1. “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):
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):
3-(
Acknowledgements
Ministry of Health and The Research Council, Oman.