Skip to content

Culturally and Linguistically Adapted Physical Activity Intervention for Latinas

Culturally and Linguistically Adapted Physical Activity Intervention for Latinas

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02630953
Enrollment
214
Registered
2015-12-15
Start date
2016-02-01
Completion date
2019-07-31
Last updated
2021-03-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Inactivity

Keywords

Physical Activity, Latinas, Spanish-language, Text-Message, English-language, Exercise

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.

Interventions

BEHAVIORALOriginal 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).

BEHAVIORALEnhanced 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.

Sponsors

National Institute of Nursing Research (NINR)
CollaboratorNIH
University of California, San Diego
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 65 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Change in Accelerometer Measured Moderate to Vigorous PA (MVPA) by the Actigraph GT3X+Baseline, 6 months and 12 monthsParticipants 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

MeasureTime frameDescription
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 monthsThe 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 Cardiovascular and Metabolic Biomarkers (e.g., HbA1c, and LDL)Baseline, 6 monthsBlood 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 CholesterolBaseline, 6 monthsBlood 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 TriglyceridesBaseline, 6 monthsBlood samples will be collected at the baseline and 6-month clinic visits.

Countries

United States

Participant flow

Pre-assignment details

Participants attended an in-person orientation session where they received information about the study, had measures of height, weight, and self-reported PA taken to confirm eligibility. During a second visit, participants were measured (e.g, hip and waist circumference)) and given an ActiGraph GT3X+ accelerometer. After one week of continuous accelerometer wear, participants returned for their baseline visit where they completed questionnaires, had blood draws, then were randomized/

Participants by arm

ArmCount
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). 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).
97
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. 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.
102
Total199

Baseline characteristics

CharacteristicTotalEnhanced Tailored InterventionOriginal Tailored Intervention
Age, Continuous43.80 years
STANDARD_DEVIATION 10.11
43.55 years
STANDARD_DEVIATION 10.63
44.14 years
STANDARD_DEVIATION 9.57
Body Mass Index (BMI)30.64 kg/m^2
STANDARD_DEVIATION 7.56
30.50 kg/m^2
STANDARD_DEVIATION 9.31
30.79 kg/m^2
STANDARD_DEVIATION 5.19
Ethnicity (NIH/OMB)
Hispanic or Latino
199 Participants102 Participants97 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
0 Participants0 Participants0 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
0 Participants0 Participants0 Participants
Objectively Measured Min/Week MVPA39.51 minutes/week
STANDARD_DEVIATION 71.2
33.61 minutes/week
STANDARD_DEVIATION 71.29
45.72 minutes/week
STANDARD_DEVIATION 70.93
Race (NIH/OMB)
American Indian or Alaska Native
6 Participants1 Participants5 Participants
Race (NIH/OMB)
Asian
1 Participants0 Participants1 Participants
Race (NIH/OMB)
Black or African American
0 Participants0 Participants0 Participants
Race (NIH/OMB)
More than one race
4 Participants2 Participants2 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Unknown or Not Reported
96 Participants52 Participants44 Participants
Race (NIH/OMB)
White
92 Participants47 Participants45 Participants
Region of Enrollment
United States
199 participants102 participants97 participants
Self Reported Min/Week MVPA12.47 minutes/week
STANDARD_DEVIATION 22.54
14.33 minutes/week
STANDARD_DEVIATION 25.06
10.51 minutes/week
STANDARD_DEVIATION 19.47
Sex: Female, Male
Female
199 Participants102 Participants97 Participants
Sex: Female, Male
Male
0 Participants0 Participants0 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
0 / 970 / 102
other
Total, other adverse events
5 / 9710 / 102
serious
Total, serious adverse events
0 / 970 / 102

Outcome results

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.

Time frame: Baseline, 6 months and 12 months

Population: Analysis was completed on the ITT sample

ArmMeasureGroupValue (MEDIAN)
Original Tailored InterventionChange in Accelerometer Measured Moderate to Vigorous PA (MVPA) by the Actigraph GT3X+Baseline10 minutes/week
Original Tailored InterventionChange in Accelerometer Measured Moderate to Vigorous PA (MVPA) by the Actigraph GT3X+6 Months36 minutes/week
Original Tailored InterventionChange in Accelerometer Measured Moderate to Vigorous PA (MVPA) by the Actigraph GT3X+12 Months36 minutes/week
Enhanced Tailored InterventionChange in Accelerometer Measured Moderate to Vigorous PA (MVPA) by the Actigraph GT3X+Baseline0 minutes/week
Enhanced Tailored InterventionChange in Accelerometer Measured Moderate to Vigorous PA (MVPA) by the Actigraph GT3X+6 Months28 minutes/week
Enhanced Tailored InterventionChange in Accelerometer Measured Moderate to Vigorous PA (MVPA) by the Actigraph GT3X+12 Months40 minutes/week
Comparison: Using a series of quantile regression models with bootstrapped standard errors (10,000 replications) we examined the potential treatment effects on MVPA at follow-ups, controlling for baseline. Quantile regression models the median outcome instead of the mean, and are appropriate when data is skewed (as was the case in both self-reported and objectively measured MVPA).p-value: 0.2495% CI: [-41.15, 28.7]quantile regression
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.

Time frame: Baseline, 6 months and 12 months

Population: Analysis was completed on the ITT sample

ArmMeasureGroupValue (MEDIAN)
Original Tailored InterventionChange 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.Baseline0 minutes/week
Original Tailored InterventionChange 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.6 Months100 minutes/week
Original Tailored InterventionChange 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.12 Months100 minutes/week
Enhanced Tailored InterventionChange 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.Baseline0 minutes/week
Enhanced Tailored InterventionChange 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.6 Months110 minutes/week
Enhanced Tailored InterventionChange 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.12 Months130 minutes/week
Comparison: Using a series of quantile regression models with bootstrapped standard errors (10,000 replications) we examined the potential treatment effects on MVPA at follow-up, controlling for baselinep-value: 0.7395% CI: [-32.37, 47.37]quantile regression
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).

Time frame: Baseline, 6 months

Population: A subset of the full sample completed biomarker analysis at baseline and 6 months

ArmMeasureGroupValue (MEAN)Dispersion
Original Tailored InterventionChanges in Cardiovascular and Metabolic Biomarkers (e.g., HbA1c, and LDL)Baseline A1c5.36 percentageStandard Deviation 0.38
Original Tailored InterventionChanges in Cardiovascular and Metabolic Biomarkers (e.g., HbA1c, and LDL)6 Month A1c5.35 percentageStandard Deviation 0.43
Enhanced Tailored InterventionChanges in Cardiovascular and Metabolic Biomarkers (e.g., HbA1c, and LDL)Baseline A1c5.43 percentageStandard Deviation 0.83
Enhanced Tailored InterventionChanges in Cardiovascular and Metabolic Biomarkers (e.g., HbA1c, and LDL)6 Month A1c5.29 percentageStandard Deviation 0.27
Comparison: Using a series of generalized linear models with identity link, we examined treatment effects on biomarkers at 6 months controlling for baseline and potential confounders.p-value: >0.06Regression, Linear
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).

Time frame: Baseline, 6 months

Population: A subset of the full sample completed biomarker analysis at baseline and 6 months

ArmMeasureGroupValue (MEAN)Dispersion
Original Tailored InterventionChanges in CholesterolBaseline Cholesterol188.65 mg/dLStandard Deviation 31.7
Original Tailored InterventionChanges in Cholesterol6 Month Cholesterol188.09 mg/dLStandard Deviation 31.17
Original Tailored InterventionChanges in CholesterolBaseline HDL51.13 mg/dLStandard Deviation 12.54
Original Tailored InterventionChanges in Cholesterol6 Month HDL53.44 mg/dLStandard Deviation 12.38
Original Tailored InterventionChanges in CholesterolBaseline LDL104.80 mg/dLStandard Deviation 26.56
Original Tailored InterventionChanges in Cholesterol6 Month LDL109.41 mg/dLStandard Deviation 28.43
Enhanced Tailored InterventionChanges in CholesterolBaseline LDL109.75 mg/dLStandard Deviation 30.94
Enhanced Tailored InterventionChanges in CholesterolBaseline Cholesterol192.00 mg/dLStandard Deviation 37.29
Enhanced Tailored InterventionChanges in Cholesterol6 Month HDL54.13 mg/dLStandard Deviation 13.5
Enhanced Tailored InterventionChanges in Cholesterol6 Month Cholesterol185.42 mg/dLStandard Deviation 38.42
Enhanced Tailored InterventionChanges in Cholesterol6 Month LDL107.71 mg/dLStandard Deviation 31.05
Enhanced Tailored InterventionChanges in CholesterolBaseline HDL52.28 mg/dLStandard Deviation 54.13
Secondary

Changes in Triglycerides

Blood samples will be collected at the baseline and 6-month clinic visits.

Time frame: Baseline, 6 months

Population: A subset of the full sample completed biomarker analysis at baseline and 6 months

ArmMeasureGroupValue (MEAN)Dispersion
Original Tailored InterventionChanges in TriglyceridesBaseline Triglycerides166.58 mg/dLStandard Deviation 101.6
Original Tailored InterventionChanges in Triglycerides6 Month Triglycerides133.91 mg/dLStandard Deviation 90.98
Enhanced Tailored InterventionChanges in TriglyceridesBaseline Triglycerides149.88 mg/dLStandard Deviation 117.94
Enhanced Tailored InterventionChanges in Triglycerides6 Month Triglycerides117.94 mg/dLStandard Deviation 57.4

Source: ClinicalTrials.gov · Data processed: Feb 21, 2026