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

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ClinicalTrials.gov Identifier: NCT01803698
Recruitment Status : Not yet recruiting
First Posted : March 4, 2013
Last Update Posted : November 18, 2016
Sponsor:
Collaborator:
Information provided by (Responsible Party):

Study Description
Brief 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. 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:

  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.

Condition or disease Intervention/treatment
Gestational Weight Gain Behavioral: Training in the use of IOM charts

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 530 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Prevention
Official Title: MANAGEMENT OF GESTATIONAL WEIGHT GAIN BY FAMILY PHYSICIANS: SEEKING CONGRUENCE WITH GUIDELINES
Study Start Date : January 2017
Estimated Primary Completion Date : December 2018
Estimated Study Completion Date : December 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Body Weight
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: Training in the use of IOM charts
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.
Behavioral: Training in the use of IOM charts
No Intervention: Usual care
Family physicians providing usual prenatal care.


Outcome Measures

Primary Outcome Measures :
  1. 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.


Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01803698


Contacts
Contact: Helena Piccinini-Vallis, MSc MD 902-473-4747 hpiccinini@me.com

Locations
Canada, Nova Scotia
Halifax Regional Municipality Not yet recruiting
Halifax, Nova Scotia, Canada
Sponsors and Collaborators
Helena Piccinini
Nova Scotia Health Authority
Investigators
Principal Investigator: Helena Piccinini-Vallis, MSc MD Department of Family Medicine Dalhousie University
More Information

Responsible Party: Helena Piccinini, Family Physician, Nova Scotia Health Authority
ClinicalTrials.gov Identifier: NCT01803698     History of Changes
Other Study ID Numbers: P20PiccVall
First Posted: March 4, 2013    Key Record Dates
Last Update Posted: November 18, 2016
Last Verified: November 2016

Keywords provided by Helena Piccinini, Nova Scotia Health Authority:
Pregnancy
Gestational weight gain
Primary care
Guidelines

Additional relevant MeSH terms:
Body Weight
Weight Gain
Signs and Symptoms
Body Weight Changes