- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT00939081
Community Based Obesity Prevention Among Blacks
Studieoversikt
Status
Forhold
Intervensjon / Behandling
Detaljert beskrivelse
Long-term promotion of physical activity is necessary to achieve obesity prevention. This represents a particular challenge for our intervention design, as few studies have demonstrated positive long-term physical activity promotion outcomes among Black women. We have demonstrated the utility of pedometers among low income, ethnically diverse populations. The efficacy of pedometer utilization for the prevention of weight gain, however, hinges on long-term utilization of the devices. We hypothesize that recommendation for the step count attainment may affect individual's long-term utilization of pedometers, as well as physical activity levels and BMI.
This study is a 24-week experimental trial to examine whether intervention recommendations promote long-term adherence to a pedometer-based physical activity regimen. A two-group, block design will be used in the proposed study. Eligible women will be randomly assigned to one of two experimental conditions (n=75 per condition): 1) receiving a 10,000 steps/day recommendation and 3 health education sessions or 2) receiving an adaptive recommendation and an obesity prevention intervention. The adaptive step recommendation will update participants' recommended step counts, starting at 7,000 steps/day, then 8,000 steps/day, then finally 10,000 steps/day. Participants in the adaptive recommendation group will be provided with 3 educational sessions and will be asked to report their daily progress on weight maintenance goals via text message.
Participants will be provided pedometers and will be asked to wear them every day of the 24-week trial period.
Assessments (including self-report survey and anthropometric measurements) will be conducted at baseline, 12 weeks and 24 weeks post-baseline.
Studietype
Registrering (Faktiske)
Fase
- Ikke aktuelt
Kontakter og plasseringer
Studiesteder
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North Carolina
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Durham, North Carolina, Forente stater, 27705
- Duke University
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Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Beskrivelse
Inclusion Criteria:
- Female
- Ages 25 and over
- BMI 25 and over
- English fluency
- Not currently pregnant
- No restrictions to ambulatory activity
Exclusion Criteria:
- Current pregnancy
- Childbearing in the past 12 months
- History of myocardial infarction or stroke in last 2 years
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Forebygging
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
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Aktiv komparator: 10,000 step/day recommendation
Participants will receive a standard 10,000 step/day recommendation and 3 education sessions: at baseline, at 3 months and at 6 months.
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Participants will receive a standard 10,000 step/day recommendation and 3 education sessions: at baseline, at 3 months and at 6 months.
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Eksperimentell: Adaptive recommendation
The adaptive recommendation will update the participant's recommended step count attainment from 7,000 to 8,000, then 10,000 steps/day.
The SMS-based self-monitoring system will collect three data points each day from participants in this group: 1) total number of steps/d recorded by the pedometer during the previous day (steps/d); 2) performance on 2nd weight loss goal; and 3) performance on 3rd weight loss goal.
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Participants in this group receive 3 education sessions: at baseline, at 3 months and at 6 months.
The adaptive recommendation will update the participant's recommended step count attainment from 7,000 to 8,000, then 10,000 steps/day.
The SMS-based self-monitoring system will collect three data points each day from participants in this group: 1) total number of steps/d recorded by the pedometer during the previous day (steps/d); 2) performance on 2nd weight loss goal; and 3) performance on 3rd weight loss goal.
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Hva måler studien?
Primære resultatmål
Resultatmål |
Tidsramme |
|---|---|
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Adherence to the pedometer-based physical activity regimen
Tidsramme: 24 weeks post baseline
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24 weeks post baseline
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Sekundære resultatmål
Resultatmål |
Tidsramme |
|---|---|
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Change in physical activity
Tidsramme: 24 weeks post baseline
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24 weeks post baseline
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Change in BMI
Tidsramme: 24 weeks post baseline
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24 weeks post baseline
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Samarbeidspartnere og etterforskere
Sponsor
Etterforskere
- Hovedetterforsker: Gary Bennett, PhD, Duke University
Publikasjoner og nyttige lenker
Hjelpsomme linker
Studierekorddatoer
Studer hoveddatoer
Studiestart
Primær fullføring (Faktiske)
Studiet fullført (Faktiske)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Anslag)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Anslag)
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
- 2794
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