Inactivity, PhysicalNCT05613231
Web-based Muscle-strengthening and Aerobic Physical Activity Intervention for Latinas
A study testing Aerobic plus muscle-strengthening physical activity intervention and Original physical activity intervention in people with Inactivity, Physical, run by Brown University at 1 site in United States.
Trial summary
The disproportionately low physical activity (PA) in Latinas, particularly muscle-strengthening activities, and related chronic diseases (e.g., obesity, diabetes, cancer) signifies an urgent public health concern. Read more about this study
- Who is it for?
- Ages 18 to 65 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Inactivity, Physical
- What is being tested?
- Aerobic plus muscle-strengthening physical activity intervention and Original physical activity intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 3 Nov 2022to 22 Apr 2024
- 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 65 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Female
- Sedentary (Less than 60 minutes per week of moderate or vigorous physical activity)
- Self-identify as Hispanic or Latino (or of a group defined as Hispanic/Latino by the Census Bureau
- Must be able to read and write Spanish fluently
- 18 - 65 years of age
- Have regular access to an Internet-connected device through home, work, or their community (e.g., public library, community center, neighbor's house) and video capabilities on cell phone, tablet, computer, for baseline and 12-week assessments.
Who cannot join
- Any orthopedic condition that would limit mobility
- History of heart disease, stroke or any other health condition that would make physical activity unsafe
- BMI above 45 kg/m2
- Current or planned pregnancy in the next 12 weeks
- Does not have regular access to an Internet-connected device
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Increasing Aerobic and Muscle-strengthening Physical Activity in Latinas Via Interactive Web-based Technology
The disproportionately low physical activity (PA) in Latinas, particularly muscle-strengthening activities, and related chronic diseases (e.g., obesity, diabetes, cancer) signifies an urgent public health concern. To address the lack of interventions promoting muscle-strengthening activities exclusively for Latinas, the investigators are testing the preliminary efficacy of a culturally and linguistically relevant, web-based aerobic plus muscle-strengthening PA intervention in this at-risk population. The web-based intervention provides a more comprehensive and highly disseminable approach for reducing PA-related health disparities in Latinas.
Read the detailed description
Cancer is the leading cause of death among Latinos in the U.S. While engaging in a physically active lifestyle is one of the most important modifiable behaviors for reducing cancer risk; few Latinas achieve health-enhancing levels of physical activity (PA) recommended by the National PA Guidelines, particularly for muscle strengthening activities (MSA). For instance, 44% of Latinas meet the national guidelines for aerobic PA but only 17% meet the full guidelines for both aerobic and MSA. While the benefits of aerobic MVPA are well established for cancer and chronic disease prevention, participating in regular MSA may be key to further reducing cancer risk, as adherence to MSA guidelines has been associated with a 19% to 31% lower cancer mortality risk, independent of aerobic PA. There is a need for interventions promoting MSA in Latinas. However, only a select few MSA interventions have included Latinas in their sample, and none to the investigators' knowledge, were designed exclusively for this population or addressed socio-cultural factors influencing Latinas' muscle strengthening behaviors (e.g., perception that MSA is for men; MSA is an avoided topic in their culture and social circles; belief that women should only do certain types of MSA). Moreover, existing interventions often involved in-person exercise programs, which can be inaccessible to many Latinas due to barriers such as lack of transportation or fear of immigration enforcement. The research team has previously developed and tested aerobic moderate-to-vigorous PA (MVPA) interventions for Latinas that overcome barriers to in-person programs and address PA-related socio-cultural factors. These theory-driven, individually tailored interventions have shown success at increasing aerobic MVPA among Latina women in both print and Internet-based randomized controlled trials, and now provide an ideal platform for promoting MSA in this at-risk population. To address the gap in literature on MSA, the investigators recently conducted qualitative interviews with 19 Latinas to identify theory-based barriers and facilitators of muscle strengthening PA, then developed MSA intervention materials and further refined them for cultural appropriateness, relevance, and appeal in Latinas. In the proposed research, the investigators will incorporate the newly developed MSA promotion materials into the existing web-based aerobic MVPA intervention and conduct a 12-week fully online randomized pilot trial testing the preliminary efficacy of the newly adapted web-based aerobic plus MSA intervention for Latinas. Fifty Latina adults (i.e., aged 18-65 years) will be randomized to either the: 1) original aerobic MVPA intervention arm, or 2) aerobic MVPA plus MSA intervention arm. This study aims to: 1) Assess the preliminary efficacy of the aerobic plus MSA intervention for increasing MSA, and 2) Explore potential mediators and moderators of MSA. This interactive and highly disseminable approach can achieve significant health improvements in an at-risk population.
- Conditions
- Inactivity, Physical
- Being tested
- Aerobic plus muscle-strengthening physical activity intervention, Original physical activity intervention
- Keywords
- physical activity, muscle-strengthening activity, strength training, Latinas, women, intervention, Internet
- Medical subject headings
- Sedentary Behavior, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Aerobic plus muscle-strengthening physical activity interventionBehavioural
The intervention is a 12-week Spanish language, Internet-based intervention promoting both aerobic and muscle-strengthening physical activity for Latina women.
Original physical activity interventionBehavioural
The intervention is a 12-week Spanish language, Internet-based intervention promoting aerobic physical activity for Latina women.
| Study group | Role | What they receive |
|---|---|---|
| Aerobic plus Muscle-Strengthening Activity Intervention | Experimental | Participants will receive access to a web-based, individually tailored, theory-driven aerobic moderate-to-vigorous physical activity (MVPA) intervention that was enhanced with content on muscle-strengthening activity. Receives: Behavioral: Aerobic plus muscle-strengthening physical activity intervention |
| Original Physical Activity Intervention | Active comparator | Participants will receive access to a web-based, individually tailored, theory-driven aerobic moderate-to-vigorous physical activity (MVPA) intervention Receives: Behavioral: Original physical activity intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in physical activity as reported by the 7-Day Physical Activity Recall (PAR) from baseline to week 12.
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.
Measured: Baseline and week 12
Change in muscle strengthening activities as reported by the Modifiable Physical Activity Questionnaire (MAQ)
The MAQ will assess frequency, intensity and duration of muscle strengthening activity
Measured: Baseline and week 12
Secondary outcomes (3)
Change in objectively measured physical activity as reported by ActiGraph accelerometer wear.
For the week prior to each assessment, participants will wear an Actigraph GT3X+ accelerometer which collects min/week of objectively measured MVPA
Measured: Baseline and week 12
Change in upper body strength will be assessed by the one-minute repeated push-up test from baseline to week 12.
Participants will complete a 1-minute repeated push-up test via Zoom video that will be used as an objective measure upper body strength.
Measured: Baseline and week 12
Change in lower body strength will be assessed by the one-minute repeated squat test from baseline to week 12..
Participants will complete a 1-minute repeated squat test via Zoom video that will be used as an objective measure upper body strength.
Measured: Baseline and week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Nov 2022
- Study start3 Nov 2022
- Primary completion22 Apr 2024
- Study completion22 Apr 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Inactivity, PhysicalStudies of the same condition, open and under way.
- More trials run by Brown UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Brown University
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Principal investigator, Tanya Benitez, Brown University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05613231
- Sponsor's protocol ID
- 2104002972
- Other IDs
- R03CA252500
- Status last verified
- Aug 2024
- First submitted
- 28 Oct 2022
- Last updated
- 12 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Increasing Aerobic and Muscle-strengthening Physical Activity in Latinas Via Interactive Web-based Technology
- ClinicalTrials.gov ID
- NCT05613231
- Acronym / sponsor ID
- 2104002972
- Conditions
- Inactivity, Physical
- Keywords
- physical activity, muscle-strengthening activity, strength training, Latinas, women, intervention, Internet
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Brown UniversityUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 3 Nov 2022 (actual)
- Primary completion
- 22 Apr 2024 (actual)
- Study completion
- 22 Apr 2024 (actual)
- First posted
- 14 Nov 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The disproportionately low physical activity (PA) in Latinas, particularly muscle-strengthening activities, and related chronic diseases (e.g., obesity, diabetes, cancer) signifies an urgent public health concern. To address the lack of interventions promoting muscle-strengthening activities exclusively for Latinas, the investigators are testing the preliminary efficacy of a culturally and linguistically relevant, web-based aerobic plus muscle-strengthening PA intervention in this at-risk population. The web-based intervention provides a more comprehensive and highly disseminable approach for reducing PA-related health disparities in Latinas.
Detailed description
Cancer is the leading cause of death among Latinos in the U.S. While engaging in a physically active lifestyle is one of the most important modifiable behaviors for reducing cancer risk; few Latinas achieve health-enhancing levels of physical activity (PA) recommended by the National PA Guidelines, particularly for muscle strengthening activities (MSA). For instance, 44% of Latinas meet the national guidelines for aerobic PA but only 17% meet the full guidelines for both aerobic and MSA. While the benefits of aerobic MVPA are well established for cancer and chronic disease prevention, participating in regular MSA may be key to further reducing cancer risk, as adherence to MSA guidelines has been associated with a 19% to 31% lower cancer mortality risk, independent of aerobic PA. There is a need for interventions promoting MSA in Latinas. However, only a select few MSA interventions have included Latinas in their sample, and none to the investigators' knowledge, were designed exclusively for this population or addressed socio-cultural factors influencing Latinas' muscle strengthening behaviors (e.g., perception that MSA is for men; MSA is an avoided topic in their culture and social circles; belief that women should only do certain types of MSA). Moreover, existing interventions often involved in-person exercise programs, which can be inaccessible to many Latinas due to barriers such as lack of transportation or fear of immigration enforcement. The research team has previously developed and tested aerobic moderate-to-vigorous PA (MVPA) interventions for Latinas that overcome barriers to in-person programs and address PA-related socio-cultural factors. These theory-driven, individually tailored interventions have shown success at increasing aerobic MVPA among Latina women in both print and Internet-based randomized controlled trials, and now provide an ideal platform for promoting MSA in this at-risk population. To address the gap in literature on MSA, the investigators recently conducted qualitative interviews with 19 Latinas to identify theory-based barriers and facilitators of muscle strengthening PA, then developed MSA intervention materials and further refined them for cultural appropriateness, relevance, and appeal in Latinas. In the proposed research, the investigators will incorporate the newly developed MSA promotion materials into the existing web-based aerobic MVPA intervention and conduct a 12-week fully online randomized pilot trial testing the preliminary efficacy of the newly adapted web-based aerobic plus MSA intervention for Latinas. Fifty Latina adults (i.e., aged 18-65 years) will be randomized to either the: 1) original aerobic MVPA intervention arm, or 2) aerobic MVPA plus MSA intervention arm. This study aims to: 1) Assess the preliminary efficacy of the aerobic plus MSA intervention for increasing MSA, and 2) Explore potential mediators and moderators of MSA. This interactive and highly disseminable approach can achieve significant health improvements in an at-risk population.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Aerobic plus Muscle-Strengthening Activity Intervention | Experimental | Behavioral: Aerobic plus muscle-strengthening physical activity interventionParticipants will receive access to a web-based, individually tailored, theory-driven aerobic moderate-to-vigorous physical activity (MVPA) intervention that was enhanced with content on muscle-strengthening activity. |
| Original Physical Activity Intervention | Active comparator | Behavioral: Original physical activity interventionParticipants will receive access to a web-based, individually tailored, theory-driven aerobic moderate-to-vigorous physical activity (MVPA) intervention |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Female
- Sedentary (Less than 60 minutes per week of moderate or vigorous physical activity)
- Self-identify as Hispanic or Latino (or of a group defined as Hispanic/Latino by the Census Bureau
- Must be able to read and write Spanish fluently
- 18 - 65 years of age
Key exclusion criteria (5 listed)
- Any orthopedic condition that would limit mobility
- History of heart disease, stroke or any other health condition that would make physical activity unsafe
- BMI above 45 kg/m2
- Current or planned pregnancy in the next 12 weeks
- Does not have regular access to an Internet-connected device
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Aerobic plus muscle-strengthening physical activity interventionThe intervention is a 12-week Spanish language, Internet-based intervention promoting both aerobic and muscle-strengthening physical activity for Latina women. | Behavioural | Aerobic plus Muscle-Strengthening Activity Intervention |
| Original physical activity interventionThe intervention is a 12-week Spanish language, Internet-based intervention promoting aerobic physical activity for Latina women. | Behavioural | Original Physical Activity Intervention |
Primary outcome
Change in physical activity as reported by the 7-Day Physical Activity Recall (PAR) from baseline to week 12.
Time frame: Baseline and week 12
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.
Change in muscle strengthening activities as reported by the Modifiable Physical Activity Questionnaire (MAQ)
Time frame: Baseline and week 12
The MAQ will assess frequency, intensity and duration of muscle strengthening activity
3 secondary outcomes
Change in objectively measured physical activity as reported by ActiGraph accelerometer wear.
Time frame: Baseline and week 12
Change in upper body strength will be assessed by the one-minute repeated push-up test from baseline to week 12.
Time frame: Baseline and week 12
Change in lower body strength will be assessed by the one-minute repeated squat test from baseline to week 12..
Time frame: Baseline and week 12
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Aug 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Aerobic plus muscle-strengthening physical activity intervention and Original physical activity intervention in people with Inactivity, Physical, run by Brown University 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 12 Aug 2024. 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. 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 in physical activity as reported by the 7-Day Physical Activity Recall (PAR) from baseline to week 12. (time frame: Baseline and week 12). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 12 Aug 2024.