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NCT07561996
A 12-week Field Trial of the Movámonos Physical Activity Support Program
Conditions: Overweight and Obese Adults, Physical Inactivity
Sex: All
Ages: 18 Years – 65 Years
Healthy volunteers: Yes
Phase: NA
Enrollment: 20
Sponsor: University of Colorado, Denver
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.
Eligibility Criteria
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 \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 the Center for Epidemiologic Studies Depression Scale (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 Eating Attitudes Test (EATS-26 Spanish version) or global scores ≥2.3 on the Spanish version of the Eating Disorder Examination Questionnaire (S-EDE-Q) 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 (thyroid stimulating hormone (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
* low density lipoprotein (LDL) cholesterol \>200 mg/dL
Source: ClinicalTrials.gov (NCT07561996). StuddyBuddy aggregates publicly available trial information.