- ICH GCP
- US-Register für klinische Studien
- Klinische Studie NCT03077464
Behaviorally Oriented Nutrition Education at a Russian Summer Camp
Behaviorally Oriented Nutrition Education at a Russian Summer Camp: A Quasi-experimental Superiority Trial
Studienübersicht
Status
Intervention / Behandlung
Detaillierte Beschreibung
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).
Studientyp
Einschreibung (Tatsächlich)
Phase
- Unzutreffend
Teilnahmekriterien
Zulassungskriterien
Studienberechtigtes Alter
Akzeptiert gesunde Freiwillige
Studienberechtigte Geschlechter
Beschreibung
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.
Studienplan
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Verhütung
- Zuteilung: Nicht randomisiert
- Interventionsmodell: Parallele Zuordnung
- Maskierung: Keine (Offenes Etikett)
Waffen und Interventionen
Teilnehmergruppe / Arm |
Intervention / Behandlung |
|---|---|
|
Aktiver Komparator: 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.
|
Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
Healthy eating choices
Zeitfenster: 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
|
Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
Nutrition knowledge
Zeitfenster: Change from Baseline at 3 weeks
|
Questionnaire assessing knowledge related to healthy eating
|
Change from Baseline at 3 weeks
|
|
Healthy eating attitudes
Zeitfenster: Change from Baseline at 3 weeks
|
Questionnaire assessing attitudes related to healthy eating
|
Change from Baseline at 3 weeks
|
|
Fruit and vegetable self-efficacy
Zeitfenster: 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
Zeitfenster: Change from Baseline at 3 weeks
|
Questionnaire assessing enjoyment related to eating fruits and vegetables
|
Change from Baseline at 3 weeks
|
Mitarbeiter und Ermittler
Sponsor
Ermittler
- Hauptermittler: Richard R Rosenkranz, PhD, Kansas State University
Studienaufzeichnungsdaten
Haupttermine studieren
Studienbeginn (Tatsächlich)
Primärer Abschluss (Tatsächlich)
Studienabschluss (Tatsächlich)
Studienanmeldedaten
Zuerst eingereicht
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
Zuerst gepostet (Tatsächlich)
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
Zuletzt verifiziert
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Schlüsselwörter
Andere Studien-ID-Nummern
- KSU-CHE-FNDH-RussCamp
Plan für individuelle Teilnehmerdaten (IPD)
Planen Sie, individuelle Teilnehmerdaten (IPD) zu teilen?
Studiendaten/Dokumente
-
preliminary results
Informationskommentare: Rodicheva master's thesis document with preliminary analyses
Arzneimittel- und Geräteinformationen, Studienunterlagen
Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt
Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt
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