Dietary ModificationNCT02591329
Increasing Household Purchase and Child Consumption of Calcium Products
A study testing Mail-out hard copy materials (education plus self-regulatory strategies examples) in people with Dietary Modification, run by University of British Columbia at 1 site in Canada.
Trial summary
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… Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Dietary Modification
- What is being tested?
- Mail-out hard copy materials (education plus self-regulatory strategies examples)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 189 participants
- Where
- 1 siteCanada
- Study dates
- Aug 2015to 31 Mar 2017
- 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Dietary restrictions, allergies, or medical reasons for limiting intake of dairy products
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: 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.
- Conditions
- Dietary Modification
- Being tested
- Mail-out hard copy materials (education plus self-regulatory strategies examples), Standard Care
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mail-out hard copy materials (education plus self-regulatory strategies examples)Behavioural
Standard CareBehavioural
| Study group | Role | What they receive |
|---|---|---|
| Experimental | 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. Receives: Behavioral: Mail-out hard copy materials (education plus self-regulatory strategies examples) |
| Standard Care | Active comparator | 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. Receives: Behavioral: Standard Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in Purchasing Behaviour
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.
Measured: 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)
Changes in Adult Consumption Behaviour
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.
Measured: 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)
Changes in Child Consumption Behaviour
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.
Measured: 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)
Secondary outcomes (4)
Changes in Outcome Expectations
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).
Measured: 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)
Changes in Self-Regulatory Efficacy Beliefs
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).
Measured: 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)
Changes in Parent Social Support
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.
Measured: 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)
Changes in Perceived Role Modelling
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).
Measured: 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)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Oct 2015 (estimated)
- Study startAug 2015
- Primary completionMar 2017
- Study completion31 Mar 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- 189 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
- NCT02591329
- Sponsor's protocol ID
- H14-02762
- Status last verified
- May 2018
- First submitted
- 27 Oct 2015
- Last updated
- 9 May 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Increasing Household Purchase and Child Consumption of Calcium Products: A Randomised Controlled Trial
- ClinicalTrials.gov ID
- NCT02591329
- Acronym / sponsor ID
- H14-02762
- Conditions
- Dietary Modification
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 189 participants (actual)
- Lead sponsor
- University of British ColumbiaUniversity, hospital or other
- Study start
- Aug 2015
- Primary completion
- Mar 2017 (actual)
- Study completion
- 31 Mar 2017 (actual)
- First posted
- 29 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.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental | Experimental | Behavioral: Mail-out hard copy materials (education plus self-regulatory strategies examples)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. |
| Standard Care | Active comparator | Behavioral: Standard CareIndividuals 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. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (1 listed)
- Dietary restrictions, allergies, or medical reasons for limiting intake of dairy products
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 |
|---|---|---|
| Mail-out hard copy materials (education plus self-regulatory strategies examples) | Behavioural | Experimental |
| Standard Care | Behavioural | Standard Care |
Primary outcome
Changes in Purchasing Behaviour
Time frame: 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)
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.
Changes in Adult Consumption Behaviour
Time frame: 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)
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.
Changes in Child Consumption Behaviour
Time frame: 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)
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.
4 secondary outcomes
Changes in Outcome Expectations
Time frame: 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)
Changes in Self-Regulatory Efficacy Beliefs
Time frame: 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)
Changes in Parent Social Support
Time frame: 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)
Changes in Perceived Role Modelling
Time frame: 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)
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 9 May 2018.
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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 Mail-out hard copy materials (education plus self-regulatory strategies examples) 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 4 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 9 May 2018. 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 in Purchasing Behaviour (time frame: 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)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 9 May 2018; AzTrials last refreshed its copy on 8 Nov 2026.