NCT06979297

Brief 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, 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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
70

participants targeted

Target at P50-P75 for not_applicable

Timeline
14mo left

Started May 2025

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress43%
May 2025Jul 2027

First Submitted

Initial submission to the registry

May 16, 2025

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 18, 2025

Completed
10 days until next milestone

Study Start

First participant enrolled

May 28, 2025

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2027

Expected
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 31, 2027

Last Updated

June 3, 2025

Status Verified

May 1, 2025

Enrollment Period

2 years

First QC Date

May 16, 2025

Last Update Submit

June 2, 2025

Conditions

Keywords

healthy eatingdietary interventionlifestyle interventionphysical activityphysical inactivity

Outcome Measures

Primary Outcomes (3)

  • 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.

    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.

    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.

    Baseline and 12 weeks

Study Arms (2)

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

Interventions

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.

Web-based physical activity and diet intervention

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.

Wait-list control arm

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Brown University

Providence, Rhode Island, 02912, United States

RECRUITING

MeSH Terms

Conditions

Motor ActivitySedentary Behavior

Condition Hierarchy (Ancestors)

Behavior

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 16, 2025

First Posted

May 18, 2025

Study Start

May 28, 2025

Primary Completion (Estimated)

June 1, 2027

Study Completion (Estimated)

July 31, 2027

Last Updated

June 3, 2025

Record last verified: 2025-05

Locations