Condition category
Nutritional, Metabolic, Endocrine
Date applied
13/08/2018
Date assigned
11/10/2018
Last edited
11/10/2018
Prospective/Retrospective
Retrospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

Plain English Summary

Background and study aims
Aboriginal rates of diabetes are estimated to be 10.3% and 7.3% for First Nations and Métis off reserve respectively, and as high as 17.2% for First Nations on-reserve. Overweight and obesity rates are also high in the Aboriginal population; prevalence rates are similar for off-reserve First Nations (26.1%), Inuit (23.9%) and Métis (26.4%) but higher for on-reserve First Nations adults (36.0%). It is important to acknowledge the younger age structure of Aboriginal peoples. Aboriginal children make up 28% of total Aboriginal population versus 16.5% for non-Aboriginal children of the non-Aboriginal population, numbers were 18.2% and 12.9% respectively for youth aged 15-24. Lastly, Aboriginals are typically diagnosed with diabetes at a younger age. It is well established that physical activity, nutrition and education programming are effective diabetes prevention strategies. Even modest changes in diet and exercise can lead to reductions of > 50% in the incidence of diabetes among individuals with impaired glucose (blood sugar) regulation. Lifestyle strategies to support weight management efforts can also impact obesity, which may reduce the rates of many other diseases including heart disease and cancer. However, physical activity and nutrition cannot be addressed in isolation. Psychosocial, socio-economic and environmental factors must also be considered, including addictions, mental health, employment status, education level, food security, housing, transportation, safety, etcetera in order for health programming to be successful. Most studies regarding the health issues in the Aboriginal populations in Canada have focused on on-reserve Aboriginal peoples or Aboriginals living in large, urban centers. There is a lack of research on off-reserve, small urban and rural centers. There has been government and tribal support for developing Aboriginal community centers in these locations to provide a cultural meeting place. Moreover, they often have some degree of health and wellness programming. Research indicates that developing pragmatic, community interventions for diabetes and obesity prevention is challenging and many programs with excellent intentions have been run with limited long-term success. Careful attention to process, implementation of clinical guidelines (while cultural needs are respected), adequate evaluation and ongoing adaptation of programs is needed to attain relevant outcomes. The aim of this study is to find out whether the Women Warriors 8-week wellness program can increase physical activity levels and confidence in exercising, and be effectively integrated into the community.

Who can participate?
The focus is on urban Aboriginal women but the study will include all women wishing to participate

What does the study involve?
All participants attend the 8-week Women Warriors program (WWP), a physical activity-based, holistic health program for Indigenous women. Participants are given a pedometer at the start of the program. Each session includes 45-60 minutes of exercise, a sharing circle to discuss barriers and facilitators to lifestyle change, and short, group-tailored, nutrition education and resource introduction (guest speakers are invited that represent different supports available to the participants in the community, an example is a local diabetes educator or social worker) for a total time of 1.5 – 2 hours. A private Facebook group is created during the program to be used to encourage each other in between sessions and after the program is completed. Interviews are conducted with facilitators after the program and focus groups and interviews are conducted with participants, exploring issues influencing physical activity levels and changes in their behavior. Anthropometric measures (height, weight, waist circumference and blood pressure), physical activity, questionnaire results and health-related quality of life are all measured before and after the program. Self-report pedometer logs and surveys before and after the program are used to assess physical activity levels (average weekly steps, weekly time being moderate-vigorously physically active and types of physical activity), perceived barriers to physical activity participation, and comfort participating in physical activity.

What are the possible benefits and risks of participating?
The main benefits to participants will be developing a sense of empowerment and building a supportive community. Participants will also benefit from being exposed to different types of physical activity and an increase in their overall physical activity to guideline recommended levels. Other benefits will include improved nutrition, stabilization of weight and improved quality of life. There will be community building amongst the participants themselves, and with the greater Aboriginal cultural community, non-Aboriginal fitness community, culinary community and traditional Canadian healthcare community. There will also be a facilitated self-awareness component using materials developed for the program. These self-awareness tools are intended to guide participants to better identify their own health issues and guide them to seek support from professionals as needed. Risks associated with a physical exercise program include fatigue, injury and cardiovascular stress, with the most extreme risk of death. The diabetic participants need to ensure that no blisters or wounds appear on their feet after the exercise class. In addition, they should monitor their blood sugars during and after class. The discomforts may include shin splints, sore muscles, shortness of breath, and fatigue. Standard care includes proper warm-up and cool down, good hydration and juice boxes on site for diabetic lows.

Where is the study run from?
1. Lloydminster Native Friendship Centre (Canada)
2. Village Square Leisure Centre (Canada)
3. Onion Lake Health Board Inc. (Canada)

When is the study starting and how long is it expected to run for?
January 2015 to December 2020

Who is funding the study?
Province of Alberta Government, Recreation and Physical Activity Division (Canada)

Who is the main contact?
Dr Sonja Wicklum

Trial website

https://www.womenwarriors.club/

Contact information

Type

Public

Primary contact

Dr Sonja Wicklum

ORCID ID

Contact details

Department of Family Medicine
University of Calgary
Calgary
T2N 4N1
Canada

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Evaluation of the Women Warriors - Eight Weeks to Healthy Living - Program as a unique model of delivery of wellness programming to Aboriginal and non-Aboriginal women in small urban and rural centers

Acronym

Study hypothesis

Can the Women Warriors 8 week wellness program increase physical activity levels, increase confidence in exercising, and be effectively integrated into the communities of Lloydminster, Onion Lake and Calgary in the province of Alberta, Canada?

Ethics approval

University of Calgary Conjoint Health Research Ethics Board, 05/01/2016, ID number REB15-2452

Study design

Multi-centre prospective observational study

Primary study design

Interventional

Secondary study design

Non randomised study

Trial setting

Community

Trial type

Other

Patient information sheet

Not available in web format, please use contact details to request a participant information sheet

Condition

Physical activity and obesity

Intervention

The Women Warriors program (WWP) is a physical activity-based, holistic health program for Indigenous women. It has been running in Lloydminster, AB for 3 years with great success. Currently, the Onion Lake Cree Nation (OLCN) (near Lloydminster) and a consortium of Calgary organizations will be running programs in their communities. The program is 8 (2016, 2017, 2018 – Calgary) – 12 (2018 – OLCN – decision made to lengthen program) weeks long, offered three times per year and consists of 1 session per week. Many participants re-enroll, largely because of its unique, culturally relevant design. Participants are given a pedometer at the start of the program. Each session includes 45-60 minutes of exercise, a sharing circle to discuss barriers and facilitators to lifestyle change and short, group-tailored, nutrition education and resource introduction (guest speakers are invited that represent different supports available to the participants in the community, an example is a local diabetes educator or social worker) for a total time of 1.5 – 2 hours. A private Facebook group is created during the program to be used to encourage each other in between sessions and after the program is completed. Follow-up at 6 months (2016, 2017, 2018) and 1 year (2018 – OLCN).

The WWP was run in Lloydminster in 2016 (4 sessions) and 2017 (3 sessions) and expanded to Calgary (2 sessions) and OLCN (2 sessions) in 2018/19. There have been slight variations to the assessment and the program over time as per WWP developer and community requests. Therefore you will see in brackets the years to which certain measurements apply. The long-term plan is to complete a control trial in multiple communities with one consistent evaluation strategy.

A mixed-methods research approach is used. Qualitative data will be obtained through individual interviews with facilitators post-program and focus groups and individual interviews of participants, exploring programmatic and community issues influencing physical activity (PA) levels and exploring changes in their behavior. Inductive thematic analysis of interviews will be completed. Quantitative data will include anthropometric measures (height, weight, waist circumference and blood pressure), physical activity (PA) data, questionnaire results and health-related quality of life (HRQoL) measures (SF-36 and EQ-5D™ in 2016, EQ-5D™ only in 2017, 2018). These will be completed pre and post-program. Self-report pedometer logs and surveys pre- and post-program will assess PA levels (average weekly steps, weekly time being moderate-vigorously physically active and types of PA), perceived barriers to PA participation, and comfort participating in PA. Pedometers were chosen to assess PA because they were successfully used in the WW pilot (2015), provide immediate motivational feedback to participants, are cost effective and are validated.

The EuroQol EQ-5D (EQ-5D™) was chosen because of its established/preferred use by Alberta Health Services for the Alberta residents. There are challenges with respect to QoL tools for the Indigenous population and although there is some evidence that the SF36 may be a valid tool in this population it appeared to be the case in very selective situations. This, in combination with its cost and length, and the first attempt to use it (2016) have resulted in the choice of the EQ-5D™. Follow-up EQ-5D™ at 12 months (2016, 2017, 2018) and 1 year (2018 – OLCN).

Baseline and follow-up data will be presented as means with standard deviations (SD) for continuous variables and proportions with 95% confidence intervals for categorical variables. Changes pre- and post-program and one year post-program will be evaluated using a one-way (ANOVA) for continuous variables and chi-square test for categorical data. Longitudinal analysis of data for participants who complete more than one program will be done. A statistician will complete the statistical analysis. The primary and co-investigators will be responsible for ensuring data collection, analysis and reporting. The Onion Lake Cree Nation will retain their own data as per First Nations principles of OCAP®. The University of Calgary will retain the Calgary-based program’s data.

Intervention type

Behavioural

Phase

Drug names

Primary outcome measure

Measurements will be taken a t1 (start of first program), t8 or 12 (end of first program), tX (start of any subsequent programs) and tX+8/12 (end of any subsequent programs) and t1 + 12 months. Groups will be analysed based on number of times they have completed the program and sub-analysed based on ethnicity. In 2016 and 2017, 6 month follow-up was desired but limited by funding. In 2018, one-year follow-up is intended. In descriptions below when one year follow-up (t1 + 12 months) is indicated it only applies to the 2018 programming.
1. The feasibility and acceptability of the WW-EP as a unique model of delivering wellness programming to Aboriginal and non-Aboriginal women in Lloydminster, Onion Lake, and Calgary, AB. This will be assessed based on attendance, individual and community response.
2.1. Knowledge of physical activity opportunities in Lloydminster, measured using pre-post questionnaires at t1, t8/12 and t1 +12
2.2. Sense of a ‘community of support’ for making healthy lifestyle changes, measured using pre-post questionnaires at t1 and t8/12 and t1 + 12, and qualitative interviews 1-4 weeks post-program
2.3. Confidence in consistent use of a pedometer as a method to track walking, measured using pre-post questionnaires at t1 and t8/12 and t1 + 12
2.4. Physical activity (PA) levels, measured using:
2.4.1. 2016 – adapted PA questionnaire, 2017, spring 2018 – WHO – Global Physical Activity Questionnaire® (GPAQ®), Fall 2018 (OLCN and Calgary programs) – International Physical Activity Questionnaire (iPAQ®), at t1 and t8/12 and t1 + 12
2.4.2. Weekly pedometer step counts during the program; in 2016 there was no wash-in, in 2017 and 2018 there was/is a wash-in period of one week followed by weekly self-recorded total steps for the duration of the program
3. Confidence at being able to develop and maintain an exercise routine, assessed using pre-post questionnaires and 2.4.1. above (PA questionnaires) at t1 and t8/12 and t1 + 12

Secondary outcome measures

1. Quality of life, measured using:
1.1. 2016: SF-36™ and EQ-5D™ t1 and t8/12
1.2. 2017: EQ-5D™ t1 and t8/12
1.3. 2018: EQ-5D™ t1 and t8/12 and t1 + 12
2. Confidence in eating a healthy diet, high in fiber and fruits and vegetables, measured using pre-post questionnaires at t1 and t8/12 and t1 + 12, likert scale used
3. Facilitators/barriers to healthy lifestyle changes, identified using qualitative interviews 1-4 weeks post program
4. Anthropometrics: weight, waist circumference, body mass index, % body fat (as per bio-impedance capable scale) at t1 and t8/12 and t1 + 12
5. Systolic and diastolic blood pressure, measured at t1 and t8/12 and t1 + 12

Overall trial start date

02/01/2015

Overall trial end date

30/12/2020

Reason abandoned (if study stopped)

Eligibility

Participant inclusion criteria

1. Women Warriors targets mothers and their children, regardless of ethnicity or age
2. Individuals > or = 18yrs of age or 5yrs - 18yrs of age with the consent of a parent or legal guardian

Participant type

Other

Age group

Mixed

Gender

Female

Target number of participants

600

Participant exclusion criteria

1. Pregnant or lactating
2. Currently enrolled in an organized weight-loss program or taking prescription weight loss medication (with the exception of liraglutide for the indication of Type 2 diabetes)

Recruitment start date

27/02/2016

Recruitment end date

30/12/2019

Locations

Countries of recruitment

Canada

Trial participating centre

Lloydminster Native Friendship Centre
4602 49 Ave
Lloydminster
S9V 0T2
Canada

Trial participating centre

Village Square Leisure Centre
2623 56 St NE
Calgary
T1Y 5J1
Canada

Trial participating centre

Onion Lake Health Board Inc.
Box 70
Onion Lake Sk.
S0M 2E0
Canada

Sponsor information

Organisation

University of Calgary

Sponsor details

HSC G012
3330 University Drive NW
Calgary
T2N4N1
Canada

Sponsor type

University/education

Website

Funders

Funder type

Government

Funder name

Province of Alberta Government, Recreation and Physical Activity Division

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

The available data and results from the 2016 pilot program and from the 2017 and 2018 expansion programs will be presented to the respective communities and will be submitted for publication. The trialists plan to submit the data and results from 2016 to the BMC Women’s Health Journal in 2018 while the data and results from 2017 and 2018 will be published in 2018-2020. Results will also be presented at lay and scientific forums when relevant and through the women warriors website and other communications.

IPD sharing statement
The datasets generated during and/or analysed during the current study will be stored in a non-publically available repository. The data sets are anonymized immediately and hard-copy questionnaires are stored in a secure cupboard in a secure room in the Department of Family Medicine at the University of Calgary. All participants have consented to have their data analysed and are able to withdraw their data at any point during the program. The 2018 programming in Onion Lake is different in that the reservation will store anonymized data and the researchers have an agreement to access this data for analysis only. All three years of study have had ethics approval from the Conjoint Health Research Ethics Board at the University of Calgary and the 2018 Onion Lake program has also had approval of the Onion Lake Ethics Committee.

Intention to publish date

31/12/2018

Participant level data

Stored in repository

Basic results (scientific)

Publication list

Publication citations

Additional files

Editorial Notes