Evaluation of the Effectiveness of Pilot Implementation of Physical Activity Intervention of WHO at the Level of Physical Activity on Adults with Type 2 Diabetes

The aim of this study is to evaluate the effectiveness of the implementation of physical activity intervention of WHO at the level of physical activity on the patients with type 2 diabetes.

Randomized controlled trial, community based, parallel group

Participants will be randomly assigned to intervention 1 group, intervention 2 group, and control, with a randomization computerized program. The participants and the data analyzers will be blinded to the study groups. In-person and leaflet educational materials will be provided for both intervention study groups, but only the intervention group 1 will receive text messages about physical activity.

Inclusion criteria include an age between 18 and 65 years old, diagnosis of type 2 diabetes, being inactive based on WHO (less than weekly 150 minutes of moderate-intensity activity), being able to read and write, having access to a mobile phone that receives text messages, and an informed consent to participate in the study. People with uncontrolled hypertension, heart failure, valvular heart disease, advanced lung disease, stroke, or myocardial infarction in the last 6 months, severe, unplanned weight loss (more than 10%) in the last 6 months, pregnant people, people with any condition or disease that prevent them from doing physical activity, or a positive response to any items of the Physical Activity Readiness Questionnaire (PARQ-10) will be excluded.

Both intervention group 1 and 2 will receive primary education about physical activity using in-person explanations and leaflets. The first case group will also receive text messages regarding physical activity, unlike the other groups. The case group will receive no primary education or text message.

Physical activity levels and attitudes toward it

Eligible participants based on inclusion and exclusion criteria, after receiving a comprehensive explanation of the study, providing written informed consent, and having their demographic information and baseline assessment data definitively recorded in the study database, will be irrevocably entered into the randomization process to prevent selection bias during participant enrollment. Participants will be individually allocated to the intervention and control groups in a 1:1 ratio. The simple randomization sequence will be generated before the commencement of participant recruitment by an independent biostatistician who is not involved in the clinical team or patient recruitment process, using the random number generation module of SPSS statistical software, version 26. To minimize selection bias at the allocation stage, sequentially numbered, opaque, sealed, foil-lined envelopes will be used for allocation concealment. Each envelope will be opened strictly in numerical sequence and only after the participant's baseline information has been definitively recorded in the study database. This procedure will ensure that the treating physician has no opportunity to predict or influence the allocation of the next participant. Thus, group allocation will remain concealed until each participant’s enrollment in the study has been finalized.

In this double-blinded study, the participants and the data analyzers are blind to the study groups. The participants of both case groups will undergo primary education about physical activity, but only one case group will receive text messages during the six weeks of intervention. The control group will receive no education and text messages. The investigator of the study is not blind to the study groups, but the analyzers are not aware of the study groups.

Information of the outcomes, including physical activity levels and attitudes towards it, will be shared.

The data will be available starting six months after publication.

People working in academic institutions can apply to receive the data.

No limitation is set.

Contact the email selk1360@gmail.com

Thr data will be available starting 6 months after publication by contacting selk1360@gmail.com for 6 month after obtaining contact information of the researcher.