- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03798808
Family and Web-based Nutrition Intervention to Increase Vegetable, Fruit, and Dairy Intakes in Children
January 9, 2019 updated by: Vicky Drapeau, Laval University
The Impact of an Innovative Family and Web-based Nutrition Intervention to Increase Vegetable, Fruit, and Dairy Intakes in Children With Overweight or Obesity: A Single-blinded Randomized Family Clustered Intervention
Considering the high prevalence of childhood obesity worldwide, effective interventions are needed .
Parental involvement in interventions and the use of web-based modalities appear to be promising approaches.
The aim of the study was to evaluate the efficacy of an innovative family and Web-based nutrition intervention called "Family Nutriathlon" on consumption of vegetables and fruit and dairy products and/or alternatives and on diet quality among children and their parents.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
Forty-three families, with at least one child with a BMI >85th percentile, participated in either the intervention (n=24) or control group (n=19) over an 8-week period.
Families in the intervention (Family Nutriathlon) will participated in a nutrition challenge that aimed to increase their consumption and variety of fruits and vegetables and dairy products by recording their daily intakes using a Web-based platform.
Families in the control group received recommendations based on general nutrition guidelines.
Three follow-ups with a dietitian once every two weeks via Skype to assess progress were scheduled.
A three-day food record was completed at baseline (week 0), immediately after (week 8) and 6 months after the intervention.
A two-way repeated measures analysis of variance was used to assess changes in consumption of fruits and vegetables and dairy products, diet quality and dietary intakes between groups and over time.
Study Type
Interventional
Enrollment (Actual)
43
Phase
- Not Applicable
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
8 years to 16 years (Child)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
All inclusion/exclusion criterion were the same between the two projects (including the intervention) except for the inclusion of a child living with obesity or overweight.
Children were aged between 8 and 16 years, but there was no age limit for parents.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Family Nutriathlon group
Web-based nutrition program (encouraging consumption of fruits, vegetables and dairy products through an online platform)
|
Family Nutriathlon was an eight-week, family-based nutrition program where children and their parents were encouraged to reach individual and team goals with respect to the quantity and variety of fruit, vegetable and dairy product consumption.
|
No Intervention: Control group
General nutrition guidelines (e.g.
following Canada's Food Guide)
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Dietary intakes and diet quality
Time Frame: 8 weeks
|
Fruit, vegetable and dairy product consumption and diet quality as measured by the Nutrient-Rich Foods Index
|
8 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Anthropometric measurements
Time Frame: Weeks 0, 9 and 18-36 (follow-up)
|
Body weight, height and body mass index
|
Weeks 0, 9 and 18-36 (follow-up)
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
February 1, 2016
Primary Completion (Actual)
March 1, 2017
Study Completion (Actual)
March 1, 2017
Study Registration Dates
First Submitted
January 8, 2019
First Submitted That Met QC Criteria
January 8, 2019
First Posted (Actual)
January 10, 2019
Study Record Updates
Last Update Posted (Actual)
January 11, 2019
Last Update Submitted That Met QC Criteria
January 9, 2019
Last Verified
January 1, 2019
More Information
Terms related to this study
Other Study ID Numbers
- NUTRIATHLON-2015-259 R-2
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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