Efficacy of Nutrition Risk Screening With NutriSTEP® in Toddlers and Preschoolers

NCT ID: NCT02582554

Last Updated: 2016-05-11

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 166 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-10-31
• Study Completion Date: 2016-05-31

Brief Summary

Good nutrition is necessary for optimal growth and development in young children. Nutrition risk screening can identify those at risk and to refer them for assessment and treatment. The NutriSTEP® (Nutrition Risk Screening for Every Preschooler) questionnaires are 17-item, community-based, parent-administered questionnaires for identifying nutritional risk in toddlers (18-35 months) and preschoolers (3-5 years). Internet versions are available on the Dietitians of Canada website as part of a Nutri-eSTEP online tool. NutriSTEP® is mandated for use in Ontario and New Brunswick and is also used in other provinces. NutriSTEP® has been implemented in Canadian jurisdictions and in research settings. Many health care practitioners, mainly registered dietitians, and policy makers, are asking for evidence that NutriSTEP® makes a difference and this project is proposed to show that nutrition screening with NutriSTEP® with its accompanying nutrition education resources will increase knowledge and change nutrition-related practices by parents of preschoolers.

This research will be a randomized control trial with more than 150 parents/caregivers of toddlers and preschoolers. The treatment group will receive screening with the Nutri-eSTEP version of NutriSTEP® and will receive the accompanying nutrition education messages and links to resources. A control group will receive the screening treatment at the end of a 12 week intervention. At the beginning and end of the 12 week period, parents/caregivers will fill out questionnaires on parental nutrition knowledge and nutrition-related behaviour (including attitudes and intentions).

This will be the first study of nutrition risk screening with NutriSTEP® to determine if the screening process, along with its accompanying nutrition education messages makes a difference.

Detailed Description

Study Design The proposed research will be a wait-listed randomized control trial of the efficacy of the NutriSTEP® screening process for toddlers and preschoolers. The treatment group will undergo screening with Nutri-eSTEP plus its accompanying nutrition education messages and links to resources. A control group will be wait-listed to receive the treatment (Nutri-eSTEP plus its accompanying nutrition education treatment) at the end of the intervention period.

Outcome variables Participants Parents/caregivers of toddlers and preschoolers will be recruited at various Ontario Early Years Centres (OEYCs) in southern Ontario.

Sample Size The sample size (http://www.stat.ubc.ca/) is estimated at 63 per group based on difference in scores on the NKQ of 2 (~half of the difference found between students and parents), with a SD of 4, alpha of 0.05 and statistical power of 0.80 (2-tailed). An allowance for 20% attrition (based on our previous test-retest reliability studies)(7,8,19) will see 77 participants per group recruited. This will also allow for enough power for an improvement in NutriSTEP® scores based on a difference of 2.2 units, standard deviation of 5, alpha of 0.05 and statistical power of 0.80 (1-tailed)(based on a difference in NutriSTEP® scores over 3 months of a parenting intervention study (56). The total sample of 154 will be recruited from ~20 OEYCs @ ~10 participants/site (based on previous experience).

Intervention NutriSTEP® Questionnaire: The toddler and preschool NutriSTEP® questionnaires will form part of the intervention for this trial.

Nutrition Education Material:

"How to Build a Healthy Toddler/Preschooler": This booklet will be part of the intervention for this trial. "How to Build a Healthy Toddler/Preschooler" are 4-page brochures that have key messages relevant to the questions on the NutriSTEP® questionnaires. Recommendations from Canada's Food Guide (CFG) are included as well as suggestions for credible nutrition resources.

Nutri-eSTEP Feedback Messages: As part of the Nutri-eSTEP platform, parents receive feedback messages based on their responses to each question on the NutriSTEP®. The feedback messages are categorized into two categories: "What is Going Well" and "What to Work On". For this study, we will provide print copies of the Results and feedback messages to participants as part of the treatment.

Conditions

Dietary Modification

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SCREENING
• Blinding Strategy: NONE

Study Groups

Intervention

Intervention: NutriSTEP The intervention will be the administration of NutriSTEP, a nutrition risk screening questionnaire for preschoolers along with a nutrition education brochure called How to Build a Healthy Preschooler

Group Type: EXPERIMENTAL

NutriSTEP

Intervention Type: BEHAVIORAL

Provision of nutrition risk screening with NutriSTEP (a nutrition risk screening questionnaire for preschoolers) and nutrition education with NutriSTEP related materials

Control

Control: Wait-list control The wait-list control group will complete the NutriSTEP and receive the nutrition education information at the end of the 3 month study period

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

NutriSTEP

Provision of nutrition risk screening with NutriSTEP (a nutrition risk screening questionnaire for preschoolers) and nutrition education with NutriSTEP related materials

Intervention Type: BEHAVIORAL

Other Intervention Names

How to Build a Healthy Preschooler

Eligibility Criteria

Inclusion Criteria

• Parents/caregivers of 3-5 year old children, speak English, read English at Grade 6 level

Exclusion Criteria

• Parent of an institutionalized child

• Minimum Eligible Age: 3 Years
• Maximum Eligible Age: 6 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Guelph

OTHER

Sponsor Role: lead

Responsible Party

Janis Randall Simpson

College Professor Emerita

Responsibility Role: PRINCIPAL_INVESTIGATOR

Other Identifiers

052454

Identifier Type: -

Identifier Source: org_study_id