Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Gestational Weight Gain in Primary Care

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02174809
Recruitment Status : Completed
First Posted : June 26, 2014
Last Update Posted : April 30, 2018
Sponsor:
Collaborator:
Nova Scotia Health Authority
Information provided by (Responsible Party):
Helena Piccinini, Nova Scotia Health Authority

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.


Condition or disease Intervention/treatment Phase
Gestational Weight Gain Behavioral: Use of 5As to discuss gestational weight gain Behavioral: Usual care Not Applicable

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 26 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Curbing Gestational Weight Gain in Primary Care: Using Technology Based on Behaviour Change Theory
Actual Study Start Date : January 1, 2017
Actual Primary Completion Date : March 31, 2018
Actual Study Completion Date : March 31, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Body Weight

Arm Intervention/treatment
Experimental: 5As
Physicians' use of the 5As tool to discuss gestational weight gain with their pregnant patients
Behavioral: Use of 5As to discuss gestational weight gain
Other Name: 5As of Healthy Pregnancy Weight Gain

Active Comparator: Usual care
Usual care by physicians in addressing gestational weight gain with their pregnant patients
Behavioral: Usual care
Other Name: Usual care by physicians in addressing gestational weight gain




Primary Outcome Measures :
  1. 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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02174809


Locations
Layout table for location information
Canada, Nova Scotia
Halifax Regional Municipality
Halifax, Nova Scotia, Canada
Nova Scotia Health Authority
Halifax, Nova Scotia, Canada
Sponsors and Collaborators
Helena Piccinini
Nova Scotia Health Authority
Layout table for additonal information
Responsible Party: Helena Piccinini, Family Physician, Nova Scotia Health Authority
ClinicalTrials.gov Identifier: NCT02174809    
Other Study ID Numbers: P12PiccVall
First Posted: June 26, 2014    Key Record Dates
Last Update Posted: April 30, 2018
Last Verified: April 2018
Keywords provided by Helena Piccinini, Nova Scotia Health Authority:
Pregnancy
Gestational Weight Gain
Primary Care
Guidelines
Additional relevant MeSH terms:
Layout table for MeSH terms
Body Weight
Weight Gain
Gestational Weight Gain
Signs and Symptoms
Body Weight Changes