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

NCT ID: NCT01803698

Last Updated: 2018-07-19

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: NA
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-01-31
• Study Completion Date: 2017-01-31

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.

Conditions

Gestational Weight Gain

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: EXPERIMENTAL

Training in the use of IOM charts

Intervention Type: BEHAVIORAL

Usual care

Family physicians providing usual prenatal care.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Training in the use of IOM charts

Intervention Type: BEHAVIORAL

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Nova Scotia Health Authority

OTHER

Sponsor Role: collaborator

Helena Piccinini

OTHER

Sponsor Role: lead

Responsible Party

Helena Piccinini

Family Physician

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Helena Piccinini-Vallis, MSc MD

Role: PRINCIPAL_INVESTIGATOR

Department of Family Medicine Dalhousie University

Locations

Halifax Regional Municipality

Halifax, Nova Scotia, Canada

Countries

Canada

Other Identifiers

P20PiccVall

Identifier Type: -

Identifier Source: org_study_id