Please be advised that due to the high volume of submissions, the ANZCTR is currently experiencing delays in processing submissions from those outside of Australia and New Zealand. As the ANZCTR is funded by Australia and New Zealand, we must prioritise submissions from these countries first. International submissions should allow additional time for registration. Apologies for any inconvenience caused.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Registration number
ACTRN12615001006538
Ethics application status
Approved
Date submitted
7/09/2015
Date registered
28/09/2015
Date last updated
5/10/2016
Type of registration
Prospectively registered

Titles & IDs
Public title
A Pilot Randomized Control Trial Exploring the Effectiveness of a Lifestyle Walking Program for Type 2 Diabetes Patients in Yogyakarta
Scientific title
Exploring the Effectiveness and the Feasibility of a Social Cognitive Theory-Based Physical Activity Intervention in Type 2 Diabetes Patients in Yogyakarta City Indonesia

Secondary ID [1] 287421 0
Nil Known
Universal Trial Number (UTN)
U1111-1174-0569
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Diabetes 296131 0
Condition category
Condition code
Metabolic and Endocrine 296398 296398 0 0
Diabetes

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The intervention will be a 24-week social cognitive-based walking program which consists of :

1. The use of pedometer (step counter) to self monitor daily participants' daily steps .

2. The use of a social cognitive-based workbook which consists of weekly activities to encourage participants to improve their daily walking steps.

The participants' activities at week 1-11 will be directed by the workbook, while activities at week 12-24 will be independently conducted by the participants to apply their skills which they have learned in the first 11 weeks of the program.

Prior to conducting weekly activities in the workbook, in the preparation week (baseline week/week 0), all participants will undergo evaluation to assess their physical activity levels (step counts and subjective physical activity rating), their social cognitive conditions regarding to physical activity (self efficacy, outcome expectations, self regulation and social support) and blood glucose levels. To collect these data, they will be invited to meet the researcher in the hospital for approximately 1 hour (one on one) to complete the questionnaire booklet which will evaluate their social cognitive status and to come to the hospital laboratory to have their blood sample withdrawn by a hospital laboratory officer for blood glucose evaluation.


Week 1 : Setting up their walking step goals using guidelines from the workbook.

Week 2 : Improving their motivation by reviewing physical activity benefit materials which are available in the workbook.

Week 3 : Managing their time better by reviewing their schedule and fit the physical activity time in their schedule.

Week 4 : Managing their stress by practicing relaxation technique available in workbook.

Week 5 : Enlisting support from family and friends to become physically active using technique available in the workbook.

Week 6 : Giving themselves rewards when achieving their step goals.

Week 7 : Practicing positive self talk to motivate them to improve their walking.

Week 8 : Expanding their walking activities during work time, use walking as an active transport, walking around the house more and schedule walking as an exercise.

Week 9 : Using physical activity prompts such as putting walking schedule in a visible place around the house.

Week 10: Evaluating and reviewing their problems along the programs and find solutions.

Week 11 :Planning to incorporate walking into their daily life while improving their walking technique to maximize the physical activity benefits.

Week 12-24 : Applying all above skills with main activities : monitoring their daily walking steps, recording their steps in daily step log, reviewing their walking progress, giving self reward, maximizing the use of social support, improving time and stress management and providing themselves self motivation to improve physical activity levels especially walking.

The weekly book activities is designed to be completed by the participants approximately 30 to 60 minutes a week.


3. The use of daily text messages to motivate participants to improve their walking and remind them to complete the workbook activities.

The text message is also used to monitor the participants' adherence to the program, because they are required to send their daily steps record in the end of this week. Any participants who do not send their daily steps record will be followed up.

The meeting in week 12 and 24 with the researchers also evaluate their adherence to the program.

Most importantly, the meetings in those weeks (week 12 and 24) are intended to conduct the same evaluation as in the baseline or preparation week, so that longitudinal data for each participant will be obtained in regards to variables:
a. Physical activity levels (steps logs and subjective physical activity rating)
b. Social cognitive variables (self efficacy, outcome expectations, self-regulation and social support regarding to physical activity)
c. Blood glucose level.
To collect the data, the meeting in those week (week 12 and 24) will be in a one-on one format and held for approximately 1 hour (the same format with the baseline assessment)

Intervention code [1] 292780 0
Lifestyle
Intervention code [2] 292830 0
Treatment: Other
Comparator / control treatment
The control group will only be given pedometers for their independent use without a social cognitive-based workbook and text message.
Control group
Active

Outcomes
Primary outcome [1] 296039 0
Physical Activity Levels
1. Objective physical activity measurement by recording the number of daily steps using pedometer
2. Subjective physical activity measurement using interviewer-administered Physical Activity Rating Scale (Sallis,1988)
Timepoint [1] 296039 0
Baseline and at 12 (in the middle of the intervention) and 24 weeks after intervention commenced (in the end of the intervention)
Secondary outcome [1] 317321 0
Blood Glucose Control (Fasting Blood Glucose, 2 hour Plasma Glucose and Hemoglobin A1c)
Timepoint [1] 317321 0
Baseline and at 12 (in the middle of the intervention) and 24 weeks after intervention commenced (in the end of the intervention)
Secondary outcome [2] 317322 0
Self-efficacy for physical activity (which will be assessed using the Self-Efficacy for Exercise Behaviours Scale developed by J. F. Sallis, Pinski, Grossman, Patterson, and Nader (1988)).
Timepoint [2] 317322 0
Baseline and at 12 (in the middle of the intervention) and 24 weeks after intervention commenced (in the end of the intervention)
Secondary outcome [3] 317674 0
Outcome expectations of physical activity (which will be measured using the Outcome Expectation for Exercise scale, which was developed by Rovniak, Anderson, Winett, and Stephens (2002) based on the Benefit of Physical Activity Scale created by J. F. Sallis et al. (1989)).
Timepoint [3] 317674 0
Baseline and at 12 (in the middle of the intervention) and 24 weeks after intervention commenced (in the end of the intervention)
Secondary outcome [4] 317675 0
Self-regulation for PA (which will be assessed using the Exercise Goal-Setting (EGS) and the Exercise Planning and Scheduling Scale (EPS), which were developed by Rovniak et al. (2002)).
Timepoint [4] 317675 0
Baseline and at 12 (in the middle of the intervention) and 24 weeks after intervention commenced (in the end of the intervention)
Secondary outcome [5] 317676 0
Social supports (which will be assessed using social support for physical activity developed by Sallis, et.al (1987)).
Timepoint [5] 317676 0
Baseline and at 12 (in the middle of the intervention) and 24 weeks after intervention commenced (in the end of the intervention)
Secondary outcome [6] 317677 0
Health-related Quality of Live (using health-related quality of life questionnaires from Euro Qol Foundation (Euro Qol 5D3L)
Timepoint [6] 317677 0
Baseline and at 12 (in the middle of the intervention) and 24 weeks after intervention commenced (in the end of the intervention)

Eligibility
Key inclusion criteria
The inclusion criteria will be a clinically confirmed T2D patients who have an ability to walk, own a mobile phone and familiar with text message and can read and write.
Minimum age
40 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Patients with health conditions which do not allow them to become physically active (e.g bone fractures and severe heart conditions)

Study design
Purpose of the study
Educational / counselling / training
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
The participants who are eligible based on the inclusion and exclusion criteria will be randomized into intervention and control group.

Each eligible participant they will be allocated into intervention or control group using 'Random Number Generator" application.

Participant will be assigned into control group if the application generates '0' and will be assigned into intervention group when the application generated '1'.

Allocation is not concealed to the primary investigator or to the participants.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
The sequence will be generated using the Random Number Generator applications by Skytrait (Gabe Brandao)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint(s)
Efficacy
Statistical methods / analysis
Sample Size Calculation :
The sample size calculation for this study is based on the expected improvement of 4000 step from baseline required to stimulate clinically significant health outcomes (Van Dyck et al., 2013).
The study will also aim to detect a 3000 step difference between groups at post-test as suggested by studies by Kang, Marshall, Barreira, & Lee, 2009 and Qiu et al., 2014). The expected standard deviation value in this study is 3000 steps, which is approximated from standard deviations found in several pedometer studies in T2D adults which ranges from 2400 (Van Dyck et al., 2013) to 3825 (De Greef et al., 2010).
To cover both aims (i.e. comparing between and within groups outcome), the study will require a total sample size of 40, at the significance level of 0.05, a power level of 80% and a predicted dropout rate of 25%.

Statistical Analysis Plan to Evaluate the Effect of the Intervention :
A descriptive analysis and inferential interpretation using linear mixed-effects models will be conducted to describe the effectiveness of the PA intervention in improving social cognitive construct measures, PA levels, glycaemic control and health-related quality of life, compared to the control group.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment outside Australia
Country [1] 7147 0
Indonesia
State/province [1] 7147 0
Yogyakarta

Funding & Sponsors
Funding source category [1] 291992 0
Government body
Name [1] 291992 0
Australian Award Scholarship
Address [1] 291992 0
Department of Foreign and Trade Australia

R G Casey Building
John McEwen Crescent
Barton ACT 0221 Australia

Country [1] 291992 0
Australia
Funding source category [2] 291993 0
University
Name [2] 291993 0
Queensland University of Technology
Address [2] 291993 0
School of Public Health and Social Work, Faculty of Health, Queensland University of Technology, Victoria Rd, Kelvin Grove, Brisbane QLD 4059
Country [2] 291993 0
Australia
Funding source category [3] 291994 0
Government body
Name [3] 291994 0
Indonesian Ministry of Research, Technology and Higher Education
Address [3] 291994 0
The Indonesian Ministry of Research , Technology and Higher Education, Gedung BPPT, Lantai 24, Jalan MH Thamrin 8 Jakarta Indonesia 10340
Country [3] 291994 0
Indonesia
Primary sponsor type
Government body
Name
Queensland University of Technology
Address
School of Public Health and Social Work, Faculty of Health, Queensland University of Technology, Victoria Rd, Kelvin Grove, Brisbane QLD 4059
Country
Australia
Secondary sponsor category [1] 290657 0
None
Name [1] 290657 0
Address [1] 290657 0
Country [1] 290657 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 293514 0
Queensland University of Technology Human Research Ethics Commitee
Ethics committee address [1] 293514 0
Office of Research Ethics & Integrity (OREI)
Division of Research & Commercialisation
Queensland University of Technology
Level 4 Synergy Building, 88 Musk Avenue, Kelvin Grove, Qld 4059
Ethics committee country [1] 293514 0
Australia
Date submitted for ethics approval [1] 293514 0
Approval date [1] 293514 0
25/08/2015
Ethics approval number [1] 293514 0
EC00171

Summary
Brief summary
The purpose of this research is to assess the effectiveness of a 24-week lifestyle walking program, “A Step by Step Walking Program for Diabetes Patients”. The program is directed at improving physical activity levels, control blood glucose levels and improve quality of life of people with type 2 diabetes who attend the Local General Hospital of Yogyakarta.

The hypothesis is that the walking program will improve participants' physical activity levels, control blood glucose and improve quality of life
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 60098 0
Mrs Novita Intan Arovah
Address 60098 0
School of Public Health and Social Works, Faculty of Health, Queensland University of Technology Block O Wing C Room 604, Victoria Rd, Kelvin Grove, Brisbane, Qld, 4059
Country 60098 0
Indonesia
Phone 60098 0
+61 7 3138 5460
Fax 60098 0
-
Email 60098 0
novitaintan.arovah@hdr.qut.edu.au
Contact person for public queries
Name 60099 0
Mrs Novita Intan Arovah
Address 60099 0
School of Public Health and Social Works, Faculty of Health, Queensland University of Technology Block O Wing C Room 604, Victoria Rd, Kelvin Grove, Brisbane, Qld, 4059
Country 60099 0
Indonesia
Phone 60099 0
+61 7 3138 5460
Fax 60099 0
-
Email 60099 0
novitaintan.arovah@hdr.qut.edu.au
Contact person for scientific queries
Name 60100 0
Mrs Novita Intan Arovah
Address 60100 0
School of Public Health and Social Works, Faculty of Health, Queensland University of Technology Block O Wing C Room 604, Victoria Rd, Kelvin Grove, Brisbane, Qld, 4059
Country 60100 0
Indonesia
Phone 60100 0
+61 7 3138 5460
Fax 60100 0
-
Email 60100 0
novitaintan.arovah@hdr.qut.edu.au

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary