SALSA: Study of Active LifeStyle Activation
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 374
- 试验地点
- 3
- 主要终点
- Sedentary time
研究概览
简要总结
This clinical trial evaluates several behavioral interventions for the improvement of physical activity in cancer patients. Childhood and adolescent/young adult cancer survivors have been reported to have poor diet quality and rarely meet recommended physical activity guidelines. This trial aims to see whether a tailored intervention based on self-determination theory may help to improve physical activity and dietary change.
详细描述
OUTLINE: Patients are randomized to Arms 1, 2, or 3.
ARM 1: Patients receive a personalized clinician-led self-management telehealth session at baseline and 2 months. Patients with poor response at 3 months are randomized to Arm 2 or 4, otherwise patients receive the same telehealth session at months 4 and 6. Patients may receive 2 additional telehealth sessions after 6 months.
ARM 2: Patients receive personalized goal setting for daily steps and activity (updated weekly) and 3 dietary goals (updated monthly) with social media peer support for 6 months. Patients with poor response at 3 months are randomized to Arms 1 or 4. Patients may receive personalized goal setting for daily steps and activity (updated monthly) and dietary goals (updated every 2 months) after 6 months.
ARM 3: Patients receive no intervention for 12 months. After 12 months, they may optionally receive their choice of intervention for up to 6 months.
ARM 4: If Arms 1 or 2 patients have poor response after 3 months, patients may be re-randomized to Arm 4. Patients receive remote sessions with a health coach every 1-2 weeks for 3 months. Patients may continue to receive remote sessions once a month after 3 months, during the maintenance phase (months 6-12).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Sequential
- 主要目的
- Prevention
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 54 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Childhood Cancer Survivor Study (CCSS) participant who is between age 18 to < 55 years at time of initial approach
- •Moderate to high CV risk status based on CCSS risk prediction models for cardiomyopathy and ischemic heart disease
- •Able to read, write, and speak English
- •Ability to understand and the willingness to provide informed consent
- •At least one of the following:
- •Less than 30 minutes/day of moderate to vigorous physical activity (MVPA) based on validated self-report instrument (Godin)
- •Healthy Eating Index (HEI)-2015 score < 60 per study food frequency questionnaire (FFQ)
- •Body mass index (BMI) >= 25 kg/m^2 per self-reported height and weight
- •Be free of any known (self-reported) ischemic heart disease or cardiomyopathy
- •Have internet access (can be via smartphone or computer; if neither device is available, the study can loan participants a Wi-Fi enabled device, but participant will need to have access to the internet)
排除标准
- •Individuals with known cardiomyopathy or ischemic heart disease based on prior CCSS surveys are excluded. While not likely to be common, participants who newly report in our study's screening questionnaire that they have newly diagnosed cardiomyopathy or ischemic heart disease will also be excluded
- •Having any self-reported contraindication to walking or being physically active
- •Not currently known to be pregnant; individuals known to be pregnant and otherwise eligible for the study can be enrolled once no longer known to be pregnant. Participants who report being pregnant after randomization can remain in the study
- •Individuals receiving active cancer treatment. Participants who report starting active cancer treatment after randomization can remain in the study
研究组 & 干预措施
Arm 1 (personalized clinician-led self-management telehealth)
Patients receive a personalized clinician-led self-management telehealth session at baseline and 2 months. Patients with poor response at 3 months are randomized to Arm 2 or 4, otherwise patients receive the same telehealth session at months 4 and 6. Patients may receive 2 additional telehealth sessions after 6 months.
干预措施: Behavioral Intervention (Behavioral)
Arm 1 (personalized clinician-led self-management telehealth)
Patients receive a personalized clinician-led self-management telehealth session at baseline and 2 months. Patients with poor response at 3 months are randomized to Arm 2 or 4, otherwise patients receive the same telehealth session at months 4 and 6. Patients may receive 2 additional telehealth sessions after 6 months.
干预措施: Survey Administration (Other)
Arm 1 (personalized clinician-led self-management telehealth)
Patients receive a personalized clinician-led self-management telehealth session at baseline and 2 months. Patients with poor response at 3 months are randomized to Arm 2 or 4, otherwise patients receive the same telehealth session at months 4 and 6. Patients may receive 2 additional telehealth sessions after 6 months.
干预措施: Interview (Other)
Arm 2 (personalized goal setting)
Patients receive personalized goal setting for daily steps and activity (updated weekly) and 3 dietary goals (updated monthly) with social media peer support for 6 months. Patients with poor response at 3 months are randomized to Arms 1 or 4. Patients may receive personalized goal setting for daily steps and activity (updated monthly) and dietary goals (updated monthly) after 6 months.
干预措施: Behavioral Intervention (Behavioral)
Arm 2 (personalized goal setting)
Patients receive personalized goal setting for daily steps and activity (updated weekly) and 3 dietary goals (updated monthly) with social media peer support for 6 months. Patients with poor response at 3 months are randomized to Arms 1 or 4. Patients may receive personalized goal setting for daily steps and activity (updated monthly) and dietary goals (updated monthly) after 6 months.
干预措施: Survey Administration (Other)
Arm 2 (personalized goal setting)
Patients receive personalized goal setting for daily steps and activity (updated weekly) and 3 dietary goals (updated monthly) with social media peer support for 6 months. Patients with poor response at 3 months are randomized to Arms 1 or 4. Patients may receive personalized goal setting for daily steps and activity (updated monthly) and dietary goals (updated monthly) after 6 months.
干预措施: Interview (Other)
Arm 3 (waitlist)
Patients receive no intervention for 12 months. After 12 months, they may optionally receive their choice of intervention for up to 6 months.
干预措施: Survey Administration (Other)
Arm 3 (waitlist)
Patients receive no intervention for 12 months. After 12 months, they may optionally receive their choice of intervention for up to 6 months.
干预措施: Interview (Other)
Arm 4 (remote sessions with a health coach)
Arm 1 and 2 patients with poor response after 3 months can be re-randomized to Arm 4. Patients receive remote sessions with a health coach every 1-2 weeks for 3 months. Patients may continue to receive remote sessions once a month after 3 months, during the maintenance phase (months 6-12).
干预措施: Behavioral Intervention (Behavioral)
Arm 4 (remote sessions with a health coach)
Arm 1 and 2 patients with poor response after 3 months can be re-randomized to Arm 4. Patients receive remote sessions with a health coach every 1-2 weeks for 3 months. Patients may continue to receive remote sessions once a month after 3 months, during the maintenance phase (months 6-12).
干预措施: Survey Administration (Other)
结局指标
主要结局
Sedentary time
时间窗: Up to 12 months
\<100 counts/minute as measured by research-grade accelerometry
Healthy Eating Index (HEI)-2015 score
时间窗: Up to 12 months
On a scale of 100 (perfect score) as measured by Food Frequency Questionnaire
次要结局
- Participant engagement(Up to 12 months)
- Health-related self-efficacy scale(Up to 12 months)
- Multidimensional Health Locus of Control Scale(Up to 12 months)