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Physical ActivityNCT02046343

Promotora-Led Physical Activity Intervention Trial for Latinas in Texas

A study testing Health education, Telephone Counseling and Newsletter in people with Physical Activity, run by The University of Texas Health Science Center at San Antonio at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 18 to 64 years, women onlyHealthy volunteers can take part
Conditions the study is for
Physical Activity
What is being tested?
Health education, Telephone Counseling and Newsletter
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
712 participants
Where
1 siteUnited States
Study dates
Aug 2012to 31 Dec 2016
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 64 years
  • Women only
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • 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

Who cannot join

  • 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 locations and contacts

1 site in 1 country.

United States1 site

  • University of Texas Health Science Center San Antonio

    San Antonio, Texas, 78229

Other trials in United States

About this study

Official title: ENLACE: A Promotora-Led Physical Activity Intervention Trial for Latinas in Texas

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.

Being tested
Health education, Telephone Counseling, Newsletter, Environmental Change
Keywords
physical activity, prevention, health disparities, behavior, community based intervention
Medical subject headings
Motor Activity, Behavior

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Health educationBehavioural

    Group health education sessions delivered by a promotora approximately 90 minutes in length. In the PA arm, health education incorporates at least 30 minutes group exercise.

  • Telephone CounselingBehavioural

    Brief (10 minute) telephone counseling calls delivered by promotoras using motivational interviewing techniques. The counseling calls will emphasize behavior change strategies, including self-monitoring, goal setting, reinforcement, problem solving, stimulus control, and enlisting social support.

  • NewsletterOther

    Educational, motivational and informational newsletters tailored for each community and hand-delivered by promotoras to participant homes.

  • Environmental ChangeOther

    Create a site atmosphere that promotes PA and increases the number of PA program offerings.

Study groups in NCT02046343
Study groupRoleWhat they receive
Physical ActivityExperimentalWeekly 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.
Receives: Behavioral: Health education; Behavioral: Telephone Counseling; Other: Newsletter; Other: Environmental Change
Community Health and SafetyPlacebo comparatorWeekly 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.
Receives: Behavioral: Health education

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change from baseline Moderate-to-vigorous physical activity (MVPA)

    Minutes per week of MVPA is assessed a baseline and immediate post-intervention (16 weeks) using accelerometry. The primary outcome is the amount of change between baseline and immediate post-intervention.

    Measured: 16 weeks

Secondary outcomes (9)

  1. Change from baseline in Physical Fitness

    The "2-minute step in place" test will be used to assess the amount of change in cardiorespiratory fitness (steps/minute) between baseline and immediate post-intervention (16 weeks).

    Measured: 16 weeks

  2. Weight maintenance (Percent Body Fat)

    Weight maintenance is defined as a change in % body fat less than ± 3% of baseline.

    Measured: 16 weeks

  3. Weight maintenance (Body Mass Index)

    Weight maintenance is defined as a change in body mass index (kg/m2) less than ± 3% of baseline.

    Measured: 16 weeks

  4. Weight maintenance (Waist Circumference)

    Weight maintenance is defined as a change in waist circumference less than ± 3% of baseline.

    Measured: 16 weeks

  5. Change from baseline Moderate-to-vigorous physical activity (MVPA)

    Minutes per week of MVPA is assessed a baseline and 24 weeks post-intervention (40 weeks) using accelerometry. The amount of change between baseline and 24 weeks post-intervention will be used to determine if the behavior was maintained.

    Measured: 40 weeks

  6. Weight maintenance (Waist Circumference)

    Weight maintenance is defined as a change in waist circumference less than ± 3% of baseline.

    Measured: 40 weeks

  7. Weight maintenance (Body Mass Index)

    Weight maintenance is defined as a change in body mass index (kg/m2) less than ± 3% of baseline.

    Measured: 40 weeks

  8. Change from baseline in Physical Fitness

    The 2-minute step in place test will be used to assess cardiorespiratory fitness (steps/minute).

    Measured: 40 weeks

  9. Weight maintenance (Percent Body Fat)

    Weight maintenance is defined as a change in % body fat less than ± 3% of baseline.

    Measured: 40 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Jan 2014 (estimated)
  2. Study startAug 2012
  3. Primary completion31 Dec 2016
  4. Study completion31 Dec 2016

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Outcomes assessor
Enrolment
712 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02046343
Sponsor's protocol ID
HSC20110460H
Other IDs
R01HL111718
Status last verified
Aug 2018
First submitted
22 Jan 2014
Last updated
31 Aug 2018
Results posted
No
Data monitoring committee
No

Publications

  • Salinas JJ, Parra-Medina D. Physical activity change after a promotora-led intervention in low-income Mexican American women residing in South Texas. BMC Public Health. 2019 Jun 20;19(1):782. doi: 10.1186/s12889-019-7105-6.

    PubMed 31221117

Questions about this trial

What is this clinical trial studying?

A study testing Health education, Telephone Counseling and Newsletter in people with Physical Activity, run by The University of Texas Health Science Center at San Antonio at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 31 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change from baseline Moderate-to-vigorous physical activity (MVPA) (time frame: 16 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02046343, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Aug 2018.

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