A 12-week Field Trial of the Movámonos Physical Activity Support Program (Movámonos)
Movámonos: Translation and Cultural Adaptation of a Theory-Based Physical Activity Support Program for Spanish-Speaking Adults - Aim 2
Studienübersicht
Status
Status
Bedingungen
Bedingungen
Intervention / Behandlung
Intervention / Behandlung
Detaillierte Beschreibung
Studientyp
Studientyp
Einschreibung (Geschätzt)
Einschreibung
Phase
Phase
- Unzutreffend
Kontakte und Standorte
Studienkontakt
Studienkontakt
- Name: Danielle Ostendorf, PhD
- Telefonnummer: 18659748606
- E-Mail: dostendo@utk.edu
Studieren Sie die Kontaktsicherung
- Name: Ryan Marker, PhD, PT
- Telefonnummer: 1303-724-0819
- E-Mail: ryan.marker@cuanschutz.edu
Teilnahmekriterien
Zulassungskriterien
Zulassungskriterien
Studienberechtigtes Alter
- Erwachsene
- Älterer Erwachsener
Akzeptiert gesunde Freiwillige
Beschreibung
Inclusion Criteria:
- Men and Women
- Age 18-65 years
- Speak Spanish as their primary language
- Self-identify as Hispanic or Latino
- Body Mass Index 25-45 kg/m2
- Insufficiently active (defined as <150 min/week of voluntary exercise at moderate intensity over the past 3 months)
- Willing not to enroll in any other formal weight loss, physical activity program, or fitness center membership over the next 6 months.
- Capable and willing to give informed consent, understand exclusion criteria, attend the Movámonos program sessions, and complete outcome measures.
- Able to provide signed physician clearance for exercise if indicated by the Physical Activity Readiness Questionnaire (PAR-Q+) and determined by the study PI.
Exclusion Criteria:
- Considered high risk, based on the American College of Sports Medicine Guidelines for Exercise Testing and Prescription33 (i.e. have cardiovascular disease symptoms or known cardiovascular disease, diabetes, or end-stage renal disease). These conditions are identified in the PAR-Q+.
- Females who are currently pregnant or lactating, were pregnant within the past 3 months, or planning to become pregnant in the next 6 months will also be excluded
- Self-reported cardiovascular disease:
- Cardiac, peripheral vascular, or cerebrovascular disease
- Self-reported symptoms suggestive of cardiovascular disease: pain, discomfort in the chest, neck, jaw, arms, or other areas that may result from cardiac ischemia; shortness of breath at rest or with mild exertion; dizziness or syncope; orthopnea or paroxysmal nocturnal dyspnea; ankle edema; palpitations or tachycardia; intermittent claudication.
- Self-reported end-stage renal disease
- Self-reported diabetes (history of type 1 or type 2 diabetes; fasting glucose ≥126 mg/dL or Hemoglobin A1C ≥6.5%)
- Uncontrolled hypertension, defined as diastolic blood pressure >100 mmHG, systolic blood pressure >160 mmHG, or resting heart rate >100 bpm as measured in duplicate at the screening visit after 5 minutes of rest in a seated position.
- Self-reported pulmonary disease requiring chronic oxygen supplementation; severe asthma or chronic obstructive pulmonary disease requiring hospitalization in past year.
- Plans to relocate in the next 6 months
- Currently participating in or planning to participate in any formal weight loss, dietary modification, or physical activity/exercise programs or clinical trials.
- Current severe depression or history of severe depression within the previous year, based on DSM-IV-TR criteria for Major Depressive Episode. Scores >=16 on CES-D will require further assessment by the Study PI to determine if it is appropriate for the subject to participate in the study.
- History of other significant psychiatric illness (e.g., psychosis, schizophrenia, mania, bipolar disorder) which in the opinion of the Study PI would interfere with ability to adhere to the exercise intervention.
- History of clinically diagnosed eating disorders including anorexia nervosa, bulimia, binge eating disorder. Scores >20 on the EATS-26 Spanish version34 or global scores ≥2.3 on the Spanish version of the Eating Disorder Examination Questionnaire (S-EDE-Q)35,36 suggestive of a possible eating disorder will require further assessment by the Study PI to determine if it is appropriate for the subject to participate in the study.
- Current alcohol or substance abuse
- Nicotine use (current or past 6 months)
- Regular use of prescription or over-the-counter medications known to significantly impact appetite, weight, sleep, or energy metabolism (e.g., appetite suppressants, lithium, stimulants, anti-psychotics, tricyclic antidepressants)
- Regular use of obesity pharmacotherapeutic agents within the last 6 months.
- Previous obesity treatment with surgery or weight loss device, except: (1) liposuction and/or abdominoplasty if performed > 1 year before screening, (2) lap banding if the band has been removed > 1 year before screening, (3) intragastric balloon if the balloon has been removed > 1 year before screening (4) duodenal-jejunal bypass sleeve, if the sleeve has been removed > 1 year before screening or 5) AspireAssist or other endoscopically placed weight loss device if the device has been removed > 1 year before screening.
- Undiagnosed hypo- or hyper-thyroidism (TSH outside of the normal range) or history of uncontrolled thyroid disorder. History of thyroid disease or current thyroid disease treated with a stable medication regimen for at least 6 months is acceptable.
- Hematocrit, white blood cell count or platelets significantly outside the normal reference range.
- Triglycerides > 400 mg/dL
- LDL cholesterol >200 mg/dL
Studienplan
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Behandlung
- Zuteilung: N / A
- Interventionsmodell: Einzelgruppenzuweisung
- Maskierung: Keine (Offenes Etikett)
Anzahl der Arme
Waffen und Interventionen
Teilnehmergruppe / ArmTeilnehmergruppe / Arm |
Intervention / BehandlungIntervention / Behandlung |
|---|---|
|
Experimental: Movámonos physical activity support program
Participants receive the physical activity support program over 12 weeks.
|
The 12-week Movámonos program includes four intervention components: 1) weekly, 60-minute group-based classes, 2) 3, 45-minute individualized support sessions, 3) group fitness classes, and 4) weekly mental guided imagery sessions.
Participants will be asked to build up their physical activity levels up to 150 minutes/week.
|
Was misst die Studie?
Primäre Ergebnismessungen
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
Program Acceptability - Qualitative
Zeitfenster: 3 months
|
Acceptability of the physical activity support program will be assessed with results of the semi-structured focus groups or interviews from the participant perspective.
|
3 months
|
|
Program Feasibility - Qualitative
Zeitfenster: 3 months
|
Feasibility of the physical activity support program will be assessed with results of the semi-structured focus groups or interviews from the participant perspective.
|
3 months
|
Sekundäre Ergebnismessungen
Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
Program Acceptability - Quantitative
Zeitfenster: 3 months
|
Acceptability of the physical activity support program components will be assessed using the Acceptability of Intervention Measure (AIM) from the participant perspective.
Scores range from 0 to 5, with higher scores indicating a better outcome.
|
3 months
|
|
Program Feasibility - Quantitative
Zeitfenster: 3 months
|
Feasibility of the physical activity support program will be assessed using the Feasibility of Intervention Measure (FIM).
Scores range from 0 to 5, with higher scores indicating a better outcome.
|
3 months
|
Mitarbeiter und Ermittler
Sponsor
Sponsor
Studienaufzeichnungsdaten
Haupttermine studieren
Studienbeginn (Geschätzt)
Studienbeginn
Primärer Abschluss (Geschätzt)
Primärer Abschluss
Studienabschluss (Geschätzt)
Studienabschluss
Studienanmeldedaten
Zuerst eingereicht
Zuerst eingereicht
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
Zuerst gepostet (Tatsächlich)
Zuerst gepostet
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
Letztes Update gepostet
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
Zuletzt verifiziert
Zuletzt verifiziert
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Zusätzliche relevante MeSH-Bedingungen
Andere Studien-ID-Nummern
Andere Studien-ID-Nummern
- 26-0439
Plan für individuelle Teilnehmerdaten (IPD)
Planen Sie, individuelle Teilnehmerdaten (IPD) zu teilen?
Beschreibung des IPD-Plans
Arzneimittel- und Geräteinformationen, Studienunterlagen
Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt
Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt
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