- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT07227220
Sommerjobbprogrammer for ungdom til helsefremmende arbeid
Utnytte sommerungdoms arbeidsprogrammer for å forebygge fedme hos ungdommer
Formålet med dette konseptbevis-studiet er å vurdere det innledende signalet for effektiviteten av sommerungdomsarbeidsprogrammer (SYEP) på lite studerte fedmerelaterte utfall hos unge. Denne lite-skala studien er avgjørende for å identifisere tidlig suksess og forbedre intervensjonen før oppskalering til en større, mer ressurskrevende randomisert studie. Spesifikt vil denne enkeltgruppestudien med pre-posttest:
Mål 1 (Primært): Vurdere om et 6-ukers SYEP gir et innledende signal for effektivitet (vedlikehold eller reduksjon i zBMI) over sommeren.
Hypotese 1: Ungdom som deltok i et SYEP vil opprettholde eller redusere sin BMI over sommeren.
Mål 2 (Sekundært): Vurdere endringer i obesogene atferder (fysisk aktivitet, søvn, stillesittende og kosthold) over sommeren.
Hypotese 2: Ungdom som deltok i et SYEP vil øke fysisk aktivitet, redusere stillesittende atferd og forbedre søvn- og kostholdskvalitet over sommeren.
Mål 3 (Sekundært): Vurdere gjennomførbarheten av SYEP for fedmeforebyggende intervensjon for å informere om intervensjonsskalerbarhet.
Hypotese 3: SYEP-programmet vil være en gjennomførbar og akseptabel intervensjonsstrategi for forebygging av fedme hos unge over sommeren.
Studieoversikt
Status
Forhold
Intervensjon / Behandling
Detaljert beskrivelse
Foreløpige bevis tyder på at sommerjobb kan være en aldersriktig, strukturert intervensjon for å forebygge usunne endringer i obesogene atferdsmønstre blant ungdom. Mens disse funnene er lovende, har ingen av de eksisterende studiene målt endringer i kroppsmasseindeks (KMI) over sommeren eller gjennomført omfattende vurderinger av obesogen atferd, inkludert kosthold, stillesittende atferd, søvn og fysisk aktivitet. For å adressere disse hullene i forskningen, foreslår denne studien en lite proof-of-concept-studie for å vurdere det innledende signalet på effekt på lite studerte fedmerelaterte utfall hos ungdom.
SYP-er (sommerungdomsprogrammer) er veletablerte, kontinuerlig operative tiltak over 60 år med påviste fordeler innen akademisk utvikling, arbeidsstyrkeutvikling og kriminalforebygging, og kan også fungere som fedmeforebyggende strategier. I stedet for å skape nye intervensjoner, kan investering i og utvidelse av tilgangen til SYP-programmer med høy etterspørsel, men begrenset kapasitet (hvor kun ~28 % av søkere får jobb hver sommer, slik at flertallet står på ventelister) tilby en praktisk løsning for forebygging av fedme hos ungdom.
Studietype
Registrering (Faktiske)
Fase
- Tidlig fase 1
Kontakter og plasseringer
Studiesteder
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Texas
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Houston, Texas, Forente stater, 77204
- University of Houston
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Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
- Barn
Tar imot friske frivillige
Beskrivelse
Inkluderingskriterier:
- Alder 14-17 år ved påmelding, i samsvar med Texas barnearbeidslov
- Villig til å jobbe på sommerleiren i seks sammenhengende uker
- I stand til å bestå ansettelsesopptakingsprosedyren (jobbintervju)
- I stand til å skaffe foresattes samtykke og gi samtykke for studiedeltakelse
Ekskluderingskriterier:
- For tiden gravid eller planlegger å bli gravid, på grunn av fysisk aktivitetsbegrensninger og potensielle vektendringer som kan forvirre studieresultatene
- Diagnose med en intellektuell og/eller fysisk funksjonshemming som krever spesialiserte ansettelsesregler eller intervensjonsstrategier
- Deltakelse i en helsefremmende intervensjon innen de siste seks månedene
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Forebygging
- Tildeling: N/A
- Intervensjonsmodell: Enkeltgruppeoppdrag
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
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Eksperimentell: Sommeryrkesutdanningsprogram
Deltakere vil jobbe som junior sommerleirveiledere ved et University of Houston-leir, opptil 24 timer/uke, mandag-torsdag, kl. 08.30-15.30 (med lunsjpause kl. 12-13), i seks uker fra midten av juni til slutten av juli.
Deltakere vil assistere seniorveiledere med innendørs/utendørs aktiviteter som spill, berikelse og akademiske aktiviteter.
På fredager, fra kl. 10.00 til 12.00, vil deltakerne delta på faglige utviklingsworkshops om emner som kommunikasjon, samarbeid, CV-bygging og jobbsøkerferdigheter.
Fra kl. 12.00 til 14.30 vil bachelorstudentpersonale lede sosiale aktiviteter og veiledning.
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Intervensjonen tar sikte på å ansette ungdommer i lønnet stilling i seks uker om sommeren, og gi dem et strukturert, rutinebasert og voksenovervåket miljø som ligner på det de har i skoleåret.
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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
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Change in Age- and Sex-Specific Body Mass Index (BMI)-For-Age Z-Score (zBMI) From Baseline to Week 6
Tidsramme: Baseline and Week 6 (post)
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Height and weight will be directly measured by trained staff.
Each measurement will be taken twice, and the average will be used for analysis.
Body mass index (BMI) will be calculated and expressed as Centers for Disease Control and Prevention (CDC) age- and sex-specific BMI-for-age z-scores (zBMI).
The outcome will represent the change in zBMI from baseline to Week 6.
A positive change score will indicate an increase (gain) in zBMI from baseline to Week 6, which will be considered a less favorable outcome.
A negative change score will indicate a decrease in zBMI, which will be considered a favorable outcome.
A change score of 0 will indicate no change in zBMI (maintenance), which will also be considered a favorable outcome for this intervention because preventing excess BMI gain during summer is a primary goal.
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Baseline and Week 6 (post)
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Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
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Change in Sedentary Behavior From Baseline to Week 6
Tidsramme: Baseline and Week 6 (post)
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Sedentary behavior will be measured in minutes per day using a wrist-worn ActiGraph GT3X accelerometer on the non-dominant wrist over 8 consecutive days, including at least 2 valid weekdays and 1 valid weekend day.
Activity intensities will be classified using cut points published by Hildebrand et al.
The reported outcome will be the change in average daily sedentary behavior (minutes/day) from baseline to Week 6.
A positive change score will indicate an increase in sedentary behavior, which will be considered an unfavorable outcome.
A negative change score will indicate a decrease in sedentary behavior, which will be considered a favorable outcome.
A change score of 0 will indicate no change in sedentary behavior (maintenance).
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Baseline and Week 6 (post)
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Change in Moderate-to-Vigorous Physical Activity (MVPA) From Baseline to Week 6
Tidsramme: Baseline and Week 6 (post)
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Moderate-to-vigorous physical activity (MVPA) will be measured in minutes per day using a wrist-worn ActiGraph GT3X accelerometer on the non-dominant wrist over 8 consecutive days, including at least 2 valid weekdays and 1 valid weekend day.
Activity intensities will be classified using cut points published by Hildebrand et al.
The reported outcome will be the change in average daily MVPA (minutes/day) from baseline to Week 6.
A positive change score will indicate an increase in MVPA, which will be considered a favorable outcome.
A negative change score will indicate a decrease in MVPA, which will be considered an unfavorable outcome.
A change score of 0 will indicate no change in MVPA (maintenance), which will also be considered a favorable outcome.
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Baseline and Week 6 (post)
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Change in Sleep Duration From Baseline to Week 6
Tidsramme: Baseline and Week 6 (post)
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Sleep duration will be measured in minutes per day using a wrist-worn ActiGraph GT3X accelerometer on the non-dominant wrist over 8 consecutive days, including at least 2 valid weekdays and 1 valid weekend day.
Sleep duration will be estimated using the heuristic algorithm looking at the distribution of change in Z-Angle (HDCZA).
The reported outcome will be the change in average daily sleep duration (minutes/day) from baseline to Week 6.
A positive change score will indicate an increase in sleep duration, which will be considered a favorable outcome.
A negative change score will indicate a decrease in sleep duration, which will be considered an unfavorable outcome.
A change score of 0 will indicate no change in sleep duration (maintenance), which will also be considered a favorable outcome.
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Baseline and Week 6 (post)
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Change in Screen Time From Baseline to Week 6
Tidsramme: Baseline and Week 6 (post)
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Screen time in hours and minutes (e.g., television, computer, video games, smart phones, tablets) will assessed via self-report during each 8-day behavioral assessment period.
Screen time will be calculated as the average daily duration (minutes/day) by summing total reported screen time across completed daily logbooks and dividing by the number of valid diary days within each assessment period.
The reported outcome will be the change in average daily screen time (minutes/day) from baseline to Week 6.
A positive change score will indicate an increase in screen time, which will be considered an unfavorable outcome.
A negative change score will indicate a decrease in screen time, which will be considered a favorable outcome.
A change score of 0 will indicate no change in screen time (maintenance), which will also be considered a favorable outcome.
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Baseline and Week 6 (post)
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Change in Unhealthy Food Intake From Baseline to Week 6
Tidsramme: Baseline and Week 6 (post)
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Dietary intake will be assessed using the NHANES 23-item Dietary Screener Questionnaire.
Adolescents will self-report consumption of food and beverage items over the past day.
For this outcome, unhealthy food items will include desserts, sugar-sweetened beverages, salty snacks, and fast food items.
Responses will be used to estimate daily intake frequency (times/day) of unhealthy food consumption.
The reported outcome will be the change in average daily frequency of unhealthy food intake (times/day) from baseline to Week 6.
A positive change score will indicate an increase in unhealthy food intake, which will be considered an unfavorable outcome.
A negative change score will indicate a decrease in unhealthy food intake, which will be considered a favorable outcome.
A change score of 0 will indicate no change in unhealthy food intake (maintenance), which will also be considered a favorable outcome.
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Baseline and Week 6 (post)
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Recruitment Capacity (Percentage Meeting Recruitment Goal)
Tidsramme: Baseline
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Recruitment capacity is the percentage meeting the recruitment goal.
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Baseline
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Retention
Tidsramme: Baseline and Week 6 (post)
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Retention will be calculated as the percentage of enrolled participants who complete both baseline and post-intervention assessments for the primary outcome measures.
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Baseline and Week 6 (post)
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Fidelity
Tidsramme: Weekly during intervention (Weeks 1-6)
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Fidelity will be assessed through weekly unannounced direct observations using a structured checklist developed by the research team specifically for the intervention.
The checklist will assess key components of intervention implementation, including adherence, dose delivered, quality of delivery, and participant engagement.
Each item will be rated using either binary scoring (0 = not implemented, 1 = implemented) or a 5-point Likert scale (1 = strongly disagree to 5 = strongly agree), depending on the construct.
All domain scores will be standardized and converted to a percentage scale.
Each intervention session will be independently rated by two trained researcher, and ratings will be averaged.
Session-level fidelity scores will then be averaged across all observation weeks to produce a single fidelity score.
The fidelity score will be expressed as a percentage, with higher scores indicating greater fidelity to the intervention protocol and lower scores indicating reduced fidelity.
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Weekly during intervention (Weeks 1-6)
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Attendance
Tidsramme: Weekly during intervention (Weeks 1-6)
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Attendance will be calculated as the average number of days attended across total offered workdays, using employer time sheets.
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Weekly during intervention (Weeks 1-6)
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Acceptability
Tidsramme: Week 7 (Follow-up)
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Acceptability will be assessed using a quantitative satisfaction measure administered to adolescents following intervention participation.
Participants will be asked to rate their likelihood of returning as a paid counselor the following summer on a scale ranging from 1 (not at all likely) to 10 (extremely likely).
Individual responses will be averaged to generate a single acceptability score.
The total score will range from 1 to 10, with higher scores indicating greater acceptability and willingness to participate again, and lower scores indicating lower acceptability.
Scores closer to 10 will represent high acceptability, while scores closer to 1 will represent low acceptability of the intervention experience.
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Week 7 (Follow-up)
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Change in Healthy Food Intake From Baseline to Week 6
Tidsramme: Baseline and Week 6 (post)
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Dietary intake will be assessed using the NHANES 23-item Dietary Screener Questionnaire.
Adolescents will self-report consumption of food and beverage items over the past day.
For this outcome, healthy food items will include fruits, vegetables, 100% fruit juice, and milk items.
Responses will be used to estimate daily intake frequency (times/day) of healthy food consumption.
The reported outcome will be the change in average daily frequency of healthy food intake (times/day) from baseline to Week 6.
A positive change score will indicate an increase in healthy food intake, which will be considered a favorable outcome.
A negative change score will indicate a decrease in healthy food intake, which will be considered an unfavorable outcome.
A change score of 0 will indicate no change in healthy food intake (maintenance), which will also be considered a favorable outcome.
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Baseline and Week 6 (post)
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Samarbeidspartnere og etterforskere
Sponsor
Samarbeidspartnere
Publikasjoner og nyttige lenker
Generelle publikasjoner
- Czajkowski SM, Powell LH, Adler N, Naar-King S, Reynolds KD, Hunter CM, Laraia B, Olster DH, Perna FM, Peterson JC, Epel E, Boyington JE, Charlson ME. From ideas to efficacy: The ORBIT model for developing behavioral treatments for chronic diseases. Health Psychol. 2015 Oct;34(10):971-82. doi: 10.1037/hea0000161. Epub 2015 Feb 2.
- Pierce B, Bowden B, McCullagh M, Diehl A, Chissell Z, Rodriguez R, Berman BM, D Adamo CR. A Summer Health Program for African-American High School Students in Baltimore, Maryland: Community Partnership for Integrative Health. Explore (NY). 2017 May-Jun;13(3):186-197. doi: 10.1016/j.explore.2017.02.002. Epub 2017 Feb 24.
- Yazel-Smith L, El-Mikati HK, Adjei M, Haberlin-Pittz KM, Agnew M, Hannon TS. Integrating Diabetes Prevention Education Among Teenagers Involved in Summer Employment: Encouraging Environments for Health in Adolescence (ENHANCE). J Community Health. 2020 Aug;45(4):856-861. doi: 10.1007/s10900-020-00802-2.
- Modestino AS, Paulsen RJ. Reducing inequality summer by summer: Lessons from an evaluation of the Boston Summer Youth Employment Program. Eval Program Plann. 2019 Feb;72:40-53. doi: 10.1016/j.evalprogplan.2018.09.006. Epub 2018 Sep 24.
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
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- STUDY00005180
- U54MD015946 (U.S. NIH-stipend/kontrakt)
Legemiddel- og utstyrsinformasjon, studiedokumenter
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