- ICH GCP
- US-Register für klinische Studien
- Klinische Studie NCT00183014
Caminemos! Trial to Increase Walking Among Sedentary Older Latinos
Trial to Increase Walking Among Sedentary Older Latinos
Studienübersicht
Status
Bedingungen
Intervention / Behandlung
Detaillierte Beschreibung
Regular physical activity contributes to the health and quality of life of older adults, but unfortunately only 20% of men and 25% of women aged 65 years and greater meet the minimal national guidelines for physical activity. Older Latinos have higher rates of diseases that are most likely to benefit from physical activity, but have disproportionately high rates of sedentary lifestyle. To address this major public health problem, this study will implement and evaluate a multifaceted intervention to raise and sustain walking levels among older Latinos.
A total of 600 sedentary older Latinos will be recruited from community-based senior centers in the greater Los Angeles region. The specific aims of the study are to test the effect of the intervention on:
- the change in steps per week measured by digital pedometer from baseline to 1, 12, and 24-month follow-up;
- self-reported physical activity level and intervening constructs (including expectations regarding aging and self-efficacy expectations for physical activity);
- psychosocial health constructs, physical performance measures, and clinical health outcomes.
The core of the intervention consists of a series of 4 weekly 1-hour group discussion sessions that utilize attribution retraining techniques from the field of motivational psychology in combination with behavioral strategies based in social cognitive theory. Discussion sessions will be conducted at senior centers and led by a bilingual health educator; each session will be followed by a 1-hour exercise class aimed at increasing strength, flexibility and endurance. During the discussion sessions, the health educator will administer a structured culturally-tailored curriculum in which participants are taught to raise their expectations for physical activity with aging and not to attribute being sedentary to "old age." The 4 weekly sessions will be followed by monthly sessions for 11 months, and sessions every 2 months for the following 12 months (total intervention duration = 24 months). Participants will be randomized to 1 of 2 arms:
- intervention arm: receiving the discussion session and the exercise class;
- control arm: receiving just the exercise class with the same frequency and duration as the intervention group.
Studientyp
Einschreibung (Voraussichtlich)
Phase
- Unzutreffend
Kontakte und Standorte
Studienorte
-
-
California
-
Los Angeles, California, Vereinigte Staaten, 90095
- UCLA Division of Geriatrics
-
-
Teilnahmekriterien
Zulassungskriterien
Studienberechtigtes Alter
Akzeptiert gesunde Freiwillige
Studienberechtigte Geschlechter
Beschreibung
Inclusion Criteria:
- Aged 60 years or older
- Self-identifying as Latino/Hispanic
- Not currently participating in 20 minutes or more of physical activity 3 times a week
- Willingness to take brief physical activity screening test and if do not pass, provide the name of a physician who has seen the patient in the recent past
Exclusion Criteria:
- Plans to move from the area in the next 24 months
- Unable to participate in 1-hour group discussion
- Unable to walk
- Physician stating that patient is not medically able to participate
- Family member already participating
- Substantial cognitive impairment (determined by a screening test)
Studienplan
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Behandlung
- Zuteilung: Zufällig
- Interventionsmodell: Parallele Zuordnung
- Maskierung: Single
Waffen und Interventionen
Teilnehmergruppe / Arm |
Intervention / Behandlung |
---|---|
Experimental: 1
discussion session and exercise class
|
A series of 4 weekly 1-hour group discussion sessions that utilize attribution retraining techniques from the field of motivational psychology in combination with behavioral strategies based in social cognitive theory; weekly for 4 weeks, monthly for 11 months, then every two months for 12 months (total duration = 24 months
1-hour exercise class aimed at increasing strength, flexibility and endurance; weekly for 4 weeks, monthly for 11 months, then every two months for 12 months (total duration = 24 months
|
Aktiver Komparator: 2
exercise class only
|
1-hour exercise class aimed at increasing strength, flexibility and endurance; weekly for 4 weeks, monthly for 11 months, then every two months for 12 months (total duration = 24 months
|
Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Zeitfenster |
---|---|
Number of steps per week on digital pedometer
Zeitfenster: baseline and 1, 12, and 24-months
|
baseline and 1, 12, and 24-months
|
Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Zeitfenster |
---|---|
Self-reported physical activity level
Zeitfenster: baseline and 1, 12, and 24-months
|
baseline and 1, 12, and 24-months
|
beliefs about aging
Zeitfenster: baseline and 1, 12, and 24-months
|
baseline and 1, 12, and 24-months
|
self-efficacy
Zeitfenster: baseline and 1, 12, and 24-months
|
baseline and 1, 12, and 24-months
|
health-related quality of life
Zeitfenster: baseline and 1, 12, and 24-months
|
baseline and 1, 12, and 24-months
|
blood pressure
Zeitfenster: baseline and 1, 12, and 24-months
|
baseline and 1, 12, and 24-months
|
body mass index (BMI)
Zeitfenster: baseline and 1, 12, and 24-months
|
baseline and 1, 12, and 24-months
|
physical performance measures
Zeitfenster: baseline and 1, 12, and 24-months
|
baseline and 1, 12, and 24-months
|
hospital days
Zeitfenster: baseline and 1, 12, and 24-months
|
baseline and 1, 12, and 24-months
|
outpatient visits
Zeitfenster: baseline and 1, 12, and 24-months
|
baseline and 1, 12, and 24-months
|
restricted activity days
Zeitfenster: baseline and 1, 12, and 24-months
|
baseline and 1, 12, and 24-months
|
cognitive function
Zeitfenster: baseline and 1, 12, and 24-months
|
baseline and 1, 12, and 24-months
|
Mitarbeiter und Ermittler
Ermittler
- Hauptermittler: Catherine Sarkisian, MD, MSPH, UCLA Division of Geriatrics
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 (Schätzen)
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
Zuletzt verifiziert
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Schlüsselwörter
Andere Studien-ID-Nummern
- AG0049
- 5R01AG024460-02 (US NIH Stipendium/Vertrag)
Diese Informationen wurden ohne Änderungen direkt von der Website clinicaltrials.gov abgerufen. Wenn Sie Ihre Studiendaten ändern, entfernen oder aktualisieren möchten, wenden Sie sich bitte an register@clinicaltrials.gov. Sobald eine Änderung auf clinicaltrials.gov implementiert wird, wird diese automatisch auch auf unserer Website aktualisiert .
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