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

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified February 2013 by Capital District Health Authority, Canada
Sponsor:
Information provided by (Responsible Party):
Capital District Health Authority, Canada
ClinicalTrials.gov Identifier:
NCT01803698
First received: March 1, 2013
Last updated: April 23, 2013
Last verified: February 2013
  Purpose

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 Intervention
Gestational Weight Gain
Behavioral: Training in the use of IOM charts

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Prevention
Official Title: MANAGEMENT OF GESTATIONAL WEIGHT GAIN BY FAMILY PHYSICIANS: SEEKING CONGRUENCE WITH GUIDELINES

Further study details as provided by Capital District Health Authority, Canada:

Primary Outcome Measures:
  • Congruence with gestational weight gain guidelines [ Time Frame: up to 38 weeks after enrolment ] [ Designated as safety issue: No ]
    The congruence of total gestational weight gain with Institute of Medicine guidelines based on pre-pregnancy body mass index.


Estimated Enrollment: 530
Study Start Date: January 2014
Estimated Study Completion Date: August 2015
Estimated Primary Completion Date: August 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
Capital District Health Authority, Canada
Investigators
Principal Investigator: Helena Piccinini-Vallis, MSc MD Department of Family Medicine Dalhousie University
  More Information

No publications provided

Responsible Party: Capital District Health Authority, Canada
ClinicalTrials.gov Identifier: NCT01803698     History of Changes
Other Study ID Numbers: P20PiccVall
Study First Received: March 1, 2013
Last Updated: April 23, 2013
Health Authority: Canada: Capital District Health Authority

Keywords provided by Capital District Health Authority, Canada:
Pregnancy
Gestational weight gain
Primary care
Guidelines

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

ClinicalTrials.gov processed this record on August 26, 2014