SCALE: Small Changes and Lasting Effects (SCALE)
Studienübersicht
Status
Bedingungen
Intervention / Behandlung
Detaillierte Beschreibung
SCALE is a five year study (October 1, 2009 through June 30, 2014) funded by NHLBI. The study will examine the possibility and acceptance of a mindful eating intervention in African American and Latino participants. We will test whether positive thinking can protect participants against the negative impact that stress and depression can have on making positive behavior changes such as mindful eating and physical activity.
Currently, the SCALE study is in the trial phase. Among overweight or obese Black or Latino adults who live in Harlem or the South Bronx, the primary goal of this project is to achieve weight loss of 7% or more over 12 months by making small sustained changes in eating behavior coupled with sustained increases in physical activity. Participants are enrolled for 12 months and are randomized to one of two study groups.
Group 1: Will choose one of ten small change eating strategies, a physical activity goal and will receive the positive affect/self affirmation component.
Group 2: Will choose one of ten small change eating strategies and a physical activity goal
For inquiries regarding potential enrollment in this study, please contact Rosio Ramos at 646-962-5070 or email ror2023@med.cornell.edu
Studientyp
Einschreibung (Tatsächlich)
Phase
- Unzutreffend
Kontakte und Standorte
Studienorte
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New York
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Bronx, New York, Vereinigte Staaten, 10451
- Lincoln Medical and Mental Health Center
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Bronx, New York, Vereinigte Staaten, 10455
- East Side House Settlement
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Bronx, New York, Vereinigte Staaten, 10457
- Iglesia Congregacion Cristiana del Bronx
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New York, New York, Vereinigte Staaten, 10026
- Renaissance Health Care Network
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New York, New York, Vereinigte Staaten, 10030
- Abyssinian Baptist Church
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New York, New York, Vereinigte Staaten, 10035
- Metropolitan Methodist Church
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Teilnahmekriterien
Zulassungskriterien
Studienberechtigtes Alter
Akzeptiert gesunde Freiwillige
Studienberechtigte Geschlechter
Beschreibung
Inclusion Criteria:
Eligibility Criteria:
Black or Latino community-dwelling subjects who are 21 years or older and have a body mass index of >25 but <50 or considered to be obese or overweight are be eligible for study participation. All participants must be able to participate in physical activity and Must be fluent in English or Spanish.
Exclusion Criteria:
Subjects will be excluded if:
- Unable to provide informed consent in either English or Spanish for any reason, including cognitive impairment, psychiatric illness, drug or alcohol addiction
- Pregnant or are planning to become pregnant within the year
- Participating in another weight loss program or trial
- On medications for obesity
- Have a history of bulimia;
- history of surgery for obesity;
- Have severe comorbid diseases that can lead to unintentional weight change including cancer, HIV/AIDS, congestive heart failure.
- They live in an institutional setting (nursing home, prison or group home).
Have severe disease or are terminally ill, including stroke, myocardial infarction, coronary artery disease requiring angioplasty.
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Studienplan
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Versorgungsforschung
- Zuteilung: Zufällig
- Interventionsmodell: Parallele Zuordnung
- Maskierung: Keine (Offenes Etikett)
Waffen und Interventionen
Teilnehmergruppe / Arm |
Intervention / Behandlung |
|---|---|
|
Experimental: Group 1
Subjects in will be randomized to the small change eating strategy, a physical activity goal and will receive the positive affect/self affirmation component. eating/physical activity/positive affect/self-affirmation group. |
Subjects will be randomized to the small change eating strategy, a physical activity goal and will receive the positive affect/self affirmation component.
Andere Namen:
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Experimental: Group 2
Subjects will be randomized to the small change eating strategy and a physical activity goal. eating/physical activity group. No intervention, just the eating strategy and physical activity components. |
Subjects will be randomized to the small change eating strategy and a physical activity goal.
Andere Namen:
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Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
Percent weight loss
Zeitfenster: 12 months
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The primary goal of this project is to achieve weight loss of 7% or more over 12 months by making small sustained changes in eating behavior coupled with sustained increases in physical activity.
|
12 months
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Mitarbeiter und Ermittler
Publikationen und hilfreiche Links
Studienaufzeichnungsdaten
Haupttermine studieren
Studienbeginn
Primärer Abschluss (Tatsächlich)
Studienabschluss (Tatsächlich)
Studienanmeldedaten
Zuerst eingereicht
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
Zuerst gepostet (Schätzen)
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
Zuletzt verifiziert
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Zusätzliche relevante MeSH-Bedingungen
Andere Studien-ID-Nummern
- 0908010566
Plan für individuelle Teilnehmerdaten (IPD)
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Beschreibung des IPD-Plans
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