NCT03199209

Brief Summary

This trial studies how well a theoretically-based motivational behavior change program called Tu Salud Si Cuenta! works in promoting healthy lifestyles in Latino families. Tu Salud Si Cuenta! will deliver programs on healthy lifestyles and healthy homes to Hispanic/Latino families and may help to improve their health.

Trial Health

75
On Track

Trial Health Score

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

Enrollment
600

participants targeted

Target at P75+ for not_applicable

Timeline
32mo left

Started Jun 2016

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
active not recruiting

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress79%
Jun 2016Dec 2028

Study Start

First participant enrolled

June 6, 2016

Completed
1 year until next milestone

First Submitted

Initial submission to the registry

June 22, 2017

Completed
4 days until next milestone

First Posted

Study publicly available on registry

June 26, 2017

Completed
11.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2028

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2028

Last Updated

February 19, 2026

Status Verified

February 1, 2026

Enrollment Period

12.6 years

First QC Date

June 22, 2017

Last Update Submit

February 17, 2026

Conditions

Keywords

physical activityhealthy eatingbehavioral interventioncommunity health workerHispanic/Latino

Outcome Measures

Primary Outcomes (2)

  • Changes in Physical Activity

    Changes in physical activity determined by using univariable and multivariable mixed effect models.

    12 months

  • Increase in Fruit and Vegetable (F/V) Consumption

    Assuming 1.6 portions of F/V consumed per day in the control group, power calculations show that Poisson regression model with a 0.05 two-sided significance level has 80% power to detect a 22% or greater increase (rate ratio (RR) =1.22) in portions of F/V consumption for intervention group if we have total 522 participants (261 dyads) with Intra-cluster correlation coefficient (ICC) of 0.08.

    12 months

Study Arms (2)

Group I (home visit, information about healthy lifestyles)

EXPERIMENTAL

Participants and their family member meet with a community health worker in their home over 90 minutes to learn about physical activity, healthy eating, and to set goals, once a month for 6 months. Participants also receive 2-5 text messages per week that contain health tips related to healthy lifestyles and information about local resources. Participants also attend a study visit with a research staff over 90-120 minutes at a community center, MD Anderson, or at home at baseline, 6 months, and 12 months.

Other: Behavioral, Psychological or Informational InterventionBehavioral: Patient VisitOther: Questionnaire AdministrationOther: Text Message

Group II (home visit, information about healthy homes)

EXPERIMENTAL

Participants and their family member meet with a community health worker in their home over 90 minutes to receive information on how to be safe and healthy at home and information about indoor air quality, home safety, CPR/first aid, how to prepare for emergencies, and keeping pests away, once a month for 6 months. Participants also receive 2-5 text messages per week that contain information about healthy homes and local resources. Participants also attend a study visit with a research staff over 90-120 minutes at a community center, MD Anderson, or at home at baseline, 6 months, and 12 months.

Other: Behavioral, Psychological or Informational InterventionBehavioral: Patient VisitOther: Questionnaire AdministrationOther: Text Message

Interventions

Patient VisitBEHAVIORAL

Attend study visit with research staff

Also known as: Healthcare Visit, Patient Encounter, Subject Visit, visit
Group I (home visit, information about healthy lifestyles)Group II (home visit, information about healthy homes)

Receive information about healthy lifestyles

Group I (home visit, information about healthy lifestyles)

Ancillary studies

Group I (home visit, information about healthy lifestyles)Group II (home visit, information about healthy homes)

Receive information about healthy lifestyles

Also known as: Text; SMS Text Message; SMS Text
Group I (home visit, information about healthy lifestyles)

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Self-reported Hispanic/Latino ethnicity.
  • Speak English or Spanish.
  • Physically able to engage in low-to-moderate physical activity (PA) as assessed by the PA Readiness Questionnaire (PAR-Q), or with medical clearance.
  • Insufficient self-reported moderate-to-vigorous PA (\< 150 minutes/week) or limited fruits and vegetable (FV) intake (defined as less than or equal to 4 cups of FV combined or \< 1 cup of vegetables per day).
  • Able to enroll with one eligible adult family member.
  • Valid home address in the Houston neighborhoods of Gulfton, the East End/Magnolia, Northside, Pasadena or adjacent neighborhoods.
  • Have a functioning cellular telephone and able and willing to send and receive text messages.
  • Blood pressure reading less than 160/100 mmHg, or with medical clearance.

You may not qualify if:

  • Pregnancy or considering pregnancy during the study period, self-reported.
  • Currently participating in a program or research study to promote physical activity, healthy eating, or weight loss.
  • Plans to move outside the greater Houston area during the study period.
  • Past weight loss surgery.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

M D Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Related Links

MeSH Terms

Conditions

Motor Activity

Condition Hierarchy (Ancestors)

Behavior

Study Officials

  • Larkin Strong

    M.D. Anderson Cancer Center

    PRINCIPAL INVESTIGATOR

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

June 22, 2017

First Posted

June 26, 2017

Study Start

June 6, 2016

Primary Completion (Estimated)

December 31, 2028

Study Completion (Estimated)

December 31, 2028

Last Updated

February 19, 2026

Record last verified: 2026-02

Locations