- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica NCT03077464
Behaviorally Oriented Nutrition Education at a Russian Summer Camp
Behaviorally Oriented Nutrition Education at a Russian Summer Camp: A Quasi-experimental Superiority Trial
Panoramica dello studio
Stato
Intervento / Trattamento
Descrizione dettagliata
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).
Tipo di studio
Iscrizione (Effettivo)
Fase
- Non applicabile
Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Descrizione
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.
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Prevenzione
- Assegnazione: Non randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Nessuno (etichetta aperta)
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
|---|---|
|
Comparatore attivo: 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.
|
|
Sperimentale: 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.
|
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Healthy eating choices
Lasso di tempo: 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
|
Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Nutrition knowledge
Lasso di tempo: Change from Baseline at 3 weeks
|
Questionnaire assessing knowledge related to healthy eating
|
Change from Baseline at 3 weeks
|
|
Healthy eating attitudes
Lasso di tempo: Change from Baseline at 3 weeks
|
Questionnaire assessing attitudes related to healthy eating
|
Change from Baseline at 3 weeks
|
|
Fruit and vegetable self-efficacy
Lasso di tempo: 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
Lasso di tempo: Change from Baseline at 3 weeks
|
Questionnaire assessing enjoyment related to eating fruits and vegetables
|
Change from Baseline at 3 weeks
|
Collaboratori e investigatori
Sponsor
Investigatori
- Investigatore principale: Richard R Rosenkranz, PhD, Kansas State University
Studiare le date dei record
Studia le date principali
Inizio studio (Effettivo)
Completamento primario (Effettivo)
Completamento dello studio (Effettivo)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Effettivo)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Altri numeri di identificazione dello studio
- KSU-CHE-FNDH-RussCamp
Piano per i dati dei singoli partecipanti (IPD)
Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?
Dati/documenti di studio
-
preliminary results
Commenti informativi: Rodicheva master's thesis document with preliminary analyses
Informazioni su farmaci e dispositivi, documenti di studio
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Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .
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