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

80 Participants Needed

Trial Summary

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 data supports the effectiveness of the treatment Tu Salud Si Cuenta Intervention for improving 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 among low-income Latinos. In a study, participants with high exposure to the intervention had significant reductions in blood pressure and weight compared to those with low exposure, indicating its effectiveness in promoting healthier lifestyles. ^{1 2 3 4 5}

Is the Healthy Lifestyle Program for Well-Being in Latino Families safe for participants?

The Tu Salud ¡Si Cuenta! intervention, which is similar to the Healthy Lifestyle Program, has been shown to improve health outcomes like blood pressure and weight loss among low-income Latinos without any reported safety concerns. This suggests that the program is generally safe for participants. ^{1 3 6 7 8}

How is the Tu Salud Si Cuenta Intervention treatment different from other treatments for promoting well-being in Latino families?

The Tu Salud Si Cuenta Intervention is unique because it is specifically designed for Latino families, incorporating cultural values like Familism, which emphasizes family respect and togetherness. This culturally tailored approach addresses food insecurity and promotes a healthy lifestyle, making it distinct from more general interventions. ^{3 9 10 11 12}

What is the purpose of this trial?

This trial studies how a program to encourage healthy behaviors (Tu Salud Si Cuenta) works to increase physical activity and healthy eating habits among Latino families. Improving physical activity and healthy eating habits may help in preventing cancer-related diseases and lead to a better quality of life among Latino families.

Research Team

Larkin Strong

Principal Investigator

M.D. Anderson Cancer Center

Eligibility Criteria

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

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

I have a working phone.

Exclusion Criteria

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

Timeline

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

References

1. Switzerland pubmed.ncbi.nlm.nih.gov

Scaling a Community-Wide Campaign Intervention to Manage Hypertension and Weight Loss. [2023]

2. 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]

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

Developing a Culturally Responsive Lifestyle Intervention for Overweight/Obese U.S. Mexicans. [2023]

4. 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]

5. Netherlands pubmed.ncbi.nlm.nih.gov

A Pilot Group-Based Lifestyle Intervention to Promote Weight Loss Among Mexican Immigrants. [2023]

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

Community engagement approach: developing a culturally appropriate intervention for Hispanic mother-child dyads. [2022]

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

Effectiveness of the Pasos Adelante chronic disease prevention and control program in a US-Mexico border community, 2005-2008. [2023]

8. England pubmed.ncbi.nlm.nih.gov

"It's about being healthy"; a novel approach to the socio-ecological model using family perspectives within the Latinx community. [2023]

9. 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]

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

Preventing diabetes in Latino families: A protocol for a randomized control trial. [2023]

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

A Healthy Lifestyle Intervention for Hispanic Families: Moderating Effects of Education, Income, Nativity. [2022]

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

Randomized-controlled trial of a whole-family obesity prevention and treatment intervention designed for low-income Hispanic families: HeLP the healthy living program. [2023]