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Web-Based Weight Management for Individuals With Mental Illness (eWellness)

30. juni 2014 oppdatert av: Alexander S. Young, MD MSHS, University of California, Los Angeles
Obesity and physical inactivity have become serious problems for individuals with mental illness, resulting in increased rates of chronic disease, premature death, and substantial health care costs. Although in-person psychoeducational interventions help individuals with mental illness manage their weight, these interventions are often not used because they require frequent travel to treatment programs and substantial time from clinicians. This project addresses these barriers by developing and evaluating the effectiveness of an web-based computer system that is focused on diet and exercise education, and designed to help individuals with mental illness manage their weight.

Studieoversikt

Detaljert beskrivelse

Background/Rationale: Obesity and physical inactivity have reached epidemic proportions, resulting in increased rates of chronic disease, premature death, and substantial health care costs. Excess weight is even more prevalent in populations with serious mental illnesses (SMI), in part due to medication-induced weight gain and social disadvantage. Since individuals with SMI often have cognitive deficits, specialized approaches are required to help people manage their weight. Researchers have found that specialized in-person interventions focused on diet and activity can help individuals with SMI manage their weight. However, these evidence-based practices have not been widely disseminated. Barriers to the use of these interventions include reluctance of individuals to participate in groups, difficulty finding transportation for frequent visits to clinics, a shortage of trained clinicians, and inadequate clinician time to provide the interventions. It is likely that these barriers can be addressed with a web-based weight intervention that is tailored for individuals with SMI. Specialized web-based approaches have been studied and found to be effective in this population, and can deliver content that is intensive and engaging with minimal requirements for clinician time.

Objectives: The investigators on this proposal previously developed a prototype web-based system that provides limited diet education to individuals with SMI. The current project extends and evaluates this system. The project's objectives are to: 1) build on the prototype to develop "eWellness," a comprehensive web-based system that delivers an evidence-based weight management program focused on diet and activity, and that meets the needs of individuals with SMI; 2) evaluate the effectiveness, in individuals with SMI, of an eWellness program compared with a control group; and, 3) characterize, from the perspective of individuals with SMI, the strengths, weaknesses, and barriers to the use of eWellness.

Methods: This is a randomized, controlled trial of individuals with SMI at a community mental health center who are overweight and prescribed medications that have weight gain as a common side-effect. Participants are assigned to the eWellness program or to continue with usual care. Research assessments occur at baseline, 3, and 6 months. Changes in outcomes are compared over time between the two groups.

Significance: By losing weight, individuals with mental illness can decrease their risk for medical problems, and improve their quality of life and life expectancy. A web-based system that helps individuals lose weight could be feasible to disseminate broadly at medical centers, clinics, and community based programs in both rural and urban areas.

Studietype

Intervensjonell

Registrering (Faktiske)

60

Fase

  • Ikke aktuelt

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

    • California
      • Los Angeles, California, Forente stater, 90024
        • UCLA Center for Health Services and Society

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

18 år og eldre (Voksen, Eldre voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Alle

Beskrivelse

Inclusion Criteria:

  • diagnosis of schizophrenia, schizoaffective disorder, bipolar disorder, recurrent major depressive disorder with psychosis, or chronic PTSD
  • age 18 and over
  • prescribed antipsychotic medication for at least 3 months
  • BMI of 30 or higher, or BMI of 28 or higher if 10 pounds of recent weight gain
  • medical clearance to participate
  • control over diet

Exclusion Criteria:

  • any medical condition for which a weight program is contraindicated
  • history of bariatric surgery
  • psychiatric hospitalization during the prior month
  • pregnant and nursing mothers
  • diagnosis of dementia
  • not able to provide informed consent by self or legally appointed representative

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Behandling
  • Tildeling: Randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Enkelt

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Ingen inngripen: Kontrollgruppe
Ta vare som vanlig
Eksperimentell: eWellness program
A comprehensive program that delivers web-based, evidence-based weight management; and structured peer supports. The program is designed to meet the needs of individuals with mental illness.
A weight management program that includes computerized delivery of evidence-based education regarding diet and physical activity, and peer coaching.
Andre navn:
  • web-based weight management with peer coaching

Hva måler studien?

Primære resultatmål

Resultatmål
Tidsramme
Midjeomkrets
Tidsramme: 6 måneder
6 måneder
vekt
Tidsramme: 6 måneder
6 måneder
dietary habits
Tidsramme: 6 months
6 months
physical activity
Tidsramme: 6 months
6 months
diet and activity-related self-efficacy, motivation, and readiness to change
Tidsramme: 6 months
6 months

Sekundære resultatmål

Resultatmål
Tidsramme
livskvalitet
Tidsramme: 6 måneder
6 måneder
health-related functioning
Tidsramme: 6 months
6 months
strengths, weaknesses, and barriers to the use of eWellness
Tidsramme: 6 months
6 months

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Etterforskere

  • Hovedetterforsker: Alexander S Young, MD, MSHS, University of California, Los Angeles

Publikasjoner og nyttige lenker

Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.

Generelle publikasjoner

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart

1. mars 2012

Primær fullføring (Faktiske)

1. april 2014

Studiet fullført (Faktiske)

1. april 2014

Datoer for studieregistrering

Først innsendt

28. mars 2011

Først innsendt som oppfylte QC-kriteriene

28. mars 2011

Først lagt ut (Anslag)

29. mars 2011

Oppdateringer av studieposter

Sist oppdatering lagt ut (Anslag)

2. juli 2014

Siste oppdatering sendt inn som oppfylte QC-kriteriene

30. juni 2014

Sist bekreftet

1. juni 2014

Mer informasjon

Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .

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