Culturally and Linguistically Adapted Physical Activity Intervention for Latinas

Not Applicable

Completed

Conditions: Inactivity

Interventions: Behavioral: Original Tailored Intervention
Behavioral: Enhanced Tailored Intervention

Registration Number: NCT02630953

Lead Sponsor: University of California, San Diego

Brief 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.

Detailed Description: Latinos are the largest racial/ethnic minority group in the U.S., and report substantial and widening health disparities. Prevalence of type II diabetes is 60-100% higher in Latinos than in non-Latino Whites, and incidence in Latinos is projected to increase by 500% by 20503. The largest disparities are projected for Latino women (Latinas). Rates of overweight and obesity are 23% and 37% higher in Latinas than in White women respectively, and have grown faster in Mexican American women, by far the largest subgroup of Latinas, than in White women during the past decade. Given that Latinos are projected to comprise nearly one-third of the US population by 2050, this signifies a pressing public health concern in terms of costs, diminished quality of life, and lost life years. Interventions are therefore needed that are not only linguistically adapted for this population but address their specific barriers. "Mediated" intervention delivery approaches (e.g., mail, phone, or web delivered) that emphasize home-based, lifestyle activities show larger effect sizes than face-to-face approaches, are more cost-effective, are likely more sustainable, and may be particularly appropriate for Latinas, as they reduce the burden of time, childcare, and transportation, barriers commonly cited by Latinas. Thus in the previously funded parent grant (R01NR011295) we responded to PAR-07-379, "Behavioral and Social Science Research on Understanding and Reducing Health Disparities," by modifying an existing print-based mail-delivered PA intervention and adapting it specifically for Latinas in the North Eastern U.S. with low acculturation, literacy, and socioeconomic status (SES), and testing the modified intervention in a randomized controlled trial (N=266). Participants in the PA intervention arm showed significantly greater increases in at least moderate intensity activity, increasing from 1.87 min/week at baseline to 73.36 min/week at 6 months (vs. 3.02 min/week to 32.98 min/week in a contact control group). However, this is still well below the national guidelines of 150 minutes per week. This intervention therefore shows potential in promoting initial PA adoption, yet enhancements are needed to further help people achieve levels of PA that will prevent disease and reduce health disparities. The objectives of this renewal are to 1) enhance the intervention to achieve greater increases in PA, 2) assess its potential clinical impact by measuring changes in biomarkers, and 3) increase its generalizability by replicating it in Latina women, all of which would further the goal of designing an innovative behavioral intervention to promote health and prevent illness in diverse populations.

Recruitment & Eligibility

Status: COMPLETED

Sex: Female

Target Recruitment: 214

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

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Original Tailored Intervention	Original Tailored Intervention	This existing empirically supported Spanish-language PA intervention, which is based on Social Cognitive Theory and the Transtheoretical Model (TTM), emphasizes behavioral strategies for increasing PA levels (goal-setting, self-monitoring, problem-solving barriers, increasing social support, self-rewards for meeting PA goals).
Enhanced Tailored Intervention	Enhanced Tailored Intervention	We designed the Enhanced Tailored Intervention to build upon our previous research in order to outperform the original tailored intervention, in a cost effective, theoretically guided and data driven manner with potential for dissemination. Participants in the Enhanced Tailored Intervention will receive an interactive technology based intervention that: 1) addresses important SCT constructs for increasing PA that were not significantly changed in the original parent trial (enjoyment/outcome expectations and social support) and 2) provides greater accountability and interactivity for self-monitoring (through text messages), as requested by participants in the original parent trial.

Primary Outcome Measures

Name	Time	Method
Change in Accelerometer Measured Moderate to Vigorous PA (MVPA) by the Actigraph GT3X+	Baseline, 6 months and 12 months	Participants will wear an Actigraph GT3X+ accelerometer, which measures movement and intensity of activity and has been validated against heart rate telemetry and total energy expenditure.

Secondary Outcome Measures

Name	Time	Method
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.	Baseline, 6 months and 12 months	The 7-Day PAR is an interviewer administered instrument that uses multiple strategies for increasing accuracy of participant recall regarding many types of activities such as time spent sleeping and moderate, hard, and very hard intensity activities. The 7-Day PAR is used across many studies assessing physical activity and has consistently demonstrated acceptable reliability, internal consistency, and congruent validity with other objective measures of activity levels.
Changes in Cholesterol	Baseline, 6 months	Blood samples will be collected at the baseline and 6-month clinic visits. Specifically, low-density lipoprotein cholesterol (LDL) will be measured. These assays will be collected by personnel at the UCSD NIH-funded Clinical and Translational Research Institute (CTRI).
Changes in Cardiovascular and Metabolic Biomarkers (e.g., HbA1c, and LDL)	Baseline, 6 months	Blood samples will be collected at the baseline and 6-month clinic visits. Specifically, low-density lipoprotein cholesterol (LDL), hemoglobin A1C (HbA1c), and blood pressure will be measured. These assays will be collected by personnel at the UCSD NIH-funded Clinical and Translational Research Institute (CTRI).
Changes in Triglycerides	Baseline, 6 months	Blood samples will be collected at the baseline and 6-month clinic visits.