Effectiveness of digital health using the transtheoretical model to prevent or delay type 2 diabetes in impaired glucose tolerance patients: protocol for a randomized control trial

Abstract

BackgroundThere is high prevalence of prediabetes and type 2 diabetes mellitus (T2DM) in Saudi Arabia that is still increasing. Early diagnosis of prediabetes, and immediate, effective intervention is yet unestablished. Conventional health promotion approaches are used to educate prediabetic patients. Behavior modification is very effective in prediabetics to delay T2DM. Thus, the main objective of this study is to examine the effect of the new behavioral model, the Transtheoretical Model short messages (text 4 change) to modify lifestyle to prevent or delay the onset of T2DM, through promotion of a healthy diet and increased physical activity, in impaired glucose tolerance patients. Another objective is to estimate the impact of this model on markers of cardiovascular and metabolic risks as T2DM is one of the modifiable risk factors to prevent cardiovascular diseases.MethodsThis is a randomized controlled trial. One thousand and sixteen, eligible Saudi adults will be recruited from the Heart Health Promotion study (HHP), which was conducted at the King Saud University from July 2013 to April 2014. These adults were at a higher risk of developing T2DM within 2–3 years. The research team’s database has a contact list and they will recruit individuals over 6–8 weeks. All participants will be randomized at a 1:1 ratio into two groups, receive group education about lifestyle modifications and written information about diet and physical activity. Text 4 change SMS texts will be sent only to the intervention group. All participants will be assessed at baseline, 6, 12, 18, 24, 30, and 36 months for behavioral change using a World Health Organization (WHO) STEPS questionnaire and for glycated hemoglobin, biochemical and anthropometric measurements using standard methods.DiscussionThis new approach for promoting the importance of behavior modification in prediabetics is expected to delay and/or prevent the development of T2DM in Saudi Arabia, subsequently reducing the risk of cardiovascular morbidity and mortality too. Results from this study will promote an innovative and high-tech way to decrease the burden of cardiovascular diseases in Saudi Arabia.Trial registrationInternational Standard Randomized Control Trial, registration number ISRCTN10857643. Registered 4 June, 2018.

Older Adults Engage With Personalized Digital Coaching Programs at Rates That Exceed Those of Younger Adults

“…In 2016 alone, $730 billion was attributable to modifiable risk factors including high body mass index (BMI), blood pressure, and fasting glucose, and the largest fraction was for those aged 65 and older ( 14 ). Digital health programs may help older adults manage modifiable risk factors through interventions that engender positive behavior changes in physical activity, weight management, nutrition, medication adherence, and monitoring of clinical indicators like blood pressure and glucose ( 15 , 16 ). Digital health programs may increase access to primary and specialty care, especially in remote or underserved areas or in populations with challenges like poor mobility ( 17 ).…”

mHealth prompts within diabetes prevention programs: a scoping review

“…Prompt content was tailored to broad groups or populations in five studies based on the religion (58) or culture (59)(60)(61)(62) of the target groups. An additional 13 studies tailored the prompt content to individual participants based on their goals (55,63,64), previous behaviours (51,52,(65)(66)(67)(68), T2D risk level (69), or stage of change (70)(71)(72). Additional information pertaining to prompting content can be found in Table 1.…”

“…Of those that did provide information, content was generally written by a team of experts (including researchers, diabetes experts, nurses, community and patient advisory boards, etc.) and based on previous literature or recommendations put forth by health authorities (52,54,60,61,70,(72)(73)(74)(75).…”

Evaluation and Refinement of a Bank of SMS Text Messages to Promote Behavior Change Adherence Following a Diabetes Prevention Program: Survey Study

“…Within the diabetes prevention literature, many SMS text messaging interventions do not provide information on how messages are developed. When formative development is described, messages are generally based on previous literature or health authority recommendations and are developed by a team of experts including clinicians, researchers, and individuals at risk of developing T2D [23][24][25][26][27][28][29][30][31]. Following message development by content experts, some studies take an additional step and have end users evaluate the messages to refine content based on key stakeholder preferences [23,25,26,29,[32][33][34].…”