Overview

This trial is active, not recruiting.

Condition dietary modification
Treatments mail-out hard copy materials (education plus self-regulatory strategies examples), standard care
Sponsor University of British Columbia
Start date August 2015
End date February 2017
Trial size 189 participants
Trial identifier NCT02591329, H14-02762

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking single blind (subject)
Primary purpose supportive care
Arm
(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.
mail-out hard copy materials (education plus self-regulatory strategies examples)
(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.
standard care

Primary Outcomes

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)
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)
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)

Secondary Outcomes

Measure
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)

Eligibility Criteria

Male or female participants of any age.

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

Additional Information

Official title Increasing Household Purchase and Child Consumption of Calcium Products: A Randomised Controlled Trial
Trial information was received from ClinicalTrials.gov and was last updated in October 2016.
Information provided to ClinicalTrials.gov by University of British Columbia.