- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT02586467
Messages for Increasing Dairy Consumption (MilkMessage)
22. oktober 2015 opdateret af: Mary Jung, University of British Columbia
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.
Studieoversigt
Status
Afsluttet
Betingelser
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
732
Fase
- Ikke anvendelig
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
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British Columbia
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Kelowna, British Columbia, Canada, V1V 1V7
- Health and Exercise Psychology Laboratory
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Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
30 år til 50 år (Voksen)
Tager imod sunde frivillige
Ja
Køn, der er berettiget til at studere
Alle
Beskrivelse
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
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Støttende pleje
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Enkelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
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Eksperimentel: Gain-Framed
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).
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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.)
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Eksperimentel: Loss-Framed
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).
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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).
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Eksperimentel: Self-Regulatory Efficacy
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.)
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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.
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Eksperimentel: Gain-Framed + Self-Regulatory Efficacy
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.).
|
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.
|
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Eksperimentel: Loss-Framed + Self-Regulatory Efficacy
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.).
|
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.
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Changes from baseline in calcium from dairy at 1 and 4-week follow up
Tidsramme: Baseline, 1-week follow-up, 4-week follow-up
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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.
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Baseline, 1-week follow-up, 4-week follow-up
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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Self-Regulatory Efficacy
Tidsramme: Baseline, Immedately after the Intervention (1-day), 4-Week Follow-Up
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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.
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Baseline, Immedately after the Intervention (1-day), 4-Week Follow-Up
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Outcome Expectations
Tidsramme: Baseline, Immedately after the Intervention (1-day), 4-Week Follow-Up
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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).
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Baseline, Immedately after the Intervention (1-day), 4-Week Follow-Up
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Outcome Values
Tidsramme: Baseline, Immedately after the Intervention (1-day), 4-Week Follow-Up
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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).
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Baseline, Immedately after the Intervention (1-day), 4-Week Follow-Up
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Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Publikationer og nyttige links
Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.
Generelle publikationer
- 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.
- 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.
- Bandura A. Social foundations of thought and action: A social cognitive theory. NJ US: Prentice-Hall, Inc; 1986.
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart
1. august 2013
Primær færdiggørelse (Faktiske)
1. november 2013
Studieafslutning (Faktiske)
1. november 2013
Datoer for studieregistrering
Først indsendt
20. oktober 2015
Først indsendt, der opfyldte QC-kriterier
22. oktober 2015
Først opslået (Skøn)
26. oktober 2015
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
26. oktober 2015
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
22. oktober 2015
Sidst verificeret
1. oktober 2015
Mere information
Begreber relateret til denne undersøgelse
Andre undersøgelses-id-numre
- H12-00332
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .