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Peer-Led Healthy Lifestyle Program in Supportive Housing

4 augustus 2021 bijgewerkt door: 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.

Studie Overzicht

Toestand

Voltooid

Conditie

Interventie / Behandeling

Studietype

Ingrijpend

Inschrijving (Werkelijk)

314

Fase

  • Niet toepasbaar

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studie Locaties

  • Verenigde Staten
    • Missouri
      • Saint Louis, Missouri, Verenigde Staten, 63130
        • Washington University in St. Louis

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

18 jaar en ouder (Volwassen, Oudere volwassene)

Accepteert gezonde vrijwilligers

Nee

Geslachten die in aanmerking komen voor studie

Allemaal

Beschrijving

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

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Behandeling
  • Toewijzing: Gerandomiseerd
  • Interventioneel model: Parallelle opdracht
  • Masker: Enkel

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Experimenteel: Peer-led Group Lifestyle Balance
Group-based behavioral healthy lifestyle program
Gedragsmatig: 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.).
Gedragsmatig: 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.
Actieve vergelijker: Usual Care Services
Usual wellness and health care services offered to clients at the two supportive housing agencies.
Gedragsmatig: 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.

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Clinically Significant Weight Loss
Tijdsspanne: 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

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Overall Reduction in Weight in lb From Baseline to 6, 12 and 18 Months
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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).
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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).

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

Washington University School of Medicine

Medewerkers

National Institute of Mental Health (NIMH)

Onderzoekers

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

Publicaties en nuttige links

De persoon die verantwoordelijk is voor het invoeren van informatie over het onderzoek stelt deze publicaties vrijwillig ter beschikking. Dit kan gaan over alles wat met het onderzoek te maken heeft.

Algemene publicaties

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Werkelijk)

1 juli 2015

Primaire voltooiing (Werkelijk)

1 februari 2018

Studie voltooiing (Werkelijk)

1 juli 2019

Studieregistratiedata

Eerst ingediend

24 juni 2014

Eerst ingediend dat voldeed aan de QC-criteria

24 juni 2014

Eerst geplaatst (Schatting)

26 juni 2014

Updates van studierecords

Laatste update geplaatst (Werkelijk)

31 augustus 2021

Laatste update ingediend die voldeed aan QC-criteria

4 augustus 2021

Laatst geverifieerd

1 augustus 2021

Meer informatie

Termen gerelateerd aan deze studie

Trefwoorden

Andere studie-ID-nummers

  • AAAN5207
  • 1R01MH104574-01 (Subsidie/contract van de Amerikaanse NIH)

Plan Individuele Deelnemersgegevens (IPD)

Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?

ONBESLIST

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