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Lo studio clinico NCT06848335 (Seamos Activas) per Inactivity, Inattività/bassi livelli di esercizio, Inattività fisica è in arruolamento. Consulti la vista a schede del Radar degli Studi Clinici e gli strumenti di scoperta IA per tutti i dettagli. Oppure, ponga pure una domanda qui. | ||
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Improving Physical Activity Participation in Latinas With Mindfulness (Seamos Activas)
I dettagli dello studio clinico sono disponibili principalmente in inglese. Tuttavia, Trial Radar IA può essere d'aiuto! Basta cliccare su 'Spiega lo studio' per visualizzare e discutere le informazioni sullo studio nella lingua selezionata.
La sperimentazione clinica NCT06848335 (Seamos Activas) è uno studio interventistico per Inactivity, Inattività/bassi livelli di esercizio, Inattività fisica, attualmente in arruolamento. Avviato il 21 marzo 2025, prevede di arruolare 258 partecipanti. Sotto la guida di Bess Marcus, dovrebbe concludersi entro il 31 luglio 2029. I dati più recenti da ClinicalTrials.gov sono stati aggiornati l'ultima volta il 25 aprile 2025.
Sommario breve
In this study, the investigators are exploring how a mindfulness-based physical activity program can help improve exercise habits and overall health among 258 inactive Latina women aged 18 to 65. The study will be conducted entirely remotely over and 18 month period. During the first 6 months, all participants will receive an exercise program that has previously been tested by our research team. After 6 months, the investigators will check if participants are meeting the recommended exercise guidelines of at least 150 minutes/week of at least moderate intensity activity. Participants who meet the guidelines will continue with the successful exercise program for another 6 months. For participants who do not meet the guidelines (are exercising less than 150 minutes/week), they will receive one of two enhanced programs, which will be randomly assigned. One program offers additional physical activity support, and the other incorporates stress management through mindfulness techniques. For all participants, over 18 months, the investigators will track physical activity levels, stress, and heart health indicators.
Descrizione dettagliata
The current study is an innovative adaptive intervention tested on inactive Latinas aged 18-65 (n=258). During the initial 6 month phase, all participants will receive our evidence based physical activity (PA) intervention. At 6 months, participants who meet national PA guidelines (at least 150 mins/week of at least moderate intensity PA) will continue to receive the standard PA intervention for another 6 months. Participants who do not meet the PA guidelines, will be randomized to continue intensive PA counseling or receive attention matched PA counseling incorporating the most potent components from Mindfulness-Based Stress Reduction (MBSR) adapted for PA. Participants in all 3 arms will be followed and compared over 18 months. The investigators will also rigorously evaluate stress as a mechanism for meeting PA guidelines using multiple measures (objective and self-report), including using wearable technology and Ecological Momentary Assessment (EMA). Finally, heart health indicators will be collected to assess long term benefits of PA.
Titolo ufficiale
Improving Physical Activity Participation in Latinas With Mindfulness
Condizioni
InactivityInattività/bassi livelli di esercizioInattività fisicaAltri ID dello studio
Numero NCT
Data di inizio (effettiva)
2025-03-21
Ultimo aggiornamento pubblicato
2025-04-25
Data di completamento (stimata)
2029-07-31
Arruolamento (previsto)
258
Tipo di studio
Interventistico
FASE
N.D.
Stato
In arruolamento
Parole chiave
Physical Activity
Latinas
Spanish-Language
Text-Message
Exercise
Mindfulness
Latinas
Spanish-Language
Text-Message
Exercise
Mindfulness
Scopo principale
Trattamento
Allocazione
Randomizzato
Modello di intervento
In parallelo
Mascheramento
Nessuno (studio in aperto)
Bracci / Interventi
| Gruppo/Braccio di partecipanti | Intervento/Trattamento |
|---|---|
SperimentaleRemote Physical Activity Intervention | Remote Physical Activity Intervention The intervention includes a Zoom goal setting session on PA at baseline and phone calls at week 1, and months 1, 2, 3, and 9 for new goal setting and to address questions and monitor progress on PA goals. Participants will receive mailings weekly in month 1, bi- weekly in months 2 and 3, and monthly in months 4 to 6, with maintenance doses in months 8 and 10. Mailings include motivation-matched physical activity manuals, tip sheets (on stretching, boredom, places to be active, etc.) and computer expert system-tailored PA feedback reports which draw from a bank of over 330 messages addressing psychosocial and environmental factors affecting PA. Participants receive one interactive text message on PA (goal setting and tips for increasing PA) daily for the first 6 months and weekly for months 7-12. |
Comparatore attivoMindfulness Enhanced Remote Physical Activity Intervention | Mindfulness Enhanced Remote Physical Activity Intervention Women who do not meet the PA guidelines (60% based on our prior work), will be randomized to receive the Attention Matched Enhanced Remote PA intervention or Mindfulness enhanced remote Physical Activity intervention. The intervention includes a Zoom goal setting session on PA at baseline and phone calls at week 1, and months 1, 2, 3, and 9 for new goal setting and to address questions and monitor progress on PA goals. Participants will receive mailings weekly in month 1, bi- weekly in months 2 and 3, and monthly in months 4 to 6. In months 7-12, they will receive 4 monthly calls, 11 mailers and daily texts. In months 13-18, they will receive 1 call, weekly texts to self monitor daily PA and meeting goals. For the Mindfulness enhanced remote Physical Activity intervention participants will receive additional messaging and support to manage their stress through incorporating evidence based MBSR and mindful movement into their daily routine. |
Comparatore attivoAttention Matched Enhanced Remote Physical Activity Intervention | Attention Matched Enhanced Remote PA Intervention Women who do not meet the PA guidelines (60% based on our prior work), will be randomized to receive the Mindfulness enhanced remote Physical Activity intervention or the Attention Matched Enhanced Remote PA intervention as described here. The intervention includes a Zoom goal setting session on PA at baseline and phone calls at week 1, and months 1, 2, 3, and 9 for new goal setting and to address questions and monitor progress on PA goals. Participants will receive mailings weekly in month 1, bi- weekly in months 2 and 3, and monthly in months 4 to 6. In months 7-12, they will receive 4 monthly calls, 11 mailers and daily texts. In months 13-18, they will receive 1 call, weekly texts to self monitor daily PA and meeting goals. |
Esito primario
Esito secondario
| Misure di esito | Descrizione della misura | Arco temporale |
|---|---|---|
Accelerometer-measured min/week MVPA | For the week prior to each assessment (baseline, 6, 12, 18-months), all participants will wear an Actigraph GT3X+ accelerometer, which measures movement and intensity of activity and has been validated against heart rate telemetry and total energy expenditure. Data will be used to generate a binary indicator of meeting national PA guidelines (at least 150 min/week MVPA) at each follow-up. | 12 and 18 Months (outcome timepoints) |
| Misure di esito | Descrizione della misura | Arco temporale |
|---|---|---|
Perceived Stress Scale(PSS) | Measured using a 14-item Perceived Stress Scale(PSS), this self-report measure assesses general perceptions of demands in life exceeding one's capacities to manage them. This scale has shown good reliability and validity in past studies with Spanish speaking Latino participants. The scale score ranges from 0 to 56, with higher scores indicative of higher perceived stress. | Baseline, 6 months, 12 months, 18 months |
Moment to moment self-reported stress evaluated via Ecological momentary assessment (EMA) | Participants will be prompted daily (via the wake-up report and random prompts) to respond to : How stressed are you feeling right now? Response options are on a 7-point Likert scale ranging from 0=Not at all to 6=Extremely. | Baseline, 6, 9, 12 months |
Criteri di eleggibilità
Età idonea
Adulto, Adulto anziano
Età minima
18 Years
Sessi idonei
Donna
Accetta volontari sani
Sì
- Female
- Generally healthy (If asthma, controlled high blood pressure and/or controlled type II diabetes, may be able to participate with physician consent)
- Sedentary (defined as participating in MVPA for 60 minutes or less per week and engaging in muscle-strengthening exercise on less than 2 days per week)
- Hispanic or Latina (self-identified)
- Must be able to read and write in Spanish fluently
- 18 - 65 years of age
- Planning on living in the area for the next 18 months
- Own a cell phone capable of sending and receiving text messages
- Required to have reliable access to the Internet via a computer or mobile device
- Must be able to receive materials in the mail, either at your own home or at a mailbox
- BMI greater than 45
- Not able to walk continuously for 30 minutes/limited ability to complete daily activity or ability to exercise
- Exercise is against advice of doctor
- Inability to walk independently
- Current or planned pregnancy in the next 12 months
- Heart disease/treatment
- Heart murmur
- Angina/chest pain or Angina/chest pain with exertion
- Palpitations
- Stroke/Transient Ischemic Attacks
- Peripheral Vascular Disease
- Diabetes that requires insulin
- Non-insulin dependent diabetes without physician approval to participate
- Chronic infectious disease- HIV, Hepatitis C but does not have doctor approval
- Chronic liver disease
- Cystic Fibrosis
- Abnormal EKG on last EKG performed
- Emphysema, Chronic bronchitis, Chronic Obstructive Pulmonary Disease
- Seizure in past year
- Surgery in past year on heart, lung, joint, orthopedic surgery
- Surgery pending in next year on lung, joint, orthopedic surgery
- Unusual/concerning shortness of breath
- Asthma (may be able to participate with physician consent)
- High blood pressure/high blood pressure medication (may be able to participate with physician consent)
- Use of Beta Blockers or medicines not approved by doctor.
- Abnormal Medical Stress Test in the last 12 months
- Musculoskeletal problems
- Fainting/dizziness more than 3 times in past year OR which interferes with daily activities OR causes loss of balance
- Cancer treatment in past 3 months
- Hospitalized for psychiatric disorder in past 3 years or suicidal
- Participation in prior Seamos Activas II study or participant in other research study about exercise currently or within the last 6 months ago
Bess Marcus- Istituto nazionale del cuore, dei polmoni e del sangue, Estados Unidos758 studi clinici attivi da esplorare
- Lifespan/ The Miriam Hospital
Parte responsabile dello studio
Bess Marcus, Promotore-investigatore, Professor of Behavioral and Social Sciences, Brown University
Contatti principali dello studio
Contatto: Bess H Marcus, PhD, (401) 863-6850, [email protected]
Contatto: Rachelle Edgar, BS, (401) 863-6850, [email protected]
1 Centri dello studio in 1 paesi
Rhode Island
Brown University, Providence, Rhode Island, 02912, United States
Rachelle Edgar, BS, Contatto, (401) 863-6850, [email protected]
Bess H. Marcus, PhD, Investigatore principale
In arruolamento