Dietary Modification Clinical Trial
Official title:
Efficacy of Nutrition Risk Screening With NutriSTEP® in Toddlers and Preschoolers
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.
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.
;
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Screening
Status | Clinical Trial | Phase | |
---|---|---|---|
Active, not recruiting |
NCT03586622 -
One Year Home Monitoring and Treatment of IBS Patients
|
N/A | |
Completed |
NCT02589769 -
Effects of Reduction in Saturated Fat on Cholesterol and Lipoproteins in Lean and Obese Persons
|
N/A | |
Completed |
NCT03048487 -
Protein Consumption in Critically Ill Patients
|
||
Withdrawn |
NCT02863822 -
Study to Evaluate Dietary Modification in Patients With Functional Dyspepsia.
|
N/A | |
Not yet recruiting |
NCT02858557 -
The Effect of Diet on Microbial Profile and Disease Outcomes in Patients With Inflammatory Bowel Diseases
|
N/A | |
Completed |
NCT02480504 -
Effects of a 5:2 Diet on Weight Loss and Cardiovascular Risk Factors in Obesity
|
N/A | |
Completed |
NCT03024983 -
Pasta and Other Durum Wheat-based Products: Effects on Post-prandial Glucose Metabolism
|
N/A | |
Recruiting |
NCT02848807 -
Chemotherapy-related Toxicity, Nutritional Status and Quality of Life
|
N/A | |
Completed |
NCT02416284 -
Compliance to the Norwegian Food-Based Dietary Guidelines in Young Females
|
N/A | |
Completed |
NCT01559896 -
Egg Protein Hydrolysate and Vascular Function
|
N/A | |
Terminated |
NCT01329172 -
Nasal Mucin Oral Supplementation Treatment Respiratory Inflammation Using PUFA in Cystic Fibrosis (CF) Patients
|
N/A | |
Completed |
NCT03698929 -
Effect of Dietary Cholesterol on Plasma Lipids
|
N/A | |
Completed |
NCT03942822 -
Chia Supplementation and Non Alcoholic Fatty Liver Disease
|
N/A | |
Completed |
NCT03319836 -
Meeting Protein Targets in Critically Ill Patients
|
||
Completed |
NCT02940197 -
Comparison of Two Calorie Restricted MediterrAsian Diet on Weight Loss in FTO rs9939609 Overweight Carriers
|
N/A | |
Completed |
NCT02811276 -
The Impact of a High Protein Diet on Substrate Oxidation and Energy Metabolism
|
N/A | |
Completed |
NCT02574052 -
Medical College Students' Responds to Menu Labeling
|
Phase 3 | |
Completed |
NCT02274220 -
Feeding Study - Effects Post-cardiac Surgery
|
N/A | |
Completed |
NCT02898844 -
Randomized Controlled Experiment of Dieting in Pairs
|
N/A | |
Completed |
NCT02189200 -
Nutritional Counseling Associated With the Ingestion of Oat Bran in Hypercholesterolemic Subjects
|
N/A |