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

July 17, 2018 updated by: Helena Piccinini

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.

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.

Study Overview

Status

Withdrawn

Study Type

Interventional

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Nova Scotia
      • Halifax, Nova Scotia, Canada
        • Halifax Regional Municipality

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / 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.
No Intervention: Usual care
Family physicians providing usual prenatal care.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
up to 38 weeks after enrolment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Helena Piccinini-Vallis, MSc MD, Department of Family Medicine Dalhousie University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2017

Primary Completion (Actual)

January 1, 2017

Study Completion (Actual)

January 1, 2017

Study Registration Dates

First Submitted

March 1, 2013

First Submitted That Met QC Criteria

March 1, 2013

First Posted (Estimate)

March 4, 2013

Study Record Updates

Last Update Posted (Actual)

July 19, 2018

Last Update Submitted That Met QC Criteria

July 17, 2018

Last Verified

July 1, 2018

More Information

Terms related to this study

Other Study ID Numbers

  • P20PiccVall

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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