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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how the program Tu Salud Si Cuenta! can help Latino families adopt healthier lifestyles. Participants will learn about physical activity, healthy eating, and maintaining a safe home environment. The trial includes two groups: one focusing on lifestyle changes and the other on home safety. Ideal candidates are Hispanic/Latino individuals in Houston who can participate with a family member and seek to improve their physical activity or diet. Participants should be able to engage in light exercise and receive text messages. As an unphased trial, this study offers families a unique opportunity to actively participate in research aimed at enhancing their health and well-being.

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 prior data suggests that this motivational behavior change program is safe for promoting healthy lifestyles in Latino families?

Research has shown that Tu Salud Si Cuenta! is supported by studies aimed at improving community health. These studies found that the program helps people in Hispanic communities eat better and be more active. No major safety issues were reported, indicating that participants generally receive the program well.

Since this trial involves educational programs rather than medications or medical procedures, participants face no risk of physical side effects. The focus is on providing information and encouraging healthier lifestyle choices, which is generally safe. Participants can expect to receive helpful tips and support for living a healthier life without worrying about physical harm. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it focuses on empowering Latino families with practical lifestyle changes that can lead to healthier living. Unlike traditional health education programs that might use generic materials, this trial offers personalized home visits and tailored text messages to meet the specific needs of the community. By involving family members and providing culturally relevant information, the trial aims to create lasting habits and improve overall wellness. This hands-on, family-centered approach is unique and has the potential to bring positive health outcomes that are both sustainable and impactful.

What evidence suggests that this trial's programs could be effective for promoting healthy lifestyles in Latino families?

Studies have shown that the Tu Salud ¡Sí Cuenta! program can effectively improve healthy habits in Latino communities. In this trial, participants in Group I will receive home visits and information about healthy lifestyles, which research has shown increases physical activity to recommended levels. Another study found that participants improved their eating habits and body measurements. Meanwhile, Group II will receive information about maintaining healthy homes. The program's home visits and regular health tips aim to help families make and sustain healthier lifestyle choices. Overall, evidence suggests that this approach can lead to meaningful health improvements in Latino families. ^{1 2 4 6 7}

Who Is on the Research Team?

Larkin Strong

Principal Investigator

M.D. Anderson Cancer Center

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

Citations

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

Tu Salud ¡Sí Cuenta! Your Health Matters! To evaluate a community-wide campaign, Tu Salud ¡Si Cuenta! (TSSC), in improving eating behaviors and anthropometric outcomes in Hispanic border communities.

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. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4642277/

Tu Salud, ¡Si Cuenta!: Exposure to a community-wide ... We examined exposure to a CWC, titled Tu Salud ¡Sí Cuenta!, and its association with meeting the recommended minutes of moderate and vigorous physical activity ...

4. mdanderson.org mdanderson.org/documents/Research%20Areas/prevention-research/tu-salud-si-cuenta-your-health-matters/Tu%20Salud%20Si%20Cuenta%20FAQ%20(English).pdf

Tu Salud Si Cuenta FAQ (English) During these visits, you will answer questions about your food and physical activity habits, your beliefs and attitudes, your neighborhood, and your household.

5. sph.uth.edu sph.uth.edu/research/centers/hispanic-health/tu-salud-si-cuenta/assets/docs/our-initiatives/Home-Visit-Intervention-Promotes-Lifestyle-Changes-2019.pdf

Home Visit Intervention Promotes Lifestyle Changes The program, Tu Salud ¡Si Cuenta! (Your Health. Matters!) at Home Intervention (TSSC), was designed to reach Mexican American adults through 6 monthly home.

6. salud-america.org salud-america.org/research-1-in-4-latino-children-live-in-doubled-up-households/

Research: 1 in 4 Latino Children Live in Doubled-Up ... One quarter (25%) of all Latino children live in doubled-up households, according to new data from the National Research Center on Hispanic ...

7. clinicaltrials.gov clinicaltrials.gov/study/NCT00788879

Tu Salud Si Cuenta Media Campaign (TSSC) The Tu Salud, Si Cuenta (TSSC) media campaign uses behavioral journalism, community outreach and environmental changes to promote physical activity and ...