- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03077464
Behaviorally Oriented Nutrition Education at a Russian Summer Camp
Behaviorally Oriented Nutrition Education at a Russian Summer Camp: A Quasi-experimental Superiority Trial
Study Overview
Status
Intervention / Treatment
Detailed Description
The project consists of the evaluation of two evidence-based nutrition education programs.
Setting and participants: A random selection of all youth with parental consent for the program will comprise the sample of 40 boys and girls, ages 8-12y. Children with food allergies (to fruits, vegetables, nuts, crackers, corn pops, cookies) will be ineligible for participation. Participants will be randomly assigned to either behaviorally oriented nutrition education or standard nutrition education group (comparison group). Measures: Questionnaires will be completed by each participant at the baseline (the first day) and post-intervention (the last session day). The questionnaire addresses nutrition knowledge, self-efficacy and enjoyment of fruit and vegetable consumption. Controlled observation of healthy/unhealthy snack selection: at the baseline and post-intervention, kids will select snacks first from a menu (individual measure) and then a buffet (group measure) with 3 healthy (fruits and vegetables, nuts) and 3 unhealthy (crackers, corn pops, cookies) snack options. Measurements of height, weight, and waist circumference will be taken prior to the first nutrition education session. Demographics: Investigators will obtain information on age, gender, ethnicity, family socioeconomic status, and parental education level via questionnaire. Procedures: Parents will be informed about potential for child to be involved in healthful nutrition and physical activity at camper check-in. After an informed consent is signed, parents/caregivers and the participant will fill out baseline questionnaires. The parent survey will ask about their child's ethnicity, parental education level, and family socioeconomic status.
Each participant will privately have their height, weight, and waist circumference measured prior to start of study. Participants will attend 45 minute sessions from Monday to Friday throughout 3 weeks at the camp. Each session will be held using different modules from the evidence-based HOP'N After School program. The difference in sessions between the intervention and comparison group will be that the intervention group will get both nutrition education and skill-training component during the session (for example, creating a healthy snack, playing games focusing on enjoyment of fruit and vegetable consumption); the control group will not receive the skill-training component, but will get the same nutrition knowledge as the intervention group. Controlled observation snack tests will take place at the beginning and at the end of the program (baseline and post-intervention).
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Children attending Yantar, a summer camp in the Northwestern part of Russia (Veshniaki village, Cherepovets district, Vologda region),
- Children of parents who provide permission to participate in a research study
Exclusion Criteria:
- Children outside the 8-12y age range
- Children not randomly selected to participate in nutrition education classes for three weeks.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: behavioral nutrition education
Set of curricular nutrition education modules, previously developed and based on Social Cognitive Theory, for the HOP'N After-School program, with additional materials from MyPlate.
Materials were employed to increase healthy eating behavioral capability, self-efficacy, attitudes, and enjoyment.
Topics included: 1) nutrition label literacy; 2) drinking water; 3) eating colors of the rainbow; 4) healthful snacks; 5) benefits of fruit and vegetable consumption; 6) moving more and sitting less; and 7) taking healthy habits home.
|
Education aimed at improving knowledge, attitudes, and practices related to dietary intake, with a focus on impacting theorized mediators of nutrition-related behavior.
|
Experimental: behavioral nutrition education plus skills
Set of curricular nutrition education modules, previously developed and based on Social Cognitive Theory for the HOP'N After-School program, with additional materials from MyPlate.
Materials were employed to increase healthy eating behavioral capability, self-efficacy, attitudes, and enjoyment.
Topics included:1) nutrition label literacy;2) drinking water;3) eating colors of the rainbow;4) healthful snacks;5) benefits of fruit and vegetable consumption;6) moving more and sitting less;and 7) taking healthy habits home.
Designed to differ from behavioral nutrition education condition by devoting at least 15 minutes of each session to an additional behavioral skills training component.
The behavioral skills component was designed to bolster behavioral capability, healthy eating attitudes, self-efficacy, and proxy efficacy with activities such as snack preparation sessions, role-playing games, fruit and vegetable tasting, and playing games that promoted healthier dietary behaviors.
|
Education aimed at improving knowledge, attitudes, and practices related to dietary intake, with a focus on impacting theorized mediators of nutrition-related behavior.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Healthy eating choices
Time Frame: Change from Baseline at 3 weeks
|
Objective selection of two snacks for consumption from a menu of six choices (direct observation)
|
Change from Baseline at 3 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Nutrition knowledge
Time Frame: Change from Baseline at 3 weeks
|
Questionnaire assessing knowledge related to healthy eating
|
Change from Baseline at 3 weeks
|
Healthy eating attitudes
Time Frame: Change from Baseline at 3 weeks
|
Questionnaire assessing attitudes related to healthy eating
|
Change from Baseline at 3 weeks
|
Fruit and vegetable self-efficacy
Time Frame: Change from Baseline at 3 weeks
|
Questionnaire assessing self-efficacy related to eating fruits and vegetables
|
Change from Baseline at 3 weeks
|
Fruit and vegetable enjoyment
Time Frame: Change from Baseline at 3 weeks
|
Questionnaire assessing enjoyment related to eating fruits and vegetables
|
Change from Baseline at 3 weeks
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Richard R Rosenkranz, PhD, Kansas State University
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- KSU-CHE-FNDH-RussCamp
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Study Data/Documents
-
preliminary results
Information comments: Rodicheva master's thesis document with preliminary analyses
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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