- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT03077464
Behaviorally Oriented Nutrition Education at a Russian Summer Camp
Behaviorally Oriented Nutrition Education at a Russian Summer Camp: A Quasi-experimental Superiority Trial
Studieoversikt
Status
Intervensjon / Behandling
Detaljert beskrivelse
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).
Studietype
Registrering (Faktiske)
Fase
- Ikke aktuelt
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Beskrivelse
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.
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Forebygging
- Tildeling: Ikke-randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Aktiv 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.
|
|
Eksperimentell: 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.
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Healthy eating choices
Tidsramme: 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
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Nutrition knowledge
Tidsramme: Change from Baseline at 3 weeks
|
Questionnaire assessing knowledge related to healthy eating
|
Change from Baseline at 3 weeks
|
|
Healthy eating attitudes
Tidsramme: Change from Baseline at 3 weeks
|
Questionnaire assessing attitudes related to healthy eating
|
Change from Baseline at 3 weeks
|
|
Fruit and vegetable self-efficacy
Tidsramme: 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
Tidsramme: Change from Baseline at 3 weeks
|
Questionnaire assessing enjoyment related to eating fruits and vegetables
|
Change from Baseline at 3 weeks
|
Samarbeidspartnere og etterforskere
Sponsor
Etterforskere
- Hovedetterforsker: Richard R Rosenkranz, PhD, Kansas State University
Studierekorddatoer
Studer hoveddatoer
Studiestart (Faktiske)
Primær fullføring (Faktiske)
Studiet fullført (Faktiske)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Andre studie-ID-numre
- KSU-CHE-FNDH-RussCamp
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
Studiedata/dokumenter
-
preliminary results
Informasjonskommentarer: Rodicheva master's thesis document with preliminary analyses
Legemiddel- og utstyrsinformasjon, studiedokumenter
Studerer et amerikansk FDA-regulert medikamentprodukt
Studerer et amerikansk FDA-regulert enhetsprodukt
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