- ICH GCP
- Registr klinických studií v USA
- Klinická studie NCT02591329
Increasing Household Purchase and Child Consumption of Calcium Products
Increasing Household Purchase and Child Consumption of Calcium Products: A Randomised Controlled Trial
The objective of this research is to test the effectiveness of persuasive messages targeted at parents who have children who consume inadequate amounts of calcium. Specifically, the effectiveness of the intervention material on increase a) the purchase of calcium-rich products by parents, and b) the consumption of calcium-rich products in the parent and child will be examined in 400 families across Canada. Families will receive either the targeted intervention materials or standard of care generic nutrition materials retrieved from Health Canada's website. Materials will be delivered to parents during weeks 0, 8, 16, and 22 of the study. Monitoring of parents' calcium product purchases and consumption behaviour in both parents and children will occur at week 0,12, 24 weeks (immediately post-intervention) and at 52 weeks (i.e., 6-month follow-up). Purchases will be verified by grocery receipts made during the aforementioned weeks. Parents will self-report on their dietary consumption as well as their child's using a food frequency questionnaire. The study hypotheses are as follows:
- Parents in the experimental condition will purchase more calcium-rich products as compared to parents in the control condition.
- Parents and children in the experimental condition will consume more calcium rich products as compared to parents and children in the control condition.
- Perceived outcome expectancies of consuming calcium-rich products will increase to a greater extent in parents in the experimental condition as compared to parents in the control condition.
- Self-regulatory efficacy to consume calcium-rich products will increase to a greater extent in parents in the experimental condition as compared to parents in the control condition.
- Perceived social support and role modelling behaviour will be highest in parents in the experimental condition as compared to parents in the control condition.
- Self-regulatory efficacy and outcome expectancies will mediate the changes in calcium-rich product purchases and consumption.
Přehled studie
Postavení
Podmínky
Typ studie
Zápis (Aktuální)
Fáze
- Nelze použít
Kontakty a umístění
Studijní místa
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British Columbia
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Kelowna, British Columbia, Kanada, V1V 1V7
- Health and Exercise Psychology Laboratory
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Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
- Dítě
- Dospělý
- Starší dospělý
Přijímá zdravé dobrovolníky
Pohlaví způsobilá ke studiu
Popis
Inclusion Criteria:
- Parent of a child between the ages of 4 and 10
- The child consumes less than the recommended daily intake of calcium (1300mg for youth aged 9-10 and 1000mg for children aged 4-8)
- Parent and child have no dietary restrictions, allergies, or medical reasons for limiting intake of dairy products
- Parent can read and speak English
Exclusion Criteria:
- Dietary restrictions, allergies, or medical reasons for limiting intake of dairy products
Studijní plán
Jak je studie koncipována?
Detaily designu
- Primární účel: Podpůrná péče
- Přidělení: Randomizované
- Intervenční model: Paralelní přiřazení
- Maskování: Singl
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
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Experimentální: Experimental
The experimental condition (EXP) will receive the targeted intervention material developed and designed by the researchers using focus group discussions with parents.
This information will include salient benefits of the consumption of calcium-rich products.
In addition, self-regulatory strategies will be provided to encourage purchasing and consumption of calcium-rich products and address any potential barriers to purchase and consumption.
Material will sent on four different occasions via mail.
At time one (week 0) participants will be sent a 13-month calendar, at time 2 (week 8) participants will be sent a grocery pad and a recipe book.
At time 3 and 4 (week 16 and 22 respectively) participants will be sent a newsletter.
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Aktivní komparátor: Standard Care
Individuals in the Control condition (CON) will receive general healthy eating materials including Canada's Food Guide, Healthier Grocery Shopping Guide and Cooking with Kids.
Material will sent on four different occasions via mail.
At time one (week 0) participants will be sent a 13-month calendar, at time 2 (week 8) participants will be sent a note pad and an activity book.
At time 3 and 4 (week 16 and 22 respectively) participants will be sent a newsletter.
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Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
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Changes in Purchasing Behaviour
Časové okno: Baseline (before the intervention begins), week-12 (mid point of the intervention), week-24 (immediately after the intervention), week-52 (6-months after the intervention is complete)
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The purchase of calcium-rich products will be assessed objectively via grocery receipts over a 7-day period.Receipts will be mailed to UBC Okanagan.
Information provided within receipts will be entered into the ESHA nutrition analyses software.
Specifically, changes in mg of calcium purchased will be examined over the above time points.
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Baseline (before the intervention begins), week-12 (mid point of the intervention), week-24 (immediately after the intervention), week-52 (6-months after the intervention is complete)
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Changes in Adult Consumption Behaviour
Časové okno: Baseline (before the intervention begins), week-12 (mid point of the intervention), week-24 (immediately after the intervention), week-52 (6-months after the intervention is complete)
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Consumption of calcium by the parent be assessed using a 3-day food diary at baseline, week-12, week-24 and week-52.
Data provided with the food diary will be entered into the ESHA nutrition analyses software and changes in mg of calcium consumed over time will be examined.
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Baseline (before the intervention begins), week-12 (mid point of the intervention), week-24 (immediately after the intervention), week-52 (6-months after the intervention is complete)
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Changes in Child Consumption Behaviour
Časové okno: Baseline (before the intervention begins), week-12 (mid point of the intervention), week-24 (immediately after the intervention), week-52 (6-months after the intervention is complete)
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Consumption of calcium by the child be assessed using a 3-day food diary to be completed by the parent at baseline, week-12, week-24 and week-52.
Data provided with the food diary will be entered into the ESHA nutrition analyses software and changes in mg of calcium consumed over time will be examined.
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Baseline (before the intervention begins), week-12 (mid point of the intervention), week-24 (immediately after the intervention), week-52 (6-months after the intervention is complete)
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Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
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Changes in Outcome Expectations
Časové okno: Baseline (before the intervention begins), week-12 (mid point of the intervention), week-24 (immediately after the intervention), week-52 (6-months after the intervention is complete)
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A total of 21 outcomes will be assessed in relation to expected outcomes of consuming adequate calcium for the parent and 8 outcomes in relation to expected outcomes of the parents child consuming adequate calcium.
Outcomes are scored on a scale from 0 (very unlikely) to 9 (very likely).
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Baseline (before the intervention begins), week-12 (mid point of the intervention), week-24 (immediately after the intervention), week-52 (6-months after the intervention is complete)
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Changes in Self-Regulatory Efficacy Beliefs
Časové okno: Baseline (before the intervention begins), week-12 (mid point of the intervention), week-24 (immediately after the intervention), week-52 (6-months after the intervention is complete)
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Distinct components of self-regulatory efficacy include confidence in one's ability to schedule, goal set, and overcome barriers to purchasing and consuming calcium-rich products.
A total of 11 items will be assessed and the items will be scored on a scale from 0% (Not at all confident) to 100% (Extremely confident).
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Baseline (before the intervention begins), week-12 (mid point of the intervention), week-24 (immediately after the intervention), week-52 (6-months after the intervention is complete)
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Changes in Parent Social Support
Časové okno: Baseline (before the intervention begins), week-12 (mid point of the intervention), week-24 (immediately after the intervention), week-52 (6-months after the intervention is complete)
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The degree to which parents perceive themselves as offering support to their child in regards to consumption of calcium-rich products will be assessed using an adapted version of the Social Support for Diet Survey (Sallis et al., 1987).
Questions will be adapted to pertain to the child's specific consumption of calcium-rich products.
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Baseline (before the intervention begins), week-12 (mid point of the intervention), week-24 (immediately after the intervention), week-52 (6-months after the intervention is complete)
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Changes in Perceived Role Modelling
Časové okno: Baseline (before the intervention begins), week-12 (mid point of the intervention), week-24 (immediately after the intervention), week-52 (6-months after the intervention is complete)
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The degree to which parents perceive themselves as role modelling consumption of calcium-rich products will be assessed using an adapted version of Cullen and colleagues (2001) family and peer influences on fruit, juice and vegetable consumption.
This measure was adapted in a similar way to the current study by Draxten and colleagues (2014).
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Baseline (before the intervention begins), week-12 (mid point of the intervention), week-24 (immediately after the intervention), week-52 (6-months after the intervention is complete)
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Spolupracovníci a vyšetřovatelé
Sponzor
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia
Primární dokončení (Aktuální)
Dokončení studie (Aktuální)
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Odhad)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Více informací
Termíny související s touto studií
Další identifikační čísla studie
- H14-02762
Tyto informace byly beze změn načteny přímo z webu clinicaltrials.gov. Máte-li jakékoli požadavky na změnu, odstranění nebo aktualizaci podrobností studie, kontaktujte prosím register@clinicaltrials.gov. Jakmile bude změna implementována na clinicaltrials.gov, bude automaticky aktualizována i na našem webu .
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