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

NCT01803698 | Withdrawn

• 1 other identifier: P20PiccVall
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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. 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. 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

Keywords

Pregnancy; Gestational weight gain; Primary care; Guidelines

Outcome Measures

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.

  up to 38 weeks after enrolment

Study Arms (2)

Training in the use of IOM charts

EXPERIMENTAL

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

Usual care

NO INTERVENTION

Family physicians providing usual prenatal care.

Interventions

Training in the use of IOM charts BEHAVIORAL

Training in the use of IOM charts

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• pregnant women \< 18 years old
• pregnant women with multiple gestation
• pregnant women with chronic disease
• pregnant women initially presenting in second trimester or later.

Sponsors & Collaborators

• Helena Piccinini: lead
• Nova Scotia Health Authority: collaborator

Study Sites (1)

Halifax Regional Municipality

Halifax, Nova Scotia, Canada

Location

MeSH Terms

Conditions

Gestational Weight Gain

Condition Hierarchy (Ancestors)

Weight Gain; Body Weight Changes; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Helena Piccinini-Vallis, MSc MD

  Department of Family Medicine Dalhousie University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Family Physician

Study Record Dates

• First Submitted: March 1, 2013
• First Posted: March 4, 2013
• Study Start: January 1, 2017
• Primary Completion: January 1, 2017
• Study Completion: January 1, 2017
• Last Updated: July 19, 2018

Record last verified: 2018-07

Locations

CA (1)