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

NCT03667976 | Completed

• 1 other identifier: 35823
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

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.

Conditions

Women's Health

Keywords

cardiovascular disease; South Asian; physical activity; peer support; pedometer

Outcome Measures

Primary Outcomes (16)

• Recruitment and Screening

  Number of participants and peers agreeing to participate compared to total screened

  Through study completion, an average of 6 months

• Recruitment and Participation

  Reasons for participant and peer non-participation

  Through study completion, an average of 12 weeks

• Recruitment Strategies

  Strategies for recruiting participants and peers

  Through study completion, an average of 12 weeks

• Retention Rates

  Participant and peer attrition

  Through study completion, an average of 12 weeks

• Retention Reasons

  Reasons for participant and peer attrition

  Through study completion, an average of 12 weeks

• Engagement in Physical Activity

  Number of participants who complete 60 minutes of physical activity daily

  Through study completion, an average of 12 weeks

• Engagement with Video

  Number of participants who watch the video

  Through study completion, an average of 12 weeks

• Engagement with Booklet

  Number of participants who read South Asian physical activity booklet

  Through study completion, an average of 12 weeks

• 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

• Engagement with Peer

  Participants who interact with peer at agreed upon intervals

  Through study completion, an average of 12 weeks

• Engagement of Peer

  Number of peers completing peer volunteer activity logs

  Through study completion, an average of 12 weeks

• Acceptability with Video

  Participant satisfaction with video

  Through study completion, an average of 12 weeks

• Acceptability with Peer

  Participant satisfaction with peer support

  Through study completion, an average of 12 weeks

• Acceptability Barriers Experienced

  Barriers to participant and peer participation

  Through study completion, an average of 12 weeks

• Acceptability of Orientation and Training

  Peer satisfaction with the orientation session and training manual

  Through study completion, an average of 12 weeks

• Acceptability and Physical Activity Strategies

  Commonly used strategies by participants to incorporate physical activity

  Through study completion, an average of 12 weeks

Secondary Outcomes (6)

• Physical Activity Step Count

  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

• Anthropometric Measures Waist Circumference

  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

Study Arms (2)

Control Group

NO INTERVENTION

All participants in the control group will receive a study pedometer and a physical activity logbook. Participants will also receive the Canadian Society of Exercise Physiology/ParticipACTION physical activity guidelines for adults ages 18 to 64.

Intervention Group

EXPERIMENTAL

All participants in the intervention group will receive a study pedometer and a physical activity logbook. Participants will also receive the South Asian women Together in a Health Initiative (SATHI) intervention which consists of a gender and culturally specific South Asian physical activity education booklet and video and 2) a matched peer. Peers will encourage physical activity and provide motivation and suggestions for incorporating physical activity into daily life of a South Asian woman based on Bandura's Self-Efficacy construct. Peer contact will occur via telephone, text/email messaging or in person at least once weekly and more often as determined by participants.

Behavioral: SATHI

Interventions

SATHI BEHAVIORAL

see above

Intervention Group

Eligibility Criteria

• Age: 24 Years - 39 Years
• Gender Eligibility Details: Must self-identify as a woman.
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Participants:
• Canadian South Asian women with ethnic roots from Indian, Pakistan, Bangladesh, Sri Lanka and Nepal
• 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
• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Toronto: lead

Study Sites (1)

Peel Public Health

Mississauga, Ontario, L5M 2C2, Canada

Location

MeSH Terms

Conditions

Cardiovascular Diseases; Motor Activity

Condition Hierarchy (Ancestors)

Behavior

Study Officials

• Abida R Dhukai, NP-A,PhD(c)

  University of Toronto

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: A pragmatic two-arm parallel 12-week pilot randomized controlled trial.

Study Record Dates

• First Submitted: July 25, 2018
• First Posted: September 12, 2018
• Study Start: February 1, 2019
• Primary Completion: August 1, 2020
• Study Completion: August 1, 2020
• Last Updated: April 27, 2021

Record last verified: 2021-04

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)