Fitness Intensive Therapy (Get FIT) to Promote Healthy Living in Older Adults
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 54
- 试验地点
- 9
- 主要终点
- Change from Baseline diet patterns at 3 months and 6 months
研究概览
简要总结
This study, "Fitness Intensive Therapy (Get FIT) to Promote Healthy Living in Older Adults", will test a mobile-health based intervention which includes use of a Fitbit activity tracker for 3 months, a smartphone application that tracks daily food intake, and one 45 minute counseling session to create personal goals and provide patient education by a health coach; versus Get FIT+ (the same items) plus personalized text messages focusing on participant's activity and nutrition progress as monitored in the app, from the health coach for 3 months. The investigators will measure the impact on participant's diet, physical activity, clinical outcomes, psychosocial well-being, and engagement.
详细描述
This study, "Fitness Intensive Therapy (Get FIT) to Promote Healthy Living in Older Adults", will test 2 behavioral interventions in community-dwelling older adults (age ≥ 60 years) at intermediate and high risk of cardiovascular disease.
- Get FIT: use of a Fitbit activity tracker, smartphone application to track daily food intake, one 45 minute counseling session to create personal goals and provide patient education by a health coach; vs.
- Get FIT+: use of a Fitbit activity tracker, smartphone application to track daily food intake, one 45 minute counseling session to create personal goals and provide patient education by a health coach, and personalized push-only text messages from the health coach based on participant's progress as monitored electronically in the application.
Each intervention lasts 3 months, with outcomes measured at baseline, 3 months, and 6 months.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 60 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •aged 60 or greater
- •at intermediate (10-20%) or high risk (>20%) of developing cardiovascular disease (as measured by Framingham Risk Assessment Tool)
- •poor eating behaviors (as measured by Block Fruit/Vegetable/Fiber Screener)
- •reduced physical activity (as measured by Block Adult Physical Activity Screener)
排除标准
- •cognitive impairment (as measured by Mini-Cog) that impairs ability to understand consent process, surveys, or use of mobile health devices
- •chronic drug use
- •end stage renal, liver, or pulmonary disease
- •current active cancer (i.e., undergoing active treatment for cancer)
- •gastrointestinal disease which requires a special diet (e.g. Crohn's, celiac, etc).
结局指标
主要结局
Change from Baseline diet patterns at 3 months and 6 months
时间窗: baseline, 3 months, 6 months
3-Day Food Record (ASA24); data from self-recorded diet as entered in smartphone application (My Fitness Pal©)
Change from Baseline adherence to recommended self-care behaviors at 3 months and 6 months
时间窗: baseline, 3 months, 6 months
The Medical Outcomes Study Specific Adherence Scale measures patient adherence to 8 recommended health behaviors (3 items on specific diet/nutrition, 1 item on smoking cessation, 1 item on alcoholic beverages, 1 item on taking prescribed medications, 1 item on regular exercise, 1 item on weight/fluid, 1 item on symptom management). Participants circle the answer that best corresponds to their behavior in the last 4 weeks ("None of the time; 1-A little of the time; 2-Some of the time; 3-A good bit of the time; 4-Most of the time; 5-All of the time"). Scoring is the average of the items for a total specific adherence score.
Change from baseline physical activity levels at 3 months and 6 months
时间窗: baseline, 3 months, 6 months
data from Fitbit activity tracker as recorded in smartphone application (My Fitness Pal©)
次要结局
- Change from Baseline height in centimeters(baseline, 3 months, 6 months)
- Change from baseline body composition-area(baseline, 6 months)
- Change from baseline in blood pressure(baseline, 3 months, 6 months)
- Change from baseline body composition-Total Mass(baseline, 6 months)
- Change from baseline in patient activation(baseline, 3 months, 6 months)
- Change from baseline body composition-Fat mass(baseline, 6 months)
- Change from baseline in Anxiety and Depression symptoms(baseline, 3 months, 6 months)
- Change from baseline weight in kilograms(baseline, 3 months, 6 months)
- Change from baseline body composition-Bone Mineral Density (BMD)(baseline, 6 months)
- cost effectiveness(6 months)
- Change from baseline body composition-Bone Mineral Content (BMC)(baseline, 6 months)
- Change from baseline in High-Density Lipoproteins (HDL)(baseline, 3 months, 6 months)
- Change from baseline in total cholesterol score(baseline, 3 months, 6 months)
- change from baseline in patterns of use of clinic attendance(baseline, 3 months, 6 months)
- change from baseline in patterns of use of mHealth(baseline, 3 months, 6 months)
- change from baseline in HgA1c(baseline, 3 months, 6 months)
- Change from baseline body composition-Lean mass(baseline, 6 months)
- Change from baseline in Low-Density Lipoproteins (LDL)(baseline, 3 months, 6 months)
- Change from baseline in Triglycerides(baseline, 3 months, 6 months)
- change from baseline in quality of life(baseline, 3 months, 6 months)
- Change from baseline body composition-% fat(baseline, 6 months)
- change from baseline in patterns of use of Retention(baseline, 3 months, 6 months)
研究者
Lorraine Evangelista
Professor
University of California, Irvine