- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT04072133
The Move Well Study (MW)
Effects of Meditative Movement on Body Composition in Midlife Women
Studieoversikt
Status
Intervensjon / Behandling
Detaljert beskrivelse
A growing body of published evidence indicates that meditative movement (MM) practices may be helpful for body composition improvement. Less strenuous forms of exercise that include a focus on the breath and meditative state (i.e., "meditative movement" such as Yoga, Qigong, or Tai Chi) may be easier to adopt for unfit, sedentary, overweight or obese women, which characterizes a large percentage of the general population. Despite this preliminary evidence, no studies have proposed a model for how or why weight loss might occur in MM interventions where the goals are not designated as weight loss, nutritional counseling is not included, and energy expenditure is not at the level assumed to be required to achieve weight loss. The proposed intervention is designed to refine and gather preliminary evidence for a novel "mindful-body-wisdom" model of intervening on improving body composition and to examine the contribution of model factors (psychological and behavioral) of how such a non-diet/non-vigorous exercise intervention might work, in 60 midlife women.
TCE is a simple TC/QG form that was developed by Dr. Roger Jahnke and developed into a standardized research intervention protocol by a team of researchers. It has been used in several prior projects and one recently completed NIH/NCCAM-funded randomized controlled trial (RCT) with breast cancer survivors showing reduction in fatigue and depression, and improved sleep and physical function.
Studietype
Registrering (Faktiske)
Fase
- Ikke aktuelt
Kontakter og plasseringer
Studiesteder
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Arizona
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Phoenix, Arizona, Forente stater, 85004
- Arizona State University Downtown Campus
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Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Beskrivelse
Inclusion Criteria:
- Female
- 45-75 years of age
- Ability to participate in low intensity activity
Exclusion Criteria:
- Women who are unable to stand for 10-minute segments (e.g., wheelchair or walker bound and too weak)
- Women who are unable to walk
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: N/A
- Intervensjonsmodell: Enkeltgruppeoppdrag
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
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Eksperimentell: Meditative Movement Intervention
Participants will complete the following components of baseline (T1) data collection: demographics, biometric measurements, a heart rate variability assessment, and questionnaires.
Participants will be asked to provide six saliva samples via passive drool to measure cortisol levels.
Participants will be assigned into hour-long meditative movement (MM) classes for eight weeks total.
Participants will be asked to practice their MM skills at home for at least 30 minutes most days per week.
The study will distribute hard-copy movement manuals and DVD instruction videos for guidance.
Participants will be asked to provide a log of all dates and lengths of their at-home practice.
After the eighth class, participants will return for post-intervention (T2) data collection, consisting of biometric measurements, a heart rate variability assessment, and questionnaires.
Participants will provide six more saliva samples via passive drool method.
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Intervention will be taught by a certified Tai Chi Easy (TCE) group practice leader.
The TCE movements will be repeated in differing sequences and time-frames during the course of the study.
The variety and combination of the exercises will begin easy and progress to more advanced movements and/or intensities as the study progresses and participants become more experienced and comfortable with the routine.
Participants spend one hour in class each week for a total of eight weeks.
Andre navn:
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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
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Body Fat Percentage
Tidsramme: 8 weeks
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Body fat percentage will be measured using Bioelectric Impedance Analysis (BIA) via the Tanita monitor.
Score range= 0% to 100%.
A higher score indicates a higher body fat percentage.
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8 weeks
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Emotional Eating
Tidsramme: 8 weeks
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Emotional eating will be measured using the Three Factor Eating Questionnaire (TFEQ) (21 items, 4-point Likert scale with response options 1 through 4 for items 1 through 17, response options 1 through 8 for item 18).
Score range= 18 to 76. Emotional eating sub-score is calculated by combining six items of the TFEQ.
A higher score indicates greater emotional eating.
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8 weeks
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Sleep Quality
Tidsramme: 8 weeks
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Sleep quality will be measured using the Pittsburgh Sleep Quality Index (PSQI) (10 items, 4-point Likert scale; 0= positive extreme of scale, 3= negative extreme of scale).
Score range= 0 to 21.
A higher score indicates worse sleep quality.
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8 weeks
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Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
---|---|---|
Perceived Stress Scale-10
Tidsramme: 8 weeks
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self-report measure of perceived stress, 10-items, Likert scale
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8 weeks
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Self-Compassion Scale (SCS)
Tidsramme: 8 weeks
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self-report measure of self-compassion as measured (26 items) by self-kindness, common humanity, non-judgment
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8 weeks
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Body Awareness Questionnaire (BAQ)
Tidsramme: 8 weeks
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self-report measure of experienced body awareness/iteroception, 18-items, Likert-scale
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8 weeks
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Cognitive and Affective Mindfulness Scale-Revised (CAMS-R)
Tidsramme: 8 weeks
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self-report measure of mindfulness, Likert-scale, 9-items
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8 weeks
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Samarbeidspartnere og etterforskere
Sponsor
Studierekorddatoer
Studer hoveddatoer
Studiestart (Faktiske)
Primær fullføring (Faktiske)
Studiet fullført (Faktiske)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Andre studie-ID-numre
- STUDY00005974
Legemiddel- og utstyrsinformasjon, studiedokumenter
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Kliniske studier på Meditative Movement
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Charite University, Berlin, GermanyRekruttering
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The Miriam HospitalBrown UniversityUkjentUtmattelseForente stater
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Saint John's Cancer InstituteFullført
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University of MelbourneUkjent
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Biola UniversityFullført
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Hugo W. Moser Research Institute at Kennedy Krieger...National Center for Advancing Translational Sciences (NCATS)Påmelding etter invitasjonMindful Movement Intervention (MMI)Forente stater
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Dartmouth-Hitchcock Medical CenterNorris Cotton Cancer Center; ZRT Laboratory; Flight Attendant Medical Research...FullførtLungesykdom | KOLS | Autonom dysfunksjonForente stater
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University of Alabama at BirminghamThe Craig H. Neilsen Foundation; Lakeshore FoundationFullførtRyggmargsskaderForente stater
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Malin Eleonora av Kák Gustafsson, MDUniversity of Southern DenmarkFullførtSmerte i korsryggen | Lumbal spinal stenoseDanmark