Clinical trial NCT03199365: Tu Salud Si Cuenta Intervention in Increasing Physical Activity and Healthy Eating Among Latino Families
Official title: Tu Salud ¡Si Cuenta! Reaching Latino Family Dyads to Increase Physical Activity and Healthy Eating
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Healthy Subject
Lead sponsor: M.D. Anderson Cancer Center
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
name: National Heart, Lung, and Blood Institute (NHLBI)
First posted: 2017-06-26
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: 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.

Detailed description: PRIMARY OBJECTIVES:

I. Conduct formative research with adult Latino family dyads to assess the home environment and current behaviors, and identify perceived determinants of healthy eating and physical activity (PA) within the family context.

II. Adapt the "Tu Salud Si Cuenta" (TSSC) intervention to focus on increasing physical activity (PA) and healthy eating among adult Latino family dyads (TSSC-Family).

III. Evaluate the acceptability of intervention content, materials, and procedures with adult Latino family dyads.

OUTLINE:

FORMATIVE RESEARCH: To adapt the intervention, participants undergo immersive assessment over 3 hours which is conducted by research staff and involves examination of the home food and PA environments, objective and self-reported PA, nutritional intake, demographics and relevant psychosocial measures. Participants are also instructed to wear an accelerometer device to measure physical activity for up to 7 days and participate in in-depth interviews over 1.5 hours.

PRE-TESTING: Participants undergo two TSSC intervention sessions delivered at participants' homes by trained community health workers (CHWs) over 1.5 hours.

Eligibility criteria: Inclusion Criteria:

1. Self-reported Hispanic/Latino ethnicity
2. Age 18-65 years
3. Speak English or Spanish
4. Physically able to engage in low-to-moderate PA
5. Consumption of fewer than 5 servings of fruits and vegetables per day
6. Valid home address in the Houston neighborhoods of Gulfton, the East End/Magnolia, or Near Northside, or adjacent neighborhoods
7. Working telephone number

Exclusion Criteria:

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

Primary outcomes:
measure: Identification of perceived determinants of healthy eating and physical activity (PA) as determined by questionnaires and interviews
timeFrame: Up to 2 years
measure: Evaluate and adapt the "Tu Salud Si Cuenta" (TSSC/Your Health Matters!) intervention
timeFrame: Up to 2 years
measure: Evaluate the acceptability of intervention content, materials, and procedures
timeFrame: Up to 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Houston
country: United States
facility: M D Anderson Cancer Center
state: Texas
Study officials:
affiliation: M.D. Anderson Cancer Center
name: Larkin Strong
role: PRINCIPAL_INVESTIGATOR
References: