South Asian Women Together in a Health Initiative (SATHI): A Pilot Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 48
- 试验地点
- 2
- 主要终点
- Recruitment Strategies
研究概览
简要总结
The overall goal of this pilot study is to assess the feasibility, acceptability and potential effects of a culturally tailored 12-week peer-based physical activity intervention compared with a control group, among young sedentary Canadian South Asian women. Specific objectives are: 1) To determine the feasibility (recruitment, retention, engagement, and acceptability) of implementing the SATHI intervention, and 2) To determine the effect of the SATHI intervention on physical activity, anthropometric risk (waist circumference, waist-hip ratio, and body mass index), and self-efficacy.
This is an innovative, gender-specific and culturally tailored primary prevention intervention for South Asian women who are at increased risk of cardiovascular disease. Information obtained from this pilot trial will inform a larger multi-centred trial and will also help inform health care providers and researchers about novel means of researching, educating and engaging South Asians in healthy lifestyle behaviours relevant to their daily lives.
详细描述
Background. Canadian South Asian women have high rates of cardiovascular disease morbidity and mortality and the lowest rates of physical activity in Canada, which increases risk for type II diabetes mellitus, hypertension, obesity and cardiovascular disease.
The overall goal of this pilot randomized controlled trial is to assess the feasibility and acceptability of a culturally tailored 12-week peer-based physical activity intervention, among 48 sedentary Canadian South Asian women, ages 24 to 39, in the Greater Toronto Area. Specific objectives are to determine: 1) The feasibility (recruitment, retention, engagement, and acceptability) of implementing the South Asian women Together in a Health Initiative (SATHI) intervention, and 2) The effect of SATHI on physical activity (step count, moderate/vigorous physical activity, weight/resistance training), anthropometric risk (waist circumference, waist-to-hip ratio, body mass index), and self-efficacy (Physical Activity Appraisal Inventory).
Sample and Setting. Participants will include: 1) Canadian South Asian women, 2) aged 24 to 39 years, 3) sedentary, 4) without unstable medical or chronic conditions, and 5) residents of the Greater Toronto Area. All participants will be screened for safety using the Physical Activity Readiness Questionnaire-Plus screening tool. Peers will be: 1) Canadian South Asian women, 2) aged 24 and 39 years, and 3) who self-report achieving at least 30 minutes continuous moderate to vigorous physical activity five days per week. This trial will be conducted at community centres in the Greater Toronto Area.
Research Design. A pragmatic two-arm parallel 12-week pilot randomized controlled trial.
Recruitment. South Asian community centres will be used for participant and peer recruitment, data collection and intervention follow-up. Other strategies for participant and peer recruitment will include flyers distributed at the Punjabi Community Health Services, the multiservice centres at Peel Public Health, religious festivals, local mosques, temples, and gurudwaras, churches, South Asian restaurants, and grocery and clothing stores within the Greater Toronto Area. Popular female South Asian online personalities will also promote the study on social media.
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
- Single (Outcomes Assessor)
盲法说明
The investigator will (a) screen, determine eligibility, and obtain consent from eligible peers, (b) schedule and deliver the peer training session, (c) provide support and answer questions of peers as required, (d) assist in the organization of peer meetings and discussions as required, and (e) will pair participants with the appropriate peer based on having children (peer-participant dyad) via telephone.
The outcome assessor (research assistant) will be blinded. Study participants will be assigned a unique study identification (ID) number and will use this study ID number when they electronically submit step counts to the research assistant at weeks 6 and 12. Intervention group participants will additionally submit step counts weekly until study completion. All other outcome data will be collected by the research assistant at the 12-weeks post-intervention follow-up.
入排标准
- 年龄范围
- 24 Years 至 39 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Participants:
- •Canadian South Asian women with ethnic roots from Indian, Pakistan, Bangladesh, Sri Lanka and Nepal
- •24 to 39 years of age
- •self-report achieving less than 30 minutes of continuous moderate to vigorous physical activity on three days per week
- •able to understand written and spoken English
- •have access to a password protected computer, tablet or smartphone with a valid email address and telephone number
- •a resident of the Greater Toronto Area for the duration of the study,
- •answer "yes" to all seven questions of the Physical Activity Readiness Questionnaire-Plus (a physical activity safety screening tool).
- •Canadian South Asian women with ethnic roots from Indian, Pakistan, Bangladesh, Sri Lanka and Nepal
- •24 to 39 years of age
- •self-report achieving at least 30 minutes continuous moderate to vigorous physical activity five days per week
- •able to understand written and spoken English
- •have access to a computer, tablet or smartphone with a valid email address and telephone number
- •a resident of the Greater Toronto Area for the duration of the study.
排除标准
- •attend a gym or physical activity classes for 30 minutes at least three times per week, or have a personal trainer
- •participate in any prescribed or self-initiated program for weight loss
- •have any known severe or chronic medical condition(s) that would prevent them from participating in the trial (e.g. uncontrolled diabetes mellitus defined as HbA1c ≥ 6.5%, uncontrolled hypertension defined as systolic blood pressure ≥130mmHg or diastolic blood pressure ≥80mmHg, unstable angina, symptomatic peripheral vascular disease [PVD], untreated depression, active treatment for depression with current adjustment of medications, cancer, chronic respiratory conditions such as severe asthma as defined as inability to control asthma despite the use of high dose treatment with inhaled corticosteroids, long-acting inhaled beta 2 agonists, montelukast, and/or theophylline, oral corticosteroid treatment for at least six months per year, or control is lost when treatment is decreased, or pulmonary fibrosis
- •physical limitations preventing participation in study (e.g. blindness, deaf, wheelchair users)
- •pregnant or lactating/breastfeeding women, or planning on becoming pregnant over the course of the study
- •a family member/ friend of another SATHI participant
结局指标
主要结局
Recruitment Strategies
时间窗: Through study completion, an average of 12 weeks
Strategies for recruiting participants and peers
Engagement in Physical Activity
时间窗: Through study completion, an average of 12 weeks
Number of participants who complete 60 minutes of physical activity daily
Engagement with Peer
时间窗: Through study completion, an average of 12 weeks
Participants who interact with peer at agreed upon intervals
Engagement of Peer
时间窗: Through study completion, an average of 12 weeks
Number of peers completing peer volunteer activity logs
Retention Reasons
时间窗: Through study completion, an average of 12 weeks
Reasons for participant and peer attrition
Retention Rates
时间窗: Through study completion, an average of 12 weeks
Participant and peer attrition
Acceptability with Video
时间窗: Through study completion, an average of 12 weeks
Participant satisfaction with video
Acceptability and Physical Activity Strategies
时间窗: Through study completion, an average of 12 weeks
Commonly used strategies by participants to incorporate physical activity
Recruitment and Screening
时间窗: Through study completion, an average of 6 months
Number of participants and peers agreeing to participate compared to total screened
Engagement with Video
时间窗: Through study completion, an average of 12 weeks
Number of participants who watch the video
Engagement in Study
时间窗: Through study completion, an average of 12 weeks
Number of participants who complete the physical activity logbook daily and upload step count data every week
Acceptability Barriers Experienced
时间窗: Through study completion, an average of 12 weeks
Barriers to participant and peer participation
Recruitment and Participation
时间窗: Through study completion, an average of 12 weeks
Reasons for participant and peer non-participation
Engagement with Booklet
时间窗: Through study completion, an average of 12 weeks
Number of participants who read South Asian physical activity booklet
Acceptability with Peer
时间窗: Through study completion, an average of 12 weeks
Participant satisfaction with peer support
Acceptability of Orientation and Training
时间窗: Through study completion, an average of 12 weeks
Peer satisfaction with the orientation session and training manual
次要结局
- Physical Activity Step Count(At baseline and at study completion, an average of 12 weeks)
- Anthropometric Measures Waist Circumference(At baseline and at study completion, an average of 12 weeks)
- Physical Activity Logbook(At baseline and at study completion, an average of 12 weeks)
- Self-efficacy for exercise(At baseline and at study completion, an average of 12 weeks)
- Anthropometric Measures Waist to Hip Ratio(At baseline and at study completion, an average of 12 weeks)
- Anthropometric Measures BMI(At baseline and at study completion, an average of 12 weeks)
研究者
Abida Ramzan Dhukai
Principal Investigator
University of Toronto