- ICH GCP
- US-Register für klinische Studien
- Klinische Studie NCT01741298
Biobehavioral Bases & Management of Metabolic Syndrome (CHARMS) (CHARMS)
30. November 2012 aktualisiert von: 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).
Studienübersicht
Detaillierte Beschreibung
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.
Studientyp
Interventionell
Einschreibung (Tatsächlich)
112
Phase
- Unzutreffend
Teilnahmekriterien
Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.
Zulassungskriterien
Studienberechtigtes Alter
30 Jahre bis 70 Jahre (Erwachsene, Älterer Erwachsener)
Akzeptiert gesunde Freiwillige
Nein
Studienberechtigte Geschlechter
Alle
Beschreibung
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.
Studienplan
Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Behandlung
- Zuteilung: Zufällig
- Interventionsmodell: Einzelgruppenzuweisung
- Maskierung: Vervierfachen
Waffen und Interventionen
Teilnehmergruppe / Arm |
Intervention / Behandlung |
---|---|
Experimental: 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.
|
Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
---|---|---|
Weight loss
Zeitfenster: 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
|
Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
---|---|---|
Measures of glycemic control/insulin resistance.
Zeitfenster: 1 year
|
Secondary outcomes measures will include glycemic control aka insulin resistance.
|
1 year
|
Mitarbeiter und Ermittler
Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.
Sponsor
Publikationen und hilfreiche Links
Die Bereitstellung dieser Publikationen erfolgt freiwillig durch die für die Eingabe von Informationen über die Studie verantwortliche Person. Diese können sich auf alles beziehen, was mit dem Studium zu tun hat.
Studienaufzeichnungsdaten
Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.
Haupttermine studieren
Studienbeginn
1. März 2008
Primärer Abschluss (Tatsächlich)
1. Dezember 2011
Studienabschluss (Tatsächlich)
1. Dezember 2011
Studienanmeldedaten
Zuerst eingereicht
27. November 2012
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
30. November 2012
Zuerst gepostet (Schätzen)
4. Dezember 2012
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Schätzen)
4. Dezember 2012
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
30. November 2012
Zuletzt verifiziert
1. November 2012
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Schlüsselwörter
Zusätzliche relevante MeSH-Bedingungen
Andere Studien-ID-Nummern
- P01 HL 36588- Proj 2
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