None listed
Conditions
Brief summary
Rationale Based on evidence from the AusDiab study, it is estimated that at least 2 million Australians have prediabetes, a condition that carries a 10–20 fold increased risk of developing T2D. In people with prediabetes, too much sitting – accumulated throughout the day and across multiple settings – is now understood to be related to increased risk of T2D, microvascular and macrovascular complications, and premature mortality. This is distinct from the known adverse consequences of too little exercise. Descriptive epidemiological evidence shows that a high proportion of adults aged in their 50s and 60s can spend more than 9 hours each day sitting. Significant health benefits can be gained through innovative and feasible lifestyle-change strategies that take a ‘whole-of-day’ approach to reducing and interrupting the multiple consecutive hours spent sitting. Those at risk of diabetes are a high priority group for preventive initiatives. Given the escalating healthcare system, societal and economic burden associated with diabetes and cardiovascular disease, this will be an important and timely study and a vital step in developing affordable and effective evidence-based interventions to reduce and interrupt prolonged sitting, which will ultimately contribute to Australia’s national strategy for the prevention of major non-communicable diseases. Aim We aim to undertake pilot work to examine the short-term feasibility and acceptance of a proposed future randomised controlled trial (RCT) investigating the long-term efficacy of an intervention to reduce and interrupt prolonged sitting time in overweight or obese adults with prediabetes. Over a 4-week period we will examine the acceptability of participants to take part in the trial, and scrutinise the feasibility of interventions and assessment procedures proposed in the future trial. Conducting this study allow us to refine the design and/or methodology for the proposed future trial. Hypothesis We hypothesise that the intervention and assessment procedures used over the 4-week trial period will prove feasible to be included in the proposed future trial. Furthermore, participants will adapt and maintain compliance with the intervention and, on reflection, will express good acceptability of the intervention. We also hypothesise that the 4-week intervention will show small improvements from baseline in postprandial insulin and glucose, sitting time and bouts of prolonged sitting, endothelial function, body composition, blood pressure, and cardiometabolic markers.
Interventions
Participants will complete a 4-week multi-component intervention aiming to reduce total sitting time by 1 hour/day, with an emphasis on interrupting prolonged bouts of sitting and sustaining this target for the duration of the 4-week intervention. The intervention consists of three distinct evidence-based components: (1) Health coaching - consisting of one in-person and two telephone sessions, conducted by project staff trained in motivational interviewing techniques and study protocols, providi
Participants will complete a 4-week multi-component intervention aiming to reduce total sitting time by 1 hour/day, with an emphasis on interrupting prolonged bouts of sitting and sustaining this target for the duration of the 4-week intervention. The intervention consists of three distinct evidence-based components: (1) Health coaching - consisting of one in-person and two telephone sessions, conducted by project staff trained in motivational interviewing techniques and study protocols, providing individually tailored support for sitting time reduction and breaking up of prolonged sitting time. The initial in-person session will occur at baseline and will assist in the installation of the sit-stand workstation (see below). Furthermore, the initial session will provide feedback on baseline levels of sitting time, assess and enhance motivation, and identify/set goals related to opportunities to reduce and breakup prolonged sitting in both the home and work environment. Total time for the in-person session (including workstation installation and coaching) is expected to be approximately 60 minutes. The two telephone sessions will be split evenly across the following four weeks of the intervention. These sessions will be guided by an intervention protocol checklist and will be brief (approximately 10 minutes). The sessions will be used to check on progress in reducing sitting at home and at work, address problems, revise goals and reinforce gaol attainment. (2) Providing a sit-stand workstation at their place of employment. (3) Providing a self-monitoring and behavioural prompting tool in the form of a wrist worn activity monitor (jawbone or similar) to continually monitor their movement patterns (via a steps function). Through the associated mobile application (IOS and Android), participants can also set goals around these behaviours, and request regular prompts to interrupt their idle states (via vibrations). Wearing the device will be self-directed and will only be used as an intervention-delivery tool, not to gather outcome data. A number of assessments proposed in the future RCT will be performed pre and post the 4-week intervention. These include: analysis of blood glucose and insulin metabolism (primary outcome); sitting time and accumulated bouts of prolonged sitting, body composition, blood pressure, fasting blood tests investigating cardio-metabolic markers, endothelial function, and interviewer-administered questionnaires to explore participants’ overall experience and acceptability of the intervention (secondary outcomes).
Sponsors
Baker IDI Heart and Diabetes Institute
Study design
Allocation
Non-randomised trial
Intervention model
Single group
Primary purpose
Prevention
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
45 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
From the general community, overweight or obese adults aged between 45-65 years, with diagnosed pre-diabetes (within the last 6 months), impaired fasting glucose and/or impaired glucose tolerance according to current World Health Organisation diagnostic criteria, who are working at least 0.5 full-time equivalent and able to elicit employer permission to install the provided sit-stand workstation.
Exclusion criteria
Previously diagnosed diabetes and/or use of glucose altering medications, regularly engaged in moderate-vigorous exercise (>150 min/week for > 3 months), self reported to be sitting <9 hours per day, pregnant, current smoker, and known physical activity contraindications and/or medical illness that may limit their ability to participate in the intervention.
Outcome results
None listed