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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03077464
Other study ID # KSU-CHE-FNDH-RussCamp
Secondary ID
Status Completed
Phase N/A
First received February 22, 2017
Last updated March 7, 2017
Start date June 1, 2014
Est. completion date May 15, 2015

Study information

Verified date March 2017
Source Kansas State University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Healthful eating is a core component of a healthy lifestyle that is associated with lower risk of obesity and chronic disease. Although adolescent health promotion programs have been extensively evaluated and applied in English-speaking Western developed nations, there is very little published literature in the Russian context. Our study seeks to determine the relative effectiveness of a healthy lifestyle intervention consisting of nutrition education at a Russian camp. Investigators will determine the impact of behaviorally focused nutrition education on nutrition knowledge, food choice, attitude, and self-efficacy for healthful eating, compared to standard nutrition education.


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).


Recruitment information / eligibility

Status Completed
Enrollment 40
Est. completion date May 15, 2015
Est. primary completion date July 28, 2014
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 8 Years to 12 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Behavioral nutrition education
Education aimed at improving knowledge, attitudes, and practices related to dietary intake, with a focus on impacting theorized mediators of nutrition-related behavior.

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Kansas State University

Outcome

Type Measure Description Time frame Safety issue
Primary Healthy eating choices Objective selection of two snacks for consumption from a menu of six choices (direct observation) Change from Baseline at 3 weeks
Secondary Nutrition knowledge Questionnaire assessing knowledge related to healthy eating Change from Baseline at 3 weeks
Secondary Healthy eating attitudes Questionnaire assessing attitudes related to healthy eating Change from Baseline at 3 weeks
Secondary Fruit and vegetable self-efficacy Questionnaire assessing self-efficacy related to eating fruits and vegetables Change from Baseline at 3 weeks
Secondary Fruit and vegetable enjoyment Questionnaire assessing enjoyment related to eating fruits and vegetables Change from Baseline at 3 weeks
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