- ICH GCP
- Yhdysvaltain kliinisten tutkimusten rekisteri
- Kliininen tutkimus NCT01324973
Web-Based Weight Management for Individuals With Mental Illness (eWellness)
Tutkimuksen yleiskatsaus
Tila
Interventio / Hoito
Yksityiskohtainen kuvaus
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.
Opintotyyppi
Ilmoittautuminen (Todellinen)
Vaihe
- Ei sovellettavissa
Yhteystiedot ja paikat
Opiskelupaikat
-
-
California
-
Los Angeles, California, Yhdysvallat, 90024
- UCLA Center for Health Services and Society
-
-
Osallistumiskriteerit
Kelpoisuusvaatimukset
Opintokelpoiset iät
Hyväksyy terveitä vapaaehtoisia
Sukupuolet, jotka voivat opiskella
Kuvaus
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
Opintosuunnitelma
Miten tutkimus on suunniteltu?
Suunnittelun yksityiskohdat
- Ensisijainen käyttötarkoitus: Hoito
- Jako: Satunnaistettu
- Inventiomalli: Rinnakkaistehtävä
- Naamiointi: Yksittäinen
Aseet ja interventiot
Osallistujaryhmä / Arm |
Interventio / Hoito |
|---|---|
|
Ei väliintuloa: Kontrolliryhmä
Huolehdi tavalliseen tapaan
|
|
|
Kokeellinen: 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.
Muut nimet:
|
Mitä tutkimuksessa mitataan?
Ensisijaiset tulostoimenpiteet
Tulosmittaus |
Aikaikkuna |
|---|---|
|
vyötärönympärys
Aikaikkuna: 6 kuukautta
|
6 kuukautta
|
|
paino
Aikaikkuna: 6 kuukautta
|
6 kuukautta
|
|
dietary habits
Aikaikkuna: 6 months
|
6 months
|
|
physical activity
Aikaikkuna: 6 months
|
6 months
|
|
diet and activity-related self-efficacy, motivation, and readiness to change
Aikaikkuna: 6 months
|
6 months
|
Toissijaiset tulostoimenpiteet
Tulosmittaus |
Aikaikkuna |
|---|---|
|
elämänlaatu
Aikaikkuna: 6 kuukautta
|
6 kuukautta
|
|
health-related functioning
Aikaikkuna: 6 months
|
6 months
|
|
strengths, weaknesses, and barriers to the use of eWellness
Aikaikkuna: 6 months
|
6 months
|
Yhteistyökumppanit ja tutkijat
Tutkijat
- Päätutkija: Alexander S Young, MD, MSHS, University of California, Los Angeles
Julkaisuja ja hyödyllisiä linkkejä
Yleiset julkaisut
- Cohen AN, Chinman MJ, Hamilton AB, Whelan F, Young AS. Using patient-facing kiosks to support quality improvement at mental health clinics. Med Care. 2013 Mar;51(3 Suppl 1):S13-20. doi: 10.1097/MLR.0b013e31827da859.
- Chinman M, Young AS, Schell T, Hassell J, Mintz J. Computer-assisted self-assessment in persons with severe mental illness. J Clin Psychiatry. 2004 Oct;65(10):1343-51. doi: 10.4088/jcp.v65n1008.
- Young AS. The client, the clinician, and the computer. Psychiatr Serv. 2010 Jul;61(7):643. doi: 10.1176/ps.2010.61.7.643. No abstract available.
- Cohen AN, Golden JF, Young AS. Peer wellness coaches for adults with mental illness. Psychiatr Serv. 2014 Jan 1;65(1):129-30. doi: 10.1176/appi.ps.650101. No abstract available.
- Chinman M, Hassell J, Magnabosco J, Nowlin-Finch N, Marusak S, Young AS. The feasibility of computerized patient self-assessment at mental health clinics. Adm Policy Ment Health. 2007 Jul;34(4):401-9. doi: 10.1007/s10488-007-0120-4. Epub 2007 Apr 24.
- Young AS, Chaney E, Shoai R, Bonner L, Cohen AN, Doebbeling B, Dorr D, Goldstein MK, Kerr E, Nichol P, Perrin R. Information technology to support improved care for chronic illness. J Gen Intern Med. 2007 Dec;22 Suppl 3(Suppl 3):425-30. doi: 10.1007/s11606-007-0303-4.
- Hamilton AB, Chinman M, Cohen AN, Oberman RS, Young AS. Implementation of consumer providers into mental health intensive case management teams. J Behav Health Serv Res. 2015 Jan;42(1):100-8. doi: 10.1007/s11414-013-9365-8.
- Niv N, Cohen AN, Hamilton A, Reist C, Young AS. Effectiveness of a psychosocial weight management program for individuals with schizophrenia. J Behav Health Serv Res. 2014 Jul;41(3):370-80. doi: 10.1007/s11414-012-9273-3.
Opintojen ennätyspäivät
Opi tärkeimmät päivämäärät
Opiskelun aloitus
Ensisijainen valmistuminen (Todellinen)
Opintojen valmistuminen (Todellinen)
Opintoihin ilmoittautumispäivät
Ensimmäinen lähetetty
Ensimmäinen toimitettu, joka täytti QC-kriteerit
Ensimmäinen Lähetetty (Arvio)
Tutkimustietojen päivitykset
Viimeisin päivitys julkaistu (Arvio)
Viimeisin lähetetty päivitys, joka täytti QC-kriteerit
Viimeksi vahvistettu
Lisää tietoa
Tähän tutkimukseen liittyvät termit
Avainsanat
Muita asiaankuuluvia MeSH-ehtoja
Muut tutkimustunnusnumerot
- 5R34MH090207 (Yhdysvaltain NIH-apuraha/sopimus)
Nämä tiedot haettiin suoraan verkkosivustolta clinicaltrials.gov ilman muutoksia. Jos sinulla on pyyntöjä muuttaa, poistaa tai päivittää tutkimustietojasi, ota yhteyttä register@clinicaltrials.gov. Heti kun muutos on otettu käyttöön osoitteessa clinicaltrials.gov, se päivitetään automaattisesti myös verkkosivustollemme .
Kliiniset tutkimukset Mielenterveyshäiriöt
-
Fayoum UniversityValmisCone Beam tietokonetomografia | Mental ForamenEgypti
-
Chinese University of Hong KongRekrytointiMielenterveys hyvinvointi 1 | Henkinen hyvinvointi | Mielenterveysongelma | Precision Mental HealthHong Kong