Promotora-Led Physical Activity Intervention Trial for Latinas in Texas

The University of Texas System (UT)

Status: Completed

Conditions: Physical Activity

Treatments: Other: Newsletter; Behavioral: Telephone Counseling; Other: Environmental Change; Behavioral: Health education

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT02046343

HSC20110460H

R01HL111718 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

The purpose of this study it to determine if a promotora-led intervention that takes a comprehensive, multi-level, community-based approach to promoting physical activity (PA) is effective among a particularly underserved segment of Latinas. We hypothesize that Latinas in the promotora-led PA Intervention will significantly increase minutes per week of moderate-to-vigorous physical activity (MVPA) compared to Latinas in the attention-control group.

Enrollment: 712 patients

Sex: Female

Ages: 18 to 64 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• women ages 18-64 years
• self-identify as Hispanic
• have a personal telephone
• reside within and intend to stay in the specified areas over the entire study period
• understand Spanish
• do not currently meet national PA recommendations

Exclusion criteria

• currently pregnant or plan to become pregnant
• insulin dependent diabetic
• uncontrolled hypertension
• undergoing therapy for life-threatening illnesses (chemotherapy or radiation therapy)
• positive (risk) responses on the PA Readiness Questionnaire (PAR-Q) and subsequent physician disapproval

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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712 participants in 2 patient groups, including a placebo group

Physical Activity

Experimental group

Description:

Weekly promotora-led group sessions on physical activity (16 weeks) and followed by monthly telephone counseling and newsletters during the 24 week maintenance period. Promotoras will also implement environmental change strategies to increase the number of PA program offerings available to study participants.

Treatment:

Other: Newsletter

Behavioral: Health education

Other: Environmental Change

Behavioral: Telephone Counseling

Community Health and Safety

Placebo Comparator group

Description:

Weekly promotora-led group sessions on home safety/first aid (16 weeks) followed by and monthly generic health education materials and informational telephone calls during the 24 week maintenance period.

Treatment:

Behavioral: Health education