Dietary ModificationNutriSTEPNCT02582554
Efficacy of Nutrition Risk Screening With NutriSTEP® in Toddlers and Preschoolers
A study testing NutriSTEP in people with Dietary Modification, run by University of Guelph.
Trial 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. Read more about this study
- Who is it for?
- Ages 3 to 6 yearsHealthy volunteers can take part
- Conditions the study is for
- Dietary Modification
- What is being tested?
- NutriSTEP
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 166 participants
- Where
- No sites listed yet
- Study dates
- Oct 2015to May 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 3 to 6 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Parents/caregivers of 3-5 year old children, speak English, read English at Grade 6 level
Who cannot join
- Parent of an institutionalized child
About this study
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.
Read the 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
- Being tested
- NutriSTEP
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NutriSTEPBehavioural
Also called How to Build a Healthy Preschooler
Provision of nutrition risk screening with NutriSTEP (a nutrition risk screening questionnaire for preschoolers) and nutrition education with NutriSTEP related materials
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | 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 Receives: Behavioral: NutriSTEP |
| Control | No intervention | 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Score of Nutritional Risk as Assessed by the NutriSTEP Nutrition Knowledge Questionnaire
A valid and reliable 40-item nutrition knowledge questionnaire has been developed to test the contents of the NutriSTEP questionnaire and its accompanying nutrition education material. Correct scores on the items on the questionnaire will be added up for a total score, with differences between the start of the study and the end of the study compared and also a comparison between the intervention and control groups.
Measured: 12 weeks
Secondary outcomes (3)
Score of Nutrition Behaviour as Assessed by the NutriSTEP Questionnaire
The NutriSTEP Behaviour Questionnaire is a valid and reliable 17-item questionnaire to assess nutrition-related behaviours in preschoolers. Each response item for the 17 questions is assigned a score. Total scores will be generated, with comparisons at the start and end of the study and between the intervention and control groups.
Measured: 12 weeks
Score of Attitudes and Self-Efficacy as Determined by the NutriSTEP Attitudes and Self-Efficacy Questionnaire
A valid and reliable 21-item questionnaire to assess attitudes and self-efficacy related to the NutriSTEP questionnaire has been developed. Response categories for each item on each of the attitudes and self-efficacy questions are scored. Scores are added up for each of the attitudes and self-efficacy portions of the questionnaire. Differences between scores before and after the intervention and between intervention and control groups will be compared.
Measured: 12 weeks
Score of Intentions to Change Behaviour as Determined by the NutriSTEP Intentions Questionnaire
The NutriSTEP Intentions Questionnaire is a valid and reliable 7-item questionnaire. A total score is generated based on the scores for the response categories for each item on the questionnaire. Differences in scores between the start of the study and the end of the study and also between the intervention and the control groups will be determined.
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Oct 2015 (estimated)
- Study startOct 2015
- Primary completionApr 2016
- Study completionMay 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dietary ModificationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 166 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Guelph
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Janis Randall Simpson, University of Guelph
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02582554
- Sponsor's protocol ID
- 052454
- Acronym
- NutriSTEP
- Status last verified
- May 2016
- First submitted
- 13 Oct 2015
- Last updated
- 11 May 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Nutrition Risk Screening With NutriSTEP® in Toddlers and Preschoolers
- ClinicalTrials.gov ID
- NCT02582554
- Acronym / sponsor ID
- NutriSTEP / 052454
- Conditions
- Dietary Modification
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 166 participants (actual)
- Lead sponsor
- University of GuelphUniversity, hospital or other
- Study start
- Oct 2015
- Primary completion
- Apr 2016 (actual)
- Study completion
- May 2016 (actual)
- First posted
- 21 Oct 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Behavioral: NutriSTEPIntervention: 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 |
| Control | No intervention | –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 |
Who may qualify
- Ages
- 3 to 6 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Parents/caregivers of 3-5 year old children, speak English, read English at Grade 6 level
Key exclusion criteria (1 listed)
- Parent of an institutionalized child
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NutriSTEPAlso: How to Build a Healthy PreschoolerProvision of nutrition risk screening with NutriSTEP (a nutrition risk screening questionnaire for preschoolers) and nutrition education with NutriSTEP related materials | Behavioural | Intervention |
Primary outcome
Score of Nutritional Risk as Assessed by the NutriSTEP Nutrition Knowledge Questionnaire
Time frame: 12 weeks
A valid and reliable 40-item nutrition knowledge questionnaire has been developed to test the contents of the NutriSTEP questionnaire and its accompanying nutrition education material. Correct scores on the items on the questionnaire will be added up for a total score, with differences between the start of the study and the end of the study compared and also a comparison between the intervention and control groups.
3 secondary outcomes
Score of Nutrition Behaviour as Assessed by the NutriSTEP Questionnaire
Time frame: 12 weeks
Score of Attitudes and Self-Efficacy as Determined by the NutriSTEP Attitudes and Self-Efficacy Questionnaire
Time frame: 12 weeks
Score of Intentions to Change Behaviour as Determined by the NutriSTEP Intentions Questionnaire
Time frame: 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 May 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing NutriSTEP in people with Dietary Modification, run by University of Guelph.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 May 2016. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Score of Nutritional Risk as Assessed by the NutriSTEP Nutrition Knowledge Questionnaire (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 May 2016.