care | No intervention | Family physicians providing usual prenatal care. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
- First posted4 Mar 2013 (estimated)
- Study startJan 2017
- Primary completionJan 2017
- Study completionJan 2017
Why it stopped: never started
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gestational 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Helena Piccinini
- Sponsor type
- University, hospital or other
- Collaborators
- Nova Scotia Health Authority
- Responsible party
- Sponsor-investigator, Helena Piccinini, Nova Scotia Health Authority
- Investigators
- Helena Piccinini-Vallis, MSc MD, Principal investigator, Department of Family Medicine Dalhousie University
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
Study at a glance
From the registry record, last updated by the sponsor on 19 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- MANAGEMENT OF GESTATIONAL WEIGHT GAIN BY FAMILY PHYSICIANS: SEEKING CONGRUENCE WITH GUIDELINES
- ClinicalTrials.gov ID
- NCT01803698
- Acronym / sponsor ID
- P20PiccVall
- Conditions
- Gestational Weight Gain
- Keywords
- Pregnancy, Gestational weight gain, Primary care, Guidelines
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: never started
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Helena PiccininiUniversity, hospital or other
- Collaborators
- Nova Scotia Health Authority
- Study start
- Jan 2017
- Primary completion
- Jan 2017 (actual)
- Study completion
- Jan 2017 (actual)
- First posted
- 4 Mar 2013 (estimated)
- 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.
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.
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:
- 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.
- 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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Training in the use of IOM charts | Experimental | Behavioral: Training in the use of IOM chartsTraining 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. |
| Usual care | No intervention | –Family physicians providing usual prenatal care. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- family physicians who provide prenatal care
- pregnant women with low risk pregnancy
Key exclusion criteria (4 listed)
- pregnant women < 18 years old
- pregnant women with multiple gestation
- pregnant women with chronic disease
- pregnant women initially presenting in second trimester or later.
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 |
|---|---|---|
| Training in the use of IOM charts | Behavioural | Training in the use of IOM charts |
Primary outcome
Congruence with gestational weight gain guidelines
Time frame: up to 38 weeks after enrolment
The congruence of total gestational weight gain with Institute of Medicine guidelines based on pre-pregnancy body mass index.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jul 2018.
Related trials for Gestational Weight Gain
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Mother and Offspring's Nutritional Status -Pregnancy After Maternal Bariatric Surgery
Bariatric Surgery, Pregnency
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Time-restricted Eating Among Pregnant Females With Severe Obesity
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Continuous Glucose and E-Monitoring to Support Healthy Weight Gain in Pregnancies - The GEM Study
Pregnancies at Increased Risk for Excessive Gestational Weight Gain, Ecological Momentary Assessment and Intervention
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Healthy Adaptation to Pregnancy, Postpartum and Parenthood
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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.
Helena Piccinini-Vallis, MSc MD principal investigator
Department of Family Medicine Dalhousie University
1 site in 1 country: see every site and its status.
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.