- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT01741298
Biobehavioral Bases & Management of Metabolic Syndrome (CHARMS) (CHARMS)
30. november 2012 oppdatert av: Neil Schneiderman, University of Miami
Biobehavioral Bases & Management of Metabolic Syndrome
The metabolic syndrome is increasingly being recognized as a major threat to good health - especially cardiovascular health - and its frequency appears to be increasing in relation to the current epidemic of obesity.
The objective of this study is to determine whether a program of enhanced lifestyle intervention can, compared to standard care, reduce the frequency and severity of the metabolic syndrome as assessed by clinical, metabolic, inflammatory and vascular outcome measures.
EC will consist of a 17-session structured, lifestyle intervention plan, directed at achieving weight reduction and increasing physical activity change through education, behavior modification and stress management, and conducted in groups.
It will comprise a 3-month Core Curriculum of 8 sessions, followed by a Maintenance phase with 9 monthly sessions delivered by lifestyle counselors, experienced in breaking through barriers in working with socioeconomically disadvantaged members of minority groups.
All participants will have baseline, 6-monthly and 1-year assessments.
This project, Project 2, entitled Community Health Approaches to Reducing Risk in the Metabolic Syndrome (CHARMS), seeks to study psychosocial and behavioral (lifestyle) variables that may contribute to the progression or amelioration of atherosclerotic processes underlying the pathogenesis of coronary heart disease (CHD).
Studieoversikt
Detaljert beskrivelse
The metabolic syndrome is increasingly being recognized as a major threat to good health - especially cardiovascular health - and its frequency appears to be increasing in relation to the current epidemic of obesity.
The objective of this study is to determine whether a program of enhanced lifestyle intervention can, compared to standard care, reduce the frequency and severity of the metabolic syndrome as assessed by clinical, metabolic, inflammatory and vascular outcome measures.
The project will compare the effects of Enhanced Care (EC) in 112 patients (80 completers) to Standard Care (SC) in 112 patients (80 completers) over a 12-month period.
Following 3 run-in sessions given to both SC and EC participants, eligible subjects randomized to SC will receive lifestyle modification advice as recommended management of the metabolic syndrome and this will be administered at the baseline and the 6 month assessment visits.
EC will consist of a 17-session structured, lifestyle intervention plan, directed at achieving weight reduction and increasing physical activity change through education, behavior modification and stress management, and conducted in groups.
It will comprise a 3-month Core Curriculum of 8 sessions, followed by a Maintenance phase with 9 monthly sessions delivered by lifestyle counselors, experienced in breaking through barriers in working with socioeconomically disadvantaged members of minority groups.
All participants will have baseline, 6-monthly and 1-year assessments.
This project, Project 2, entitled Community Health Approaches to Reducing Risk in the Metabolic Syndrome (CHARMS), seeks to study psychosocial and behavioral (lifestyle) variables that may contribute to the progression or amelioration of atherosclerotic processes underlying the pathogenesis of coronary heart disease (CHD).
Outcome variables will include measures of glycemic control/insulin resistance and/or dyslipidemia, oxidative stress, inflammation and overt manifestations of disease.
Studietype
Intervensjonell
Registrering (Faktiske)
112
Fase
- Ikke aktuelt
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
30 år til 70 år (Voksen, Eldre voksen)
Tar imot friske frivillige
Nei
Kjønn som er kvalifisert for studier
Alle
Beskrivelse
Inclusion Criteria:
- Men and women
- Age 30-70 years
- Language: English or Spanish
- At least 3 features of the NCEP ATP-III metabolic syndrome
Exclusion Criteria:
- Diabetes
- Established CVD
- Uncontrolled hypertension (systolic BP >160 and diastolic BP >100 mm Hg)
- Established liver disease
- Renal insufficiency
- Psychiatric illness
- Chronic substance abuse within the past 5 years
- Chronic obstructive pulmonary disease or severe asthma.
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: Enkeltgruppeoppdrag
- Masking: Firemannsrom
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
---|---|
Eksperimentell: Lifestyle counseling
CHARMS Intervention Participants (Pts) randomized to the lifestyle intervention received a yr long, 17 session intervention.
Pts were asked to wear a pedometer and record their food intake for at least the week prior to each session.
The first 4 sessions were delivered weekly, followed by 4 sessions delivered biweekly and finally 9 sessions delivered monthly.
Each session was approximately 1-2 hrs.
At the beginning of each session anthropometric, physical activity and dietary data were collected.
Participants were lead in a 5 min deep breathing exercise before the didactic portion of the session began.
Sessions targeted a broad range of material related to diet, physical activity, and psychosocial well-being.
Participants were given homework assignments to incorporate covered material into their daily lives.
Participants randomized to the intervention arm received follow-up assessments at 6 and 12 months post randomization.
|
Participants (Pts) randomized to the lifestyle intervention received a yr long, 17 session intervention.
Pts were asked to wear a pedometer and record their food intake for at least the week prior to each session.
The first 4 sessions were delivered weekly, followed by 4 sessions delivered biweekly and finally 9 sessions delivered monthly.
Each session was approximately 1-2 hrs.
At the beginning of each session anthropometric, physical activity and dietary data were collected.
Participants were lead in a 5 min deep breathing exercise before the didactic portion of the session began.
Sessions targeted a broad range of material related to diet, physical activity, and psychosocial well-being.
Participants were given homework assignments to incorporate covered material into their daily lives.
Participants randomized to the intervention arm received follow-up assessments at 6 and 12 months post randomization.
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
---|---|---|
Weight loss
Tidsramme: 1 year
|
Weight will be checked during each intervention session with the goal of losing 7% of total body weight from the enrollment date.
|
1 year
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
---|---|---|
Measures of glycemic control/insulin resistance.
Tidsramme: 1 year
|
Secondary outcomes measures will include glycemic control aka insulin resistance.
|
1 year
|
Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
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.
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 2008
Primær fullføring (Faktiske)
1. desember 2011
Studiet fullført (Faktiske)
1. desember 2011
Datoer for studieregistrering
Først innsendt
27. november 2012
Først innsendt som oppfylte QC-kriteriene
30. november 2012
Først lagt ut (Anslag)
4. desember 2012
Oppdateringer av studieposter
Sist oppdatering lagt ut (Anslag)
4. desember 2012
Siste oppdatering sendt inn som oppfylte QC-kriteriene
30. november 2012
Sist bekreftet
1. november 2012
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- P01 HL 36588- Proj 2
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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