NCT02174809

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
26

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2017

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 28, 2014

Completed
3 months until next milestone

First Posted

Study publicly available on registry

June 26, 2014

Completed
2.5 years until next milestone

Study Start

First participant enrolled

January 1, 2017

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2018

Completed
Last Updated

April 30, 2018

Status Verified

April 1, 2018

Enrollment Period

1.2 years

First QC Date

March 28, 2014

Last Update Submit

April 26, 2018

Conditions

Keywords

PregnancyGestational Weight GainPrimary CareGuidelines

Outcome Measures

Primary Outcomes (1)

  • 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

    12 months

Study Arms (2)

5As

EXPERIMENTAL

Physicians' use of the 5As tool to discuss gestational weight gain with their pregnant patients

Behavioral: Use of 5As to discuss gestational weight gain

Usual care

ACTIVE COMPARATOR

Usual care by physicians in addressing gestational weight gain with their pregnant patients

Behavioral: Usual care

Interventions

Also known as: 5As of Healthy Pregnancy Weight Gain
5As
Usual careBEHAVIORAL
Also known as: Usual care by physicians in addressing gestational weight gain
Usual care

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Family physicians providing prenatal care
  • Patients who are pregnant

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Halifax Regional Municipality

Halifax, Nova Scotia, Canada

Location

Nova Scotia Health Authority

Halifax, Nova Scotia, Canada

Location

MeSH Terms

Conditions

Gestational Weight Gain

Condition Hierarchy (Ancestors)

Weight GainBody Weight ChangesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Family Physician

Study Record Dates

First Submitted

March 28, 2014

First Posted

June 26, 2014

Study Start

January 1, 2017

Primary Completion

March 31, 2018

Study Completion

March 31, 2018

Last Updated

April 30, 2018

Record last verified: 2018-04

Locations