- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT00593749
Healthy Corner Store Initiative (HCSI)
Studieoversigt
Status
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
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.
Undersøgelsestype
Tilmelding (Forventet)
Fase
- Ikke anvendelig
Kontakter og lokationer
Studiesteder
-
-
Pennsylvania
-
Philadelphia, Pennsylvania, Forenede Stater, 19140
- Temple University - Center for Obesity Research and Education
-
-
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
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
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Forebyggelse
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
---|---|
Placebo komparator: Styring
|
control group in study
|
Aktiv komparator: HCS
Intervention group
|
modification of snacks and beverages offered in corner store surrounding 10 schools
Andre navne:
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Tidsramme |
---|---|
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.
Tidsramme: post
|
post
|
Sekundære resultatmål
Resultatmål |
Tidsramme |
---|---|
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.
Tidsramme: post
|
post
|
To understand the correlates and determinants of corner store shopping behavior.
Tidsramme: post
|
post
|
Samarbejdspartnere og efterforskere
Sponsor
Samarbejdspartnere
Efterforskere
- Ledende efterforsker: Gary D Foster, PhD, Temple University- Center for Obesity Research and Education
Publikationer og nyttige links
Datoer for undersøgelser
Studer store datoer
Studiestart
Primær færdiggørelse (Faktiske)
Studieafslutning (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Skøn)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- NEP - 10520
- 10520 (Registry Identifier: DAIDS ES Registry ID)
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