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Recruiting NCT06979297

Promoting Physical Activity and Healthy Eating in Latinas

No phase Interventional Physical Inactivty Physical Activity Diet Quality

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Web-based physical activity and diet intervention, Wait-list control arm.
Who it may be relevant to
Registry conditions: Physical Inactivty, Physical Activity, Diet Quality. Basic parameters: from 18 years · Female.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

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

Overview

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.

Interventions

  • Behavioral Web-based physical activity and diet intervention
    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.
  • Other Wait-list control arm
    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 outcome measures

  • Accelerometer-measured min/week moderate to vigorous physical activity (MVPA) [Time frame: Baseline and 12 weeks]
  • Consumption of fruit and vegetables [Time frame: Baseline and 12 weeks]
  • Consumption of sugar-sweetened beverages [Time frame: Baseline and 12 weeks]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Prevention

Study locations

United States · 1 center
  • Brown University — Providence

Identifiers

NCT: NCT06979297 · 2022003270 · 5K01HL159044

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗