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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02586467
Other study ID # H12-00332
Secondary ID
Status Completed
Phase N/A
First received October 20, 2015
Last updated October 22, 2015
Start date August 2013
Est. completion date November 2013

Study information

Verified date October 2015
Source University of British Columbia
Contact n/a
Is FDA regulated No
Health authority Canada: Institutional Review Board
Study type Interventional

Clinical Trial Summary

Over 35,000 Canadians, 65% of men and 72% of women aged 31-50 years fail to consume the recommended number of milk and milk product servings (≤2 servings per day). Given the wide range of health benefits associated with increased dietary intake of milk and milk products the objectives of this study were to conduct a prospective, 5-arm randomised controlled trial in order to test the effectiveness of a variety of messages for increasing milk and milk product consumption in men and women aged 30-50 years old. The five arms consisted of 4 messages that contained slightly different content specifically: 1) gain-framed message condition, 2) loss-framed message condition, 3) self-regulatory efficacy-enhancing message condition, 4) gain-framed and self-regulatory efficacy-enhancing message condition and 5) loss-framed plus self-regulatory efficacy-enhancing message condition. It was hypothesised that those who receive self-regulatory efficacy-enhancing information would consume more dairy than those who received messages without such information. Second, those who received gain-framed messages would consume more dairy as compared to those who received loss-framed messages. Third, those who received gain-framed messages that include self-regulatory efficacy-enhancing information would consume the most dairy in comparison to the other four conditions.


Recruitment information / eligibility

Status Completed
Enrollment 732
Est. completion date November 2013
Est. primary completion date November 2013
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 30 Years to 50 Years
Eligibility Inclusion Criteria:

- Between 30 and 50 years of age

- Consume less than 2 servings of milk or milk products per day

- No health or religious reasons to avoid milk and milk products

- Regular access to the internet

- Can speak and read English

Exclusion Criteria:

- Dietary restrictions, allergies, or medical reasons for limiting dairy intake will be excluded

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Supportive Care


Related Conditions & MeSH terms


Intervention

Behavioral:
Gain-Framed
Participants will be randomised to one of five message conditions. Each condition will receive a total of four emailed messages on four consecutive days (i.e., 1 message per day). Participants in the Gain-Framed message condition will receive message content that highlights the potential benefits of consuming milk and milk products (i.e., high protein content, stronger hair and nail etc.)
Loss-Framed
Participants will be randomised to one of five message conditions. Each condition will receive a total of four emailed messages on four consecutive days (i.e., 1 message per day). Participants in the Loss-Framed message condition will receive message content that highlights the potential losses of not consuming milk and milk products (i.e., lack of essential nutrients, less calcium).
Self-Regulatory Efficacy
Participants will be randomised to one of five message conditions. Each condition will receive a total of four emailed messages on four consecutive days (i.e., 1 message per day). Participants in the Self-Regulatory Efficacy message condition will receive information pertaining to how to include milk and milk products within their diet. This information will come in the form of recipes, meal planning, food combining etc.
Gain-Framed + Self-Regulatory Efficacy
Participants will be randomised to one of five message conditions. Each condition will receive a total of four emailed messages on four consecutive days (i.e., 1 message per day). Participants in the Gain-Framed message + Self-Regulatory Efficacy condition will receive message content that highlights the potential benefits of consuming milk and milk products (i.e., high protein content, stronger hair and nail etc.) and information pertaining to how to include milk and milk products within their diet.
Loss-Framed + Self-Regulatory Efficacy
Participants will be randomised to one of five message conditions. Each condition will receive a total of four emailed messages on four consecutive days (i.e., 1 message per day). Participants in the Loss-Framed message + Self-Regulatory Efficacy condition will receive message content that highlights the potential losses of not consuming milk and milk products (i.e., lack of essential nutrients, less calcium) and information pertaining to how to include milk and milk products within their diet.

Locations

Country Name City State
Canada Health and Exercise Psychology Laboratory Kelowna British Columbia

Sponsors (1)

Lead Sponsor Collaborator
University of British Columbia

Country where clinical trial is conducted

Canada, 

References & Publications (3)

Bandura A. Social foundations of thought and action: A social cognitive theory. NJ US: Prentice-Hall, Inc; 1986.

Jung ME, Martin Ginis KA, Phillips SM, Lordon CD. Increasing calcium intake in young women through gain-framed, targeted messages: a randomised controlled trial. Psychol Health. 2011 May;26(5):531-47. doi: 10.1080/08870441003611544. — View Citation

Tversky A, Kahneman D. The framing of decisions and the psychology of choice. Science. 1981 Jan 30;211(4481):453-8. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Changes from baseline in calcium from dairy at 1 and 4-week follow up Calcium consumed from dairy was assessed using a modified version of the "Calcium Calculatorâ„¢" developed by the British Columbia Dairy Foundation. The original tool assesses consumption of calcium from a comprehensive list of 30 commonly consumed calcium containing products. For this study individuals were asked to indicate the portions they ate of 10 dairy products included in the list. An explanation of a portion was provided for each item. Milligrams of calcium consumed by participants on the previous day was determined for baseline, week 1 and week 4 follow-up. Baseline, 1-week follow-up, 4-week follow-up No
Secondary Self-Regulatory Efficacy Changes in participants self-regulatory efficacy beliefs was assessed using an 18-item measure at baseline, 1-day after completion of the intervention and at 4-week follow-up. Self-regulatory efficacy beliefs items were context specific. Responses were scored on a scale of 0% (not at all) to 100% (extremely confident) with response options in 10% increments. Baseline, Immedately after the Intervention (1-day), 4-Week Follow-Up No
Secondary Outcome Expectations Changes in participants outcome expectations was assessed at baseline, 1-day after completion of the intervention and at 4-week follow-up. The perceived likelihood of positive (16 items) and negative (5 items) outcomes occurring as a result of consuming milk and milk products was assessed using a 21-item measure. Responses were scored on a 9-point scale from 1 (very unlikely) to 9 (very likely). Baseline, Immedately after the Intervention (1-day), 4-Week Follow-Up No
Secondary Outcome Values Changes in participants outcome values was assessed at baseline, 1-day after completion of the intervention and at 4-week follow-up. The perceived value of positive (16 items) and negative (5 items) outcomes occurring as a result of consuming milk and milk products was assessed using a 21-item measure. Responses were scored on a 9-point scale with a range of 1 (little value to me) to 9 (high value to me). Baseline, Immedately after the Intervention (1-day), 4-Week Follow-Up No
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