Tu Salud ¡Si Cuenta! (Your Health Matters!): Promoting Healthy Lifestyles in Latino Family Dyads
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 600
- 试验地点
- 1
- 主要终点
- Increase in Fruit and Vegetable (F/V) Consumption
研究概览
简要总结
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.
详细描述
PRIMARY OBJECTIVES:
I. To evaluate the efficacy of the Tu Salud, Si Cuenta! Familiar (TSSC-Family) intervention in facilitating positive changes in physical activity and nutrition among Latino adults not meeting physical activity or nutrition recommendations.
SECONDARY OBJECTIVES:
I. To test the effects of TSSC-Family on hypothesized intervention mechanisms (e.g., self-efficacy, stage of change, social support, social control), and the role of those mechanisms in mediating TSSC-Family effects of physical activity and nutrition outcomes.
OUTLINE: Participants are randomized to 1 of 2 groups.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Self-reported Hispanic/Latino ethnicity.
- •Speak English or Spanish.
- •Physically able to engage in low-to-moderate physical activity (PA) as assessed by the PA Readiness Questionnaire (PAR-Q), or with medical clearance.
- •Insufficient self-reported moderate-to-vigorous PA (< 150 minutes/week) or limited fruits and vegetable (FV) intake (defined as less than or equal to 4 cups of FV combined or < 1 cup of vegetables per day).
- •Able to enroll with one eligible adult family member.
- •Valid home address in the Houston neighborhoods of Gulfton, the East End/Magnolia, Northside, Pasadena or adjacent neighborhoods.
- •Have a functioning cellular telephone and able and willing to send and receive text messages.
- •Blood pressure reading less than 160/100 mmHg, or with medical clearance.
排除标准
- •Pregnancy or considering pregnancy during the study period, self-reported.
- •Currently participating in a program or research study to promote physical activity, healthy eating, or weight loss.
- •Plans to move outside the greater Houston area during the study period.
- •Past weight loss surgery.
研究组 & 干预措施
Group I (home visit, information about healthy lifestyles)
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.
干预措施: Behavioral, Psychological or Informational Intervention (Other)
Group I (home visit, information about healthy lifestyles)
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.
干预措施: Patient Visit (Behavioral)
Group I (home visit, information about healthy lifestyles)
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.
干预措施: Questionnaire Administration (Other)
Group I (home visit, information about healthy lifestyles)
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.
干预措施: Text Message (Other)
Group II (home visit, information about healthy homes)
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.
干预措施: Behavioral, Psychological or Informational Intervention (Other)
Group II (home visit, information about healthy homes)
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.
干预措施: Patient Visit (Behavioral)
Group II (home visit, information about healthy homes)
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.
干预措施: Questionnaire Administration (Other)
Group II (home visit, information about healthy homes)
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.
干预措施: Text Message (Other)
结局指标
主要结局
Increase in Fruit and Vegetable (F/V) Consumption
时间窗: 12 months
Assuming 1.6 portions of F/V consumed per day in the control group, power calculations show that Poisson regression model with a 0.05 two-sided significance level has 80% power to detect a 22% or greater increase (rate ratio (RR) =1.22) in portions of F/V consumption for intervention group if we have total 522 participants (261 dyads) with Intra-cluster correlation coefficient (ICC) of 0.08.
Changes in Physical Activity
时间窗: 12 months
Changes in physical activity determined by using univariable and multivariable mixed effect models.
次要结局
未报告次要终点