“MOVEdiabetes” 12 months intervention

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Presentation transcript:

“MOVEdiabetes” 12 months intervention Study Protocol for “MOVEdiabetes”: A Trial to Promote Physical Activity for Adults with Type 2 Diabetes in Primary Health Care in Oman   Thamra S Alghafri1, Saud M Alharthi1, Angela M Craigie2, Maureen Mcleod2 , Annie S Anderson2 ,Yahya Al-Farsi3 Directorate General of Health Services, Ministry of Health, Muscat, Oman Centre for Public Health Nutrition Research, University of Dundee, Ninewells Hospital and Medical School Sultan Qaboos University, College of Medicine & Health Sciences , Sultanate Of Oman Background Benefits of physical activity in the management of diabetes are well documented1. However, evidence on the effectiveness of interventions integrating physical activity in diabetes care is inadequate especially in the countries of the Gulf Cooperation Council where both diabetes and physical inactivity are highly prevalent. Following formative work on barriers and opportunities to increase physical activity in patients with diabetes in Oman and a literature review of effective behavior change programmes focused on increasing physical activity, a protocol for the MOVEdiabetes study was developed. Subjects and study size (Figure 1) Patients attending their routine diabetes clinic in 8 health centres will be approached and screened for inactivity using the Scottish Physical Activity Screening Questionnaire (Scot-PASQ)3. Inactive adults with type 2 diabetes and no contraindication to physical activity will be recruited over a two months period, and followed up for 12 months. To demonstrate a 50% between group difference in physical activity levels (MET-mins/week), 128 participants would be required to complete the study (64 in each arm). Based on a drop-out rate of 20%, and a recruitment rate of 70%, 220 potential eligible participants would need to be approached. Aim To evaluate the impact of a multi-component intervention aimed at achieving 150minutes of moderate to vigorous physical activity in inactive adults with T2D. To examine possible relationship between response to the MOVEdiabetes intervention and cardio metabolic risk factors. To evaluate the impact of utilizing a common telephone application, WhatsApp, as a reminder and follow up tool2. To examine the acceptability of the intervention (content, delivery and aims) to the participants and project officers (health care providers). Methods Outcome measures (Table 1) Changes in physical activity measured by the Global Physical Activity Questionnaire (GPAQ). Accelerometers will be used in a sub group to objectively assess physical activity. Changes in metabolic, cardiovascular biomarkers. An exit survey to measure acceptability of the intervention. The study is a 1 year 1:1 cluster randomized controlled trial of the MOVEdiabetes programme versus usual care. Appointment booked within a week & accelerometer offered   Primary health centres in Muscat region, Oman (n=8) Comparison Health Centres (CHC) n=4 Intervention Health Centres (IHC) Participants in the CHC n=110 Randomization Patients fulfilling inclusion and exclusion criteria will be given information about the study followed by a reminder phone call n=220 Participants in the IHC “MOVEdiabetes” 12 months intervention Follow up at 3 months Follow up at 12 months Exit survey Accelerometer collected Baseline measures   Tool When Primary Outcome Intervention Comparison GPAQ-MET-mins/week Questionnaire B, 3F, 12F Accelerometer (activePALTM) Reporting step count, MET-min/week Pedometer (YAMAX Digi-walker SW-200) Reporting step counts - Secondary Outcomes Socio-demographic data B Height (m) Stadiometer Body weight (Kg) Calibrated scales Waist circumference (cm) Tape measure Lipid profile (mmol/l) Blood test (venous fasted sample) Blood pressure (mmHg) Sphygmomanometer HbA1c (%) (fasted sample) Self-assessed general health Self-efficacy for PA Social support for exercise Cost analysis (description) Detailed cost description 12F Exit survey Questionnaire (participants & project officers) Figure 1: Participants flow chart Intervention programme Face to face physical activity consultations (advice, goal setting, self- monitoring) promoting 150 minutes of moderate to vigorous physical activity per week (≥600MET-mins/week) and accelerometers for a subset of population. Pedometers. Monthly telephone WhatsApp messages for follow up support offered as individual or in groups. Table 1: Outcome measures (B=baseline; 3F= 3 month follow-up, 12F= 12 month follow-up) References 1-American Diabetes Association: Exercise and type 2 diabetes: American College of Sports Medicine and the American Diabetes Association: Joint Position Statement. Medicine and Science in Sports and Exercise 2010, 42(12):2282-2303. 2-Connelly J, Kirk A, Masthoff J, Macrury S: The use of technology to promote physical activity in Type 2 diabetes management: A systematic review. Diabet Med 2013, 30(12):1420-1432. 3-(www.paha.org.uk/Resource/scottish-physical-activity-screening-question-scot-pasq) Acknowledgements Ministry of Health and The Research Council, Oman.