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

NCT07561996 | Not Yet Recruiting

• 1 other identifier: 26-0439
• Study Type: interventional
• Target: 20
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Overweight and Obese Adults; Physical Inactivity

Outcome Measures

Primary Outcomes (2)

• Program Acceptability - Qualitative

  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

  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

Secondary Outcomes (2)

• Program Acceptability - Quantitative

  3 months

• Program Feasibility - Quantitative

  3 months

Study Arms (1)

Movámonos physical activity support program

EXPERIMENTAL

Participants receive the physical activity support program over 12 weeks.

Behavioral: Movámonos Physical Activity Support Program

Interventions

Movámonos Physical Activity Support Program BEHAVIORAL

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.

Movámonos physical activity support program

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Able to provide signed physician clearance for exercise if indicated by the Physical Activity Readiness Questionnaire (PAR-Q+) and determined by the study PI.
• 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.

Sponsors & Collaborators

• University of Colorado, Denver: lead

MeSH Terms

Conditions

Overweight; Sedentary Behavior

Condition Hierarchy (Ancestors)

Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Behavior

Central Study Contacts

Danielle Ostendorf, PhD

CONTACT

18659748606; dostendo@utk.edu

Ryan Marker, PhD, PT

CONTACT

1303-724-0819; ryan.marker@cuanschutz.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 24, 2026
• First Posted: May 1, 2026
• Study Start (Estimated): May 15, 2026
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): July 31, 2027
• Last Updated: May 1, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share