Comparison of the Effectiveness of Lifestyle Modification with Other Treatments on the Incidence of Type 2 Diabetes in People at High Risk: A Network Meta-Analysis

Background: Many clinical trials have been conducted to verify the effects of interventions for prevention of type 2 diabetes (T2D) using different treatments and outcomes. The aim of this study was to compare the effectiveness of lifestyle modifications (LM) with other treatments in persons at high risk of T2D by a network meta-analysis (NMA). Methods: Searches were performed of PUBMED up to January 2018 to identify randomized controlled trials. The odds ratio (OR) with onset of T2D at 1 year in the intervention group (LM, dietary, exercise, or medication) versus a control group (standard treatments or placebo) were the effect sizes. Frequentist and Bayesian NMAs were conducted. Results: Forty-seven interventions and 12 treatments (20,113 participants) were used for the analyses. The OR in the LM was approximately 0.46 (95% CI: 0.33 to 0.61) times lower compared to the standard intervention by the Bayesian approach. The effects of LM compared to other treatments by indirect comparisons were not significant. Conclusions: This meta-analysis further strengthened the evidence that LM reduces the onset of T2D compared to standard and placebo interventions and appears to be at least as effective as nine other treatments in preventing T2D.

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Influence of physical activity on periodontal health in patients with type 2 diabetes mellitus. A blinded, randomized, controlled trial

Clinical Oral Investigations ◽

10.1007/s00784-021-03908-6 ◽

2021 ◽

Author(s):

K. Wernicke ◽

J. Grischke ◽

M. Stiesch ◽

S. Zeissler ◽

K. Krüger ◽

...

Keyword(s):

Physical Activity ◽

Diabetes Mellitus ◽

Type 2 Diabetes ◽

Controlled Trial ◽

Intervention Group ◽

Control Group ◽

Periodontal Health ◽

Randomized Controlled ◽

Hba1c Levels

Abstract Objectives The aim was to investigate the effect of physical activity on periodontal health and HbA1c levels in patients with type 2 diabetes mellitus (T2DM) over a period of 6 months. Materials and methods Thirty-seven patients with non-insulin-dependent T2DM were included in the study. The intervention group (n=20) performed physical activity over a period of 6 months. The control group (n=17) did not receive any intervention. Baseline and final examinations included dental parameters and concentrations of glycosylated hemoglobin (HbA1c) and high-sensitivity C-reactive protein (hsCRP). Results Physical activity showed a positive effect on periodontal health. Both the BOP (p= 0.005) and the severity of periodontitis (p= 0.001) were significantly reduced in the intervention group compared to the control group. Furthermore, HbA1c levels were reduced (p= 0.010) significantly in the intervention group while hsCRP levels significantly increased in the control group (p= 0.04). Conclusions Within the limitations of this randomized, controlled trial, physical activity over a period of 6 months is a health-promoting measure for patients with T2DM and improves both periodontal health and HbA1c concentrations.

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Effectiveness of diabetes self-management education and support via a smartphone application in insulin-treated patients with type 2 diabetes: results of a randomized controlled trial (TRIGGER study)

BMJ Open Diabetes Research & Care ◽

10.1136/bmjdrc-2019-000981 ◽

2019 ◽

Vol 7 (1) ◽

pp. e000981 ◽

Cited By ~ 2

Author(s):

Anne Meike Boels ◽

Rimke C Vos ◽

Lioe-Ting Dijkhorst-Oei ◽

Guy E H M Rutten

Keyword(s):

Type 2 Diabetes ◽

Dietary Habits ◽

Management Education ◽

Intervention Group ◽

Self Management ◽

Smartphone App ◽

Control Group ◽

Hypoglycemic Event ◽

Randomized Controlled

ObjectiveTo investigate the effect of diabetes self-management education and support via a smartphone app in individuals with type 2 diabetes on insulin therapy.Research design and methodsOpen two-arm multicenter parallel randomized controlled superiority trial. The intervention group (n=115) received theory and evidence-based self-management education and support via a smartphone app (optionally two or six times per week, once daily at different times). The control group (n=115) received care as usual. Primary outcome: HbA1c at 6 months. Other outcomes included HbA1c ≤53 mmol/mol (≤7%) without any hypoglycemic event, body mass index, glycemic variability, dietary habits and quality of life. We performed multiple imputation and regression models adjusted for baseline value, age, sex, diabetes duration and insulin dose.ResultsSixty-six general practices and five hospital outpatient clinics recruited 230 participants. Baseline HbA1c was comparable between groups (8.1% and 8.3%, respectively). At 6 months, the HbA1c was 63.8 mmol/mol (8.0%) in the intervention vs 66.2 mmol/mol (8.2%) in the control group; adjusted difference −0.93 mmol/mol (−0.08%), 95% CI −4.02 to 2.17 mmol/mol (−0.37% to 0.20%), p=0.557. The odds for achieving an HbA1c level ≤7% without any hypoglycemic event was lower in the intervention group: OR 0.87, 95% CI 0.33 to 2.35. There was no effect on secondary outcomes. No adverse events were reported.ConclusionsThis smartphone app providing diabetes self-management education and support had small and clinically not relevant effects. Apps should be more personalized and target individuals who think the app will be useful for them.Trial registration numberNTR5515.

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Effect of Precede–Proceed Model on Preventive Behaviors for Type 2 Diabetes Mellitus in High-Risk Individuals

Clinical Nursing Research ◽

10.1177/1054773815621026 ◽

2016 ◽

Vol 26 (2) ◽

pp. 241-253 ◽

Cited By ~ 9

Author(s):

Mahdi Moshki ◽

Atefeh Dehnoalian ◽

Ali Alami

Keyword(s):

Diabetes Mellitus ◽

Type 2 Diabetes ◽

Type 2 Diabetes Mellitus ◽

High Risk ◽

Intervention Group ◽

Control Group ◽

Preventive Behaviors ◽

Type 2 Dm ◽

Face To Face Instruction

This study sought to assess the effect of precede–proceed model on preventive behaviors for type 2 diabetes mellitus (DM) in high-risk individuals. In this semi-experimental study, 164 high-risk individuals for type 2 DM were selected and were randomly divided into two groups of intervention and control ( n = 85). Educational intervention was performed as a single session face-to-face instruction for 1.5 hr for the intervention group participants. Data were collected before (baseline) and immediately and 1 month after the intervention in the two groups. The mean score of predisposing (knowledge) factors ( p = .001), reinforcing factors ( p = .001), and enabling factors ( p = .02) were significantly different at baseline and 1 month after the intervention in the intervention group compared with the control group ( p < .05). A significant improvement occurred in the nutritional habits of high-risk participants in the intervention group at 1 month after the intervention compared with controls ( p = .001). The precede–proceed model can be effective for promoting the preventive behaviors for type 2 DM in high-risk individuals.

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A Highly Tailored Text and Voice Messaging Intervention to Improve Medication Adherence in Patients With Either or Both Hypertension and Type 2 Diabetes in a UK Primary Care Setting: Feasibility Randomized Controlled Trial of Clinical Effectiveness

Journal of Medical Internet Research ◽

10.2196/16629 ◽

2020 ◽

Vol 22 (5) ◽

pp. e16629 ◽

Cited By ~ 2

Author(s):

Aikaterini Kassavou ◽

Venus Mirzaei ◽

James Brimicombe ◽

Simon Edwards ◽

Efthalia Massou ◽

...

Keyword(s):

Type 2 Diabetes ◽

Primary Care ◽

Randomized Controlled Trial ◽

Medication Adherence ◽

Controlled Trial ◽

Intervention Group ◽

Clinical Effectiveness ◽

Control Group ◽

Randomized Controlled

Background The efficacy of a highly tailored digital intervention to support medication adherence and feasibility to support clinical effectiveness as an adjunct to the primary care setting has not been evaluated. Objective This trial aimed to assess the behavioral efficacy of a highly tailored digital intervention to support medication adherence and to evaluate the feasibility of its clinical effectiveness, in patients with either or both hypertension and type 2 diabetes. We also examined quality of life and mechanisms of behavior change. Intervention fidelity, engagement, and satisfaction were also explored. Methods This was a multicenter, individually randomized controlled trial of 2 parallel groups: an intervention group that received a highly tailored text message and interactive voice response intervention for 12 weeks, and a control group that received usual care. Medication adherence was measured using self-reports and assessor-blinded practice records of a repeat prescription. Systolic blood pressure and glucose levels were assessed by nurses blinded to group allocation during practice visits at 3 months follow-up. Questionnaires obtained data to assess intervention mechanisms of action and satisfaction and digital log files captured data to evaluate fidelity and engagement. Results A total of 135 nonadherent patients (62/135, 46% female; 122/135, 90.3%; aged above 50 years) were randomly allocated in the intervention (n=79) or in the control group (n=56); of whom 13% (18/135) were lost at follow-up. Medication adherence was significantly improved in the intervention group compared with the control group (t116=2.27; P=.02, 2-tailed). Systolic blood pressure was 0.6 mmHg (95% CI −7.423 to 6.301), and hemoglobin A1c was 4.5 mmol/mol (95% CI −13.099 to 4.710) lower in the intervention group compared with the control group. Changes in intentional nonadherence and nonintentional nonadherence explained the improvements in medication adherence in the intervention group (beta=.074, SE=0.464; P=.04), but not in the control group (beta=.00, SE 1.35; P=.37). The intervention had 100% fidelity, a median of 12 days of engagement, and 76% overall satisfaction. Conclusions Our trial is the first that has been conducted in the United Kingdom and showed that among nonadherent patients with either or both hypertension and type 2 diabetes, a highly tailored digital intervention was effective at improving treatment adherence and feasible to obtain clinically meaningful outcomes. Changes in intentional and nonintentional nonadherence predicted the improvements in medication adherence. The intervention had high fidelity, engagement, and satisfaction. Future research using a rigorous design is needed to evaluate the clinical effectiveness and cost-effectiveness of the intervention in primary care. Trial Registration International Standard Randomized Controlled Trial Number (ISRCTN) 10668149; http://www.controlled-trials.com/ISRCTN10668149.

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Effectiveness of a clinic-based randomized controlled intervention for type 2 diabetes management: an innovative model of intensified diabetes management in Mainland China (C-IDM study)

BMJ Open Diabetes Research & Care ◽

10.1136/bmjdrc-2019-001030 ◽

2020 ◽

Vol 8 (1) ◽

pp. e001030 ◽

Cited By ~ 1

Author(s):

Qinglin Lou ◽

Qing Ye ◽

Haidi Wu ◽

Zhiyong Wang ◽

Robert S Ware ◽

...

Keyword(s):

Type 2 Diabetes ◽

Large Scale ◽

Diabetes Management ◽

Controlled Trial ◽

Intervention Group ◽

Mainland China ◽

Outcome Variable ◽

Control Group ◽

Randomized Controlled

ObjectivesHighly efficient diabetes management programs are needed for tackling diabetes in China. This study aimed to assess the effectiveness of a clinic-based intensified diabetes management model (C-IDM) in Mainland China.Research design and methodsA 2-year clinic-based randomized controlled trial was conducted among patients with type 2 diabetes in Nanjing, China. The C-IDM intervention components comprised four domains (disease targeting management, express referral channel, expert visit, patients’ self-management) and an integrated running system (disease control centers, general hospitals and local clinics). Control group participants received their usual care, while intervention participants received both the C-IDM package and the usual services. The primary outcome variable was change of hemoglobin A1c (HbA1c). Mixed-effects models were used to compute effect estimates and 95% CI with consideration of both individual and cluster-level confounders.ResultsOverall, 1095 of 1143 participants were assessed at study completion. The mean change in HbA1c was significantly greater in the intervention group than in the control group (mean difference (MD)=−0.57, 95% CI −0.79 to –0.36). Similar results were observed for change in body mass index (MD=−0.29, 95% CI −0.49 to –0.10). Participants in the intervention group were more likely to achieve normal HbA1c and body weight compared with their counterparts in control group after adjusting for potentially confounding variables (adjusted OR=1.94, 95% CI 1.35 to 2.81 and 1.79, 95% CI 1.13 to 2.85, respectively).ConclusionsThe C-IDM model is feasible and effective in large-scale management of patients with type 2 diabetes in China. It has public health implications for tackling the burden of diabetes in China.Trial registration numberChiCTR-IOR-15006019.

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Efficacy of a Self-Regulation–Based Electronic and Mobile Health Intervention Targeting an Active Lifestyle in Adults Having Type 2 Diabetes and in Adults Aged 50 Years or Older: Two Randomized Controlled Trials

Journal of Medical Internet Research ◽

10.2196/13363 ◽

2019 ◽

Vol 21 (8) ◽

pp. e13363 ◽

Cited By ~ 7

Author(s):

Louise Poppe ◽

Ilse De Bourdeaudhuij ◽

Maïté Verloigne ◽

Samyah Shadid ◽

Jelle Van Cauwenberg ◽

...

Keyword(s):

Type 2 Diabetes ◽

Mobile Health ◽

Intervention Group ◽

Sitting Time ◽

Control Group ◽

Controlled Trials ◽

Active Lifestyle ◽

Mhealth Intervention ◽

Randomized Controlled

Background Adopting an active lifestyle plays a key role in the prevention and management of chronic diseases such as type 2 diabetes mellitus (T2DM). Web-based interventions are able to alter health behaviors and show stronger effects when they are informed by a behavior change theory. MyPlan 2.0 is a fully automated electronic health (eHealth) and mobile health (mHealth) intervention targeting physical activity (PA) and sedentary behavior (SB) based on the Health Action Process Approach (HAPA). Objective This study aimed to test the short-term effect of MyPlan 2.0 in altering levels of PA and SB and in changing personal determinants of behavior in adults with T2DM and in adults aged ≥50 years. Methods The study comprised two randomized controlled trials (RCTs) with an identical design. RCT 1 was conducted with adults with T2DM. RCT 2 was performed in adults aged ≥50 years. Data were collected via face-to-face assessments. The participants decided either to increase their level of PA or to decrease their level of SB. The participants were randomly allocated with a 2:1 ratio to the intervention group or the waiting-list control group. They were not blinded for their group allocation. The participants in the intervention group were instructed to go through MyPlan 2.0, comprising 5 sessions with an interval of 1 week between each session. The primary outcomes were objectively measured and self-reported PA (ie, light PA, moderate-to-vigorous PA, total PA, number of steps, and domain-specific [eg, transport-related] PA) and SB (ie, sitting time, number of breaks from sitting time, and length of sitting bouts). Secondary outcomes were self-reported behavioral determinants for PA and SB (eg, self-efficacy). Separate linear mixed models were performed to analyze the effects of MyPlan 2.0 in the two samples. Results In RCT 1 (n=54), the PA intervention group showed, in contrast to the control group, a decrease in self-reported time spent sitting (P=.09) and an increase in accelerometer-measured moderate (P=.05) and moderate-to-vigorous PA (P=.049). The SB intervention group displayed an increase in accelerometer-assessed breaks from sedentary time in comparison with the control group (P=.005). A total of 14 participants of RCT 1 dropped out. In RCT 2 (n=63), the PA intervention group showed an increase for self-reported total PA in comparison with the control group (P=.003). Furthermore, in contrast to the control group, the SB intervention group decreased their self-reported time spent sitting (P=.08) and increased their accelerometer-assessed moderate (P=.06) and moderate-to-vigorous PA (P=.07). A total of 8 participants of RCT 2 dropped out. Conclusions For both the samples, the HAPA-based eHealth and mHealth intervention, MyPlan 2.0, was able to improve only some of the primary outcomes. Trial Registration ClinicalTrials.gov NCT03291171; http://clinicaltrials.gov/ct2/show/NCT03291171. ClinicalTrials.gov NCT03799146; http://clinicaltrials.gov/ct2/show/NCT03799146. International Registered Report Identifier (IRRID) RR2-10.2196/12413

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Reversing Type 2 Diabetes in a Primary Care-Anchored eHealth Web-based Lifestyle Coaching Program in Denmark: Randomized Controlled Trial (Preprint)

10.2196/preprints.27240 ◽

2021 ◽

Author(s):

Jeanette Reffstrup Christensen ◽

Camilla Sortsø ◽

Jørgen T Lauridsen ◽

Pernille R Jakobsen ◽

Ditte H Laursen ◽

...

Keyword(s):

Type 2 Diabetes ◽

Weight Loss ◽

Body Composition ◽

Body Weight ◽

Intervention Group ◽

Control Group ◽

Randomized Controlled ◽

Number Of Patients ◽

And Control

BACKGROUND Lifestyle interventions can delay and reverse the onset of type 2 diabetes (T2D) and decrease morbidity and mortality. Studies suggest that digital coaching based on real-time monitoring can lead to clinically relevant weight loss, as well as decreased or normalized hemoglobin A1c (HbA1c) for a significant number of patients. OBJECTIVE To assess whether an eHealth lifestyle coaching program (LIVA 2.0) for patients with T2D who are motivated for lifestyle changes leads to significant weight loss and decreased HbA1c, compared to usual care. METHODS In a randomized controlled single-blinded trial, 170 patients with T2D were enrolled from March 2018 to March 2019 and randomized to the intervention (100) and control (70) groups. Patients were recruited via their general practitioners, the Danish diabetes organization, and social media. The intervention comprised an initial face-to-face motivational interview followed by digital coaching. The same healthcare professional coach provided synchronous and asynchronous multimodal feedback and used digital behavioral change techniques enabled by an app providing live monitoring of lifestyle behaviors. Primary outcome was body weight. Secondary outcomes were changes in HbA1c, body composition, lipids, and quality of life at 6 months. RESULTS At 6 months, 75 patients (75%) in the intervention group and 53 patients (76%) in the control group remained in the study. Mean body weight loss was 4.2 kg (95% CI, 5.5- 3.0) in the intervention group vs 1.5 kg (95% CI, 2.57- 0.48) in the control group (P = .005). In the intervention group, 36 (52%) patients lost > 3% body weight, compared to 12 (32%) patients in the control group. Mean HbA1c was lower in both groups at 6 months, with reductions of 8.2% (95% CI, 11.01 to 5.29) and 5.5% (95% CI, 8.75 to 2.76) for the intervention and control groups, respectively (P = .203). In the intervention group, 24 (32%) had an HbA1c <6.5% at 6 months, compared to 8 (15%) in the control group (P = .03). CONCLUSIONS Reduction in body weight and remission rate for HbA1c, as well as improved body composition can be enhanced by using digital lifestyle coaching for patients with T2D. CLINICALTRIAL Trial Registration: Clinicaltrials.gov NCT03788915 https://clinicaltrials.gov/ct2/show/NCT03788915 International Registered Report Identifier (IRRID): DERR2-10.2196/19172 INTERNATIONAL REGISTERED REPORT RR2-10.2196/19172

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Safety of Ertugliflozin in Patients with Type 2 Diabetes Mellitus Inadequately Controlled with Conventional Therapy at Different Periods: A Meta-Analysis of Randomized Controlled Trials

Journal of Diabetes Research ◽

10.1155/2020/9704659 ◽

2020 ◽

Vol 2020 ◽

pp. 1-13

Author(s):

Jing Huang ◽

Shuyuan Xiong ◽

Shenglan Ding ◽

Qingfeng Cheng ◽

Zhiping Liu

Keyword(s):

Diabetes Mellitus ◽

Type 2 Diabetes ◽

Type 2 Diabetes Mellitus ◽

Adverse Events ◽

Conventional Therapy ◽

Meta Analysis ◽

Control Group ◽

Controlled Trials ◽

Randomized Controlled

Aims. To assess the safety of ertugliflozin in patients with type 2 diabetes mellitus (T2DM) inadequately controlled with conventional therapy at different periods. Methods. We searched PubMed, Embase, and The Cochrane Library from inception to September 23, 2020. A total of six studies involving 4120 patients were included. Results. Compared with the control group, 15 mg and 5 mg of ertugliflozin were associated with higher risks of genital mycotic infections (GMIs) at 26 weeks ( p < 0.0001 and p < 0.0001 , respectively), 52 weeks ( p < 0.00001 and p < 0.0001 , respectively), and 104 weeks ( p < 0.00001 and p < 0.0001 , respectively). Moreover, females had a higher risk of GMIs than males in the 15 mg group at 26 weeks ( p = 0.0008 ), 52 weeks ( p < 0.0001 ), and 104 weeks ( p = 0.02 ). At 104 weeks, 15 mg and 5 mg of ertugliflozin showed beneficial effects on symptomatic hypoglycemia ( p < 0.00001 and p = 0.004 , respectively) compared with the effects observed in the control group. Compared with the control group, 15 mg and 5 mg of ertugliflozin were associated with higher risks of drug-related adverse events at 26 weeks ( p = 0.002 and p = 0.002 , respectively); 15 mg of ertugliflozin was associated with a higher risk of discontinuation related to adverse events at 104 weeks ( p = 0.03 ). No significant differences were found in the remaining safety outcomes. Conclusion. This meta-analysis of randomized controlled trials indicates that ertugliflozin is tolerated by T2DM, but the risk of GMIs is noteworthy, especially among females in the high-dose group.

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A Highly Tailored Text and Voice Messaging Intervention to Improve Medication Adherence in Patients With Either or Both Hypertension and Type 2 Diabetes in a UK Primary Care Setting: Feasibility Randomized Controlled Trial of Clinical Effectiveness (Preprint)

10.2196/preprints.16629 ◽

2019 ◽

Author(s):

Aikaterini Kassavou ◽

Venus Mirzaei ◽

James Brimicombe ◽

Simon Edwards ◽

Efthalia Massou ◽

...

Keyword(s):

Type 2 Diabetes ◽

Primary Care ◽

Randomized Controlled Trial ◽

Medication Adherence ◽

Controlled Trial ◽

Intervention Group ◽

Clinical Effectiveness ◽

Control Group ◽

Randomized Controlled

BACKGROUND The efficacy of a highly tailored digital intervention to support medication adherence and feasibility to support clinical effectiveness as an adjunct to the primary care setting has not been evaluated. OBJECTIVE This trial aimed to assess the behavioral efficacy of a highly tailored digital intervention to support medication adherence and to evaluate the feasibility of its clinical effectiveness, in patients with either or both hypertension and type 2 diabetes. We also examined quality of life and mechanisms of behavior change. Intervention fidelity, engagement, and satisfaction were also explored. METHODS This was a multicenter, individually randomized controlled trial of 2 parallel groups: an intervention group that received a highly tailored text message and interactive voice response intervention for 12 weeks, and a control group that received usual care. Medication adherence was measured using self-reports and assessor-blinded practice records of a repeat prescription. Systolic blood pressure and glucose levels were assessed by nurses blinded to group allocation during practice visits at 3 months follow-up. Questionnaires obtained data to assess intervention mechanisms of action and satisfaction and digital log files captured data to evaluate fidelity and engagement. RESULTS A total of 135 nonadherent patients (62/135, 46% female; 122/135, 90.3%; aged above 50 years) were randomly allocated in the intervention (n=79) or in the control group (n=56); of whom 13% (18/135) were lost at follow-up. Medication adherence was significantly improved in the intervention group compared with the control group (t116=2.27; P=.02, 2-tailed). Systolic blood pressure was 0.6 mmHg (95% CI −7.423 to 6.301), and hemoglobin A1c was 4.5 mmol/mol (95% CI −13.099 to 4.710) lower in the intervention group compared with the control group. Changes in intentional nonadherence and nonintentional nonadherence explained the improvements in medication adherence in the intervention group (beta=.074, SE=0.464; P=.04), but not in the control group (beta=.00, SE 1.35; P=.37). The intervention had 100% fidelity, a median of 12 days of engagement, and 76% overall satisfaction. CONCLUSIONS Our trial is the first that has been conducted in the United Kingdom and showed that among nonadherent patients with either or both hypertension and type 2 diabetes, a highly tailored digital intervention was effective at improving treatment adherence and feasible to obtain clinically meaningful outcomes. Changes in intentional and nonintentional nonadherence predicted the improvements in medication adherence. The intervention had high fidelity, engagement, and satisfaction. Future research using a rigorous design is needed to evaluate the clinical effectiveness and cost-effectiveness of the intervention in primary care. CLINICALTRIAL International Standard Randomized Controlled Trial Number (ISRCTN) 10668149; http://www.controlled-trials.com/ISRCTN10668149.

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Efficacy of a Self-Regulation–Based Electronic and Mobile Health Intervention Targeting an Active Lifestyle in Adults Having Type 2 Diabetes and in Adults Aged 50 Years or Older: Two Randomized Controlled Trials (Preprint)

10.2196/preprints.13363 ◽

2019 ◽

Author(s):

Louise Poppe ◽

Ilse De Bourdeaudhuij ◽

Maïté Verloigne ◽

Samyah Shadid ◽

Jelle Van Cauwenberg ◽

...

Keyword(s):

Type 2 Diabetes ◽

Mobile Health ◽

Intervention Group ◽

Sitting Time ◽

Control Group ◽

Controlled Trials ◽

Active Lifestyle ◽

Mhealth Intervention ◽

Randomized Controlled

BACKGROUND Adopting an active lifestyle plays a key role in the prevention and management of chronic diseases such as type 2 diabetes mellitus (T2DM). Web-based interventions are able to alter health behaviors and show stronger effects when they are informed by a behavior change theory. MyPlan 2.0 is a fully automated electronic health (eHealth) and mobile health (mHealth) intervention targeting physical activity (PA) and sedentary behavior (SB) based on the Health Action Process Approach (HAPA). OBJECTIVE This study aimed to test the short-term effect of MyPlan 2.0 in altering levels of PA and SB and in changing personal determinants of behavior in adults with T2DM and in adults aged ≥50 years. METHODS The study comprised two randomized controlled trials (RCTs) with an identical design. RCT 1 was conducted with adults with T2DM. RCT 2 was performed in adults aged ≥50 years. Data were collected via face-to-face assessments. The participants decided either to increase their level of PA or to decrease their level of SB. The participants were randomly allocated with a 2:1 ratio to the intervention group or the waiting-list control group. They were not blinded for their group allocation. The participants in the intervention group were instructed to go through MyPlan 2.0, comprising 5 sessions with an interval of 1 week between each session. The primary outcomes were objectively measured and self-reported PA (ie, light PA, moderate-to-vigorous PA, total PA, number of steps, and domain-specific [eg, transport-related] PA) and SB (ie, sitting time, number of breaks from sitting time, and length of sitting bouts). Secondary outcomes were self-reported behavioral determinants for PA and SB (eg, self-efficacy). Separate linear mixed models were performed to analyze the effects of MyPlan 2.0 in the two samples. RESULTS In RCT 1 (n=54), the PA intervention group showed, in contrast to the control group, a decrease in self-reported time spent sitting (P=.09) and an increase in accelerometer-measured moderate (P=.05) and moderate-to-vigorous PA (P=.049). The SB intervention group displayed an increase in accelerometer-assessed breaks from sedentary time in comparison with the control group (P=.005). A total of 14 participants of RCT 1 dropped out. In RCT 2 (n=63), the PA intervention group showed an increase for self-reported total PA in comparison with the control group (P=.003). Furthermore, in contrast to the control group, the SB intervention group decreased their self-reported time spent sitting (P=.08) and increased their accelerometer-assessed moderate (P=.06) and moderate-to-vigorous PA (P=.07). A total of 8 participants of RCT 2 dropped out. CONCLUSIONS For both the samples, the HAPA-based eHealth and mHealth intervention, MyPlan 2.0, was able to improve only some of the primary outcomes. CLINICALTRIAL ClinicalTrials.gov NCT03291171; http://clinicaltrials.gov/ct2/show/NCT03291171. ClinicalTrials.gov NCT03799146; http://clinicaltrials.gov/ct2/show/NCT03799146. INTERNATIONAL REGISTERED REPOR RR2-10.2196/12413

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