Podpora fyzické aktivity u starších dospělých hispánců/latino(a).
Studie De Pie y a Movernos: Podpora fyzické aktivity u starších dospělých hispánců/latino(a)
In this randomized controlled trial, study staff will randomize 130 Hispanic/Latino adults without dementia and over age 55 from Southern California and from Kaiser Permanente Washington (State) to either the culturally adapted De Pie physical activity intervention or an active comparison program focusing on general brain health topics. The purpose of this study is to determine if 12 weeks of the culturally adapted and fully remote De Pie y a Movernos intervention improves self-efficacy, habit strength, social support, and enjoyment for physical activity (PA), thus promoting adherence to moderate-intensity physical activity (MIPA) guidelines (150 minutes/week).
Přehled studie
Postavení
Detailní popis
Building on the cultural adaptation of our preliminary R61 De Pie pilot study, study staff will randomize 130 Hispanic/Latino adults without dementia and over age 55 from Southern California and from Kaiser Permanente Washington to either the culturally adapted De Pie physical activity intervention or an active comparison program, Healthy Actions and Lifestyles to Avoid Dementia (HALT-AD), focusing on general brain health topics. The investigators will determine if De Pie improves physical activity (Aim 1) and psychosocial mediators (self-efficacy, habit strength, social support, and enjoyment for physical activity, [PA]), thus promoting adherence to moderate-intensity physical activity (MIPA) guidelines (150 minutes/week; Aim 2). The intervention period lasts 12 weeks.
The investigators target middle-aged and older Hispanic/Latino adults that are under-studied and have a higher risk of Alzheimer's disease and related dementias (ADRD), compared to non-Hispanic White older adults. Study staff employ a community engaged and collaborative approach to culturally adaptive the intervention framework and a staircase intervention approach designed to build self-efficacy, PA habit strength, social support, and PA enjoyment. Results will inform culturally adapted, theory-based approaches to prevent ADRD in the Hispanic/Latino community.
Typ studie
Zápis (Odhadovaný)
Fáze
- Nelze použít
Kontakty a umístění
Studijní místa
-
-
California
-
San Diego, California, Spojené státy, 92093
- University of California San Diego
-
-
Washington
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Seattle, Washington, Spojené státy, 98101
- Kaiser Permanente Washington
-
-
Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
Přijímá zdravé dobrovolníky
Pohlaví způsobilá ke studiu
Popis
Inclusion Criteria:
- be 55-89 and self-identify as Hispanic/Latino(a)
- able to participate for up to 20 weeks in the study
- willing to be randomized to the intervention or active comparison program
- willing to follow study procedures depending on program assignment
- available M-F for study phone calls between 8am-5pm
- able to walk one block unassisted,
- able to speak and can read Spanish or English,
- have a smartphone (85% of the Hispanic/Latino(a) population has a smartphone)
- willing to wear an ActiGraph for up to 2 weeks, twice during the course of the study
- willing to complete study questionnaires via weblink, paper, or phone call
- have an email address and be willing to share it with the team
- have a US mailing address where they receive mail regularly (confirmed in pre-screen)
Exclusion criteria are as follows:
- score less than or equal to 4 on the Six-Item Screener (Callahan et al., 2002)
- unable to hear phone conversation, even with a hearing aid
- planned surgeries or travel that would interfere with participation
- had a fall in the last year that resulted in hospitalization
- had a cancer diagnosis that requires treatment in the past year (other than skin cancer)
- had a diagnosis of heart attack or irregular heart beat (arrythmia) in the past year
- been advised recently by their doctor to avoid physical activity
- does not want to share cognitive health information collected during the study with researchers at UCSD
- unwilling to share their email address
- unwilling to obtain an email address if they do not already have one
- currently participating in another institution's physical activity study
Studijní plán
Jak je studie koncipována?
Detaily designu
- Primární účel: Prevence
- Přidělení: Randomizované
- Intervenční model: Paralelní přiřazení
- Maskování: Dvojnásobek
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
|---|---|
|
Experimentální: De Pie Intervention
The De Pie intervention program receives a sedentary behavior reduction and physical activity promotion intervention centered on two steps: Step 1) reduce sitting time and move more throughout the day; Step 2) if cleared by a safety assessment and blood pressure check, participants can work towards adding structured bouts of exercise into their day. |
Participants are guided by a health coach trained in motivational interviewing through 6 biweekly phone sessions. Each session involves reviewing goals and problem-solving barriers from the prior 2 weeks experience; covering a topic related to Step 1 goals (or Step 2 goals if they pass the safety assessment) such as how to enjoy movement, social support, and using your surroundings; and setting goals and an action plan for the following two weeks. |
|
Aktivní komparátor: HALT-AD Active Comparison Group
Those randomized to HALT-AD (Healthy Actions and Lifestyles to Avoid Dementia) will receive one phone call to introduce them to preventing cognitive decline through various lifestyle behaviors (e.g. stress reduction, healthy diet, healthy sleep) other than physical activity. They will be encouraged by the Health Coach upon randomization to complete one module approximately every week (there are 10 modules in total). |
Those in the active comparison program will receive no additional health coaching sessions. They will work through the HALT-AD content at their own pace, setting goals in the online platform as they go. |
Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Change in Moderate Intensity Physical Activity (MIPA) minutes/day
Časové okno: Baseline to 12 weeks
|
Time (minutes) spent being physically active during waking hours will be measured objectively by the ActiGraph worn for one week at Baseline and again after 12 weeks |
Baseline to 12 weeks
|
Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Meet MIPA guidelines of 150 minutes physical activity per week
Časové okno: Baseline to 12 weeks
|
Time (minutes) spent being physical active during waking hours (mins/day, >1951 counts per minute) will be measured objectively by the ActiGraph worn for one week at Baseline and again after 12 weeks |
Baseline to 12 weeks
|
|
Average daily sedentary time
Časové okno: Baseline to 12 weeks
|
mins/day; ≤99 counts per minute will be measured objectively by the ActiGraph worn for one week at baseline and again after 12 weeks. |
Baseline to 12 weeks
|
|
Average daily light intensity physical activity (LPA)
Časové okno: Baseline to 12 weeks
|
mins/day; 100-1951 counts per minute will be measured objectively by the ActiGraph worn for one week at Baseline and again after 12 weeks |
Baseline to 12 weeks
|
|
Average steps/day
Časové okno: Baseline to 12 weeks
|
Change in daily steps will be measured objectively by the ActiGraph worn for one week at Baseline and again after 12 weeks |
Baseline to 12 weeks
|
Spolupracovníci a vyšetřovatelé
Sponzor
Spolupracovníci
Vyšetřovatelé
- Vrchní vyšetřovatel: Zvinka Z Zlatar, PhD, University of California, San Diego
- Vrchní vyšetřovatel: Dori E Rosenberg, PhD, MPH, Kaiser Permanente
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia (Aktuální)
Primární dokončení (Odhadovaný)
Dokončení studie (Odhadovaný)
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Aktuální)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Více informací
Termíny související s touto studií
Další relevantní podmínky MeSH
Další identifikační čísla studie
- 2094138
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