Clinical trial NCT03667976: South Asian Women Together in a Health Initiative: A Pilot RCT
Official title: South Asian Women Together in a Health Initiative (SATHI): A Pilot Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Women's Health
Keywords: cardiovascular disease
South Asian
physical activity
peer support
pedometer
Lead sponsor: University of Toronto
Sponsor class: OTHER
First posted: 2018-09-12
Enrollment: 48
Sex: FEMALE
Minimum age (years): 24
Maximum age (years): 39
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: A pragmatic two-arm parallel 12-week pilot randomized controlled trial.
Primary purpose: PREVENTION

Brief 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Recruitment and Screening
timeFrame: Through study completion, an average of 6 months
measure: Recruitment and Participation
timeFrame: Through study completion, an average of 12 weeks
measure: Recruitment Strategies
timeFrame: Through study completion, an average of 12 weeks
measure: Retention Rates
timeFrame: Through study completion, an average of 12 weeks
measure: Retention Reasons
timeFrame: Through study completion, an average of 12 weeks
measure: Engagement in Physical Activity
timeFrame: Through study completion, an average of 12 weeks
measure: Engagement with Video
timeFrame: Through study completion, an average of 12 weeks
measure: Engagement with Booklet
timeFrame: Through study completion, an average of 12 weeks
measure: Engagement in Study
timeFrame: Through study completion, an average of 12 weeks
measure: Engagement with Peer
timeFrame: Through study completion, an average of 12 weeks
measure: Engagement of Peer
timeFrame: Through study completion, an average of 12 weeks
measure: Acceptability with Video
timeFrame: Through study completion, an average of 12 weeks
measure: Acceptability with Peer
timeFrame: Through study completion, an average of 12 weeks
measure: Acceptability Barriers Experienced
timeFrame: Through study completion, an average of 12 weeks
measure: Acceptability of Orientation and Training
timeFrame: Through study completion, an average of 12 weeks
measure: Acceptability and Physical Activity Strategies
timeFrame: Through study completion, an average of 12 weeks
Secondary outcomes:
measure: Physical Activity Step Count
timeFrame: At baseline and at study completion, an average of 12 weeks
measure: Physical Activity Logbook
timeFrame: At baseline and at study completion, an average of 12 weeks
measure: Anthropometric Measures Waist Circumference
timeFrame: At baseline and at study completion, an average of 12 weeks
measure: Anthropometric Measures Waist to Hip Ratio
timeFrame: At baseline and at study completion, an average of 12 weeks
measure: Anthropometric Measures BMI
timeFrame: At baseline and at study completion, an average of 12 weeks
measure: Self-efficacy for exercise
timeFrame: At baseline and at study completion, an average of 12 weeks
Other outcomes:
Locations:
city: Mississauga
country: Canada
facility: Peel Public Health
state: Ontario
Study officials:
affiliation: University of Toronto
name: Abida R Dhukai, NP-A,PhD(c)
role: PRINCIPAL_INVESTIGATOR
References: