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Peer-Led Healthy Lifestyle Program in Supportive Housing

4. August 2021 aktualisiert von: Leopoldo J. Cabassa, Washington University School of Medicine

Peer-Led Healthy Lifestyle Program in Supportive Housing Agencies

This goal of this randomized controlled effectiveness trial is to compare the effectiveness of a peer-led health lifestyle intervention (Peer GLB) versus usual care services in supportive housing agencies in New York City and Philadelphia serving diverse clients with serious mental illness who are overweight or obese. The intervention follows the Group Lifestyle Balance curriculum derived from the Diabetes Prevention Program and that has been shown to help people achieve clinically significant weight loss (equal to or greater than 5% weight loss of initial weight). The intervention will be delivered by trained peer-specialists employed at the supportive housing agencies and supervised by the study team. Peer GLB is a 12-month group intervention that focuses helping people lose weight by improving people's diet and increasing their physical activity and consists of weekly core group sessions (3 mo.), bi-monthly transitional group sessions (3 mo.), and maintenance monthly sessions (6 mo.).

We plan to enroll 300 clients with serious mental illness who are overweight/obese (BMI equal to or greater than 25) from our two supportive housing agencies. Clients will be randomized to either the Peer-led healthy lifestyle intervention or usual care conditions. The primary outcome for this study is achieving clinically significant weight loss (equal to or greater than 5% weight loss from baseline weight) at 12 and 18 months post randomization. The secondary outcomes for this study include overall reductions in weight, waist circumference, blood pressure, and improvements in physical activity, self-efficacy, recovery and health-related quality of life. Repeated assessments will be at baseline, 6, 12 and 18 month post randomization.

Primary Hypothesis: Peer GLB participants will have a higher proportion of persons achieving clinically significant weight loss (equal to or greater than 5% weight loss) at 12 and 18 months than UC participants.

Secondary Hypothesis: At 6, 12, and 18 months post-randomization, there will be significant reductions in average weight, waist circumference, blood pressure, and significant improvements in physical activity, self-efficacy, recovery, and health-related quality of life in Peer GLB compared to UC.

Studienübersicht

Status

Abgeschlossen

Bedingungen

Intervention / Behandlung

Studientyp

Interventionell

Einschreibung (Tatsächlich)

314

Phase

  • Unzutreffend

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienorte

  • Vereinigte Staaten
    • Missouri
      • Saint Louis, Missouri, Vereinigte Staaten, 63130
        • Washington University in St. Louis

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

18 Jahre und älter (Erwachsene, Älterer Erwachsener)

Akzeptiert gesunde Freiwillige

Nein

Studienberechtigte Geschlechter

Alle

Beschreibung

Inclusion Criteria:

  • Male or female,18 years of age or older, of any race/ethnicity, who are English and/or Spanish speakers.
  • Chart diagnosis of a serious mental illness (SMI; e.g., schizophrenia, bipolar disorder, schizoaffective disorders, major depression).
  • Overweight/obese as determined by a Body Mass Index (BMI) equal to or greater than 25 (kg/m2) at the time of recruitment.
  • Able and willing to give informed consent and participate in the intervention.
  • Received a medical clearance from a primary care or medical provider to participate in light-to-moderate physical activity (e.g., 150 minutes a week of brisk walking).

Exclusion Criteria:

  • Need for detoxification services at the time of recruitment.
  • Pose a danger to self or others at the time of recruitment.
  • Have medical conditions that contraindicate their participation in a healthy lifestyle program focusing on weight loss and physical activity, such as active cancer treatment, liver failure, history of anorexia nervosa, cardiovascular event [e.g., unstable angina, myocardial infraction] within the past 6 months, untreated exercise- induced asthma, walking limitations preventing participation in exercise, and pregnant or planning a pregnancy during study period.
  • Fail a capacity-to-consent questionnaire.
  • Cognitive impairment as detected by the Mini-Cog Examination

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: Parallele Zuordnung
  • Maskierung: Single

Waffen und Interventionen

Teilnehmergruppe / Arm
Intervention / Behandlung
Experimental: Peer-led Group Lifestyle Balance
Group-based behavioral healthy lifestyle program
Verhalten: Peer-Led Group Lifestyle Balance
The intervention follows the Group Lifestyle Balance curriculum derived from the Diabetes Prevention Program and The intervention will be delivered by trained peer-specialists employed at the supportive housing agencies and supervised by the study team. Peer GLB is a 12-month group intervention that focuses helping people lose weight by improving people's diet and increasing their physical activity and consists of weekly core group sessions (3 mo.), bi-monthly transitional group sessions (3 mo.), and maintenance monthly sessions (6 mo.).
Verhalten: Usual Care Services
The usual care condition encompasses the regular services offered at supportive housing agencies to help clients with their physical health and wellness.
Aktiver Komparator: Usual Care Services
Usual wellness and health care services offered to clients at the two supportive housing agencies.
Verhalten: Usual Care Services
The usual care condition encompasses the regular services offered at supportive housing agencies to help clients with their physical health and wellness.

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Clinically Significant Weight Loss
Zeitfenster: Baseline to 18 Months
Percentage of participants that achieve equal to or greater than 5% weight loss in lb from baseline at 12 and 18th months
Baseline to 18 Months

Sekundäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Overall Reduction in Weight in lb From Baseline to 6, 12 and 18 Months
Zeitfenster: At study endpoint (18 months).
Weight (in pounds) was measured by a trained research assistant with a calibrated digital scale (participants wore indoor clothing without shoes).
At study endpoint (18 months).
Overall Reduction in Waist Circumference Measures to the Nearest cm From Baseline to 6, 12 and 18 Months
Zeitfenster: At study endpoint (18 months).
Waist circumference measured by a trained research assistant to the nearest 0.1 cm with an anthropometric tape, in a horizontal plane 1 cm above the navel in light indoor clothing.
At study endpoint (18 months).
Overall Reductions in Systolic Blood Pressure From Baseline, 6, 12 and 18 Months
Zeitfenster: At study endpoint (18 months).
Blood pressure assessed on the right arm of participants after they rest quietly in a seated position for at least 5 minutes, using a validated automated sphygmomanometer.
At study endpoint (18 months).
Self-Efficacy for Exercise
Zeitfenster: At study endpoint (18 months).
Self-efficacy for exercise was measured with a three-item scale assessing a person's confidence that they can engage in physical activity. The scores from this scale range from 1 to 10 with higher scores indicating higher self-efficacy.
At study endpoint (18 months).
Change From Baseline in Recovery Using the Recovery Assessment Scale (RAS).
Zeitfenster: At study endpoint (18 months).
The Recovery Assessment Scale is a 24-item measure that captures different aspects of recovery and produces a total recovery score ranging from 1 to 5 with higher scores indicating higher recovery.
At study endpoint (18 months).
Health-related Quality of Life
Zeitfenster: At study endpoint (18-months).
The 12-Item Short-Form Health Survey (SF-12) was used to capture participants health-related quality of life. The Physical Composite Score derived from the SF-12 is an indicator of health-related quality of life with scores that range from 0 to 100 with higher scores indicating higher health-related quality of life.
At study endpoint (18-months).
6-Minutes Walking Test
Zeitfenster: At study endpoint (18-months).
The 6-minutes Walking Test is an objective measure of functional exercise capacity that captures the distance (in meters) that participants walk at a normal pace along a flat and straight course for 6 minutes.
At study endpoint (18-months).

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Sponsor

Washington University School of Medicine

Mitarbeiter

National Institute of Mental Health (NIMH)

Ermittler

  • Hauptermittler: Leopoldo J Cabassa, Ph. D., Washington University School of Medicine

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.

Allgemeine Veröffentlichungen

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 (Tatsächlich)

1. Juli 2015

Primärer Abschluss (Tatsächlich)

1. Februar 2018

Studienabschluss (Tatsächlich)

1. Juli 2019

Studienanmeldedaten

Zuerst eingereicht

24. Juni 2014

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

24. Juni 2014

Zuerst gepostet (Schätzen)

26. Juni 2014

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Tatsächlich)

31. August 2021

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

4. August 2021

Zuletzt verifiziert

1. August 2021

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Schlüsselwörter

Andere Studien-ID-Nummern

  • AAAN5207
  • 1R01MH104574-01 (US NIH Stipendium/Vertrag)

Plan für individuelle Teilnehmerdaten (IPD)

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UNENTSCHIEDEN

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