Mobile Health Biometrics to Enhance Exercise and Physical Activity Adherence in Type 2 Diabetes (MOTIVATE-T2D): a decentralised feasibility randomised controlled trial delivered across the UK and Canada

An umbrella review found little evidence that physical activity trackers improve HbA1c in people with T2D.

“An umbrella review found little evidence that PA trackers improve HbA1c in people with T2D.15”

• cites [15] Ferguson, 2022, Effectiveness of wearable activity trackers to increase physical activity and improve health: a systematic review of systematic reviews and meta-analyses, Lancet Digit Health sourcePartly supported

  The ‘Wearable activity trackers and physiological outcomes’ section says there was little evidence that tracker-based interventions significantly affected glycosylated haemoglobin (HbA1c); two of four meta-analyses found a small significant improvement. The passage does not establish that this HbA1c finding applies specifically to people with type 2 diabetes, so that population qualifier is not supported by our copy. (LLM, conf=0.85)

  Experimental — accuracy not yet measured

Qualitative data suggests such remote feedback may encourage adherence to a physical activity programme, through enhanced relatedness between patients and health professionals.

“Qualitative data suggests such remote feedback may encourage adherence to a PA programme, through enhanced relatedness between patients and health professionals.19”

• cites [19] Bannell, 2023, Adherence to unsupervised exercise in sedentary individuals: A randomised feasibility trial of two mobile health interventions, Digit Health sourceSupported

The effects of increasing physical activity via the use of physical activity trackers on outcomes relevant to the clinical management of T2D are unclear.

“However, the effects of increasing PA via the use of PA trackers on outcomes relevant to the clinical management of T2D are unclear.”

• cites [15] Ferguson, 2022, Effectiveness of wearable activity trackers to increase physical activity and improve health: a systematic review of systematic reviews and meta-analyses, Lancet Digit Health sourceSupported

People with T2D tend to exhibit lower levels of physical activity compared with people who do not have diabetes.

“However, people with T2D tend to exhibit lower levels of PA compared with people who do not have diabetes.6 7”

• cites [6] sourcePartly supported

  The Results (p. 4) report that 39% of adults with diabetes were physically active, compared with 58% of adults without diabetes. However, the ascertainment section (p. 3) says the study did not distinguish type 2 from type 1 diabetes, so the comparison was not measured specifically for people with T2D. (LLM, conf=0.86)

  Experimental — accuracy not yet measured
• cites [7] sourceNot checked — no full text of the source

Previous reports have cited issues with using accelerometers to assess non-ambulatory activity such as cycling and resistance exercise.

“Previous reports have also cited issues with using accelerometers to assess non-ambulatory activity (eg, cycling and resistance exercise), which may be promoted through purposeful exercise programmes.19”

• cites [19] Bannell, 2023, Adherence to unsupervised exercise in sedentary individuals: A randomised feasibility trial of two mobile health interventions, Digit Health sourceSupported

The recruitment rate compares well with the Early-ACTID trial, where 98% of eligible patients with newly diagnosed T2D were randomised.

“This recruitment rate compares well with the Diet or diet plus physical activity versus usual care in patients with newly diagnosed type 2 diabetes trial (Early-ACTID), where 98% of eligible patients with newly diagnosed T2D (5- to 8 months since diagnosis) were randomised to receive usual care or lifestyle advice.14”

• cites [14] Andrews, 2011, Diet or diet plus physical activity versus usual care in patients with newly diagnosed type 2 diabetes: the Early ACTID randomised controlled trial, The Lancet sourcePartly supported

  The Patients section reports that participants had been diagnosed within the previous 5–8 months and were randomised to usual care, intensive diet, or intensive diet plus activity. But the Results section says 712 were eligible for face-to-face screening and 593 were enrolled—about 83%, not 98%. The cited copy does not substantiate the stated 98% recruitment rate. (LLM, conf=0.88)

  Experimental — accuracy not yet measured

There was evidence that a clinically important difference may be plausible for a number of secondary outcomes, including total cholesterol and LDL cholesterol at 12 months and quality of life at 12 months indicated by the SF-12 mental component score.

“As well as the encouraging data for HbA1c and systolic blood pressure, there was evidence that a clinically important difference may be plausible for a number of secondary outcomes, including total cholesterol and LDL cholesterol at 12 months57 and quality of life at 12 months, indicated by the SF-12 mental component score.58”

• cites [57] Goldenberg, 2021, Efficacy and safety of low and very low carbohydrate diets for type 2 diabetes remission: systematic review and meta-analysis of published and unpublished randomized trial data, BMJ sourcePartly supported

  The Results (secondary outcomes; page unavailable) report a clinically important worsening in LDL cholesterol at 12 months, but little or no effect on total cholesterol. Citation 57 is attached to the cholesterol outcomes; the SF-12 quality-of-life claim has a separate citation (58) and is not judged here. (LLM, conf=0.86)

  Experimental — accuracy not yet measured
• cites [58] Schunk, 2015, Health-related quality of life in women and men with type 2 diabetes: a comparison across treatment groups, J Diabetes Complicat sourceNot checked — no full text of the source

The centralised Early-ACTID trial collected primary outcome data (HbA1c) from 98% of participants at 12 months.

“the centralised Early-ACTID trial collected primary outcome data (HbA1c) from 98% of participants at 12 months.”

• cites [14] Andrews, 2011, Diet or diet plus physical activity versus usual care in patients with newly diagnosed type 2 diabetes: the Early ACTID randomised controlled trial, The Lancet sourceSupported

The goal for clinical management of type 2 diabetes is to achieve and maintain tight control of HbA1c and systolic blood pressure.

“Due to the association of HbA1c and systolic blood pressure with diabetes complications and mortality,4951 the goal for clinical management of T2D is to achieve and maintain tight control of HbA1c and systolic blood pressure.52”

• cites [4951]Not matched

  Couldn’t be matched to a paper in Crossref, so it can’t be checked.

• cites [52] sourcePartly supported

  The Introduction says type 2 diabetes care requires glycemic control and cardiovascular risk-factor management, and the cardiovascular outcomes section calls for continued efforts to achieve glycemic and blood-pressure targets. But the Rationale section recommends individualized HbA1c targets and cautions that intensive glucose control can cause immediate harms; the paper does not endorse uniformly tight control of both HbA1c and systolic blood pressure. Page numbers are unavailable in our copy. (LLM, conf=0.88)

  Experimental — accuracy not yet measured

Compared with Early-ACTID, the current trial recruited a more ethnically diverse population.

“Compared with Early-ACTID, which also recruited people with newly diagnosed T2D in the UK, the current trial recruited a more ethnically diverse population.14”

• cites [14] Andrews, 2011, Diet or diet plus physical activity versus usual care in patients with newly diagnosed type 2 diabetes: the Early ACTID randomised controlled trial, The Lancet sourcePartly supported

  The Patients section (page unavailable) confirms that Early ACTID recruited people recently diagnosed with type 2 diabetes in southwest England. Our copy does not report the participants’ ethnicity, so it cannot establish that the current trial recruited a more ethnically diverse population (searched: ethnic, white, and baseline ethnicity). (LLM, conf=0.79)

  Experimental — accuracy not yet measured

MOTIVATE-T2D participants were more likely to maintain purposeful exercise at 12 months than active control participants (OR 2.9, CI 1.2 to 7.4).

“MOTIVATE-T2D participants were more likely to start (OR 10.4, CI 3.4 to 32.1) and maintain purposeful exercise at 6 (OR 7.1, CI 3.2 to 15.7) and 12 months (OR 2.9, CI 1.2 to 7.4).”

At 12 months, the between-group mean difference in HbA1c change from baseline was −2% (CI −8 to −4) in favour of MOTIVATE-T2D.

“12 months: −2% change from baseline, CI −8 to −4”

The recruitment rate was 93% of eligible participants.

“a recruitment rate of 93%”

• Also stated in: § Recruitment and retention of participants and acceptability of trial design · plain

  “125 participants (93% of eligible participants) randomised”

MOTIVATE-T2D participants were more likely to start purposeful exercise than active control participants (OR 10.4, CI 3.4 to 32.1).

“MOTIVATE-T2D participants were more likely to start (OR 10.4, CI 3.4 to 32.1) and maintain purposeful exercise at 6 (OR 7.1, CI 3.2 to 15.7) and 12 months (OR 2.9, CI 1.2 to 7.4).”

MOTIVATE-T2D participants were more likely to maintain purposeful exercise at 6 months than active control participants (OR 7.1, CI 3.2 to 15.7).

“MOTIVATE-T2D participants were more likely to start (OR 10.4, CI 3.4 to 32.1) and maintain purposeful exercise at 6 (OR 7.1, CI 3.2 to 15.7) and 12 months (OR 2.9, CI 1.2 to 7.4).”

At 6 months, the between-group mean difference in systolic blood pressure was −1 mm Hg (CI −5 to 3) in favour of MOTIVATE-T2D.

“systolic BP: 6 months: −1 mm Hg, CI −5 to 3”

Retention at 12 months was 82%.

“Retention at 12 months was 82%.”

At 12 months, the between-group mean difference in systolic blood pressure was −4 mm Hg (CI −8 to 1) in favour of MOTIVATE-T2D.

“12 months: −4 mm Hg, CI −8 to 1”

At 6 months, the between-group mean difference in HbA1c change from baseline was −5% (CI −10 to 2) in favour of MOTIVATE-T2D.

“HbA1c: 6 months: −5% change from baseline, CI −10 to 2”

125 participants were randomised in the MOTIVATE-T2D trial.

“resulting in 125 participants randomised”

• Also stated in: § Recruitment and retention of participants and acceptability of trial design · plain

  “resulting in 125 participants (93% of eligible participants) randomised”

Medication changes were more common in Canadian participants (46%) than UK participants (16%).

“Medication changes were more common in Canadian participants (Canada 29 (46%); UK 10 (16%)).”

At the end of the 6-month intervention period (weeks 24-28), 52% of MOTIVATE-T2D participants completed >150 min of MVE per week at least once compared with 17% in active control.

“At the end of the 6-onth intervention period (weeks 24–28), 52% of MOTIVATE-T2D participants completed>150 min of MVE per week at least once compared with 17% in active control (figure 2B).”

At 12 months, 71% of participants wore the accelerometer for at least 16 hours on 1 day.

“At 12 months, 58% of participants wore the accelerometer for 16 hours on four or more days, including one weekend day, and 71% wore the device for at least 16 hours on 1 day (online supplemental eTable 10).”

Enrolment success appeared to be influenced by recruitment strategy.

“Enrolment success appeared to be influenced by recruitment strategy (online supplemental eTable 1).”

At 6 months, changes to glucose-lowering medication were seen in 13 MOTIVATE-T2D participants.

“At 6 months, changes to glucose-lowering medication were seen in 10 active control (one stopped a medication, one started a new medication, five decreased dose and three increased dose) and 13 MOTIVATE-T2D (three stopped a medication, one started a new medication, four decreased dose and five increased dose) participants.”

Participants had a high level of satisfaction with their participation in the trial.

“Participants had a high level of satisfaction with their participation in the trial (online supplemental eTable 3).”

Active control participants interacted more with the exercise videos than MOTIVATE-T2D (total video views: MOTIVATE-T2D 101, active control 135).

“Active control participants interacted more with the exercise videos (total video views; MOTIVATE-T2D 101, active control 135).”

Retention rate differed between study groups, with 13% of MOTIVATE-T2D versus 22% of active control participants lost to follow-up.

“There was evidence of imbalance in retention rate between study groups and country, with 8 (13%) MOTIVATE-T2D versus 14 (22%) active control and 9 (14%) UK versus 13 (21%) Canadian participants lost to follow-up.”

At 6 and 12 months, within- and between-group differences in PA outcomes were highly variable.

“At 6 and 12 months, within- and between-group (table 3) differences in PA outcomes were highly variable, but there was no evidence of compensatory reduction in lifestyle PA alongside increases in purposeful exercise in either group.”

At 12-month follow-up, 22 (18%) participants were lost to follow-up.

“At 6- and 12-month follow-ups, 16 (13%) and 22 (18%) participants were lost to follow-up, respectively.”

The average cost of the active control intervention per participant was estimated to be £128.99/$C169.37, based on delivery to 100 people.

“The average cost of the interventions per participant was estimated to be MOTIVATE-T2D £321.32/$C532.17 and active control £128.99/$C169.37, based on delivery of the interventions to 100 people (online supplemental eTable 20 for cost breakdown).”

The achieved recruitment rate exceeded the predetermined progression criterion, with 93% of eligible people approached being randomised (criterion >20%).

“The achieved recruitment and retention rates exceeded the predetermined progression criteria for the trial, with 93% of eligible people approached being randomised (criterion: >20%) and 82% of participants retained at 12 months (criterion: >80%).24”

At 12 months, medication changes were seen in 12 MOTIVATE-T2D participants.

“At 12 months, medication changes were seen in 12 active control (two started a new medication, four decreased dose and six increased dose) and 12 MOTIVATE-T2D (two started a new medication, three decreased dose and seven increased dose) participants.”

Participants cited technical aspects of the watch and app as a challenge.

“However, participants cited technical aspects of the watch and app as a challenge, highlighting the need for additional resources/training in the future.”

The flexibility of the PA and exercise programme was found to promote autonomy.

“The flexibility of the PA and exercise programme was also found to promote autonomy.”

Qualitative interviews indicated high levels of satisfaction and acceptability of the MOTIVATE-T2D intervention in people with recently diagnosed T2D.

“Qualitative interviews indicated high levels of satisfaction and acceptability of the MOTIVATE-T2D intervention in people with recently diagnosed T2D (online supplemental eTable 9).”

The average cost of the MOTIVATE-T2D intervention per participant was estimated to be £321.32/$C532.17, based on delivery to 100 people.

“The average cost of the interventions per participant was estimated to be MOTIVATE-T2D £321.32/$C532.17 and active control £128.99/$C169.37, based on delivery of the interventions to 100 people (online supplemental eTable 20 for cost breakdown).”

At 12 months, the odds of participants still exercising were 3 times higher for MOTIVATE-T2D compared with active control (OR 2.9, 95% CI 1.2 to 7.4).

“At 6 and 12 months, the OR for participants still exercising were 7 (OR 7.1, CI 3.2 to 15.7; MOTIVATE-T2D 79% still training, active control 34% still training) and 3 (OR 2.9, CI 1.2 to 7.4; MOTIVATE-T2D 30% still training, active control 13% still training) times higher for MOTIVATE-T2D compared with active control, respectively (figure 2A).”

At 6-month follow-up, 16 (13%) participants were lost to follow-up.

“At 6- and 12-month follow-ups, 16 (13%) and 22 (18%) participants were lost to follow-up, respectively.”

MOTIVATE-T2D participants exercised more regularly than active control during the 6-month intervention period and the 6- to 12-month follow-up, measured via optical HR monitor.

“participants in the MOTIVATE-T2D group exercised, measured via optical HR monitor, more regularly than active control during the 6month-intervention period and the 6- to 12-month follow-up (table 5).”

• AssumptionRests on an assumption: Optical heart rate monitor measurements accurately reflect participants' exercise behaviour.

At 12 months, medication changes were seen in 12 active control participants.

“At 12 months, medication changes were seen in 12 active control (two started a new medication, four decreased dose and six increased dose) and 12 MOTIVATE-T2D (two started a new medication, three decreased dose and seven increased dose) participants.”

The role of the exercise specialist, including counselling sessions and regular text messages, was a highly valued element of MOTIVATE-T2D.

“Highly valued elements of MOTIVATE-T2D included the role of the exercise specialist, where the counselling sessions and regular text messages were seen as a source of support and reassurance.”

At 12 months, 58% of participants wore the accelerometer for 16 hours on four or more days, including one weekend day.

“At 12 months, 58% of participants wore the accelerometer for 16 hours on four or more days, including one weekend day, and 71% wore the device for at least 16 hours on 1 day (online supplemental eTable 10).”

Participant interaction with their counsellor by text message was higher in MOTIVATE-T2D (mean 49±38 texts) than in active control (mean 18±14 texts).

“Participant interaction with their counsellor by text message was higher in MOTIVATE-T2D (mean number of texts sent by participants (49±38) than in active control (18±14).”

The odds of participants starting training (completed ≥1 training session) was more than 10 times higher for MOTIVATE-T2D compared with active control (OR 10.4, 95% CI 3.4 to 32.1).

“The OR of participants starting training (completed ≥1 training session) was more than 10 times higher for MOTIVATE-T2D compared with active control (OR 10.4, CI 3.4 to 32.1; MOTIVATE-T2D 93% started training, active control 58% started training).”

At the end of the 12-month follow-up period (weeks 48-52), 28% of MOTIVATE-T2D participants completed >150 min of MVE per week at least once compared with 11% in active control.

“At the end of the 12-month follow-up period (weeks 48–52), this proportion dropped to 28% of MOTIVATE-T2D participants compared with 11% in the active control (figure 2C).”

At 6 months, the odds of participants still exercising were 7 times higher for MOTIVATE-T2D compared with active control (OR 7.1, 95% CI 3.2 to 15.7).

“At 6 and 12 months, the OR for participants still exercising were 7 (OR 7.1, CI 3.2 to 15.7; MOTIVATE-T2D 79% still training, active control 34% still training) and 3 (OR 2.9, CI 1.2 to 7.4; MOTIVATE-T2D 30% still training, active control 13% still training) times higher for MOTIVATE-T2D compared with active control, respectively (figure 2A).”

Wear time tended to be higher in MOTIVATE-T2D compared with active control.

“Wear time tended to be higher in MOTIVATE-T2D compared with the active control and in participants recruited in the UK (online supplemental eTable 12).”

None of the serious adverse events at 6 months were considered related to the study processes or interventions.

“At 6 months, four participants (UK—two and Canada—two) experienced a serious adverse event, with none of these considered related to the study processes or interventions.”

No serious adverse events were reported at 12 months.

“No serious adverse events were reported at 12 months.”

At 6 months, four participants experienced a serious adverse event.

“At 6 months, four participants (UK—two and Canada—two) experienced a serious adverse event, with none of these considered related to the study processes or interventions.”

There was no evidence of compensatory reduction in lifestyle PA alongside increases in purposeful exercise in either group.

“At 6 and 12 months, within- and between-group (table 3) differences in PA outcomes were highly variable, but there was no evidence of compensatory reduction in lifestyle PA alongside increases in purposeful exercise in either group.”

Retention rate differed between countries, with 14% of UK versus 21% of Canadian participants lost to follow-up.

“There was evidence of imbalance in retention rate between study groups and country, with 8 (13%) MOTIVATE-T2D versus 14 (22%) active control and 9 (14%) UK versus 13 (21%) Canadian participants lost to follow-up.”

Wear time tended to be higher in participants recruited in the UK.

“Wear time tended to be higher in MOTIVATE-T2D compared with the active control and in participants recruited in the UK (online supplemental eTable 12).”

During the follow-up period (6 to 12 months), participants in MOTIVATE-T2D had three times higher odds of still completing purposeful exercise versus those in the active control.

“During the follow-up period (6 to 12 months), participants in MOTIVATE-T2D had three times higher odds of still completing purposeful exercise versus those in the active control.”

The between-group difference for HbA1c was not maintained at 12 months.

“However, the between-group difference for HbA1c was not maintained at 12 months.”

Participant interviews suggested that the decentralised approach was broadly acceptable.

“Participant interviews suggested that the decentralised approach was broadly acceptable, although future iterations may need to consider how participants are supported with taking blood samples.”

There was a noticeable reduction in engagement with purposeful exercise during the unsupported phase following either intervention.

“However, there was a noticeable reduction in engagement with purposeful exercise during this unsupported phase following either intervention.”

Increased engagement in purposeful exercise did not seem to lead to a compensatory reduction in lifestyle-based physical activity.

“However, increased engagement in purposeful exercise did not seem to lead to a compensatory reduction in lifestyle-based PA, which has previously been cited as a concern during supervised exercise interventions.46 47”

The 95% confidence intervals for systolic blood pressure in this study included 5 mm Hg.

“and the 95% CIs for systolic blood pressure in this study included 5 mm Hg.”

The MOTIVATE-T2D intervention has promising effects on adherence to purposeful exercise.

“with promising effects on adherence to purposeful exercise”

The mean weekly exercise duration was greater in MOTIVATE-T2D than active control.

“The device-derived measurements of purposeful exercise demonstrated that MOTIVATE-T2D participants were more likely to start an exercise programme and the mean weekly exercise duration was greater.”

The −5% between-group difference in HbA1c at 6 months is equivalent to approximately 3 mmol/mol.

“and the −5% between-group difference at 6 months is equivalent to ~3 mmol/mol.”

The active control intervention was matched to the MOTIVATE-T2D intervention aside from the availability of technology.

“Our active control intervention was matched aside from the availability of technology in Mobile Health Biometrics to Enhance Exercise and Physical Activity Adherence in Type 2 Diabetes (MOTIVATE-T2D) to assess how the addition of mHealth technology can influence physical activity (PA).”

• Also stated in: § Interventions · plain

  “Briefly, by design, the active control and MOTIVATE-T2D interventions were matched aside from the availability of technology in MOTIVATE-T2D.”

The findings support the feasibility of delivering the MOTIVATE-T2D mHealth-supported PA intervention for people with recently diagnosed T2D.

“Our findings support the feasibility of delivering the MOTIVATE-T2D mHealth-supported PA intervention for people with recently diagnosed T2D”

• AssumptionRests on an assumption: The observed recruitment rate of 93% and retention of 82% are sufficient to support the feasibility of a future definitive trial.

The study was not designed or powered to definitively assess the efficacy or cost-effectiveness of the MOTIVATE-T2D intervention on clinical outcomes in people with newly diagnosed T2D.

“This study was not designed or powered to definitively assess the efficacy or cost-effectiveness of the MOTIVATE-T2D intervention on clinical outcomes in people with newly diagnosed T2D.”

Participants do not receive appropriate support from health providers in the time between scheduled meetings.

“One such barrier is that participants do not receive appropriate support from health providers in the time between scheduled meetings.22”

• cites [22] Lidegaard, 2016, Barriers to and motivators for physical activity among people with Type 2 diabetes: patients’ perspectives, Diabet Med sourceNot checked — no full text of the source

There is poor adherence to existing physical activity interventions and strategies.

“However, given the poor adherence to existing PA interventions and strategies,10 innovative interventions which capitalise on the potential of new technologies are urgently needed to effectively support PA and health in people with T2D.”

• cites [10] MacDonald, 2021, A systematic review of adherence to physical activity interventions in individuals with type 2 diabetes, Diabetes Metab Res Rev sourceNot checked — no full text of the source

The planned recruitment target of 120 participants (60 per arm) allowed the study to achieve its feasibility aims and objectives.

“Our planned recruitment target of 120 participants (60 per arm) allowed us to achieve the feasibility aims and objectives of this study; that is, an estimate of attrition, estimates of the SD of the secondary outcomes to inform power calculations for a future definitive trial and enough participants for qualitative interviews.”

Heart rate monitoring has several advantages over accelerometers when targeting purposeful exercise of moderate-to-vigorous intensity.

“HR monitoring has several advantages over accelerometers when targeting purposeful exercise of moderate-to-vigorous intensity.”

• cites [20] sourceNot checked — no full text of the source
• cites [21] Nes, 2017, Personalized Activity Intelligence (PAI) for Prevention of Cardiovascular Disease and Promotion of Physical Activity, Am J Med sourceNot checked — no full text of the source

Diabetes care pathways are increasingly prioritising the provision of personalised physical activity guidance for individuals recently diagnosed with T2D.

“To address this gap, diabetes care pathways are increasingly prioritising the provision of personalised PA guidance for individuals recently diagnosed with T2D.8 9”

• cites [8] NHS RightCare . NHS rightcare pathway: diabetes. 2018.Not matched

  Couldn’t be matched to a paper in Crossref, so it can’t be checked.

• cites [9] Diabetes Canada . Diabetes 360°: a framework for a diabetes strategy for Canada. 2018.Not matched

  Couldn’t be matched to a paper in Crossref, so it can’t be checked.

Heart rate reflects intensity regardless of the type of activity performed.

“HR also reflects intensity regardless of the type of activity performed.21”

• cites [21] Nes, 2017, Personalized Activity Intelligence (PAI) for Prevention of Cardiovascular Disease and Promotion of Physical Activity, Am J Med sourceNot checked — no full text of the source

Acceptability and feasibility were established using a multidisciplinary approach drawing on quantitative, qualitative and trial procedure data.

“Acceptability and feasibility were established using a multidisciplinary approach drawing on quantitative, qualitative and trial procedure data.”

Regular physical activity has known benefits on glycaemia, incidence of microvascular complications, cardiovascular events and all-cause mortality in people living with T2D.

“These guidelines draw on the known benefits of regular PA on glycaemia,4 the incidence of microvascular complications, cardiovascular events and all-cause mortality in people living with T2D.5”

• cites [4] sourceNot checked — no full text of the source
• cites [5] sourceNot checked — no full text of the source

The findings of this trial indicate that it is feasible to recruit and retain newly diagnosed people with T2D in a randomised trial with a 12-month follow-up.

“The findings of this trial support the acceptability of the MOTIVATE-T2D intervention and indicate that it is feasible to recruit and retain newly diagnosed people with T2D in a randomised trial with a 12month- follow-up.”

Intervention adherence was excellent.

“MOTIVATE-T2D was well received by participants, and intervention adherence was excellent.”

There was evidence of higher engagement in purposeful exercise in MOTIVATE-T2D compared with active control.

“There was evidence of higher engagement in purposeful exercise compared with the active control group and no apparent evidence of compensatory reductions in lifestyle PA.”

There was no apparent evidence of compensatory reductions in lifestyle PA.

“There was evidence of higher engagement in purposeful exercise compared with the active control group and no apparent evidence of compensatory reductions in lifestyle PA.”

There was evidence that wear time may have influenced between-group differences at follow-up.

“There was evidence that wear time may have influenced between-group differences at follow-up (online supplemental eTables 15 and 16).”

Data availability for secondary outcomes ranged from 58% to 74% at 12 months.

“Data availability for secondary outcomes ranged from 58% to 74% at 12 months (online supplemental eTables 10 and 11).”

At follow-up, several outcomes showed a potential direction of effect in favour of MOTIVATE-T2D, including HbA1c and systolic blood pressure.

“At follow-up, compared with active control, several outcomes showed a potential direction of effect in favour of MOTIVATE-T2D, including our proposed primary outcomes of HbA1c and systolic blood pressure.”

Data on HbA1c were available from 95%, 78% and 74% of participants at baseline, 6 and 12 months, respectively.

“Data on likely primary outcomes, HbA1c and systolic blood pressure, were available from 95%, 78% and 74%, and 97%, 71% and 63% of participants at baseline, 6 and 12 months, respectively (online supplemental eTable 10).”

Wear time criteria influenced data availability for CGM, with data availability at 12 months ranging from 58% to 69%.

“Wear time criteria influenced data availability for CGM, with data availability at 12 months ranging from 58% to 69% (online supplemental eTable 10).”

Availability of data for HbA1c at 12 months appeared to be influenced by country, with data available from 81% of participants in the UK and 67% in Canada.

“Availability of data for HbA1c appeared to be influenced by country, with data available from 81% of participants in the UK and 67% of participants in Canada at 12 months (online supplemental eTables 13 and 14).”

MOTIVATE-T2D was well received by participants.

“MOTIVATE-T2D was well received by participants, and intervention adherence was excellent.”

The findings of this trial support the acceptability of the MOTIVATE-T2D intervention.

“The findings of this trial support the acceptability of the MOTIVATE-T2D intervention and indicate that it is feasible to recruit and retain newly diagnosed people with T2D in a randomised trial with a 12month- follow-up.”

Data on systolic blood pressure were available from 97%, 71% and 63% of participants at baseline, 6 and 12 months, respectively.

“Data on likely primary outcomes, HbA1c and systolic blood pressure, were available from 95%, 78% and 74%, and 97%, 71% and 63% of participants at baseline, 6 and 12 months, respectively (online supplemental eTable 10).”

The retention rate compares well with studies in a systematic review of pedometer/accelerometer interventions in T2D (n=7, mean 78%, range 63%-98%).

“The retention rate also compares well with studies included in a systematic review of interventions using pedometers or accelerometers to promote PA in people with T2D (n=7 randomised trials, mean 78%, range 63%–98%).13”

• cites [13] sourceNot checked — no full text of the source

A similar meta-analysis of unsupervised behavioural interventions in people with type 2 diabetes on systolic blood pressure suggested a small but significant effect, with a weighted mean difference of 3 mm Hg (95% CI −5 to −1).

“A similar meta-analysis of unsupervised behavioural interventions in people with T2D on systolic blood pressure suggested a small (weighted mean difference of 3 mm Hg, 95% CI −5 to −1) but significant effect.56”

• cites [56] sourceNot checked — no full text of the source

The study was not designed or powered to definitively assess the efficacy of MOTIVATE-T2D in people with recently diagnosed type 2 diabetes.

“the study was not designed or powered to definitively assess the efficacy of MOTIVATE-T2D in people with recently diagnosed T2D”

The UK Prospective Diabetes Study showed the importance of dyslipidaemia for cardiovascular disease risk in people with type 2 diabetes.

“The UK prospective diabetes study showed the importance of dyslipidaemia for cardiovascular disease risk in people with T2D.59”

• cites [59] Turner, 1998, The U.K. Prospective Diabetes Study. A review, Diabetes Care sourceNot checked — no full text of the source

Device-derived purposeful exercise metrics may be underestimated in the active control group.

“Therefore, device-derived purposeful exercise metrics may be underestimated in the active control group”

Adherence to MOTIVATE-T2D compares favourably to a meta-analysis of cardiac rehabilitation programmes (14 trials, n=8176, mean adherence 67±18.2%).

“Adherence to MOTIVATE-T2D compares favourably to a meta-analysis (14 trials, n=8176) of cardiac rehabilitation programmes, where mean adherence (prescribed sessions attended) was 67±18.2%.37”

• cites [37] Oosenbrug, 2016, Sex Differences in Cardiac Rehabilitation Adherence: A Meta-analysis, Can J Cardiol sourceNot checked — no full text of the source

Adherence, assessed as prescribed sessions attended (MOTIVATE-T2D 78%), was comparable to data reported in a systematic review of supervised exercise interventions in people with T2D (18 trials, n=523, adherence: 87±8%).

“However, adherence, assessed as prescribed sessions attended (MOTIVATE-T2D 78%), was comparable to data reported in a systematic review of supervised exercise interventions in people with T2D (18 trials, n=523, adherence: 87±8%).4”

• cites [4] sourceNot checked — no full text of the source

Data from the qualitative evaluation suggest that extending the text message feedback period may be a simple and cost-effective way of supporting participants to maintain changes in behaviour.

“Data from our qualitative evaluation suggest that extending the text message feedback period may be a simple and cost-effective way of supporting participants to maintain changes in behaviour.”

There was evidence that a clinically important difference in HbA1c at 6 months and systolic blood pressure at 12 months between MOTIVATE-T2D and active control was plausible.

“Using this approach, there was evidence that a clinically important difference in HbA1c at 6 months and systolic blood pressure at 12 months between MOTIVATE-T2D and active control was plausible.”

The provision of heart rate monitoring to guide participants' purposeful exercise in real time and facilitate personalised feedback from exercise specialists appeared to be an important strategy within the MOTIVATE-T2D intervention.

“In particular, the provision of HR monitoring to guide participants’ purposeful exercise in real time and facilitate personalised feedback from exercise specialists appeared to be an important strategy within the MOTIVATE-T2D intervention.”

The results suggest that the MOTIVATE-T2D approach was promising for the promotion, uptake and adherence to purposeful exercise in people with newly diagnosed T2D.

“The results from this trial suggest that the MOTIVATE-T2D approach of using biometrics from wearable technologies to support a home-delivered, personalised behavioural counselling service was promising for the promotion, uptake and adherence to purposeful exercise in people with newly diagnosed T2D.”

The active control group completed a complex intervention containing behaviour change techniques previously associated with effective physical activity interventions, including goal setting, action planning, implementing graded tasks and self-monitoring of behaviour.

“As per the study design, the active control group also completed a complex intervention containing a range of behaviour change techniques that have previously been associated with effective PA interventions, including goal setting, action planning, implementing graded tasks and self-monitoring of behaviour.4145”

• cites [4145]Not matched

  Couldn’t be matched to a paper in Crossref, so it can’t be checked.

It is plausible that between-group differences would have been larger if compared with a usual care control group, increasing the likelihood of clinically important effects in the real world.

“As discussed above, the active control group received a complex intervention, and it is plausible that between-group differences would have been larger if compared with a usual care control group, increasing the likelihood of clinically important effects in the real world.”

There was evidence of imbalances between the intervention and active control groups in their demographic characteristics.

“there was evidence of imbalances between intervention and active control groups in their demographic characteristics”

The study did not employ a strict target-driven approach to the regulation of glucose-lowering medication.

“the study did not employ a strict target-driven approach to the regulation of glucose-lowering medication”

Both groups received similar support from an exercise specialist to codesign the personalised programme.

“This was achieved despite both groups receiving similar support from an exercise specialist to codesign the personalised programme.”

Potential improvements in these secondary outcomes are highly relevant for people with type 2 diabetes.

“As such, potential improvements in these secondary outcomes are highly relevant for people with T2D.”

The addition of biofeedback to support a complex behavioural intervention was an effective strategy to partner with behaviour change.

“However, our findings suggest the addition of biofeedback to support a complex behavioural intervention was an effective strategy to partner with behaviour change.”

Participant and researcher blinding was not possible because of the nature of the intervention.

“participant and researcher blinding was not possible because of the nature of the intervention”

The sample size estimate is based on detecting a minimum clinically important difference of 3 mmol/mol, an SD at baseline of 10 mmol/mol, an assumed attrition rate of 20%, at 90% power and a two-tailed 5% α level.

“This estimate is based on detecting a minimum clinically important difference of 3 mmol/mol,54 55 an SD at baseline of 10 mmol/mol (as seen in this feasibility trial) and an assumed attrition rate of 20% (as seen in this feasibility trial), at 90% power and a two-tailed 5% α level.”

• cites 54 55Not matched

  Couldn’t be matched to a paper in Crossref, so it can’t be checked.

Both the active control and MOTIVATE-T2D interventions encouraged participants to take part in types or modes of exercise whose intensity may not have been accurately captured by the accelerometer, such as cycling or resistance exercise.

“Both the active control and MOTIVATE-T2D interventions encouraged participants to take part in types/modes of exercise whose intensity may not have been accurately captured by the accelerometer (eg, cycling or resistance exercise).19 46”

• cites 19 46Not matched

  Couldn’t be matched to a paper in Crossref, so it can’t be checked.

A difference of 3 mmol/mol would represent a clinically important difference in HbA1c.

“Studies also suggest a difference of 3 mmol/mol would represent a clinically important difference in HbA1c,54 55”

• cites 54 55Not matched

  Couldn’t be matched to a paper in Crossref, so it can’t be checked.

Studies measuring physical activity have shown that maintaining behaviour change after the conclusion of an intervention is challenging.

“However, studies measuring PA have shown that maintaining behaviour change after the conclusion of an intervention is challenging.38”

• cites [38] McEwan, 2022, What Happens When the Party is Over?: Sustaining Physical Activity Behaviors after Intervention Cessation, Behav Med sourceNot checked — no full text of the source

Meta-analysis of unsupervised behavioural interventions suggested that they were not associated with changes in HbA1c unless combined with dietary advice.

“However, meta-analysis of unsupervised behavioural interventions suggested that they were not associated with changes in HbA1c unless combined with dietary advice.4”

• cites [4] sourceNot checked — no full text of the source

The additional step of shipping samples to the UK for analysis may have been responsible for the reduced HbA1c and blood lipid data availability in Canada.

“We believe this additional step may have been responsible for the reduced HbA1c and blood lipid data availability in Canada.”

• AssumptionRests on an assumption: During study planning, there were no services that could process capillary blood samples in Canada.

Data availability for outcome measures was good.

“Although data availability for outcome measures was good”

It was difficult to draw conclusions from the physical activity data due to the small sample size and large variability.

“It was difficult to draw conclusions from the PA data due to the small sample size and large variability.”

The decentralised design could positively impact trial feasibility, as recruitment was not limited by geographic constraints.

“Our experience was that the decentralised design could positively impact trial feasibility, as recruitment was not limited by geographic constraints.”

A 5 mm Hg reduction in systolic blood pressure is reported as the minimal clinically important difference.

“Studies report a 5 mm Hg reduction in systolic blood pressure as the MCID,53”

• cites [53] sourceNot checked — no full text of the source

The decentralised design may have provided an opportunity for greater diversity in the trial population.

“As suggested previously,60 the decentralised design may also have provided an opportunity for greater diversity in our trial population.”

• cites [60] Sinha, 2024, Decentralisation in Clinical Trials and Patient Centricity: Benefits and Challenges, Pharmaceut Med sourceNot checked — no full text of the source