Gestational Weight Gain in Primary Care

April 26, 2018 updated by: Helena Piccinini

Curbing Gestational Weight Gain in Primary Care: Using Technology Based on Behaviour Change Theory

Excess weight gain in pregnancy is linked to a number of adverse outcomes for mothers and their offspring, and in 2011, 59 % of women in Nova Scotia gained weight in excess of recommendations. A number of factors influence how much weight a woman gains, including lack of knowledge, age, the number of previous pregnancies she's had, smoking, ethnicity, income, and education. Although a clinician's advice also plays a role, simply giving advice does not necessarily translate into patient behaviour change. On the other hand, advice that is given through a patient-centred approach is significantly associated with increased patient acceptance of and adherence to recommendations, and increased intentions and attempts at behaviour change. In addition, this approach has been shown to decrease costs to the health care system. Patient-centredness can measured from the perspective of the clinician, an observer, or the patient. Research suggests that the patient's perspective of patient-centredness is the perspective most significantly associated with improved health outcomes.

Clinicians avoid discussing weight-related matters for a number of reasons, including a lack of time and general discomfort in raising the subject. There are some tools that can address some of these barriers, and example being the "5As of Obesity Management". This tool is based on principles of behaviour change science and patient-centredness. Pilot data on the use of this tool showed a two-fold increase in the initiation of weight-related discussions between clinicians and their patients. Our team was instrumental in the development, dissemination and initial evaluation of this tool, and Dr. Piccinini-Vallis has recently led a national multidisciplinary endeavor to adapt it to pregnancy, which has resulted in the "5As of Healthy Pregnancy Weight Gain" tool. It is now time to evaluate whether the use of this tool is acceptable to clinicians and whether its use translates into any patient outcomes.

Study Overview

Study Type

Interventional

Enrollment (Actual)

26

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
      • Halifax, Nova Scotia, Canada
        • Nova Scotia Health Authority

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

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Family physicians providing prenatal care
  • Patients who are pregnant

Exclusion Criteria:

  • Multiple pregnancy
  • Abnormal pregnancy
  • Inability to read and inability to speak English

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: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 5As
Physicians' use of the 5As tool to discuss gestational weight gain with their pregnant patients
Other Names:
  • 5As of Healthy Pregnancy Weight Gain
Active Comparator: Usual care
Usual care by physicians in addressing gestational weight gain with their pregnant patients
Other Names:
  • Usual care by physicians in addressing gestational weight gain

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Guideline-concordance of women's total gestational weight gain
Time Frame: 12 months
The congruence of total gestational weight gain with Institute of Medicine guidelines based on pre-pregnancy body mass index
12 months

Collaborators and Investigators

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

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 (Actual)

January 1, 2017

Primary Completion (Actual)

March 31, 2018

Study Completion (Actual)

March 31, 2018

Study Registration Dates

First Submitted

March 28, 2014

First Submitted That Met QC Criteria

June 25, 2014

First Posted (Estimate)

June 26, 2014

Study Record Updates

Last Update Posted (Actual)

April 30, 2018

Last Update Submitted That Met QC Criteria

April 26, 2018

Last Verified

April 1, 2018

More Information

Terms related to this study

Other Study ID Numbers

  • P12PiccVall

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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