Management of Gestational Weight Gain by Family Physicians: Seeking Congruence With Guidelines
Primary Purpose
Gestational Weight Gain
Status
Withdrawn
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Training in the use of IOM charts
Sponsored by
About this trial
This is an interventional prevention trial for Gestational Weight Gain focused on measuring Pregnancy, Gestational weight gain, Primary care, Guidelines
Eligibility 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.
Sites / Locations
- Halifax Regional Municipality
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Training in the use of IOM charts
Usual care
Arm Description
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.
Family physicians providing usual prenatal care.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT01803698
First Posted
March 1, 2013
Last Updated
July 17, 2018
Sponsor
Helena Piccinini
Collaborators
Nova Scotia Health Authority
1. Study Identification
Unique Protocol Identification Number
NCT01803698
Brief Title
Management of Gestational Weight Gain by Family Physicians: Seeking Congruence With Guidelines
Official Title
MANAGEMENT OF GESTATIONAL WEIGHT GAIN BY FAMILY PHYSICIANS: SEEKING CONGRUENCE WITH GUIDELINES
Study Type
Interventional
2. Study Status
Record Verification Date
July 2018
Overall Recruitment Status
Withdrawn
Why Stopped
never started
Study Start Date
January 2017 (undefined)
Primary Completion Date
January 2017 (Actual)
Study Completion Date
January 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Helena Piccinini
Collaborators
Nova Scotia Health Authority
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. 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:
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gestational Weight Gain
Keywords
Pregnancy, Gestational weight gain, Primary care, Guidelines
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Training in the use of IOM charts
Arm Type
Experimental
Arm Description
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.
Arm Title
Usual care
Arm Type
No Intervention
Arm Description
Family physicians providing usual prenatal care.
Intervention Type
Behavioral
Intervention Name(s)
Training in the use of IOM charts
Primary Outcome Measure Information:
Title
Congruence with gestational weight gain guidelines
Description
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Helena Piccinini-Vallis, MSc MD
Organizational Affiliation
Department of Family Medicine Dalhousie University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Halifax Regional Municipality
City
Halifax
State/Province
Nova Scotia
Country
Canada
12. IPD Sharing Statement
Learn more about this trial
Management of Gestational Weight Gain by Family Physicians: Seeking Congruence With Guidelines
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