scholarly journals Process evaluation of the Sophia Step Study- a primary care based three-armed randomized controlled trial using self-monitoring of steps with and without counseling in prediabetes and type 2 diabetes

2021 ◽  
Vol 21 (1) ◽  
Author(s):  
Jenny Rossen ◽  
Maria Hagströmer ◽  
Agneta Yngve ◽  
Kerstin Brismar ◽  
Barbara Ainsworth ◽  
...  
Keyword(s):  
Physical Activity ◽  
Primary Care ◽  
Intervention Group ◽  
Single Component ◽  
Control Group ◽  
Self Monitoring ◽  
Component Group ◽  
The Mean ◽  
Step Study

Abstract Background Describing implementation features of an intervention is required to compare interventions and to inform policy and best practice. The aim of this study was to conduct a process evaluation of the first 12 months of the Sophia Step Study: a primary care based RCT evaluating a multicomponent (self-monitoring of daily steps plus counseling) and a single component (self-monitoring of steps only) physical activity intervention to standard care on cardiometabolic health. Methods The evaluation was guided by the Medical Research Council Guidance for complex interventions. To describe the implementation communication with the health professionals implementing the interventions, attendance records and tracking of days with self-monitored pedometer-determined steps were used. Change in physical activity behaviour was measured at baseline, 6 and 12 months as daily steps by accelerometry. Results During April 2013 to January 2018 188 participants were randomized and intervened directly after inclusion. Response rate was 49% and drop out was 10%. A majority, 78%, had type 2 diabetes and 22% were diagnosed with prediabetes. Mean [Standard deviation (SD)] body mass index was 30.4 (4.4) kg/m2 and steps per day was 6566 (3086). The interventions were delivered as intended with minor deviation from the protocol and dose received was satisfying for both the multicomponent and single component group. The mean [95% Confidence Interval (CI)] change in daily steps from baseline to 6 months was 941(227, 1655) steps/day for the multicomponent intervention group, 990 (145, 1836) step/day for the single component group and − 506 (− 1118, 107) for the control group. The mean (95% CI) change in daily steps from baseline to 12 months was 31(− 507, 570) steps/day for the multicomponent intervention group, 144 (− 566, 853) step/day for the single component group and − 890 (− 1485, − 294) for the control group. There was a large individual variation in daily steps at baseline as well as in step change in all three groups. Conclusions Applying self-monitoring of steps is a feasible method to implement as support for physical activity in the primary care setting both with and without counseling support. Trial registration ClinicalTrials.gov, NCT02374788. Registered 2 March 2015.

scholarly journals Process Evaluation of the Sophia Step Study-A Primary Care Based Three-Armed Randomized Controlled Trial Using Self-Monitoring of Steps With and Without Counseling in Prediabetes and Type 2 Diabetes

2020 ◽  
Author(s):  
Jenny Rossen ◽  
Maria Hagströmer ◽  
Agneta Yngve ◽  
Kerstin Brismar ◽  
Barbara Ainsworth ◽  
...  
Keyword(s):  
Physical Activity ◽  
Primary Care ◽  
Intervention Group ◽  
Single Component ◽  
Control Group ◽  
Self Monitoring ◽  
Component Group ◽  
Multicomponent Intervention ◽  
The Mean ◽  
Step Study

Abstract Background Describing implementation features of an intervention is required to compare interventions and to inform policy and best practice. The aim of this study was to conduct a process evaluation of the first 12 months of the Sophia Step Study: a primary care based RCT evaluating a multicomponent (self-monitoring of daily steps plus counseling) and a single component (self-monitoring of steps only) physical activity intervention to standard care on cardiometabolic health. Methods The evaluation was guided by the Medical Research Council Guidance for complex interventions. To describe the implementation communication with the health professionals implementing the interventions, attendance records and tracking of days with self-monitored pedometer-determined steps were used. Change in physical activity behaviour was measured at baseline, 6 and 12 months as daily steps by accelerometry. Results From April 2013 to January 2018 188 participants were randomized. Response rate was 49% and drop out was 10%. The interventions were delivered as intended with minor deviation from the protocol and dose received was satisfying for both the multicomponent and single component group. The mean [95% Confidence Interval (CI)] change in daily steps from baseline to 6 months was 941(227, 1655) steps/day for the multicomponent intervention group, 990 (145, 1836) step/day for the single component group and -506 (-1118, 107) for the control group. The mean (95% CI) change in daily steps from baseline to 12 months was 31(-507, 570) steps/day for the multicomponent intervention group, 144 (-566, 853) step/day for the single component group and -890 (-1485, -294) for the control group. There was a large individual variation in daily steps at baseline as well as in step change in all three groups.Conclusions Applying self-monitoring of steps is a feasible method to implement as support for physical activity in the primary care setting both with and without counseling support. While physical activity levels increased after 6 months, maintenance of physical activity is a more realistic expectation in the long term. Physical activity behavior varies among individuals and support for physical activity should be tailored to the person. Trial registration ClinicalTrials.gov, NCT02374788. Registered 2 March 2015 - Retrospectively registered, https://clinicaltrials.gov/ct2/show/NCT02374788

scholarly journals Effects of a three-armed randomised controlled trial using self-monitoring of daily steps with and without counselling in prediabetes and type 2 diabetes—the Sophia Step Study

2021 ◽  
Vol 18 (1) ◽  
Author(s):  
Jenny Rossen ◽  
Kristina Larsson ◽  
Maria Hagströmer ◽  
Agneta Yngve ◽  
Kerstin Brismar ◽  
...  
Keyword(s):  
Physical Activity ◽  
Type 2 Diabetes ◽  
Primary Outcome ◽  
Controlled Trial ◽  
Single Component ◽  
Control Group ◽  
Self Monitoring ◽  
Randomised Controlled ◽  
Step Study

Abstract Background This aimed to evaluate the effects of self-monitoring of daily steps with or without counselling support on HbA1c, other cardiometabolic risk factors and objectively measured physical activity (PA) during a 2-year intervention in a population with prediabetes or type 2 diabetes. Methods The Sophia Step Study was a three-armed parallel randomised controlled trial. Participants with prediabetes or type 2 diabetes were recruited in a primary care setting. Allocation (1:1:1) was made to a multi-component intervention (self-monitoring of steps with counselling support), a single-component intervention (self-monitoring of steps without counselling support) or standard care. Data were collected for primary outcome HbA1c at baseline and month 6, 12, 18 and 24. Physical activity was assessed as an intermediate outcome by accelerometer (ActiGraph GT1M) for 1 week at baseline and the 6-, 12-, 18- and 24-month follow-up visits. The intervention effects were evaluated by a robust linear mixed model. Results In total, 188 subjects (64, 59, 65 in each group) were included. The mean (SD) age was 64 (7.7) years, BMI was 30.0 (4.4) kg/m2 and HbA1c was 50 (11) mmol/mol, 21% had prediabetes and 40% were female. The dropout rate was 11% at 24 months. Effect size (CI) for the primary outcome (HbA1c) ranged from -1.3 (-4.8 to 2.2) to 1.1 (-2.4 to 4.6) mmol/mol for the multi-component vs control group and from 0.3 (-3.3 to 3.9) to 3.1 (-0.5 to 6.7) mmol/mol for the single-component vs control group. Effect size (CI) for moderate-to-vigorous physical activity ranged from 8.0 (0.4 to 15.7) to 11.1 (3.3 to 19.0) min/day for the multi-component vs control group and from 7.6 (-0.4 to 15.6) to 9.4 (1.4 to 17.4) min/day for the single-component group vs control group. Conclusion This 2-year intervention, including self-monitoring of steps with or without counselling, prevented a decrease in PA but did not provide evidence for improved metabolic control and cardiometabolic risk factors in a population with prediabetes or type 2 diabetes. Trial registration ClinicalTrials.gov, NCT02374788. Registered 2 March 2015—Retrospectively registered.

scholarly journals A Wearable Technology Delivering a Web-Based Diabetes Prevention Program to People at High Risk of Type 2 Diabetes: Randomized Controlled Trial

10.2196/15448 ◽  
2020 ◽  
Vol 8 (7) ◽  
pp. e15448
Author(s):  
Emily Staite ◽  
Adam Bayley ◽  
Ebaa Al-Ozairi ◽  
Kurtis Stewart ◽  
David Hopkins ◽  
...  
Keyword(s):  
Physical Activity ◽  
Controlled Trial ◽  
Intervention Group ◽  
Diabetes Prevention Program ◽  
Mean Difference ◽  
Control Group ◽  
Web Based ◽  
The Mean

Background Intensive lifestyle interventions are effective in reducing the risk of type 2 diabetes, but the implementation of learnings from landmark studies is expensive and time consuming. The availability of digital lifestyle interventions is increasing, but evidence of their effectiveness is limited. Objective This randomized controlled trial (RCT) aimed to test the feasibility of a web-based diabetes prevention program (DPP) with step-dependent feedback messages versus a standard web-based DPP in people with prediabetes. Methods We employed a two-arm, parallel, single-blind RCT for people at high risk of developing diabetes. Patients with a hemoglobin A1c (HbA1c) level of 39-47 mmol/mol were recruited from 21 general practices in London. The intervention integrated a smartphone app delivering a web-based DPP course with SMS texts incorporating motivational interviewing techniques and step-dependent feedback messages delivered via a wearable device over 12 months. The control group received the wearable technology and access to the web-based DDP but not the SMS texts. As this was a feasibility study, the primary aim was to estimate potential sample size at different stages of the study, including the size of the target study population and the proportion of participants who consented, were randomized, and completed follow-up. We also measured the main outcomes for a full-scale RCT, namely, change in weight and physical activity at 6- and 12-month follow-ups, and secondary outcomes, including changes in the HbA1c level, blood pressure, waist circumference, waist-to-hip ratio, and lipid levels. Results We enrolled 200 participants: 98 were randomized to the intervention and 102 were randomized to the control group. The follow-up rate was higher in the control group (87/102, 85.3%) than in the intervention group (69/98, 70%) at 12 months. There was no treatment effect on weight at 6 months (mean difference 0.15; 95% CI −0.93 to 1.23) or 12 months (mean difference 0.07 kg; 95% CI −1.29 to 1.44) or for physical activity levels at 6 months (mean difference −382.90 steps; 95% CI −860.65 to 94.85) or 12 months (mean difference 92.64 steps; 95% CI −380.92 to 566.20). We did not observe a treatment effect on the secondary outcomes measured at the 6-month or 12-month follow-up. For the intervention group, the mean weight was 92.33 (SD 15.67) kg at baseline, 91.34 (SD 16.04) kg at 6 months, and 89.41 (SD 14.93) kg at 12 months. For the control group, the mean weight was 92.59 (SD 17.43) kg at baseline, 91.71 (SD 16.48) kg at 6 months, and 91.10 (SD 15.82) kg at 12 months. In the intervention group, the mean physical activity was 7308.40 (SD 4911.93) steps at baseline, 5008.76 (SD 2733.22) steps at 6 months, and 4814.66 (SD 3419.65) steps at 12 months. In the control group, the mean physical activity was 7599.28 (SD 3881.04) steps at baseline, 6148.83 (SD 3433.77) steps at 6 months, and 5006.30 (SD 3681.1) steps at 12 months. Conclusions This study demonstrates that it is feasible to successfully recruit and retain patients in an RCT of a web-based DPP. Trial Registration ClinicalTrials.gov NCT02919397; http://clinicaltrials.gov/ct2/show/NCT02919397

scholarly journals A Wearable Technology Delivering a Web-Based Diabetes Prevention Program to People at High Risk of Type 2 Diabetes: Randomized Controlled Trial (Preprint)

2019 ◽  
Author(s):  
Emily Staite ◽  
Adam Bayley ◽  
Ebaa Al-Ozairi ◽  
Kurtis Stewart ◽  
David Hopkins ◽  
...  
Keyword(s):  
Physical Activity ◽  
Controlled Trial ◽  
Intervention Group ◽  
Diabetes Prevention Program ◽  
Mean Difference ◽  
Control Group ◽  
Web Based ◽  
The Mean

BACKGROUND Intensive lifestyle interventions are effective in reducing the risk of type 2 diabetes, but the implementation of learnings from landmark studies is expensive and time consuming. The availability of digital lifestyle interventions is increasing, but evidence of their effectiveness is limited. OBJECTIVE This randomized controlled trial (RCT) aimed to test the feasibility of a web-based diabetes prevention program (DPP) with step-dependent feedback messages versus a standard web-based DPP in people with prediabetes. METHODS We employed a two-arm, parallel, single-blind RCT for people at high risk of developing diabetes. Patients with a hemoglobin A<sub>1c</sub> (HbA<sub>1c</sub>) level of 39-47 mmol/mol were recruited from 21 general practices in London. The intervention integrated a smartphone app delivering a web-based DPP course with SMS texts incorporating motivational interviewing techniques and step-dependent feedback messages delivered via a wearable device over 12 months. The control group received the wearable technology and access to the web-based DDP but not the SMS texts. As this was a feasibility study, the primary aim was to estimate potential sample size at different stages of the study, including the size of the target study population and the proportion of participants who consented, were randomized, and completed follow-up. We also measured the main outcomes for a full-scale RCT, namely, change in weight and physical activity at 6- and 12-month follow-ups, and secondary outcomes, including changes in the HbA<sub>1c</sub> level, blood pressure, waist circumference, waist-to-hip ratio, and lipid levels. RESULTS We enrolled 200 participants: 98 were randomized to the intervention and 102 were randomized to the control group. The follow-up rate was higher in the control group (87/102, 85.3%) than in the intervention group (69/98, 70%) at 12 months. There was no treatment effect on weight at 6 months (mean difference 0.15; 95% CI −0.93 to 1.23) or 12 months (mean difference 0.07 kg; 95% CI −1.29 to 1.44) or for physical activity levels at 6 months (mean difference −382.90 steps; 95% CI −860.65 to 94.85) or 12 months (mean difference 92.64 steps; 95% CI −380.92 to 566.20). We did not observe a treatment effect on the secondary outcomes measured at the 6-month or 12-month follow-up. For the intervention group, the mean weight was 92.33 (SD 15.67) kg at baseline, 91.34 (SD 16.04) kg at 6 months, and 89.41 (SD 14.93) kg at 12 months. For the control group, the mean weight was 92.59 (SD 17.43) kg at baseline, 91.71 (SD 16.48) kg at 6 months, and 91.10 (SD 15.82) kg at 12 months. In the intervention group, the mean physical activity was 7308.40 (SD 4911.93) steps at baseline, 5008.76 (SD 2733.22) steps at 6 months, and 4814.66 (SD 3419.65) steps at 12 months. In the control group, the mean physical activity was 7599.28 (SD 3881.04) steps at baseline, 6148.83 (SD 3433.77) steps at 6 months, and 5006.30 (SD 3681.1) steps at 12 months. CONCLUSIONS This study demonstrates that it is feasible to successfully recruit and retain patients in an RCT of a web-based DPP. CLINICALTRIAL ClinicalTrials.gov NCT02919397; http://clinicaltrials.gov/ct2/show/NCT02919397

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

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.

Effectiveness of a Primary Care Program to Increase Physical Activity in People With Dementia and Their Family Caregivers (AFISDEMYF Study).

2021 ◽  
Author(s):  
Elena DE DIOS-RODRIGUEZ ◽  
María C PATINO-ALONSO ◽  
Susana GONZÁLEZ-SÁNCHEZ ◽  
Joana RIPOLL ◽  
Olaya TAMAYO-MORALES ◽  
...  
Keyword(s):  
Physical Activity ◽  
Blood Pressure ◽  
Primary Care ◽  
Systolic Blood Pressure ◽  
Family Caregivers ◽  
Intervention Group ◽  
Care Program ◽  
Control Group ◽  
People With Dementia ◽  
The Family

Abstract Aim: To evaluate the effectiveness of an intervention in primary health care designed to increase physical activity in people with dementia and their family caregivers.Methods: A cluster-randomized multicentre clinical trial was carried out.Participants: 140 people with dementia (median age 82 years;63.6% women) and 176 caregivers (median age 62 years ;72.7% women). Seventy patients and 80 caregivers were assigned to the Control Group (CG) and 70 patients and 96 caregivers to the Intervention Group (IG). The physical activity was measured with the pedometer and with the IPAQ-SF questionnaire. The intervention consisted of applying in primary care the program promoting physical activity (PEPAF) for 3 months. The changes observed at 6 months were analyzed. Results:In people with dementia, in the pedometer assessment a decrease was observed in both groups, but it was larger in the CG both in the total number step/day lower in the IG than in the CG and in the aerobic steps / day (52.89 vs -615.93). The activity reported with the IPAQ-SF decreased more in IG, both in the MET/min/week (-258.470 vs -148.23) and in the MVPA min/week. In caregivers the pedometer assessment showed that total steps/day increased more in the IG, as did aerobic steps/day (356.91 vs -12.95). The IPAQ-SF a smaller increase in global activity was declared in the IG than in the CG (545.25 MET/min/week vs 609.55), but the increase in vigorous activity was greater. No differences were found in changes in the functional status and the cognitive performances of people with dementia nor in the mental health in the caregivers, but systolic blood pressure, the Family APGAR and overload in the IG did improve.Conclusions: The results suggest that the intervention carried out may be effective on physical activity in both patients and caregivers. It can also improve systolic blood pressure, the Family APGAR and overload in caregivers. This is the first study to implement a primary care intervention aimed at simultaneously increasing physical activity in people with dementia and their relatives. These results reinforce the importance of using objective measures in clinical trials in people with dementia.Trial registration number: NCT 02044887.

scholarly journals The effects of Anethum graveolens (dill) powder supplementation on clinical and metabolic status in patients with type 2 diabetes

2020 ◽  
Author(s):  
Fatemeh Haidari ◽  
Mehrnoosh Zakerkish ◽  
Fatemeh Borazjani ◽  
Kambiz Ahmadi Angali ◽  
Golnaz Amoochi
Keyword(s):  
Type 2 Diabetes ◽  
Lipid Profile ◽  
Intervention Group ◽  
Gastrointestinal Symptoms ◽  
Control Group ◽  
Diabetic Patients ◽  
Anethum Graveolens ◽  
Type 2 Diabetic Patients ◽  
The Mean

Abstract Background: The objective of this study was to investigate the effects of anethum graveolens (dill) powder supplementation on glycemic control, lipid profile, some antioxidants and inflammatory markers, and gastrointestinal symptoms in type 2 diabetic patients. Material and methods: In this study, 42 patients with type 2 diabetes were randomly allocated to intervention and control groups and received either 3g/day dill powder or placebo (3 capsules/day, 1 g each). Fasting blood sugar (FBS), insulin, homeostatic model assessment of insulin resistance (HOMA- IR), lipid profile, hs-C-reactive protein (hs-CRP), total antioxidant capacity (TAC), malondialdehyde (MDA), and gastrointestinal symptoms were measured in all of the subjects at baseline and post-intervention. Results: The dill powder supplementation significantly decreased the mean serum levels of insulin, HOMA-IR, LDL-C, TC, and MDA in the intervention group in comparison with the baseline measurements (p < 0.05). Also, the mean serum levels of HDL and TAC were significantly increased in the intervention group in comparison with the baseline measurement (p < 0.05). Colonic motility disorder was the only gastrointestinal symptom whose frequency was significantly reduced by supplementation (P = 0.01). The mean changes of insulin, LDL-C , TC, and MDA were significantly lower in the intervention group than in the control group (p < 0.05). In addition, the mean changes in HDL were significantly higher in the intervention group than in the control group (p < 0.05). Conclusion: Dill powder supplementation can be effective in controlling the glycemic, lipid, stress oxidative, and gastrointestinal symptoms in type 2 diabetic patients. Keywords: Type 2 diabetes; Dill powder; Glycemic control; Lipid profile; Stress oxidative status

scholarly journals The individual empowerment program improves glycemic and lipid controls in admitted type 2 DM patients

2018 ◽  
Vol 21 (2) ◽  
pp. 113-117
Author(s):  
Ampornpan Theeranut ◽  
Nonglak Methakanjanasak ◽  
Pattama Surit ◽  
Wasana Ruaisungnoen ◽  
Kittisak Sawanyawisuth ◽  
...  
Keyword(s):  
Intervention Group ◽  
Control Group ◽  
P Value ◽  
Inpatient Setting ◽  
Short Term ◽  
The Mean ◽  
The Individual ◽  
Diabetes Patients ◽  
Empowerment Program

Aim. To evaluate the short-term effects of the empowerment program on glycemic and lipid profiles in an inpatient setting for DM type 2 patients. Materials and methods. This was a quasi-experimental study conducted between October 2013 and June 2015. We enrolled diabetes patients admitted to the hospital, age over 35 years, and HbA1c 7%. During the admission, the intervention group received the empowerment course three times prior to discharge, the control group received standard diabetes and nursing care. All patients body weight, HbA1c, HDL-c, and LDL levels were evaluated at three and six months after discharge. All outcomes were compared between the control and intervention group. Results. A total of 57 diabetes patients participated in the study, with 27 in the intervention group and 30 in the control group. The intervention group had significantly higher HbA1c levels than the control group (10.3% vs 8.0%; p value 0.001). After discharge, the mean HbA1c and LDL-c levels of the intervention group were significantly lower than those of the control group at three and six months, while the mean HDL-c level of the intervention group was significantly higher than that of the control group at six months (1.54 vs 1.29 mmol/L; p value 0.001). The average body mass index of the intervention group was also significantly lower than that of the control group at six months (22.74 vs 25.54 kg/m2; p value = 0.016). Conclusion. The individual empowerment program improved short-term glycemic and lipid outcomes in admitted diabetes mellitus patients.

scholarly journals 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

10.2196/16629 ◽  
2020 ◽  
Vol 22 (5) ◽  
pp. e16629 ◽  
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.

Short-Term Effect of Hypergastrinemia Following Esomeprazole Treatment On Well-Controlled Type 2 Diabetes Mellitus: A Prospective Study

2020 ◽  
Vol 20 (7) ◽  
pp. 1090-1096
Author(s):  
Yusuf Bozkuş ◽  
Umut Mousa ◽  
Özlem T. İyidir ◽  
Nazlı Kırnap ◽  
Canan Ç. Demir ◽  
...  
Keyword(s):  
Diabetes Mellitus ◽  
Type 2 Diabetes ◽  
Type 2 Diabetes Mellitus ◽  
Hba1c Level ◽  
Intervention Group ◽  
Control Group ◽  
Metformin Monotherapy ◽  
The Mean ◽  
Hba1c Levels

Objective: Proton pump inhibitor (PPI) drugs reduce gastric acid secretion and lead to an increase in serum gastrin levels. Many preclinical and some clinical researches have established some positive effects of gastrin or PPI therapy on glucose regulation. The aim of this study was to prospectively investigate the short term effects of esomeprazole on glycaemic control in patients with type 2 diabetes mellitus. In addition, the presence of an association between this effect and gastrin levels was evaluated. Methods: Thirty-two subjects with type 2 diabetes mellitus were enrolled and grouped as intervention (n=16) and control (n=16). The participants in the intervention group were prescribed 40 mg of esomeprazole treatment for three months. At the beginning of the study and at the 3rd month, HbA1c level (%) and gastrin levels (pmol/L) of participants were assessed. Then, the groups were compared in terms of their baseline and 3rd month values. Results: In the intervention group, the mean gastrin level increased significantly from 34.3±14.4 pmol/L to 87.4±43.6 pmol/L (p<0.001). The mean HbA1c level was similar to the pre-treatment level (6.3±0.7% vs. 6.4±0.9%, p=0.441). There were no statistically significant differences in all parameters of the control group. The majority of individuals were on metformin monotherapy (65.6 %). The subgroup analysis of metformin monotherapy revealed that, in intervention group, there was a significant increase in gastrin levels (39.9±12.6 vs. 95.5±52.5, p=0.026), but the HbA1c levels did not change (6.0±0.4 % vs. 5.9±0.6 %, p=0.288); and in control group, gastrin levels did not change (37.5 ± 26.7 vs. 36.1 ±23.3, p=0.367), but there was an increase in HbA1c levels (6.1 ± 0.50 vs. 6.4 ± 0.60, p=0.01). Conclusion: Our study demonstrates that esomeprazole has no extra benefit for the controlled diabetic patient in three months. However, in only the metformin-treated subgroup, esomeprazole may prevent the rise in HbA1c level.

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