The Lifestyle, Exercise, and Diet Trial: A Virtual, Lifestyle Approach to Improve Cognition
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 140
- 试验地点
- 2
- 主要终点
- Feasibility: Recruitment
研究概览
简要总结
The objective of this study is to investigate the feasibility of a virtually-delivered 6-month exercise and nutrition intervention in older adults with executive subjective cognitive decline (SCD). Feasibility will be determined by recruitment, retention, and adherence rates. Preliminary changes in cognition, physical function, and quality of life will be assessed as secondary outcomes. The study will recruit 140 participants aged 65 to 80 who report they feel that their memory or other thinking abilities are declining. Participants will be randomized into one of four study arms receiving different combinations of healthy lifestyle interventions. Assessments will be conducted virtually at baseline, post-intervention (6 months), and follow-up (12 months). All intervention sessions and assessment visits will be conducted online using the Zoom Healthcare platform and participants will log on using their own devices from home.
详细描述
The study will be a randomized control trial examining the feasibility of a 6-month virtually delivered exercise and nutrition intervention in older adults with executive SCD. The study aims to recruit 140 participants. After initial contact with potential participants, 2 screening visits (up to 45 minutes each) will be conducted to assess eligibility and obtain consent to participate in the study. At the start of the program, after completing the program (6 months), and at follow-up (12 months), assessors will conduct 2 assessments (30-65 min each) using Zoom video conferencing to measure thinking abilities, physical function, and quality of life. Participants will be randomized into one of four 6-month intervention arms (35 individuals per group x 4 groups): 1) EX + DIET: aerobic and resistance exercise (EX) with healthy diet counseling (DIET), 2) EX + ED: aerobic and resistance exercise (EX) with education on healthy lifestyle related to brain health (ED), 3) STRETCH + DIET: stretching and toning exercises (STRETCH) with healthy diet counseling (DIET), 4) STRETCH + ED: stretching and toning exercises (STRETCH) with education on healthy lifestyle related to brain health (ED). All groups that receive EX and/or DIET will also receive the "Adult Strategies Put Into Real World Environments" (ASPIRE) goal strategy training, with goals focused on exercise and/or diet in order to overcome barriers and increase maintenance of lifestyle changes. All intervention sessions and assessment visits will be conducted online using the Zoom Healthcare platform, and participants will log on using their own devices from home.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Prevention
- 盲法
- Double (Participant, Outcomes Assessor)
盲法说明
Outcome assessors will be masked to intervention group.
Careful wording will be used to describe the intervention groups to participants as to not disclose whether they are in experimental or control groups. For instance, all participants will be told that they will be receiving different combinations of exercise (stretching/toning is the control for aerobic/resistance exercise) and healthy lifestyle interventions (lifestyle education is control for dietary intervention).
入排标准
- 年龄范围
- 65 Years 至 80 Years（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •65-80 years old
- •Meet criteria for executive SCD
- •Answer Yes to both following questions:
- •Do you feel like your memory or thinking is becoming worse?
- •Does this worry you?
- •≥1SD above age and sex-based means on any of the sub scales of the Comprehensive Executive Function Inventory (CEFI) - Adult Version, indicative of concerns about executive function.
- •No objective cognitive impairment as indicated by:
- •A global Clinical Dementia Rating (CDR) of ≤ 0.5
- •A Blind Montreal Cognitive Assessment (MoCA) total score of >17
- •Able to communicate in English
- •Residents of Quebec, Ontario, Manitoba, and Saskatchewan to facilitate concurrent intervention delivery
- •Low physical activity levels (<75min/week of moderate/vigorous physical activity on the Get Active Questionnaire)
- •Screened safe to participate in moderate exercise using the Get Active Questionnaire or physician approval to engage in moderate intensity exercise without in-person supervision
- •Poor diet quality (below Canadian older adults' median intake of fruits, vegetables, nuts and fish, reported using our Diet Screening Questionnaire)
- •Able to participate remotely (i.e., availability of, or ability/willingness to adopt, a computer or tablet alongside high speed internet/data networks)
排除标准
- •Dementia, stroke, or other chronic brain disease
- •Chemotherapy or radiation to the head/neck in the past year
- •Sensory impairments that would impede participation in the intervention or assessments
- •Major psychiatric disorder
- •Ongoing alcohol or drug abuse that in the opinion of the investigator may interfere with the subject's ability to comply with the study procedures.
- •Contraindications for exercise as determined by the American College of Sports Medicine criteria
结局指标
主要结局
Feasibility: Recruitment
时间窗: 6 months
Recruitment rate per month
Feasibility: Retention
时间窗: 6 months
Percent of consented participants who complete the post-intervention assessment of executive function
Feasibility: Adherence
时间窗: 6 months
Percent of study intervention sessions attended by type
Feasiliby: Adherence (diet)
时间窗: 6 months
Change in diet quality as assessed with the Eating Pattern Self-Assessment (minimum score 0, maximum score 15; higher scores indicate better diet quality)
次要结局
- Memory(6 months)
- Physical Activity(6 months)
- Physical Function(6 months)
- Retention by gender(6 months)
- Adherence by gender(6 months)
- Diet(6 months)
- Waist Circumference(6 months)
- Maintenance of change in executive function(12 months)
- Maintenance of physical activity(12 months)
- Executive Function(6 months)
- Maintenance of diet quality(12 months)
- Effect modification of executive function by sex(6 months)
- Effect modification of executive function by gender(6 months)
- Health-related quality of life(6 months)
- Effective modification of diet quality by sex(12 months)
- Effect modification of physical activity by sex(12 months)
- Effect modification of physical activity by gender(12 months)
- Effective modification of diet quality by gender(12 months)
研究者
Laura Middleton
Assistant Professor
University of Waterloo