Dietary ModificationMilkMessageNCT02586467
Messages for Increasing Dairy Consumption
A study testing Gain-Framed, Loss-Framed and Self-Regulatory Efficacy in people with Dietary Modification, run by University of British Columbia at 1 site in Canada.
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… Read more about this study
- Who is it for?
- Ages 30 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Dietary Modification
- What is being tested?
- Gain-Framed, Loss-Framed and Self-Regulatory Efficacy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 732 participants
- Where
- 1 siteCanada
- Study dates
- Aug 2013to Nov 2013
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- Dietary restrictions, allergies, or medical reasons for limiting dairy intake will be excluded
Trial locations and contacts
1 site in 1 country.
Canada1 site
Health and Exercise Psychology Laboratory
Kelowna, British Columbia, V1V 1V7
About this study
Official title: Testing the Effectiveness of Targeted, Framed, -Efficacy Enhancing Messages for Increasing Milk and Milk Product Consumption in Adults Aged 30--50 Years.
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.
- Conditions
- Dietary Modification
- Being tested
- Gain-Framed, Loss-Framed, Self-Regulatory Efficacy, Gain-Framed + Self-Regulatory Efficacy, Loss-Framed + Self-Regulatory Efficacy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Gain-FramedBehavioural
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-FramedBehavioural
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 EfficacyBehavioural
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 EfficacyBehavioural
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 EfficacyBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Gain-Framed | Experimental | Participants receive messages that highlight the potential benefits of engaging in a specific behaviour (i.e., what positive outcomes they could experience from consuming milk and milk products). Receives: Behavioral: Gain-Framed |
| Loss-Framed | Experimental | Participants receive messages that highlight the potentially loses of not engaging in a specific behaviour (i.e., what they could lose from not consuming milk and milk products). Receives: Behavioral: Loss-Framed |
| Self-Regulatory Efficacy | Experimental | Participants receive messages that provide them with tips and strategies on how to engage in the consumption of milk and milk products (i.e., recipes, meal planning etc.) Receives: Behavioral: Self-Regulatory Efficacy |
| Gain-Framed + Self-Regulatory Efficacy | Experimental | Participants receive messages that highlight the potential benefits of engaging in a specific behaviour (i.e., what positive outcomes they could experience from consuming milk and milk products) and these messages also provide tips and strategies on how to engage in the consumption of milk and milk products (i.e., recipes, meal planning etc.). Receives: Behavioral: Gain-Framed + Self-Regulatory Efficacy |
| Loss-Framed + Self-Regulatory Efficacy | Experimental | Participants receive messages that highlight the potentially loses of not engaging in a specific behaviour (i.e., what they could lose from not consuming milk and milk products) and these messages also provide tips and strategies on how to engage in the consumption of milk and milk products (i.e., recipes, meal planning etc.). Receives: Behavioral: Loss-Framed + Self-Regulatory Efficacy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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 Calculator™" 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.
Measured: Baseline, 1-week follow-up, 4-week follow-up
Secondary outcomes (3)
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.
Measured: Baseline, Immedately after the Intervention (1-day), 4-Week Follow-Up
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).
Measured: Baseline, Immedately after the Intervention (1-day), 4-Week Follow-Up
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).
Measured: Baseline, Immedately after the Intervention (1-day), 4-Week Follow-Up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Oct 2015 (estimated)
- Study startAug 2013
- Primary completionNov 2013
- Study completionNov 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Dietary ModificationStudies of the same condition, open and under way.
- More trials run by University of British ColumbiaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 732 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of British Columbia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mary Jung, University of British Columbia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02586467
- Sponsor's protocol ID
- H12-00332
- Acronym
- MilkMessage
- Status last verified
- Oct 2015
- First submitted
- 20 Oct 2015
- Last updated
- 26 Oct 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Tversky A, Kahneman D. The framing of decisions and the psychology of choice. Science. 1981 Jan 30;211(4481):453-8. doi: 10.1126/science.7455683.
PubMed 7455683Jung 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.
PubMed 21557134Bandura A. Social foundations of thought and action: A social cognitive theory. NJ US: Prentice-Hall, Inc; 1986.
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Testing the Effectiveness of Targeted, Framed, -Efficacy Enhancing Messages for Increasing Milk and Milk Product Consumption in Adults Aged 30--50 Years.
- ClinicalTrials.gov ID
- NCT02586467
- Acronym / sponsor ID
- MilkMessage / H12-00332
- Conditions
- Dietary Modification
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 732 participants (actual)
- Lead sponsor
- University of British ColumbiaUniversity, hospital or other
- Study start
- Aug 2013
- Primary completion
- Nov 2013 (actual)
- Study completion
- Nov 2013 (actual)
- First posted
- 26 Oct 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Gain-Framed | Experimental | Behavioral: Gain-FramedParticipants receive messages that highlight the potential benefits of engaging in a specific behaviour (i.e., what positive outcomes they could experience from consuming milk and milk products). |
| Loss-Framed | Experimental | Behavioral: Loss-FramedParticipants receive messages that highlight the potentially loses of not engaging in a specific behaviour (i.e., what they could lose from not consuming milk and milk products). |
| Self-Regulatory Efficacy | Experimental | Behavioral: Self-Regulatory EfficacyParticipants receive messages that provide them with tips and strategies on how to engage in the consumption of milk and milk products (i.e., recipes, meal planning etc.) |
| Gain-Framed + Self-Regulatory Efficacy | Experimental | Behavioral: Gain-Framed + Self-Regulatory EfficacyParticipants receive messages that highlight the potential benefits of engaging in a specific behaviour (i.e., what positive outcomes they could experience from consuming milk and milk products) and these messages also provide tips and strategies on how to engage in the consumption of milk and milk products (i.e., recipes, meal planning etc.). |
| Loss-Framed + Self-Regulatory Efficacy | Experimental | Behavioral: Loss-Framed + Self-Regulatory EfficacyParticipants receive messages that highlight the potentially loses of not engaging in a specific behaviour (i.e., what they could lose from not consuming milk and milk products) and these messages also provide tips and strategies on how to engage in the consumption of milk and milk products (i.e., recipes, meal planning etc.). |
Who may qualify
- Ages
- 30 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (1 listed)
- Dietary restrictions, allergies, or medical reasons for limiting dairy intake will be excluded
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Gain-FramedParticipants 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.) | Behavioural | Gain-Framed |
| Loss-FramedParticipants 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). | Behavioural | Loss-Framed |
| Self-Regulatory EfficacyParticipants 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. | Behavioural | Self-Regulatory Efficacy |
| Gain-Framed + Self-Regulatory EfficacyParticipants 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. | Behavioural | Gain-Framed + Self-Regulatory Efficacy |
| Loss-Framed + Self-Regulatory EfficacyParticipants 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. | Behavioural | Loss-Framed + Self-Regulatory Efficacy |
Primary outcome
Changes from baseline in calcium from dairy at 1 and 4-week follow up
Time frame: Baseline, 1-week follow-up, 4-week follow-up
Calcium consumed from dairy was assessed using a modified version of the "Calcium Calculator™" 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.
3 secondary outcomes
Self-Regulatory Efficacy
Time frame: Baseline, Immedately after the Intervention (1-day), 4-Week Follow-Up
Outcome Expectations
Time frame: Baseline, Immedately after the Intervention (1-day), 4-Week Follow-Up
Outcome Values
Time frame: Baseline, Immedately after the Intervention (1-day), 4-Week Follow-Up
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Oct 2015.
- Background: PubMed 7455683Tversky A, Kahneman D. The framing of decisions and the psychology of choice. Science. 1981 Jan 30;211(4481):453-8. doi: 10.1126/science.7455683.
- Background: PubMed 21557134Jung 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.
- BackgroundBandura A. Social foundations of thought and action: A social cognitive theory. NJ US: Prentice-Hall, Inc; 1986.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Gain-Framed, Loss-Framed and Self-Regulatory Efficacy in people with Dietary Modification, run by University of British Columbia at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Oct 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes from baseline in calcium from dairy at 1 and 4-week follow up (time frame: Baseline, 1-week follow-up, 4-week follow-up). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02586467, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Oct 2015.