Culturally and Linguistically Adapted Physical Activity Intervention for Latinas

NCT02630953 | Completed Results DMC

• 2 other identifiers: Seamos Activas2R01NR011295
• Study Type: interventional
• Target: 214
• Locations: 1 country
• Sites: 1

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.

Conditions

Inactivity

Keywords

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

Outcome Measures

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.

  Baseline, 6 months and 12 months

Secondary Outcomes (4)

• 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

• Changes in Cardiovascular and Metabolic Biomarkers (e.g., HbA1c, and LDL)

  Baseline, 6 months

• Changes in Cholesterol

  Baseline, 6 months

• Changes in Triglycerides

  Baseline, 6 months

Study Arms (2)

Original Tailored Intervention

ACTIVE COMPARATOR

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

Enhanced Tailored Intervention

EXPERIMENTAL

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

Original Tailored Intervention BEHAVIORAL

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).

Original Tailored Intervention

Enhanced Tailored Intervention BEHAVIORAL

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.

Enhanced Tailored Intervention

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of California, San Diego: lead
• National Institute of Nursing Research (NINR): collaborator

Study Sites (1)

University of California San Diego

La Jolla, California, 92093-0628, United States

Location

Related Publications (2)

• Larsen B, Gilmer T, Pekmezi D, Hartman SJ, Benitez T, Rabin B, Marcus BH, Mendoza-Vasconez AS, Groessl EJ. Cost effectiveness of a technology-enhanced physical activity intervention for Latinas. Transl Behav Med. 2023 Sep 12;13(9):675-682. doi: 10.1093/tbm/ibad021.

  PMID: 37208924 DERIVED

• 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.

  PMID: 34379236 DERIVED

MeSH Terms

Conditions

Sedentary Behavior; Motor Activity

Condition Hierarchy (Ancestors)

Behavior

Results Point of Contact

• Title: Dr. Bess Marcus, Principle Investigator
• Organization: Brown University

bess_marcus@brown.edu

401-863-6950

Study Officials

• Bess H Marcus, PhD

  University of California, San Diego

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor and Chair

Study Record Dates

• First Submitted: December 11, 2015
• First Posted: December 15, 2015
• Study Start: February 1, 2016
• Primary Completion: July 31, 2019
• Study Completion: July 31, 2019
• Last Updated: March 4, 2021
• Results First Posted: March 4, 2021

Record last verified: 2021-03

Locations

US (1)