Culturally and Linguistically Adapted Physical Activity Intervention for Latinas

Inactivity Clinical Trial

Official title:

Culturally and Linguistically Adapted Physical Activity Intervention for Latinas

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02630953
• Other study ID #: Seamos Activas
• Secondary ID: 2R01NR011295
• Status: Completed
• Phase: N/A
• Start date: February 1, 2016
• Est. completion date: July 31, 2019

Study information

• Verified date: March 2021
• Source: University of California, San Diego
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 214
• Est. completion date: July 31, 2019
• Est. primary completion date: July 31, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Inactivity

Intervention

Behavioral:
• Original Tailored Intervention
The intervention includes regular mailings: weekly in month 1, biweekly in months 2 and 3, monthly in months 4 to 6, and a maintenance dose. Mailings consist of; 1) Manuals matched to the participant's current level of motivational readiness to change, based on TTM 2) Individually tailored computerized expert system feedback reports based on the participant's answers to monthly questionnaires. The computer expert system draws from a bank of over 330 messages developed from previous studies that address different levels of psychosocial and environmental factors affecting PA. 3) PA tip sheets addressing PA barriers specifically identified by Latinas in our formative research (e.g., caregiving duties, neighborhood safety).
• Enhanced Tailored Intervention
Participants in the Enhanced Tailored arm will receive all the intervention components of the original tailored intervention, as well as: 1) additional print materials; 2) more in-depth tailored reports; and 3) text-messages. Self-monitoring was an important aspect in increasing PA in our previous trials however, participants were only asked to turn in the self-monitoring logs once a month. Based on the importance of self-monitoring and feedback from participants (R01NR011295; R01CA15994) that they wanted greater accountability and interactivity, we added a text-message component for self-monitoring.

Locations

Country	Name	City	State
United States	University of California San Diego	La Jolla	California

Sponsors (2)

Lead Sponsor	Collaborator
University of California, San Diego	National Institute of Nursing Research (NINR)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Accelerometer Measured Moderate to Vigorous PA (MVPA) by the Actigraph GT3X+	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.	Baseline, 6 months and 12 months
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.	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.	Baseline, 6 months and 12 months
Secondary	Changes in Cardiovascular and Metabolic Biomarkers (e.g., HbA1c, and LDL)	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).	Baseline, 6 months
Secondary	Changes in Cholesterol	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).	Baseline, 6 months
Secondary	Changes in Triglycerides	Blood samples will be collected at the baseline and 6-month clinic visits.	Baseline, 6 months