Healthy Lifestyle Education for Latino Families

Overseen By Larkin L. Strong

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: M.D. Anderson Cancer Center

Disqualifiers: Pregnancy, Weight loss surgery, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 8

Duration: 6 months

600 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

Do I have to stop taking my current medications for this trial?

The trial protocol does not specify whether you need to stop taking your current medications.

What data supports the effectiveness of the treatment Tu Salud Si Cuenta! for Latino families?

Research shows that culturally-tailored lifestyle programs, like those reviewed in studies, can improve health outcomes in Latino communities by focusing on physical activity and nutrition education. These programs have been effective in addressing obesity and improving health knowledge, suggesting that similar approaches could benefit Latino families participating in Tu Salud Si Cuenta!. ^{1 2 3 4 5}

Is the Healthy Lifestyle Education for Latino Families program safe for participants?

The Healthy Lifestyle Education for Latino Families program, similar to other community-based health education initiatives like Salud Para Su Corazón, has been shown to improve knowledge and behaviors related to heart health without any reported safety concerns. These programs are generally considered safe as they focus on education and lifestyle changes. ^{6 7 8 9 10}

How is the treatment 'Tu Salud Si Cuenta!' unique compared to other treatments for promoting a healthy lifestyle among Latino families?

The 'Tu Salud Si Cuenta!' treatment is unique because it focuses on culturally tailored education and support for Latino families, emphasizing healthy lifestyle changes through community engagement and culturally relevant materials, unlike standard treatments that may not address cultural and linguistic needs. ^{6 11 12 13 14}

Research Team

Larkin Strong

Principal Investigator

M.D. Anderson Cancer Center

Eligibility Criteria

This trial is for Hispanic/Latino families in certain Houston neighborhoods who speak English or Spanish, are able to do some physical activity, and have a working cell phone. They should not be very active or eat many fruits and veggies. Pregnant individuals, those in similar programs, planning to move away from Houston soon, or with past weight loss surgery can't join.

Inclusion Criteria

Able to enroll with one eligible adult family member

I am cleared for low-to-moderate exercise.

Blood pressure reading less than 160/100 mmHg, or with medical clearance

Exclusion Criteria

Plans to move outside the greater Houston area during the study period

I have had weight loss surgery in the past.

Pregnancy or considering pregnancy during the study period, self-reported

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

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.

6 months

6 visits (in-person), weekly text messages

Follow-up

Participants are monitored for changes in physical activity and nutrition outcomes after the intervention

6 months

2 visits (in-person) at 6 and 12 months

Treatment Details

Interventions

• Tu Salud Si Cuenta!

Trial Overview The study tests the 'Tu Salud Si Cuenta!' program which aims to promote healthier lifestyles among Latino families through education on healthy living and homes. It involves visits, questionnaires, and text messages as part of the intervention.

Participant Groups

Group I: Group II (home visit, information about healthy homes) Experimental Treatment 4 Interventions

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.

Group II: Group I (home visit, information about healthy lifestyles) Experimental Treatment 4 Interventions

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.

Who Is Running the Clinical Trial?

M.D. Anderson Cancer Center

Lead Sponsor

Trials

3,107

Recruited

1,813,000+

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+

National Heart, Lung, and Blood Institute (NHLBI)

Collaborator

Trials

3,987

Recruited

47,860,000+

Findings from Research

The Environmental Health/Home Safety Education Project has effectively increased knowledge and changed behaviors related to fire and food safety among participants living on the U.S.-Mexico border, demonstrating its impact from 2002 to 2005.

Utilizing trained community members (promotoras) for home assessments has led to significant improvements in home safety, making the project sustainable and appealing for future funding.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Environmental Health/Home Safety Education Project: a successful and practical U.S.-Mexico border initiative. Forster-Cox, SC., Mangadu, T., Jacquez, B., et al.[2019]

The Papás Saludables, Niños Saludables (PSNS) program, a 10-week lifestyle intervention for Hispanic fathers and children, received positive feedback for its culturally relevant content on nutrition and physical activity, highlighting its effectiveness in improving father-child bonding.

Participants, including 26 fathers, 26 mothers, and 45 children, suggested extending the program duration, indicating a strong engagement and interest in continuing the lifestyle changes promoted by PSNS.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Papás Saludables, Niños Saludables: Perspectives From Hispanic Parents and Children in a Culturally Adapted Father-Focused Obesity Program. Perez, O., Beltran, A., Isbell, T., et al.[2022]

References

1. Netherlands pubmed.ncbi.nlm.nih.gov

Trends in Evidence-Based Lifestyle Interventions Directed at Obese and Overweight Adult Latinos in the US: A Systematic Review of the Literature. [2021]

2. United States pubmed.ncbi.nlm.nih.gov

Culturally-Tailored Education Programs to Address Health Literacy Deficits and Pervasive Health Disparities among Hispanics in Rural Shelbyville, Kentucky. [2023]

3. Netherlands pubmed.ncbi.nlm.nih.gov

The effectiveness of a community health program in improving diabetes knowledge in the Hispanic population: Salud y Bienestar (Health and Wellness). [2021]

4. United States pubmed.ncbi.nlm.nih.gov

Integrating health literacy and ESL: an interdisciplinary curriculum for Hispanic immigrants. [2021]

5. England pubmed.ncbi.nlm.nih.gov

Evaluation of ¡Vivir Mi Vida! to improve health and wellness of rural-dwelling, late middle-aged Latino adults: results of a feasibility and pilot study of a lifestyle intervention. [2021]

6. Netherlands pubmed.ncbi.nlm.nih.gov

Preferences among immigrant Hispanic women for written educational materials regarding upper respiratory infections. [2021]

7. United States pubmed.ncbi.nlm.nih.gov

The Environmental Health/Home Safety Education Project: a successful and practical U.S.-Mexico border initiative. [2019]

8. United States pubmed.ncbi.nlm.nih.gov

A Qualitative Exploration of Less Acculturated Mexican Mothers' Safety Perceptions of Herbs, Medicines, and Cleaners in the Home. [2018]

9. England pubmed.ncbi.nlm.nih.gov

Impact evaluation of a healthy lifestyle intervention to reduce cardiovascular disease risk in health centers in San José, Costa Rica and Chiapas, Mexico. [2019]

10. United States pubmed.ncbi.nlm.nih.gov

Salud Para Su Carozón--a Latino promotora-led cardiovascular health education program. [2021]

11. England pubmed.ncbi.nlm.nih.gov

Engaging Community With Promotores de Salud to Support Infant Nutrition and Breastfeeding Among Latinas Residing in Los Angeles County: Salud con Hyland's. [2021]

12. Spain pubmed.ncbi.nlm.nih.gov

[The food jaima, food guide for the Saharawi children host families]. [2016]

13. England pubmed.ncbi.nlm.nih.gov

Outcomes from a multiple risk factor diabetes self-management trial for Latinas: ¡Viva Bien! [2022]

14. United States pubmed.ncbi.nlm.nih.gov

Papás Saludables, Niños Saludables: Perspectives From Hispanic Parents and Children in a Culturally Adapted Father-Focused Obesity Program. [2022]