Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12610000224022
Ethics application status
Approved
Date submitted
11/03/2010
Date registered
17/03/2010
Date last updated
7/02/2014
Type of registration
Prospectively registered

Titles & IDs
Public title
Improving metabolic fitness in Indigenous women: A pragmatic controlled trial of waist loss.
Scientific title
A group based 12-week physical activity and nutrition program for overweight Aboriginal and Torres Strait Islander women, comparing waist circumference to Aboriginal and Torres Strait Islander women who are wait listed for the program.
Secondary ID [1] 1505 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Obesity. Waist circumference >80cm. 256955 0
Condition category
Condition code
Public Health 257097 257097 0 0
Health promotion/education
Diet and Nutrition 257098 257098 0 0
Obesity

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Participants will be expected to attend two 60 minute group exercise classes per week for a 12 week period. The classes will be facilitated by qualified instructors. The classes will be in a circuit format, with minimal equipment, and are suitable for women of all fitness levels and can be modified to accommodate individual needs. Each participant will be given a pedometer to wear and will be asked to record their daily steps, and other physcial activity in their exercise log. During the 12 week program participants will also be required to attend 4 nutrition and lifestyle workshops facilitated by a qualified nutritionist.
Intervention code [1] 256132 0
Lifestyle
Comparator / control treatment
No exercise, no nutrition workshops for 15 months. Then the comparator group undergoes the 12 week exercise and nutrition program.
Control group
Active

Outcomes
Primary outcome [1] 257988 0
Reduction in waist circumference.

Participants will have their height, weight, waist and hip circumference, and Body Mass Index (BMI) measured.
Timepoint [1] 257988 0
Baseline, 12 weeks, 24 weeks and 64 weeks.
Primary outcome [2] 257989 0
Improved average metabolic profile (lower blood pressure (BP)), improved cholesterol fraction, lower fasting glycemia, reduction in markers of inflammation).

Participants will have fasting blood collected for analysis, and their blood pressure taken.
Timepoint [2] 257989 0
Baseline, 12 weeks, 24 weeks and 64 weeks.
Primary outcome [3] 257990 0
Improved scores in tests of self-efficacy and social support for physical activity and self-reported diet, physical activity and sedentary behaviour, motives for physical activity and quality of life.
These measures will be assessed via self-reported questionnaires.
Timepoint [3] 257990 0
Baseline, 12 weeks, 24 weeks and 64 weeks.
Secondary outcome [1] 263544 0
Participant satisfaction interview with a semi-structured format.
Timepoint [1] 263544 0
12 weeks
Secondary outcome [2] 263545 0
Waist circumference interviews; 2 types, 1. Those maintaining waist loss from 12 weeks and 2. Those not maintaining waist loss from 12 weeks.

These interviews seek to understand the reasons behind participants' level of success in maintaining waist loss.
Timepoint [2] 263545 0
24 weeks and 64 weeks

Eligibility
Key inclusion criteria
Women who identify as an Aboriginal and/or Torres Strait Islander, waist circumference >80 cm, willing to participate in the study.
Minimum age
18 Years
Maximum age
64 Years
Sex
Females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Diagnosed with a chronic condition which limits physical activity.

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Advertising through local networks encourage possible participants to register their interest with researchers. Information sessions are also held. Potential participants are invited to attend baseline assessments. If eligible they will be randomly assigned to the active group or the comparator group. Allocation is not concealed.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation by using a randomization table created by a computer software (i.e., computerised sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
The coomparator group will receive the same intervention as the participants, but will be delayed by 64 weeks. The comparator group will also act as their own controls.
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
8/03/2010
Actual
1/04/2010
Date of last participant enrolment
Anticipated
Actual
5/03/2012
Date of last data collection
Anticipated
Actual
Sample size
Target
100
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 256634 0
Government body
Name [1] 256634 0
National Health & Medical Research Council
Country [1] 256634 0
Australia
Primary sponsor type
University
Name
University of South Australia
Address
GPO Box 2471
Adelaide SA 5001
Country
Australia
Secondary sponsor category [1] 255921 0
None
Name [1] 255921 0
Address [1] 255921 0
Country [1] 255921 0
Other collaborator category [1] 1151 0
Other Collaborative groups
Name [1] 1151 0
Aboriginal Sobriety Group Incorporated
Address [1] 1151 0
182-190 Wakefield Street
Adelaide SA 5000
Country [1] 1151 0
Australia
Other collaborator category [2] 1150 0
Other Collaborative groups
Name [2] 1150 0
Nunkuwarrin Yunti Inc
Address [2] 1150 0
182-190 Wakefield Street
Adelaide SA 5000
Country [2] 1150 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 258664 0
University of South Australia Human Research Ethics Committee
Ethics committee address [1] 258664 0
Ethics committee country [1] 258664 0
Australia
Date submitted for ethics approval [1] 258664 0
Approval date [1] 258664 0
29/09/2009
Ethics approval number [1] 258664 0
P006/09
Ethics committee name [2] 258666 0
Cairns and Hinterland Health Service District Human Research Ethics Committee
Ethics committee address [2] 258666 0
Ethics committee country [2] 258666 0
Australia
Date submitted for ethics approval [2] 258666 0
Approval date [2] 258666 0
12/02/2009
Ethics approval number [2] 258666 0
HREC/09QCH/5-552
Ethics committee name [3] 258665 0
Aboriginal Health Council of South Australia, Aboriginal Health Research Ethics Committee
Ethics committee address [3] 258665 0
Ethics committee country [3] 258665 0
Australia
Date submitted for ethics approval [3] 258665 0
Approval date [3] 258665 0
19/08/2009
Ethics approval number [3] 258665 0
4/09/0298

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 30921 0
Prof Robyn McDermott
Address 30921 0
University of South Australia Sansom Institute for Health Research GPO Box 2471 Adelaide SA 5001
Country 30921 0
Australia
Phone 30921 0
+61 8 8302 2922
Fax 30921 0
Email 30921 0
robyn.mcdermott@unisa.edu.au
Contact person for public queries
Name 14168 0
Robyn McDermott
Address 14168 0
University of South Australia
Sansom Institute for Health Research
GPO Box 2471
Adelaide SA 5001
Country 14168 0
Australia
Phone 14168 0
+61 8 8302 2922
Fax 14168 0
+61 8 8302 2842
Email 14168 0
robyn.mcdermott@unisa.edu.au
Contact person for scientific queries
Name 5096 0
Robyn McDermott
Address 5096 0
University of South Australia
Sansom Institute for Health Research
GPO Box 2471
Adelaide SA 5001
Country 5096 0
Australia
Phone 5096 0
+61 8 8302 2922
Fax 5096 0
+61 8 8302 2842
Email 5096 0
robyn.mcdermott@unisa.edu.au

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided


Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
SourceTitleYear of PublicationDOI
Dimensions AIPragmatic randomised trial of a 12-week exercise and nutrition program for Aboriginal and Torres Strait Islander women: clinical results immediate post and 3 months follow-up2012https://doi.org/10.1186/1471-2458-12-933
EmbaseFactors influencing attendance in a structured physical activity program for aboriginal and Torres strait islander women in an urban setting: A mixed methods process evaluation.2013https://dx.doi.org/10.1186/1475-9276-12-11
Dimensions AIParticipant views on participating in a pragmatic randomised controlled trial: the Aboriginal and Torres Strait Islander Women´s Fitness Program2014https://doi.org/10.1186/s12939-014-0077-3
N.B. These documents automatically identified may not have been verified by the study sponsor.