Seamos Saludables - Physical Activity Intervention Study for Latinas

NCT01583140 | Completed

• 2 other identifiers: SALUDABLES-20095R01NR011295
• Study Type: interventional
• Target: 312
• Locations: 1 country
• Sites: 1

Brief Summary

In this study the investigators are specifically targeting Latina women because they are more likely to be inactive and, therefore, are at higher risk for developing chronic conditions like obesity, diabetes, or cardiovascular disease. Through focus groups and cognitive interviews with Latinas in the Providence area, the investigators have modified our print-based intervention, already tested and proven to be effective in English-speaking communities, to be culturally and linguistically appropriate for the Latina community. The objective of Seamos Saludables is to determine whether this culturally tailored print intervention will produce greater increases in physical activity levels among Latina women than a program focused on general health topics. Participants are randomly assigned to one of two groups (exercise and general wellness) and attend 4 clinic visits to complete baseline and follow-up assessments. The investigators hypothesize that at the end of treatment, intervention participants will report significantly more minutes of at least moderate intensity physical activity per week than the wellness contact control participants.

Conditions

Sedentary Lifestyle

Keywords

physical activity; Latinas

Outcome Measures

Primary 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 including time spent sleeping and in moderate, hard, and very hard activity. The 7-Day PAR is used across many studies in physical activity and has consistently demonstrated acceptable reliability, internal consistency, and congruent validity with other more objective measures of activity levels, along with sensitivity to changes in both moderate and intensive levels of physical activity.

  6 and 12 months

Study Arms (2)

Exercise Intervention

EXPERIMENTAL

Culturally-modified, individually tailored physical activity print materials

Behavioral: Physical Activity Intervention

Control

ACTIVE COMPARATOR

Bilingual health education booklets

Behavioral: Wellness control

Interventions

Wellness control BEHAVIORAL

Participants in the Wellness Control arm of the study receive a variety of print materials focused on general health topics.

Control

Physical Activity Intervention BEHAVIORAL

Participants in the Physical Activity Intervention arm of the study receive culturally-modified, individually tailored physical activity print materials.

Exercise 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:

• Females
• Generally healthy
• Sedentary (Less than 60 minutes per week of mod or vigorous physical activity)
• Latina (self-defined)
• Must be able to read and write Spanish fluently
• years of age
• Planning on living in the area for the next 12 months

You may not qualify if:

• Pregnant or planning on becoming pregnant
• 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
• Heart disease/treatment
• Heart murmur
• Angina/chest pain or Angina/chest pain with exertion
• Palpitations
• Stroke/TIA
• Peripheral vascular disease
• Diabetes I or II
• Chronic Infectious Disease - HIV, Hepatitis
• Chronic liver disease
• Cystic fibrosis
• Abnormal EKG on last EKG performed

Sponsors & Collaborators

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

Study Sites (1)

Brown University Institute for Community Health Promotion

Providence, Rhode Island, 02903, United States

Location

Related Publications (4)

• Pekmezi DW, Neighbors CJ, Lee CS, Gans KM, Bock BC, Morrow KM, Marquez B, Dunsiger S, Marcus BH. A culturally adapted physical activity intervention for Latinas: a randomized controlled trial. Am J Prev Med. 2009 Dec;37(6):495-500. doi: 10.1016/j.amepre.2009.08.023.

  PMID: 19944914 BACKGROUND

• Benitez TJ, Dunsiger S, Marquez B, Larsen B, Pekmezi D, Marcus BH. Increases in Muscle-Strengthening Activities Among Latinas in Seamos Saludables. Health Educ Behav. 2022 Jun;49(3):446-454. doi: 10.1177/10901981221074908. Epub 2022 Feb 28.

  PMID: 35227112 DERIVED

• Larsen B, Gilmer T, Pekmezi D, Napolitano MA, Marcus BH. Cost effectiveness of a mail-delivered individually tailored physical activity intervention for Latinas vs. a mailed contact control. Int J Behav Nutr Phys Act. 2015 Nov 11;12:140. doi: 10.1186/s12966-015-0302-5.

  PMID: 26559336 DERIVED

• Marcus BH, Dunsiger SI, Pekmezi D, Larsen BA, Marquez B, Bock BC, Gans KM, Morrow KM, Tilkemeier P. Twelve-month physical activity outcomes in Latinas in the Seamos Saludables trial. Am J Prev Med. 2015 Feb;48(2):179-182. doi: 10.1016/j.amepre.2014.08.032. Epub 2014 Nov 6.

  PMID: 25442225 DERIVED

MeSH Terms

Conditions

Sedentary Behavior; Motor Activity

Condition Hierarchy (Ancestors)

Behavior

Study Officials

• Bess H Marcus, Ph.D.

  University of California, San Diego

  PRINCIPAL INVESTIGATOR

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, Department of Family and Preventive Medicine

Study Record Dates

• First Submitted: March 6, 2012
• First Posted: April 23, 2012
• Study Start: October 1, 2009
• Primary Completion: September 1, 2012
• Study Completion: September 1, 2012
• Last Updated: January 28, 2013

Record last verified: 2013-01

Locations

US (1)