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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]

Nil Known

Universal Trial Number (UTN)

U1111-1174-0569

Trial acronym

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Diabetes

Condition category

Condition code

Metabolic and Endocrine

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which will evaluate their social cognitive status and to come to the hospital laboratory to have their blood sample withdrawn by a hospital laboratory officer for blood glucose evaluation.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]

Lifestyle

Intervention code [2]

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]

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]