Harmony & Health: En kulturelt tilpasset mindbody-intervention for at reducere siddetid og forbedre psykosocialt velvære hos sorte voksne
This community-based study will assess the efficacy of a culturally adapted, yoga-based intervention to reduce sitting time, increase physical activity, and improve psychosocial wellbeing among insufficiently active Black adults in the Houston area.
Studieoversigt
Status
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
Primary Objectives:
--The primary aim of the proposed study is to determine the efficacy of HH in reducing sitting time and increasing physical activity in insufficiently active Black adults. Hypothesis: HH participants will spend less time sitting and more time moving at post-intervention (week 9) compared to participants in the attention control group.
Secondary Objectives:
The secondary aims of this proposed study are to:
- Examine the effects of HH on psychosocial wellbeing and the association of psychosocial wellbeing with behavioral outcomes. Hypothesis: HH participants will report improved psychosocial wellbeing, including reduced stress, depressive symptoms, and negative affect and improved quality of life, which will in turn mediate intervention outcomes at post-intervention (week 9) and follow up (week 24).
- Evaluate the long-term benefits of the HH intervention. Hypothesis: HH participants will spend less time sitting and more time moving at follow up (week 24) compared to participants in the attention control group.
An exploratory aim of the proposed study is to identify implementation facilitators and barriers using a mixed-methods approach. Implementation of HH will be evaluated using the Consolidated Framework for Implementation Research (CFIR) and the RE-AIM Framework. In-depth interviews with key informants combined with administrative and questionnaire data will be used to identify critical facilitators and barriers for implementing HH and to evaluate reach, implementation, adoption, and maintenance.
Undersøgelsestype
Tilmelding (Faktiske)
Fase
- Ikke anvendelig
Kontakter og lokationer
Studiesteder
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Texas
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Houston, Texas, Forenede Stater, 77030
- M D Anderson Cancer Center
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-
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
Inclusion Criteria:
- Adults ≥18 years old
- Self-identify as Black or African American
- Self-reports MVPA <150 minutes/week
- Self-reports sedentary time ≥6 hours/ day
- Body mass index [BMI] ≥25.0 kg/m2 based on self-reported height and weight (and verified at baseline)
- Able to pass the modified Physical Activity Readiness Questionnaire (PAR-Q) or provide physician's clearance to participate
- Willing to be randomized to intervention or control
- Comfortable participating in group-based physical activity
- Able to read, speak, and write in English
- Able to provide written informed consent without assistance
Exclusion Criteria:
- < 18 years old
- Self-reports MVPA .150 minutes/week
- Self-reports sedentary time <6 hours/day
- Not classified as overweight or obese (BMI <25.0 kg/m2)
- Absolute contraindications to unassisted physical activity (e.g. acute MI, orthopedic and musculoskeletal limitations)
- Practicing yoga or enrolled in another program targeting physical activity, sedentary behavior, or weight loss in the last 6 months
- Previously participated in Harmony & Health
- Pregnant or planning to become pregnant in the next 6 months
- Planning to move from the Houston area within the next 6 months
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Forebyggelse
- Tildeling: N/A
- Interventionel model: Enkelt gruppeopgave
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
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Eksperimentel: Harmony & Health program
Participants will take part in the Harmony & Health program or participants will attend in-person group health education sessions 2 times a week for 8 weeks. |
Harmony & Health program may help improve psychosocial wellbeing in participants and if improvements in physical activity and wellbeing can last after the program ends. Yoga combines gentle movements, breathing exercises, relaxation techniques, and meditation all tailored to the participant's needs. |
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Tidsramme |
|---|---|
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Spørgeskemaer om livskvalitet
Tidsramme: gennem studieafslutning; i gennemsnit 6 måneder
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gennem studieafslutning; i gennemsnit 6 måneder
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Samarbejdspartnere og efterforskere
Sponsor
Samarbejdspartnere
Efterforskere
- Ledende efterforsker: Scherezade Mama, DRPH, M.D. Anderson Cancer Center
Publikationer og nyttige links
Hjælpsomme links
Datoer for undersøgelser
Studer store datoer
Studiestart (Faktiske)
Primær færdiggørelse (Anslået)
Studieafslutning (Anslået)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Andre undersøgelses-id-numre
- 2023-0321
- NCI-2023-04992 (Anden identifikator: NCI-CTRP Clinical Trials Registry)
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
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Studerer et amerikansk FDA-reguleret enhedsprodukt
produkt fremstillet i og eksporteret fra U.S.A.
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