NCT02591329

Brief 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. 1.Parents in the experimental condition will purchase more calcium-rich products as compared to parents in the control condition.
  2. 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. 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. 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. 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. 6.Self-regulatory efficacy and outcome expectancies will mediate the changes in calcium-rich product purchases and consumption.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
189

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Aug 2015

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2015

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

October 27, 2015

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 29, 2015

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2017

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2017

Completed
Last Updated

May 9, 2018

Status Verified

May 1, 2018

Enrollment Period

1.6 years

First QC Date

October 27, 2015

Last Update Submit

May 3, 2018

Conditions

Outcome Measures

Primary Outcomes (3)

  • 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)

  • 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)

  • 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 Outcomes (4)

  • Changes in Outcome Expectations

    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

    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

    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

    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)

Study Arms (2)

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.

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.

Behavioral: Standard Care

Interventions

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Dietary restrictions, allergies, or medical reasons for limiting intake of dairy products

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Health and Exercise Psychology Laboratory

Kelowna, British Columbia, V1V 1V7, Canada

Location

MeSH Terms

Interventions

Educational StatusStandard of Care

Intervention Hierarchy (Ancestors)

Socioeconomic FactorsPopulation CharacteristicsQuality Indicators, Health CareQuality of Health CareHealth Services AdministrationHealth Care Quality, Access, and Evaluation

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

October 27, 2015

First Posted

October 29, 2015

Study Start

August 1, 2015

Primary Completion

March 1, 2017

Study Completion

March 31, 2017

Last Updated

May 9, 2018

Record last verified: 2018-05

Locations