South Asian Women Together in a Health Initiative: A Pilot RCT
Condition: Women's Health
Study type: Interventional

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.
    

Intervention name(s): SATHI
Intervention type(s): Behavioral
Intervention description(s): see above
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: A pragmatic two-arm parallel 12-week pilot randomized controlled trial.
Masking: Single (Outcomes Assessor)
Primary purpose: Prevention
Keywords: cardiovascular disease; South Asian; physical activity; peer support; pedometer