N/A N=199 Randomized Treatment

Culturally and Linguistically Adapted Physical Activity Intervention for Latinas

Inactivity

Bottom Line

View on ClinicalTrials.gov: NCT02630953 ↗

Enrolled (actual)

199

Serious AEs

0.0%

Results posted

Mar 2021

Primary outcome: Primary: Change in Accelerometer Measured Moderate to Vigorous PA (MVPA) by the Actigraph GT3X+ — 10; 0; 36; 28 minutes/week — p=0.24

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: Original Tailored Intervention (Behavioral); Enhanced Tailored Intervention (Behavioral)
Age: Adult, Older Adult · 18+ yrs
Sex: Female
Sponsor: University of California, San Diego
Primary completion: Jul 2019

Outcome Measures

Outcome	Result	p-value
PRIMARY Change in Accelerometer Measured Moderate to Vigorous PA (MVPA) by the Actigraph GT3X+	10; 0; 36; 28; 36; 40	0.24
SECONDARY Change in Total Weekly Minutes of Physical Activity as Measured by the 7-Day PAR (Physical Activity Recall), From Baseline to 6-months and 12-months.	0; 0; 100; 110; 100; 130	0.73
SECONDARY Changes in Cardiovascular and Metabolic Biomarkers (e.g., HbA1c, and LDL)	5.36; 5.43; 5.35; 5.29	>.06
SECONDARY Changes in Cholesterol	188.65; 192.00; 188.09; 185.42; 51.13; 52.28	—
SECONDARY Changes in Triglycerides	166.58; 149.88; 133.91; 117.94	—

Summary

The overall goals of this renewal are to replicate the findings of Seamos Saludables in Latina women, increase the effectiveness of the intervention, and measure intervention-related changes in clinical biomarkers. We will enhance the existing intervention by incorporating participant feedback (desire for greater interactivity and accountability), further targeting Social Cognitive Theory (SCT) constructs that were not influenced overall by the original intervention yet improved amongst our most successful participants (social support, outcome expectancies), and responding to changing trends and technology use in Latinos. We will conduct a clinical trial among Latina women in California randomized to either 1) the original Seamos Saludables tailored print only intervention or 2) a theory and text messaging-enhanced interactive technology based version of the Seamos Saludables intervention. We will also measure changes in cardiovascular and metabolic biomarkers (e.g., HbA1c, and LDL) to assess potential clinical impact of the intervention.

Eligibility Criteria

Inclusion Criteria

Female
Generally healthy (If asthma, controlled high blood pressure and/or controlled type II diabetes, may be able to participate with physician consent)
Sedentary (Less than 60 minutes per week of moderate or vigorous physical activity)
Hispanic or Latina (self-identified)
Must be able to read and write in English or Spanish fluently
18 - 65 years of age
Planning on living in the area for the next 12 months
Own a cell phone capable of sending and receiving text messages

Exclusion Criteria

BMI greater than 45
Not able to walk continuously for 30 minutes/limited ability to complete daily activity or ability to exercise
Exercise is against advice of doctor
Current or planned pregnancy
Heart disease/treatment
Heart murmur
Angina/chest pain or Angina/chest pain with exertion
Palpitations
Stroke/Transient Ischemic Attacks
Peripheral Vascular Disease
Type I Diabetes
Uncontrolled Type II Diabetes
Chronic Infectious Disease - HIV, Hepatitis
Chronic liver disease
Cystic Fibrosis
Abnormal EKG on last EKG performed
Emphysema, Chronic bronchitis, Chronic Obstructive Pulmonary Disease
Seizure in past year
Surgery in past year on heart, lung, joint, orthopedic surgery
Surgery pending in next year on lung, joint, orthopedic surgery
Unusual/concerning shortness of breath
Asthma (may be able to participate with physician consent)
High blood pressure/high blood pressure medication (may be able to participate with physician consent)
Use of beta blockers
Abnormal Medical Stress Test
Musculoskeletal problems
Fainting/dizziness more than 3 times in past year OR interferes with daily activities OR causes loss of balance
Cancer treatment in past 3 months
Hospitalized for psychiatric disorder in past 3 years or suicidal

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02630953). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.