Physical InactivtyNCT06979297
Promoting Physical Activity and Healthy Eating in Latinas
A study testing Web-based physical activity and diet intervention in people with Physical Inactivty and Physical Activity, run by Brown University at 1 site in United States.
Trial summary
The goal of this clinical trial is to learn if an Internet-based behavioral intervention can increase physical activity and improve diet quality among Latina adults. The main question aims to answer is whether participants in the Internet-based behavioral intervention group increase their physical activity levels… Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Physical Inactivty, Physical Activity, Diet Quality
- What is being tested?
- Web-based physical activity and diet intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteUnited States
- Study dates
- 28 May 2025to 31 Jul 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Ages 18 years and over; Self-identify as Hispanic or Latino (or of a group defined as Hispanic/Latino by the Census Bureau); Report insufficient PA levels (according to the national PA guidelines); Consume less than 1.5 cups of fruit/day and 2.5 cups of vegetables/day, and/or consume SSB ≥2 times/week; Have regular access to an Internet-connected device through phone, home, work, or their community (e.g., public library, community center, neighbor's house); Are not pregnant or planning to become pregnant during the course of the study.
Who cannot join
- Any orthopedic condition that would limit their mobility; History of heart disease, stroke or any other health condition that would make PA or dietary change unsafe.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Brown University
Providence, Rhode Island, 02912
Tanya Benitez, PhD, 401-863-6928, tanya_benitez@brown.edu
About this study
Official title: Promoting Physical Activity and Healthy Eating in Latinas Via Interactive Web-Based Technology
The goal of this clinical trial is to learn if an Internet-based behavioral intervention can increase physical activity and improve diet quality among Latina adults. The main question aims to answer is whether participants in the Internet-based behavioral intervention group increase their physical activity levels, increase their consumption of fruits and vegetables, and decrease their consumption of sugar-sweetened beverages over 12 weeks. Researchers will compare the Internet-based physical activity and healthy eating intervention to a wait-list control group (participants who do not receive any intervention until after completing the study) to see if the Internet-based behavioral intervention works to improve physical activity and diet quality. Participants who receive the Internet-based behavioral intervention receive access to the online intervention for 12 weeks, and complete assessments at baseline and week-12. Participants in the wait-list control complete the same assessments at baseline and week 12, then receive access to the online intervention for 12 weeks.
Read the detailed description
Participants (N=70) will be Latinas aged 18 years and over who report insufficient physical activity levels, insufficient consumption of fruits and vegetables, and regular consumption of sugar-sweetened beverages (according to the National Guidelines for Physical Activity and National Dietary Guidelines for Americans). Participants who meet eligibility criteria will attend an online orientation session where they will receive thorough information about the study, including any risks/benefits, study requirements and expectations, and will have the opportunity to ask questions about the study. Latinas who are interested in participating will complete the informed consent process and will be mailed an accelerometer with detailed instruction to wear during the next seven days (until their baseline visit). At their online baseline visit, participants will complete physical activity and dietary assessments and will be randomized to one of two study conditions: 1) the PA and Diet Intervention, or 2) the wait-list control. Participants randomized to the PA and Diet Intervention arm will be given access to an interactive Internet-based intervention for 12 weeks, will establish their goals for increasing fruits and vegetables, decreasing sugar-sweetened beverages, and increasing physical activity, and will complete assessments at baseline and 12 weeks. Participants in the wait-list control will complete the same measures as the intervention group for the first 12 weeks, then will receive access to the Internet-based intervention for another 12 weeks.
- Conditions
- Physical Inactivty, Physical Activity, Diet Quality
- Being tested
- Web-based physical activity and diet intervention, Wait-list control arm
- Keywords
- healthy eating, dietary intervention, lifestyle intervention, physical activity, physical inactivity
- Medical subject headings
- Motor Activity, Sedentary Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Web-based physical activity and diet interventionBehavioural
Participants receive access to a theory-driven, web-based intervention for 12 weeks that provides interactive information on diet and physical activity, including goal setting, diet and activity tracking, tailored information on healthy eating and increasing exercise, and videos on topics of healthy eating and physical activity.
Wait-list control armOther
Participants in the wait-list control will complete all the same measures as the intervention group for the first 12 weeks, then will receive access to the Internet-based intervention for another 12 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Web-based physical activity and diet intervention | Experimental | Not described Receives: Behavioral: Web-based physical activity and diet intervention |
| Wait-list control arm | Other | Not described Receives: Other: Wait-list control arm |
What is being measured
The primary outcome is the main question the study is designed to answer.
Accelerometer-measured min/week moderate to vigorous physical activity (MVPA)
All participants will wear an Actigraph GT3X+ accelerometer during the week prior to their baseline and week 12 assessments. The Actigraph is a device that measures movement and intensity of activity and has been validated against heart rate telemetry and total energy expenditure.
Measured: Baseline and 12 weeks
Consumption of fruit and vegetables
All participants will complete the NCI Eating at America's Table All Day Fruit and Vegetable Screener at baseline and week 12. The NCI Eating at America's Table Fruit and Vegetable Screener is self-report questionnaire that assesses the frequency of usual fruit and vegetable consumption.
Measured: Baseline and 12 weeks
Consumption of sugar-sweetened beverages
All participants will complete the Beverage Intake Questionnaire (BEV-Q) at baseline and week 12. The BEV-Q is a self-administered, valid and reliable tool measuring the frequency and amount of beverages consumed in 19 categories of drinks, including sugar-sweetened beverages.
Measured: Baseline and 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 May 2025
- Study start28 May 2025
- Primary completion1 Jun 2027 (estimated)
- Study completion31 Jul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Physical InactivtyStudies 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
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Brown University
- Sponsor type
- University, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06979297
- Sponsor's protocol ID
- 2022003270
- Other IDs
- 5K01HL159044
- Status last verified
- May 2025
- First submitted
- 16 May 2025
- Last updated
- 3 Jun 2025
- 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 3 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Promoting Physical Activity and Healthy Eating in Latinas Via Interactive Web-Based Technology
- ClinicalTrials.gov ID
- NCT06979297
- Acronym / sponsor ID
- 2022003270
- Conditions
- Physical Inactivty, Physical Activity, Diet Quality
- Keywords
- healthy eating, dietary intervention, lifestyle intervention, physical activity, physical inactivity
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Brown UniversityUniversity, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Study start
- 28 May 2025 (actual)
- Primary completion
- 1 Jun 2027 (estimated)
- Study completion
- 31 Jul 2027 (estimated)
- First posted
- 18 May 2025 (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 goal of this clinical trial is to learn if an Internet-based behavioral intervention can increase physical activity and improve diet quality among Latina adults. The main question aims to answer is whether participants in the Internet-based behavioral intervention group increase their physical activity levels, increase their consumption of fruits and vegetables, and decrease their consumption of sugar-sweetened beverages over 12 weeks. Researchers will compare the Internet-based physical activity and healthy eating intervention to a wait-list control group (participants who do not receive any intervention until after completing the study) to see if the Internet-based behavioral intervention works to improve physical activity and diet quality. Participants who receive the Internet-based behavioral intervention receive access to the online intervention for 12 weeks, and complete assessments at baseline and week-12. Participants in the wait-list control complete the same assessments at baseline and week 12, then receive access to the online intervention for 12 weeks.
Detailed description
Participants (N=70) will be Latinas aged 18 years and over who report insufficient physical activity levels, insufficient consumption of fruits and vegetables, and regular consumption of sugar-sweetened beverages (according to the National Guidelines for Physical Activity and National Dietary Guidelines for Americans). Participants who meet eligibility criteria will attend an online orientation session where they will receive thorough information about the study, including any risks/benefits, study requirements and expectations, and will have the opportunity to ask questions about the study. Latinas who are interested in participating will complete the informed consent process and will be mailed an accelerometer with detailed instruction to wear during the next seven days (until their baseline visit). At their online baseline visit, participants will complete physical activity and dietary assessments and will be randomized to one of two study conditions: 1) the PA and Diet Intervention, or 2) the wait-list control. Participants randomized to the PA and Diet Intervention arm will be given access to an interactive Internet-based intervention for 12 weeks, will establish their goals for increasing fruits and vegetables, decreasing sugar-sweetened beverages, and increasing physical activity, and will complete assessments at baseline and 12 weeks. Participants in the wait-list control will complete the same measures as the intervention group for the first 12 weeks, then will receive access to the Internet-based intervention for another 12 weeks.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Web-based physical activity and diet intervention | Experimental | Behavioral: Web-based physical activity and diet intervention |
| Wait-list control arm | Other | Other: Wait-list control arm |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Ages 18 years and over; Self-identify as Hispanic or Latino (or of a group defined as Hispanic/Latino by the Census Bureau); Report insufficient PA levels (according to the national PA guidelines); Consume less than 1.5 cups of fruit/day and 2.5 cups of vegetables/day, and/or consume SSB ≥2 times/week; Have regular access to an Internet-connected device through phone, home, work, or their community (e.g., public library, community center, neighbor's house); Are not pregnant or planning to become pregnant during the course of the study.
Key exclusion criteria (1 listed)
- Any orthopedic condition that would limit their mobility; History of heart disease, stroke or any other health condition that would make PA or dietary change unsafe.
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 |
|---|---|---|
| Web-based physical activity and diet interventionParticipants receive access to a theory-driven, web-based intervention for 12 weeks that provides interactive information on diet and physical activity, including goal setting, diet and activity tracking, tailored information on healthy eating and increasing exercise, and videos on topics of healthy eating and physical activity. | Behavioural | Web-based physical activity and diet intervention |
| Wait-list control armParticipants in the wait-list control will complete all the same measures as the intervention group for the first 12 weeks, then will receive access to the Internet-based intervention for another 12 weeks. | Other | Wait-list control arm |
Primary outcome
Accelerometer-measured min/week moderate to vigorous physical activity (MVPA)
Time frame: Baseline and 12 weeks
All participants will wear an Actigraph GT3X+ accelerometer during the week prior to their baseline and week 12 assessments. The Actigraph is a device that measures movement and intensity of activity and has been validated against heart rate telemetry and total energy expenditure.
Consumption of fruit and vegetables
Time frame: Baseline and 12 weeks
All participants will complete the NCI Eating at America's Table All Day Fruit and Vegetable Screener at baseline and week 12. The NCI Eating at America's Table Fruit and Vegetable Screener is self-report questionnaire that assesses the frequency of usual fruit and vegetable consumption.
Consumption of sugar-sweetened beverages
Time frame: Baseline and 12 weeks
All participants will complete the Beverage Intake Questionnaire (BEV-Q) at baseline and week 12. The BEV-Q is a self-administered, valid and reliable tool measuring the frequency and amount of beverages consumed in 19 categories of drinks, including sugar-sweetened beverages.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jun 2025.
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Web-based physical activity and diet intervention in people with Physical Inactivty and Physical Activity, 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 1 inclusion and 1 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: looking for participants now, as of the sponsor's last update on 3 Jun 2025. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Accelerometer-measured min/week moderate to vigorous physical activity (MVPA) (time frame: Baseline and 12 weeks). The study lists 3 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 3 Jun 2025.