South Asian Women Together in a Health Initiative: A Pilot RCT

Women's Health Clinical Trial

— SATHI  

Official title:

South Asian Women Together in a Health Initiative (SATHI): A Pilot Randomized Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03667976
• Other study ID #: 35823
• Status: Completed
• Phase: N/A
• Start date: February 1, 2019
• Est. completion date: August 1, 2020

Study information

• Verified date: April 2021
• Source: University of Toronto
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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. Procedures. Upon completion of participant and peer recruitment, consent and collection of baseline demographic, anthropometric, and self-efficacy for exercise data, participants will be randomly allocated to either a control or intervention group, using block sizes of 4 and 8. All participants will receive a study pedometer, instructions on its use, and a physical activity logbook in which they will document daily step counts and physical activity. Control Group. Participants allocated to the control group will receive the Canadian Society of Exercise Physiology/ParticipACTION physical activity guidelines for adults ages 18 to 64. Intervention Group. Participants allocated to the intervention group will receive the: 1) South Asian physical activity education which includes a culturally specific physical activity education booklet and video and 2) peer support. Peers will encourage physical activity and provide motivation and suggestions for incorporating physical activity into daily life of a South Asian woman using Bandura's Self-Efficacy construct. Peer contact will occur via telephone/text/email messaging or in person at least once a week and more often as determined by participants. All peers will receive 4-hours of training and will be matched to participants based on presence of child(ren). Peers will not provide medical advice and will document all participant-peer interactions on a log sheet that will be submitted to the trial investigator. Outcomes. Participants in control and intervention groups will submit baseline step counts. After randomization, intervention group participants will submit weekly step counts to the research assistant. All other outcome data will be collected at 12-weeks. Primary Outcomes. Participant and peer recruitment, retention, engagement, and acceptability rates for the SATHI intervention. Secondary Outcomes. Physical activity (step count, physical activity logbook), anthropometric measures (waist circumference, waist-to-hip ratio, body mass index) and self-efficacy (Physical Activity Appraisal Inventory). Data Analysis. All statistical analysis will be completed using SPSS Statistics v.24. Descriptive statistics will be conducted to analyze baseline outcome measures. Paired t-tests will be used to assess between-group mean differences. Mean change scores (T2-T1) for both control and intervention groups will be calculated for within group differences. Since this is a feasibility trial, a p-value will be set at p<0.10.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 48
• Est. completion date: August 1, 2020
• Est. primary completion date: August 1, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 24 Years to 39 Years

Eligibility

Inclusion Criteria:

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).

Peers:

• 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.

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• Women's Health

Intervention

Behavioral:
• SATHI
see above

Locations

Country	Name	City	State
Canada	Peel Public Health	Mississauga	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
University of Toronto

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Recruitment and Screening	Number of participants and peers agreeing to participate compared to total screened	Through study completion, an average of 6 months
Primary	Recruitment and Participation	Reasons for participant and peer non-participation	Through study completion, an average of 12 weeks
Primary	Recruitment Strategies	Strategies for recruiting participants and peers	Through study completion, an average of 12 weeks
Primary	Retention Rates	Participant and peer attrition	Through study completion, an average of 12 weeks
Primary	Retention Reasons	Reasons for participant and peer attrition	Through study completion, an average of 12 weeks
Primary	Engagement in Physical Activity	Number of participants who complete 60 minutes of physical activity daily	Through study completion, an average of 12 weeks
Primary	Engagement with Video	Number of participants who watch the video	Through study completion, an average of 12 weeks
Primary	Engagement with Booklet	Number of participants who read South Asian physical activity booklet	Through study completion, an average of 12 weeks
Primary	Engagement in Study	Number of participants who complete the physical activity logbook daily and upload step count data every week	Through study completion, an average of 12 weeks
Primary	Engagement with Peer	Participants who interact with peer at agreed upon intervals	Through study completion, an average of 12 weeks
Primary	Engagement of Peer	Number of peers completing peer volunteer activity logs	Through study completion, an average of 12 weeks
Primary	Acceptability with Video	Participant satisfaction with video	Through study completion, an average of 12 weeks
Primary	Acceptability with Peer	Participant satisfaction with peer support	Through study completion, an average of 12 weeks
Primary	Acceptability Barriers Experienced	Barriers to participant and peer participation	Through study completion, an average of 12 weeks
Primary	Acceptability of Orientation and Training	Peer satisfaction with the orientation session and training manual	Through study completion, an average of 12 weeks
Primary	Acceptability and Physical Activity Strategies	Commonly used strategies by participants to incorporate physical activity	Through study completion, an average of 12 weeks
Secondary	Physical Activity Step Count	Step count	At baseline and at study completion, an average of 12 weeks
Secondary	Physical Activity Logbook	Physical activity logbook entries	At baseline and at study completion, an average of 12 weeks
Secondary	Anthropometric Measures Waist Circumference	Waist circumference	At baseline and at study completion, an average of 12 weeks
Secondary	Anthropometric Measures Waist to Hip Ratio	Waist-to-hip ratio	At baseline and at study completion, an average of 12 weeks
Secondary	Anthropometric Measures BMI	Body mass index	At baseline and at study completion, an average of 12 weeks
Secondary	Self-efficacy for exercise	Physical Activity Appraisal Inventory	At baseline and at study completion, an average of 12 weeks