Gestational Weight Gain in Primary Care
Primary Purpose
Gestational Weight Gain
Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Use of 5As to discuss gestational weight gain
Usual care
Sponsored by
About this trial
This is an interventional treatment trial for Gestational Weight Gain focused on measuring Pregnancy, Gestational Weight Gain, Primary Care, Guidelines
Eligibility Criteria
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
Sites / Locations
- Halifax Regional Municipality
- Nova Scotia Health Authority
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
5As
Usual care
Arm Description
Physicians' use of the 5As tool to discuss gestational weight gain with their pregnant patients
Usual care by physicians in addressing gestational weight gain with their pregnant patients
Outcomes
Primary Outcome Measures
Guideline-concordance of women's total gestational weight gain
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
NCT02174809
First Posted
March 28, 2014
Last Updated
April 26, 2018
Sponsor
Helena Piccinini
Collaborators
Nova Scotia Health Authority
1. Study Identification
Unique Protocol Identification Number
NCT02174809
Brief Title
Gestational Weight Gain in Primary Care
Official Title
Curbing Gestational Weight Gain in Primary Care: Using Technology Based on Behaviour Change Theory
Study Type
Interventional
2. Study Status
Record Verification Date
April 2018
Overall Recruitment Status
Completed
Study Start Date
January 1, 2017 (Actual)
Primary Completion Date
March 31, 2018 (Actual)
Study Completion Date
March 31, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Helena Piccinini
Collaborators
Nova Scotia Health Authority
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
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
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
26 (Actual)
8. Arms, Groups, and Interventions
Arm Title
5As
Arm Type
Experimental
Arm Description
Physicians' use of the 5As tool to discuss gestational weight gain with their pregnant patients
Arm Title
Usual care
Arm Type
Active Comparator
Arm Description
Usual care by physicians in addressing gestational weight gain with their pregnant patients
Intervention Type
Behavioral
Intervention Name(s)
Use of 5As to discuss gestational weight gain
Other Intervention Name(s)
5As of Healthy Pregnancy Weight Gain
Intervention Type
Behavioral
Intervention Name(s)
Usual care
Other Intervention Name(s)
Usual care by physicians in addressing gestational weight gain
Primary Outcome Measure Information:
Title
Guideline-concordance of women's total gestational weight gain
Description
The congruence of total gestational weight gain with Institute of Medicine guidelines based on pre-pregnancy body mass index
Time Frame
12 months
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Facility Information:
Facility Name
Halifax Regional Municipality
City
Halifax
State/Province
Nova Scotia
Country
Canada
Facility Name
Nova Scotia Health Authority
City
Halifax
State/Province
Nova Scotia
Country
Canada
12. IPD Sharing Statement
Learn more about this trial
Gestational Weight Gain in Primary Care
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