Healthy Lifestyle Program for Well-Being in Latino Families

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: M.D. Anderson Cancer Center

Disqualifiers: Pregnancy

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

Compensation: Varies

Number of Visits: 9

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine how a program called Tu Salud Si Cuenta can help Latino families become more active and eat healthier. By improving these habits, the researchers aim to prevent cancer-related diseases and enhance overall quality of life. Participants will attend two sessions, each lasting about 1.5 hours, with trained community health workers visiting their homes. Ideal candidates are Latino adults living in specific Houston neighborhoods who currently consume fewer than five servings of fruits and vegetables daily and can engage in light to moderate physical activity. As an unphased trial, this study offers a unique opportunity to contribute to community health improvements and personal well-being.

Will I have to stop taking my current medications?

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

What prior data suggests that the Tu Salud Si Cuenta program is safe for promoting healthy behaviors?

Research shows that the Tu Salud Si Cuenta program is generally safe and well-received. In past studies, this program helped Latino families become more active and eat healthier. No reports of harmful effects have emerged from participation in the program.

The program encourages habits like eating more fruits and vegetables and exercising more. These changes are typically safe and can help reduce the risk of diseases linked to cancer. Since the program focuses on healthy lifestyle changes instead of medication, it avoids the risks associated with some drugs.

Overall, many communities have successfully used the Tu Salud Si Cuenta program without major safety concerns. Participants usually find it to be a positive and supportive experience. ^{1 2 3 4 5}

Why are researchers excited about this trial?

The Tu Salud Si Cuenta (TSSC) intervention is unique because it leverages community health workers (CHWs) to deliver personalized health education directly in participants' homes. Unlike standard treatments that often involve clinic visits or impersonal programs, this method provides a culturally tailored approach that respects and integrates the values of Latino families. Researchers are excited about this treatment because it addresses health and well-being through community engagement and empowerment, potentially leading to more sustainable lifestyle changes.

What evidence suggests that the Tu Salud Si Cuenta intervention is effective for increasing physical activity and healthy eating habits?

Research has shown that the Tu Salud Si Cuenta Program, which participants in this trial will undergo, helps improve health for people with chronic conditions like high blood pressure and obesity. Studies have found that participation in the program is linked to better eating habits and increased physical activity. The program encourages Latino families to eat more fruits and vegetables and to watch their portion sizes. Early results suggest these changes can lead to weight loss and better overall health. By adopting these healthier habits, participants might also lower their risk of cancer-related diseases and improve their quality of life. ^{1 2 3 4 6}

Who Is on the Research Team?

Larkin Strong

Principal Investigator

M.D. Anderson Cancer Center

Are You a Good Fit for This Trial?

The trial is for Latino families with adults aged 18-65 who speak English or Spanish, live in specific Houston neighborhoods, and are physically able to do some exercise. They should eat less than 5 servings of fruits and veggies daily. Pregnant individuals or those considering pregnancy during the study can't participate.

Inclusion Criteria

Physically able to engage in low-to-moderate PA

Consumption of fewer than 5 servings of fruits and vegetables per day

Valid home address in the Houston neighborhoods of Gulfton, the East End/Magnolia, or Near Northside, or adjacent neighborhoods

Exclusion Criteria

Pregnancy at any point during the study period OR considering pregnancy during the study period

Timeline for a Trial Participant

Formative Research

Participants undergo immersive assessment to adapt the intervention, including home environment examination and interviews.

1 week

1 visit (in-person), 1 week of accelerometer use

Pre-testing

Participants undergo two TSSC intervention sessions delivered at participants' homes by trained community health workers.

2 weeks

2 visits (in-person)

Intervention

Participants receive the TSSC intervention focusing on physical activity and healthy eating, involving six monthly home visits.

6 months

6 visits (in-person)

Follow-up

Participants are monitored for the effectiveness of the intervention and its acceptability.

Up to 2 years

What Are the Treatments Tested in This Trial?

Interventions

• Tu Salud Si Cuenta Intervention

Trial Overview The 'Tu Salud Si Cuenta' program is being tested to see if it helps increase physical activity and encourages eating more fruits and vegetables among Latino families, potentially preventing cancer-related diseases.

How Is the Trial Designed?

Group I: Prevention (TSSC intervention) Experimental Treatment 2 Interventions

Participants undergo two TSSC intervention sessions delivered at participants' homes by trained CHWs over 1.5 hours.

Who Is Running the Clinical Trial?

M.D. Anderson Cancer Center

Lead Sponsor

Trials

3,107

Recruited

1,813,000+

National Heart, Lung, and Blood Institute (NHLBI)

Collaborator

Trials

3,987

Recruited

47,860,000+

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+

Published Research Related to This Trial

A community needs assessment involving 31 overweight/obese Mexicans in New York City identified key themes for a culturally-tailored weight loss program, SANOS, emphasizing the importance of family support and group motivation for behavior change.

The study highlighted ecological factors, such as acculturation and socioenvironmental barriers, that should be considered when designing effective dietary and lifestyle interventions for Mexican Americans.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Developing a Culturally Responsive Lifestyle Intervention for Overweight/Obese U.S. Mexicans. Leng, J., Lui, F., Narang, B., et al.[2023]

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]

The study aims to evaluate a culturally-grounded lifestyle intervention for Latino families, involving 132 participants, to improve glucose tolerance and quality of life over 12 months.

The intervention includes 16 weeks of nutrition and wellness classes led by bilingual professionals and supervised physical activities, which may enhance family engagement and empowerment in diabetes prevention.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Preventing diabetes in Latino families: A protocol for a randomized control trial. Braxton, ME., Nwabichie, E., Diaz, M., et al.[2023]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5682211/

Tu Salud ¡Sí Cuenta! Your Health Matters! The objective of this study was to assess the associations of exposure to a community-wide campaign with healthy eating, unhealthy eating, and average hip and ...

2. sph.uth.edu sph.uth.edu/research/centers/hispanic-health/tu-salud-si-cuenta/

Tu Salud ¡Si Cuenta! - Hispanic Health Research Center Tu Salud ¡Si Cuenta! is evidence-based, collaborative, innovative, and results-driven - focused on improving health outcomes.

3. withpower.com withpower.com/trial/phase-5-2016-86264

Healthy Lifestyle Program for Well-Being in Latino Families The Tu Salud Si Cuenta Intervention has been shown to improve health outcomes related to chronic diseases like hypertension (high blood pressure) and obesity ...

4. clinicaltrials.gov clinicaltrials.gov/ct2/show/NCT00788879

NCT00788879 | Tu Salud Si Cuenta Media Campaign This intervention posits that increased physical activity and increased fruit and vegetable consumption with smaller portion sizes will result in a decrease in ...

5. ctv.veeva.com ctv.veeva.com/study/your-health-matters-tu-salud-si-cuenta-promoting-healthy-lifestyles-in-latino-families

Promoting Healthy Lifestyles in Latino Families This trial studies how well a theoretically-based motivational behavior change program called Tu Salud Si Cuenta! works in promoting healthy lifestyles in ...

6. withpower.com withpower.com/trial/phase-5-2016-5b1cb

Healthy Lifestyle Education for Latino Families This trial studies how well a theoretically-based motivational behavior change program called Tu Salud Si Cuenta! works in promoting healthy lifestyles in ...