Increasing Household Purchase and Child Consumption of Calcium Products

Dietary Modification Clinical Trial

Official title:

Increasing Household Purchase and Child Consumption of Calcium Products: A Randomised Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02591329
• Other study ID #: H14-02762
• Status: Completed
• Phase: N/A
• Start date: August 2015
• Est. completion date: March 31, 2017

Study information

• Verified date: May 2018
• Source: University of British Columbia
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 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:

1. Parents in the experimental condition will purchase more calcium-rich products as compared to parents in the control condition.

2. Parents and children in the experimental condition will consume more calcium rich products as compared to parents and children in the control condition.

3. 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.

4. 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.

5. Perceived social support and role modelling behaviour will be highest in parents in the experimental condition as compared to parents in the control condition.

6. Self-regulatory efficacy and outcome expectancies will mediate the changes in calcium-rich product purchases and consumption.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 189
• Est. completion date: March 31, 2017
• Est. primary completion date: March 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Dietary Modification

Intervention

Behavioral:
• Mail-out hard copy materials (education plus self-regulatory strategies examples)

• Standard Care

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, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	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)
Primary	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.	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)
Primary	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.	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	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).	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	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).	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	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.	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	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).	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)