- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica NCT00593749
Healthy Corner Store Initiative (HCSI)
Panoramica dello studio
Stato
Condizioni
Intervento / Trattamento
Descrizione dettagliata
The HCSI is a community-based, multi-faceted, and broad-based intervention administered by The Food Trust. The HCSI is designed to permeate multiple aspects (i.e., social, educational, food availability) of the corner store environment. Moreover, it takes into account the unique aspects of each corner store.
Theoretical Framework. The HCSI is grounded in social cognitive theory (SCT). By incorporating the environment, personal factors (including cognitions) and behavior, SCT provides a framework for designing, implementing, and evaluating behavioral change. It supports traditional behavioral methods (positive reinforcement, specific behavioral outcomes). Moreover, it underscores the critical role of the social environment (modeling, social reinforcement, social norms - as well as reducing the antecedents for purchasing unhealthy foods) in affecting change. Our initial work has assessed the feasibility of implementing the HCSI and collecting data (see preliminary studies). We are poised to test the efficacy of the HCSI in the proposed study.
Behavioral Goals. The HCSI intervention seeks to: 1) decrease the purchase of high calorie snacks and beverages and to 2) increase the percentage of healthy snacks and beverages at the store level. Decreasing the purchase of high-calorie foods in the corner stores and/or decreasing sugar-sweetened soft drinks (assuming no change in physical activity) will shift energy balance to favor the prevention of overweight and obesity. These dietary goals are also consistent with the Institute of Medicine report on childhood obesity (Preventing Childhood Obesity: Health in the Balance, 2004). While we will measure BMI in the proposed study, our primary outcome of this initial randomized trial of efficacy is energy intake assessed at the time of purchase.
Although the implementation of the intervention will vary depending on the characteristics of the corner store, the major components of the program are summarized below:
Key informant interviews with corner store owners and teachers at local schools and after-school programs to determine how best to work with these key groups Social marketing campaign to reinforce messages about healthy snacking, Grouping healthy snacks and/or displaying signage for easy identification of healthier items, Integrating healthy snacking information into school and after-school programs to teach youngsters what comprises a healthy snack Involving family members and the community in promoting healthy snacking Working with snack and beverage manufacturers and distributors to increase the number of healthy snacks available in corner stores.
Tipo di studio
Iscrizione (Anticipato)
Fase
- Non applicabile
Contatti e Sedi
Luoghi di studio
-
-
Pennsylvania
-
Philadelphia, Pennsylvania, Stati Uniti, 19140
- Temple University - Center for Obesity Research and Education
-
-
Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Descrizione
Inclusion Criteria:
- 4th, 5th and 6th grade students
- Schools who meet eligibility for 50% of students eligible to receive free or reduced lunches at their school
- Corner stores surrounding these schools within a 4 block radius in either direction
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Prevenzione
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Nessuno (etichetta aperta)
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
|---|---|
|
Comparatore placebo: Controllo
|
control group in study
|
|
Comparatore attivo: HCS
Intervention group
|
modification of snacks and beverages offered in corner store surrounding 10 schools
Altri nomi:
|
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Lasso di tempo |
|---|---|
|
To compare the intervention and control on changes, over a 2 year period, in the energy content of snacks purchased before and after school at corner stores.
Lasso di tempo: post
|
post
|
Misure di risultato secondarie
Misura del risultato |
Lasso di tempo |
|---|---|
|
To compare the intervention and control groups on the percentage of available healthy snacks, the percentage of dedicated space for shelving healthy snacks, and the allocation of dedicated space where healthy items will be grouped for display.
Lasso di tempo: post
|
post
|
|
To understand the correlates and determinants of corner store shopping behavior.
Lasso di tempo: post
|
post
|
Collaboratori e investigatori
Sponsor
Collaboratori
Investigatori
- Investigatore principale: Gary D Foster, PhD, Temple University- Center for Obesity Research and Education
Pubblicazioni e link utili
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 (Stima)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- NEP - 10520
- 10520 (Identificatore di registro: DAIDS ES Registry ID)
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 .