Gestational Weight Gain in Primary Care

Gestational Weight Gain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02174809
• Other study ID #: P12PiccVall
• Status: Completed
• Phase: N/A
• Start date: January 1, 2017
• Est. completion date: March 31, 2018

Study information

• Verified date: April 2018
• Source: Nova Scotia Health Authority
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 26
• Est. completion date: March 31, 2018
• Est. primary completion date: March 31, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Body Weight
• Gestational Weight Gain
• Weight Gain

Intervention

Behavioral:
• Use of 5As to discuss gestational weight gain

• Usual care

Locations

Country	Name	City	State
Canada	Halifax Regional Municipality	Halifax	Nova Scotia
Canada	Nova Scotia Health Authority	Halifax	Nova Scotia

Sponsors (2)

Lead Sponsor	Collaborator
Helena Piccinini	Nova Scotia Health Authority

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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