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NCT Number: NCT06979297

Promoting Physical Activity and Healthy Eating in Latinas

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.

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Key information

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Brown University

Providence, Rhode Island, 02912, United States

Location status: Recruiting

Location contact

Tanya Benitez, PhD

CONTACT

[email protected]

401-863-6928

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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.

Exclusion criteria

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.

Treatment and study plan

Web-based physical activity and diet intervention

Behavioral

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 arm

Other

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.

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

Sponsors and collaborators

Lead sponsor

Brown University

Other

Collaborators

  • National Heart, Lung, and Blood Institute (NHLBI)

Registry information

Official study title

Promoting Physical Activity and Healthy Eating in Latinas Via Interactive Web-Based Technology

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
May 18, 2025
Registry last updated
Jun 3, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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