CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 214 enrolled
Drug / intervention
Original Tailored Intervention +1 morebehavioral
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02630953
NCT02630953N/ACompleted

Culturally and Linguistically Adapted Physical Activity Intervention for Latinas

University of California, San Diego·interventional·Posted Dec 15, 2015·Updated Mar 4, 2021

In Brief

A clinical study evaluating Original Tailored Intervention and Enhanced Tailored Intervention for Inactivity. Completed, enrolled 214 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsInactivity
CountriesUnited States

Timeline

N/ACompletedFinished
20162017201820192020202120222023202420252026
First PostedDec 15, 2015
Enrollment StartFeb 1, 2016
Primary CompletionJul 31, 2019
TodayJul 2, 2026
Enrollment to primary: 3.5 yearsPosted 10.5 years ago

Interventions

Original Tailored Interventionbehavioral

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 Interventionbehavioral

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.