- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica NCT02399436
Appalachians Together Restoring the Eating Environment (Appal-TREE)
Panoramica dello studio
Stato
Condizioni
Intervento / Trattamento
Descrizione dettagliata
This pilot study evaluates two principal components of a community-based intervention to improve dietary habits and access to healthy foods: a school-based healthy snacking campaign and a series of community cooking classes for adults. The primary outcome assessed within each intervention component is dietary intake as measured by self-reported beverage and food consumption in pre-post surveys. Secondary outcome variables include attitudes, preferences, confidence, self-efficacy and other psychosocial variables related to healthy eating behaviors, perceptions of healthy food availability, food purchasing and preparation habits, and perceived barriers to healthy eating.
The school-based intervention component employs a nonequivalent control group research design. A subset of middle- and high-schools within a single county in eastern KY will receive a healthy snacking campaign intervention, and students from randomly selected classrooms within these schools will be invited to enroll in the study. Students from middle- and high-school classrooms in a comparison county that receives no intervention will serve as nonequivalent controls. The investigators specific aims for this component are to improve the availability of healthy snack foods that students may purchase at school, increase student consumption of healthy snacks over unhealthy snacks, and increase the consumption of water over sugar-sweetened beverages. Following baseline, posttest surveys will be administered at 3, 6 and 14 months.
Community cooking classes will be delivered to a non-random sample of adults who will complete pretest-posttest measures at baseline and 8 weeks. The specific aims of this component are to increase the consumption of healthy foods at home, and increase participant knowledge, skills, and self-efficacy around healthy home cooking.
Tipo di studio
Iscrizione (Effettivo)
Fase
- Non applicabile
Contatti e Sedi
Luoghi di studio
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Kentucky
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Lexington, Kentucky, Stati Uniti, 40506
- University of Kentucky
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Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
- Bambino
- Adulto
- Adulto più anziano
Accetta volontari sani
Sessi ammissibili allo studio
Descrizione
Inclusion Criteria:
- For School-Based Component: 6th-12th grade students enrolled in a participating school and classroom in the intervention or comparison county.
- For Cooking Classes: Adults aged 18 years and older residing in intervention county who have at least one juvenile in household.
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Altro
- Assegnazione: Non randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Nessuno (etichetta aperta)
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
|---|---|
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Sperimentale: School-Based Healthy Snacking Campaign
Students who attend middle and high schools in the experimental county that participate in the healthy snacking campaign intervention.
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The school-based healthy snacking campaign includes the following activities:
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Nessun intervento: Comparison Schools
Students who attend middle and high schools in the comparison county, which does not receive any intervention components.
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Sperimentale: Community Cooking Classes
Adults in the intervention county who enroll in group cooking classes (single-group pretest-posttest)
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Cooking classes will be delivered to groups of 8-12 adult participants as a series of 8 weekly classes in community venues.
The content of each class is driven by topics and themes identified and prioritized by community members, namely cooking healthy on tight budget.
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Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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Change in Beverage Consumption (Students)
Lasso di tempo: Baseline, 3 months, 6 months, and 14 months
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Frequency and quantity of beverages consumed in past month.
Includes water, 100% fruit juice, sugar-sweetened beverages, sugar-free beverages and milk.
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Baseline, 3 months, 6 months, and 14 months
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Change in Snack Consumption (Students)
Lasso di tempo: Baseline, 3 months, 6 months, and 14 months
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Frequency and quantity of snacks consumed in past month.
Includes chips (regular and low-fat), salty snacks, candy, desserts, vegetables, fruit, nuts and seeds, vegetable dips, yogurt, and popcorn.
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Baseline, 3 months, 6 months, and 14 months
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Change in Dietary intake (Adults)
Lasso di tempo: Baseline to 8 weeks
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Frequency of consumption of fruits, vegetables, beans, candy, pastries, desserts, and salty snacks in the past month.
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Baseline to 8 weeks
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Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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Change in Snacking Attitudes and Preferences (Students)
Lasso di tempo: Baseline, 3 months, 6 months, and 14 months
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Survey items address taste preferences, attitudes about healthy eating behaviors and body image
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Baseline, 3 months, 6 months, and 14 months
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Change in Healthy Snacking Confidence and Self-efficacy (Students)
Lasso di tempo: Baseline, 3 months, 6 months, and 14 months
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Baseline, 3 months, 6 months, and 14 months
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Change in Availability of Healthy Snack Foods (Students)
Lasso di tempo: Baseline, 3 months, 6 months, and 14 months
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Frequency of availability of healthy and unhealthy snack foods at school
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Baseline, 3 months, 6 months, and 14 months
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Change in Snack Food Purchasing Habits (Students)
Lasso di tempo: Baseline, 3 months, 6 months, and 14 months
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Frequency of purchasing snack foods and beverages at fast food restaurants, convenience stores, and school venues and events
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Baseline, 3 months, 6 months, and 14 months
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Change in Food Preparation Habits (Adults)
Lasso di tempo: Baseline to 8 weeks
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Likelihood of performing healthy food preparation behaviors; survey items address meal planning and preparation
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Baseline to 8 weeks
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Change in Food Purchasing Habits (Adults)
Lasso di tempo: Baseline to 8 weeks
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Frequency of purchasing food at work, grocery/convenience stores, restaurants and produce stands
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Baseline to 8 weeks
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Change in Perceptions of Availability of Healthy Foods (Adults)
Lasso di tempo: Baseline to 8 weeks
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Survey items address availability of high quality fruits and vegetables and low-fat foods
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Baseline to 8 weeks
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Change in Barriers to Healthy Eating (Adults)
Lasso di tempo: Baseline to 8 weeks
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Survey items address physical, psychosocial, emotional, and financial barriers to healthy eating
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Baseline to 8 weeks
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Collaboratori e investigatori
Sponsor
Collaboratori
Studiare le date dei record
Studia le date principali
Inizio studio
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 (Stima)
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
Altri numeri di identificazione dello studio
- 12-0900-P3H
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 .