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A 12-week Field Trial of the Movámonos Physical Activity Support Program (Movámonos)

24 de abril de 2026 actualizado por: University of Colorado, Denver

Movámonos: Translation and Cultural Adaptation of a Theory-Based Physical Activity Support Program for Spanish-Speaking Adults - Aim 2

The objective of this study is to design and refine an activity support program, called Movámonos, for adults with overweight or obesity who speak Spanish. The primary outcomes are feasibility and acceptability of the Movámonos physical activity support program.

Descripción general del estudio

Descripción detallada

The purpose of this study is to pilot test a 12-week physical activity support program, called Movámonos, designed for Spanish-speaking adults with overweight or obesity. Movámonos includes four intervention components: 1) weekly 60-minute group-based classes, 2) 3, 45-minute individualized support sessions, 3) group fitness classes, and 4) mental guided imagery sessions. Participants will be asked to build their physical activity levels up to 150 minutes/week. The primary outcome is to evaluate the program's acceptability and feasibility from the participant perspective.

Tipo de estudio

Intervencionista

Inscripción (Estimado)

20

Fase

  • No aplica

Contactos y Ubicaciones

Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.

Estudio Contacto

  • Nombre: Danielle Ostendorf, PhD
  • Número de teléfono: 18659748606
  • Correo electrónico: dostendo@utk.edu

Copia de seguridad de contactos de estudio

Criterios de participación

Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.

Criterio de elegibilidad

Edades elegibles para estudiar

  • Adulto
  • Adulto Mayor

Acepta Voluntarios Saludables

Sí

Descripción

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

Plan de estudios

Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.

¿Cómo está diseñado el estudio?

Detalles de diseño

  • Propósito principal: Tratamiento
  • Asignación: N / A
  • Modelo Intervencionista: Asignación de un solo grupo
  • Enmascaramiento: Ninguno (etiqueta abierta)

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
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.

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Program Acceptability - Qualitative
Periodo de tiempo: 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
Periodo de tiempo: 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

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Program Acceptability - Quantitative
Periodo de tiempo: 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
Periodo de tiempo: 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

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Fechas de registro del estudio

Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados ​​por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.

Fechas importantes del estudio

Inicio del estudio (Estimado)

15 de mayo de 2026

Finalización primaria (Estimado)

31 de diciembre de 2026

Finalización del estudio (Estimado)

31 de julio de 2027

Fechas de registro del estudio

Enviado por primera vez

24 de abril de 2026

Primero enviado que cumplió con los criterios de control de calidad

24 de abril de 2026

Publicado por primera vez (Actual)

1 de mayo de 2026

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

1 de mayo de 2026

Última actualización enviada que cumplió con los criterios de control de calidad

24 de abril de 2026

Última verificación

1 de abril de 2026

Más información

Términos relacionados con este estudio

Plan de datos de participantes individuales (IPD)

¿Planea compartir datos de participantes individuales (IPD)?

NO

Descripción del plan IPD

Participants have not consented to individual level data being shared.

Información sobre medicamentos y dispositivos, documentos del estudio

Estudia un producto farmacéutico regulado por la FDA de EE. UU.

No

Estudia un producto de dispositivo regulado por la FDA de EE. UU.

No

Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .

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