- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica NCT05880901
Bambini sani oltre la campana: indagare sull'impatto dei programmi doposcuola ed estivi
Aumentare l'accesso dei bambini a basso reddito a programmi strutturati sani per ridurre l'obesità
Nearly one in five children are obese, and disparities in overweight and obesity between children from low- and middle-to-high-income households persist despite a multitude of school-based interventions. The structured days hypothesis posits that structure within a school day plays a protective role for children against obesogenic behaviors, and, ultimately, prevents the occurrence of excessive weight gain, thus, past school-based efforts are misplaced. This study will provide access to healthy structured programming via vouchers to afterschool programs and summer day camps during two "windows of vulnerability" (ie afterschool and summer) for low-income children.
Panoramica dello studio
Stato
Intervento / Trattamento
Descrizione dettagliata
Despite the public health field's best efforts, disparities in overweight and obesity (OWOB) prevalence between children (6-11) from low- and middle-to-high-income families persist. Previous interventions to address disparate rates of childhood OWOB have focused almost exclusively on school settings. Given that disparities in OWOB persist, current school-based efforts may be misplaced because children engage in more unhealthy behaviors outside of school (e.g., afterschool during weekdays and during the summer). The structured days hypothesis posits that a structure within a day, defined as a pre-planned, segmented, and adult-supervised compulsory environment (like a school day), plays a protective role for children against obesogenic behaviors, and, ultimately, prevents the occurrence of negative health-outcomes, such as, excessive weight gain. Essentially, the structured days hypothesis draws upon concepts in the 'filled-time perspective' literature which posits that time filled with favorable activities cannot be filled with unfavorable activities. There are at least two "windows of vulnerability" for children outside of the school day. These critically important windows include the hours immediately following school (i.e., 3-6pm school days) and the 10 weeks of summer vacation. Programs that can provide a healthy structured environment and prevent unhealthy weight gains exist for both of these time periods (i.e., afterschool programs and summer day camps). Unfortunately, these programs are too expensive for children from low-income families to attend. Thus, this study will rigorously test the impact of providing access to existing, community-operated afterschool and summer programs on weight status (i.e., BMI z-score) and obesogenic behaviors (i.e., physical activity, screen use, diet, and sleep) of elementary children from low-income households. The study will employ a 2x2 full factorial design. The two factors will be access, through vouchers, to structured programming. The four groups will be a no treatment control, afterschool program voucher only, summer day camp voucher only, and vouchers for afterschool and summer day camp combined. The study will accomplish the following specific aims: AIM 1 (Primary): Compare changes in z-BMI among children in the no treatment control, afterschool only, summer camp only, and afterschool and summer day camp combined groups. AIM 2 (Secondary): Compare differences in obesogenic behaviors during the school year and the summer among children in the no treatment control, school only, summer camp only, and afterschool and summer day camp combined intervention groups. AIM 3 (Secondary): Evaluate the cost-effectiveness of delivering the afterschool only, summer camp only, and combined interventions. This study is significant because nearly one in five children are obese, and disparities in OWOB between children from low- and middle-to-high-income households persist despite past school-based interventions. This study is innovative because it represents one of the first attempts to provide access to healthy structured programming during two "windows of vulnerability" for children outside of the school day. Should the proposed intervention strategy prove effective it has the potential to mitigate disparities in OWOB prevalence.
Tipo di studio
Iscrizione (Stimato)
Fase
- Fase 2
Contatti e Sedi
Luoghi di studio
-
-
South Carolina
-
Columbia, South Carolina, Stati Uniti, 29205
- University of South Carolina
-
-
Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Descrizione
Inclusion Criteria:
- k-4th grader in a partner school
- eligible for free and reduced price lunch (a widely recognized indicator of
- socioeconomic level and poverty status)
- parent that indicates "yes' on an informed consent document for participation in the study
Exclusion Criteria:
- Diagnosis of an intellectual disability, such as Down Syndrome, Fragile X, Fetal Alcohol
- a physical disability, such as wheelchair use, that prevents the ability to ambulate without assistance.
- Families who plan to enroll their children in a summer camp or after school program or relocate (i.e., move) during the 14-month period that they participate
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Prevenzione
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione fattoriale
- Mascheramento: Doppio
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
|---|---|
|
Nessun intervento: Control
does not attend afterschool or summer programing |
|
|
Sperimentale: After school
Attends after school programming for 32 weeks during the school year |
The after school program are existing community-based programs that take place immediately after the regular school day (typically 3:00-6:00pm); are located in a school; are available daily throughout the academic year (Monday through Friday); and provide a combination of scheduled activities, which include a snack, homework assistance/tutoring, enrichment activities (e.g., arts and crafts, music), and opportunities for children to be physically active. |
|
Sperimentale: Summer camp
Attends summer day camp programming for 8 weeks during the summer vacation from school |
The summer day camp programs are existing camps which take place at schools from which children will be recruited. The camps are not singularly focused, such as sport camps or academic only camps. Rather, the camps provide indoor and outdoor opportunities for children to be physically active each day, provide enrichment and academic programming, as well as provide breakfast, lunch, and snacks. |
|
Sperimentale: After school and Summer Camp
Attends after school programming for 32 weeks during the school year and summer day camp programming for 8 weeks during the summer vacation from school |
The after school program are existing community-based programs that take place immediately after the regular school day (typically 3:00-6:00pm); are located in a school; are available daily throughout the academic year (Monday through Friday); and provide a combination of scheduled activities, which include a snack, homework assistance/tutoring, enrichment activities (e.g., arts and crafts, music), and opportunities for children to be physically active. The summer day camp programs are existing camps which take place at schools from which children will be recruited. The camps are not singularly focused, such as sport camps or academic only camps. Rather, the camps provide indoor and outdoor opportunities for children to be physically active each day, provide enrichment and academic programming, as well as provide breakfast, lunch, and snacks. |
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Change in Body Mass Index
Lasso di tempo: End of school year (0 months, start of summer), beginning of school year (3 months, end of summer) and end of following school year (12 months)
|
BMI translated into BMI z-scores based on Centers for Disease Control age-sex-specific zBMI growth charts |
End of school year (0 months, start of summer), beginning of school year (3 months, end of summer) and end of following school year (12 months)
|
Collaboratori e investigatori
Sponsor
Pubblicazioni e link utili
Pubblicazioni generali
- Eglitis EK, Savidge M, Adams EL, Beets MW, Kaczynski AT, Chen B, Armstrong B, Burkart S, Kiely KP, White JW 3rd, Finnegan O, Parker H, Randolf GAT, Maher C, Weaver RG. "I feel better as a parent" - summer programs help support children's health behaviors and parent wellbeing. Res Sq [Preprint]. 2026 Apr 23:rs.3.rs-9125988. doi: 10.21203/rs.3.rs-9125988/v1.
- Weaver RG, Beets MW, Adams EL, Kaczynski AT, Chen B, Armstrong B, Burkart S, Kiely K, Cepni AB, White JW 3rd, Finnegan O, Savidge M, Parker H, Randolph GAT. Rationale and design of Healthy Kids Beyond the Bell: a 2x2 full factorial study evaluating the impact of summer and after-school programming on children's body mass index and health behaviors. Trials. 2024 Oct 24;25(1):714. doi: 10.1186/s13063-024-08555-2.
Studiare le date dei record
Studia le date principali
Inizio studio (Effettivo)
Completamento primario (Stimato)
Completamento dello studio (Stimato)
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
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- Pro00125471
Piano per i dati dei singoli partecipanti (IPD)
Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?
Informazioni su farmaci e dispositivi, documenti di studio
Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti
Studia un dispositivo regolamentato dalla FDA degli Stati Uniti
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 .