CClinicalTrials.gg
WithdrawnNCT01803698Updated Jul 19, 2018

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

An interventional study of Training in the use of IOM charts in Gestational Weight Gain, sponsored by Helena Piccinini. Withdrawn at 1 site in Canada. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2018-07-19.

Sponsored by Helena Piccinini · Not applicable, Interventional, and Prevention

Why this study was withdrawn
never started
Phase
Not applicable
Study type
Interventional
Enrollment
0
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.
02

Conditions studied

  • Gestational Weight Gain

Keywords

  • Pregnancy
  • Gestational weight gain
  • Primary care
  • Guidelines
03

In context

Body Weight

1,223 studies on the registry are indexed under Body Weight; 131 are open to participants now.

Browse Body Weight studies →

Lead sponsor

Helena Piccinini is the lead sponsor of 2 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

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

Exclusion criteria

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.
05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
0 participants (actual)

Study arms

  • 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.

Interventions

  • BehavioralTraining in the use of IOM charts
06

What researchers measure

Primary outcomes

  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.

    Time frame: up to 38 weeks after enrolment

07

Study locations

1 site
  • Halifax Regional Municipality
    Halifax, Nova Scotia, Canada
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 19, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01803698
Lead sponsor
Helena Piccinini
Collaborators
Nova Scotia Health Authority
Responsible party
Helena Piccinini (Family Physician, Nova Scotia Health Authority) — Sponsor-investigator
First posted
Mar 4, 2013
Start date
Jan 2017
Primary completion
Jan 2017
Completion
Jan 2017
Last update
Jul 19, 2018

Study contacts

Helena Piccinini-Vallis, MSc MD
principal investigator · Department of Family Medicine Dalhousie University

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is withdrawn, as verified in Jul 2018. You cannot join it, but the record below documents what was studied.

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