Culturally and Linguistically Adapted Physical Activity Intervention for Latinas

Keywords

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

Lead sponsor

University of California, San Diego is the lead sponsor of 958 studies on the registry; 191 are open to participants now.

Of its 110 completed or terminated interventional studies of FDA-regulated products, 70 (64%) have results posted.

Study arms

• Active comparator
  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).

  Behavioral: Original Tailored Intervention

• Experimental
  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.

  Behavioral: Enhanced Tailored Intervention

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.

Primary outcomes

1. 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

Secondary outcomes

1. 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

2. 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

3. 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

4. Changes in Triglycerides

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

   Time frame: Baseline, 6 months

Baseline characteristics

Publications

• Marcus BH, Dunsiger S, Pekmezi D, Benitez T, Larsen B, Meyer D. Physical activity outcomes from a randomized trial of a theory- and technology-enhanced intervention for Latinas: the Seamos Activas II study. J Behav Med. 2022 Feb;45(1):1-13. doi: 10.1007/s10865-021-00246-6. Epub 2021 Aug 11. PubMed 34379236 ↗

Study documents

• Study protocol · Dec 4, 2020
• Statistical analysis plan · Sep 25, 2015

Documents are hosted by the registry — open the source record to download them.