Randomized Control Trial to Reduce Sitting Time in Postmenopausal Latina Women at Increased Risk for Heart Disease
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 254
- 试验地点
- 2
- 主要终点
- Sitting, standing and stepping time
研究概览
简要总结
Project 2 of the University of California, San Diego (UCSD) American Heart Association (AHA) Women's Health Program will assess 3-month changes in sitting time, standing time, physical activity and blood pressure in a randomized control trial (RCT). This 2-arm RCT will occur in the community with post menopausal Latina women (N=250) who spend at least 8 hrs/day sitting and have increased risk for cardiovascular disease through high BMI and other cardiometabolic risk factors. Women will be identified through the San Ysidro Health Center and assessed at the South Bay Latino Research Center.
详细描述
Project 2 will address the following aims:
- Investigate the 3 month effect of the intervention to impact the primary behavioral outcomes of sitting, standing and stepping time assessed objectively by a thigh worn inclinometer (ActivPAL) in Latinas at risk for heart disease.
- Investigate the 3 month effect of the intervention to impact the secondary health outcomes of blood pressure, depressive symptoms, and anthropometrics.
- Explore the psychosocial & environmental mediators & moderators of changes in sitting time.
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
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 55 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •for RCT (n=250):
- •Postmenopausal woman, no menstruation for at least 1 year, 55+ years of age.
- •Self-identify as Hispanic ethnicity, able to read and write in English or Spanish,
- •Ambulatory, medically stable, able to give informed consent, and safely complete the protocols.
- •Body Mass Index range of 25.0-45.0kg/m
- •Sedentary: Average >8 hours sitting/day, as measured by ActivPAL on 4+ days per week
- •Phone access (to receive counseling)
- •Prisoners will not be used for this study.
排除标准
- •applicable only to the RCT intervention trial participants include:
- •Unable to complete the Short Physical Performance Battery.
- •Mental states that would preclude complete understanding of the protocol and compliance.
- •Active cancer or another serious chronic illness that may be associated with weight change
- •Body Mass Index <25.0 or >45.0kg/m
- •Use of insulin medications.
- •≤ 8hr average daily sitting time, as measured by ActivPAL.
- •Participating in another clinical trial related to study outcomes (as determined by the PI).
- •Unable to wear devices
研究组 & 干预措施
Sitting Less group
The 'reduce sitting' intervention group will receive three in-person health coaching sessions followed by five counseling phone calls. Participants will wear a thigh worn inclinometer for the first 3 weeks of the intervention, and at the mid-point of the intervention. At each in-person health coaching session participants will receive feedback from the ActivPAL showing periods throughout the day where participants have been sitting. In addition to the three initial in-person counseling sessions using the ActivPAL feedback, participants will receive phone calls from the health educator biweekly to help overcome barriers, to work on self-monitoring and planning skills, and to prepare relapse prevention. Tools to help prompt standing, including a standing desk, will also be provided.
干预措施: ActivPAL inclinometer (Device)
Sitting Less group
The 'reduce sitting' intervention group will receive three in-person health coaching sessions followed by five counseling phone calls. Participants will wear a thigh worn inclinometer for the first 3 weeks of the intervention, and at the mid-point of the intervention. At each in-person health coaching session participants will receive feedback from the ActivPAL showing periods throughout the day where participants have been sitting. In addition to the three initial in-person counseling sessions using the ActivPAL feedback, participants will receive phone calls from the health educator biweekly to help overcome barriers, to work on self-monitoring and planning skills, and to prepare relapse prevention. Tools to help prompt standing, including a standing desk, will also be provided.
干预措施: Phone counseling call: Breaking up sitting time (Behavioral)
Sitting Less group
The 'reduce sitting' intervention group will receive three in-person health coaching sessions followed by five counseling phone calls. Participants will wear a thigh worn inclinometer for the first 3 weeks of the intervention, and at the mid-point of the intervention. At each in-person health coaching session participants will receive feedback from the ActivPAL showing periods throughout the day where participants have been sitting. In addition to the three initial in-person counseling sessions using the ActivPAL feedback, participants will receive phone calls from the health educator biweekly to help overcome barriers, to work on self-monitoring and planning skills, and to prepare relapse prevention. Tools to help prompt standing, including a standing desk, will also be provided.
干预措施: In-person counseling: Breaking up sitting time (Behavioral)
Sitting Less group
The 'reduce sitting' intervention group will receive three in-person health coaching sessions followed by five counseling phone calls. Participants will wear a thigh worn inclinometer for the first 3 weeks of the intervention, and at the mid-point of the intervention. At each in-person health coaching session participants will receive feedback from the ActivPAL showing periods throughout the day where participants have been sitting. In addition to the three initial in-person counseling sessions using the ActivPAL feedback, participants will receive phone calls from the health educator biweekly to help overcome barriers, to work on self-monitoring and planning skills, and to prepare relapse prevention. Tools to help prompt standing, including a standing desk, will also be provided.
干预措施: Tools to prompt standing (Other)
Attention Control
Participants in the attention control condition will receive a healthy aging educational intervention developed and tested by the investigators in previous studies. This group will receive one in-person coaching session followed by seven phone coaching sessions.
干预措施: Phone counseling call: Healthy living (Behavioral)
Attention Control
Participants in the attention control condition will receive a healthy aging educational intervention developed and tested by the investigators in previous studies. This group will receive one in-person coaching session followed by seven phone coaching sessions.
干预措施: In-person counseling: Healthy living (Behavioral)
结局指标
主要结局
Sitting, standing and stepping time
时间窗: 3 months
Change in daily time spent sitting, standing and stepping during waking hours as measured objectively by the ActivPAL
次要结局
- Psychosocial and environmental mediators: habit formation(3 months)
- Anthropometrics(3 months)
- Psychosocial and environmental mediators: benefits and barriers(3 months)
- Psychosocial and environmental mediators: self-efficacy(3 months)
- Demographic moderators: retirement status(3 months)
- Demographic moderators: age(3 months)
- Demographic moderators: education(3 months)
- Blood pressure(3 months)
- Depressive symptoms(3 months)
- Psychosocial and environmental mediators: home environment support(3 months)
- Improvement in Quality of Life(3 months)
- Psychosocial and environmental mediators: social support(3 months)
- Demographic moderators: sex(3 months)
- Demographic moderators: marital status(3 months)
研究者
Matthew Allison
Professor
University of California, San Diego