scholarly journals Evaluation of the Clinical and Economic Effects of a Primary Care Anchored, Collaborative, Electronic Health Lifestyle Coaching Program in Denmark: Protocol for a Two-Year Randomized Controlled Trial

10.2196/19172 ◽  
2020 ◽  
Vol 9 (6) ◽  
pp. e19172
Author(s):  
Carl J Brandt ◽  
Jeanette Reffstrup Christensen ◽  
Jørgen T Lauridsen ◽  
Jesper Bo Nielsen ◽  
Jens Søndergaard ◽  
...  
Keyword(s):  
Type 2 Diabetes ◽  
Weight Loss ◽  
Controlled Trial ◽  
Intervention Group ◽  
Economic Effects ◽  
Control Group ◽  
Preventive Program ◽  
Web Based

Background Obesity is linked to a number of chronic health conditions, such as type 2 diabetes, heart disease, and cancer, and weight loss interventions are often expensive. Recent systematic reviews concluded that app and web-based interventions can improve lifestyle behaviors and weight loss at a reasonable cost, but long-term sustainability needs to be demonstrated. Objective This study protocol is for a 2-year randomized controlled trial that aims to evaluate the clinical and economic effects of a primary care, anchored, collaborative, electronic health (eHealth) lifestyle coaching program (long-term Lifestyle change InterVention and eHealth Application [LIVA] 2.0) in obese participants with and without type 2 diabetes. The program’s primary outcome is weight loss. Its secondary outcome is the hemoglobin A1c (HbA1c) level, and its tertiary outcomes are retention rate, quality of life (QOL), and cost effectiveness. Analytically, the focus is on associations of participant characteristics with outcomes and sustainability. Methods We conduct a multicenter trial with a 1-year intervention and 1-year retention. LIVA 2.0 is implemented in municipalities within administrative regions in Denmark, specifically eight municipalities located within the Region of Southern Denmark and two municipalities located within the Capital Region of Denmark. The participants are assessed at baseline and at 6-, 12-, and 24-month follow-ups. Individual data from the LIVA 2.0 platform are combined with clinical measurements, questionnaires, and participants’ usage of municipality and health care services. The participants have a BMI ≥30 but ≤45 kg/m2, and 50% of the participants have type 2 diabetes. The participants are randomized in an approximately 60:40 manner, and based on sample size calculations on weight loss and intention-to-treat statistics, 200 participants are randomized to an intervention group and 140 are randomized to a control group. The control group is offered the conventional preventive program of the municipality, and it is compared to the intervention group, which follows the LIVA 2.0 in addition to the conventional preventive program. Results The first baseline assessments have been carried out in March 2018, and the 2-year follow-up will be carried out between March 2020 and April 2021. The hypothesis is that the trial results will demonstrate decreased body weight and that the number of patients who show normalization of their HbA1c levels in the intervention group will be much higher than that in the control group. The participants in the intervention group are also expected to show a greater decrease in their use of glucose-lowering medication and a greater improvement in their QOL when compared with the control group. Operational costs are expected to be lower than standard care, and the intervention is expected to be cost-effective. Conclusions This is the first time that an app and web-based eHealth lifestyle coaching program implemented in Danish municipalities will be clinically and economically evaluated. If the LIVA 2.0 eHealth lifestyle coaching program is proven to be effective, there is great potential for decreasing the rates of obesity, diabetes, and related chronic diseases. Trial Registration ClinicalTrials.gov NCT03788915; https://clinicaltrials.gov/ct2/show/NCT03788915 International Registered Report Identifier (IRRID) DERR1-10.2196/19172

scholarly journals Evaluation of the Clinical and Economic Effects of a Primary Care Anchored, Collaborative, Electronic Health Lifestyle Coaching Program in Denmark: Protocol for a Two-Year Randomized Controlled Trial (Preprint)

2020 ◽  
Author(s):  
Carl J Brandt ◽  
Jeanette Reffstrup Christensen ◽  
Jørgen T Lauridsen ◽  
Jesper Bo Nielsen ◽  
Jens Søndergaard ◽  
...  
Keyword(s):  
Type 2 Diabetes ◽  
Weight Loss ◽  
Controlled Trial ◽  
Intervention Group ◽  
Economic Effects ◽  
Control Group ◽  
Preventive Program ◽  
Web Based

BACKGROUND Obesity is linked to a number of chronic health conditions, such as type 2 diabetes, heart disease, and cancer, and weight loss interventions are often expensive. Recent systematic reviews concluded that app and web-based interventions can improve lifestyle behaviors and weight loss at a reasonable cost, but long-term sustainability needs to be demonstrated. OBJECTIVE This study protocol is for a 2-year randomized controlled trial that aims to evaluate the clinical and economic effects of a primary care, anchored, collaborative, electronic health (eHealth) lifestyle coaching program (long-term Lifestyle change InterVention and eHealth Application [LIVA] 2.0) in obese participants with and without type 2 diabetes. The program’s primary outcome is weight loss. Its secondary outcome is the hemoglobin A<sub>1c</sub> (HbA<sub>1c</sub>) level, and its tertiary outcomes are retention rate, quality of life (QOL), and cost effectiveness. Analytically, the focus is on associations of participant characteristics with outcomes and sustainability. METHODS We conduct a multicenter trial with a 1-year intervention and 1-year retention. LIVA 2.0 is implemented in municipalities within administrative regions in Denmark, specifically eight municipalities located within the Region of Southern Denmark and two municipalities located within the Capital Region of Denmark. The participants are assessed at baseline and at 6-, 12-, and 24-month follow-ups. Individual data from the LIVA 2.0 platform are combined with clinical measurements, questionnaires, and participants’ usage of municipality and health care services. The participants have a BMI ≥30 but ≤45 kg/m2, and 50% of the participants have type 2 diabetes. The participants are randomized in an approximately 60:40 manner, and based on sample size calculations on weight loss and intention-to-treat statistics, 200 participants are randomized to an intervention group and 140 are randomized to a control group. The control group is offered the conventional preventive program of the municipality, and it is compared to the intervention group, which follows the LIVA 2.0 in addition to the conventional preventive program. RESULTS The first baseline assessments have been carried out in March 2018, and the 2-year follow-up will be carried out between March 2020 and April 2021. The hypothesis is that the trial results will demonstrate decreased body weight and that the number of patients who show normalization of their HbA<sub>1c</sub> levels in the intervention group will be much higher than that in the control group. The participants in the intervention group are also expected to show a greater decrease in their use of glucose-lowering medication and a greater improvement in their QOL when compared with the control group. Operational costs are expected to be lower than standard care, and the intervention is expected to be cost-effective. CONCLUSIONS This is the first time that an app and web-based eHealth lifestyle coaching program implemented in Danish municipalities will be clinically and economically evaluated. If the LIVA 2.0 eHealth lifestyle coaching program is proven to be effective, there is great potential for decreasing the rates of obesity, diabetes, and related chronic diseases. CLINICALTRIAL ClinicalTrials.gov NCT03788915; https://clinicaltrials.gov/ct2/show/NCT03788915 INTERNATIONAL REGISTERED REPORT DERR1-10.2196/19172

scholarly journals Low-energy total diet replacement intervention in patients with type 2 diabetes mellitus and obesity treated with insulin: a randomized trial

2020 ◽  
Vol 8 (1) ◽  
pp. e001012 ◽  
Author(s):  
Adrian Brown ◽  
Anne Dornhorst ◽  
Barbara McGowan ◽  
Omar Omar ◽  
Anthony R Leeds ◽  
...  
Keyword(s):  
Type 2 Diabetes ◽  
Weight Loss ◽  
Glycemic Control ◽  
Controlled Trial ◽  
Intervention Group ◽  
Low Energy ◽  
Control Group ◽  
Total Diet ◽  
Diabetes And Obesity

ObjectivesThe management of patients with long-standing type 2 diabetes and obesity receiving insulin therapy (IT) is a substantial clinical challenge. Our objective was to examine the effect of a low-energy total diet replacement (TDR) intervention versus standardized dietetic care in patients with long-standing type 2 diabetes and obesity receiving IT.Research design and methodsIn a prospective randomized controlled trial, 90 participants with type 2 diabetes and obesity receiving IT were assigned to either a low-energy TDR (intervention) or standardized dietetic care (control) in an outpatient setting. The primary outcome was weight loss at 12 months with secondary outcomes including glycemic control, insulin burden and quality of life (QoL).ResultsMean weight loss at 12 months was 9.8 kg (SD 4.9) in the intervention and 5.6 kg (SD 6.1) in the control group (adjusted mean difference −4.3 kg, 95% CI −6.3 to 2.3, p<0.001). IT was discontinued in 39.4% of the intervention group compared with 5.6% of the control group among completers. Insulin requirements fell by 47.3 units (SD 36.4) in the intervention compared with 33.3 units (SD 52.9) in the control (−18.6 units, 95% CI −29.2 to –7.9, p=0.001). Glycated Hemoglobin (HbA1c) fell significantly in the intervention group (4.7 mmol/mol; p=0.02). QoL improved in the intervention group of 11.1 points (SD 21.8) compared with 0.71 points (SD 19.4) in the control (8.6 points, 95% CI 2.0 to 15.2, p=0.01).ConclusionsPatients with advanced type 2 diabetes and obesity receiving IT achieved greater weight loss using a TDR intervention while also reducing or stopping IT and improving glycemic control and QoL. The TDR approach is a safe treatment option in this challenging patient group but requires maintenance support for long-term success.Trial registration numberISRCTN21335883.

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.

Increasing Medical Adherence in Elderly With Type 2 Diabetes Mellitus: A Systematic Review

2018 ◽  
Vol 39 (2) ◽  
pp. 109-117
Author(s):  
Seyed Mohammad Mehdi Hazavehei ◽  
Sahar Khoshravesh ◽  
Zahra Taheri-Kharameh
Keyword(s):  
Systematic Review ◽  
Type 2 Diabetes ◽  
Educational Intervention ◽  
Controlled Trial ◽  
Intervention Group ◽  
The Elderly ◽  
Risk Of Bias ◽  
Control Group ◽  
Medical Adherence

Background One of the most common problems that the elderly with chronic diseases, especially diabetes, faces is lack or poor medical adherence. The aim of this study was to determine the effect of interventions in increasing medical adherence in the elderly with type 2 diabetes. Methods The databases of Cochrane, Embase, PubMed, Scopus, Science Direct, and web of science were searched until April 2017 free from time and language limitation. In review, only randomized controlled trial (RCT) design studies were investigated. The studies of interest were evaluated from three perspectives: educational intervention with or without theories/models of health education and promotion, educational intervention (individual or group education), and noneducational intervention to increase medical adherence. The qualification of RCTs was evaluated through Cochrane Collaboration Risk of Bias Tool. Results Finally, five studies were considered in this systematic review. Educational interventions were used in all of the studies, and in three of these studies, noneducational interventions such as support group, psychiatric consultation, and phone consultation were implemented along with educational intervention. In all studies, medical adherence in the intervention group increased when compared with the control group or basic conditions ( p < .05). All RCTs had high risk of bias. Conclusion This review provides evidence which must be considered in the elderly with diabetes a combination of the educational and noneducational methods to increase medical adherence. It is necessary to conduct studies with higher quality to assess the efficacy of interventions.

scholarly journals Development and Evaluation of a Computer-Based, Self-Management Tool for People Recently Diagnosed with Type 2 Diabetes

2016 ◽  
Vol 2016 ◽  
pp. 1-11 ◽  
Author(s):  
Alison O. Booth ◽  
Carole Lowis ◽  
Steven J. Hunter ◽  
Moira Dean ◽  
Chris R. Cardwell ◽  
...  
Keyword(s):  
Type 2 Diabetes ◽  
Computer Program ◽  
User Satisfaction ◽  
Controlled Trial ◽  
Intervention Group ◽  
Management Tool ◽  
Self Management ◽  
Control Group ◽  
Computer Based

Aim. The purpose of this study was to develop and evaluate a computer-based, dietary, and physical activity self-management program for people recently diagnosed with type 2 diabetes.Methods. The computer-based program was developed in conjunction with the target group and evaluated in a 12-week randomised controlled trial (RCT). Participants were randomised to the intervention (computer-program) or control group (usual care). Primary outcomes were diabetes knowledge and goal setting (ADKnowl questionnaire, Diabetes Obstacles Questionnaire (DOQ)) measured at baseline and week 12. User feedback on the program was obtained via a questionnaire and focus groups.Results. Seventy participants completed the 12-week RCT (32 intervention, 38 control, mean age 59 (SD) years). After completion there was a significant between-group difference in the “knowledge and beliefs scale” of the DOQ. Two-thirds of the intervention group rated the program as either good or very good, 92% would recommend the program to others, and 96% agreed that the information within the program was clear and easy to understand.Conclusions. The computer-program resulted in a small but statistically significant improvement in diet-related knowledge and user satisfaction was high. With some further development, this computer-based educational tool may be a useful adjunct to diabetes self-management. This trial is registered with clinicaltrials.gov NCT numberNCT00877851.

scholarly journals Health education improves referral compliance of persons with probable Diabetic Retinopathy: A randomized controlled trial

PLoS ONE ◽  
2020 ◽  
Vol 15 (11) ◽  
pp. e0242047
Author(s):  
Zara Khair ◽  
Md Moshiur Rahman ◽  
Kana Kazawa ◽  
Yasmin Jahan ◽  
Abu S. G. Faruque ◽  
...  
Keyword(s):  
Type 2 Diabetes ◽  
Diabetic Retinopathy ◽  
Health Education ◽  
Controlled Trial ◽  
Compliance Rate ◽  
Intervention Group ◽  
Multivariate Logistic Regression Model ◽  
Control Group ◽  
Referral Compliance

Objective Lack of awareness about Diabetic Retinopathy (DR) is the most commonly cited reason why many persons with type 2 diabetes are non-compliant with referral instruction to undergo retinal screening. The purpose of this study was to evaluate the efficacy of a culturally, geographically and socially appropriate, locally adapted five-month-long health education on referral compliance of participants. Method A prospective randomized, open-label parallel group study was conducted on persons with type 2 diabetes who underwent basic eye screening at a diabetes hospital between September 2017 and August 2018. Participants who were noncompliant with referral instruction to visit a hospital for advanced DR management were randomly divided into health education intervention group (n = 143) and control group (n = 156). Both groups received information regarding DR and referral instruction at the diabetes hospital. The intervention group was provided personalized education followed by telephonic reminders. The primary endpoint was ‘increase in referral compliance’ and the secondary endpoint was ‘increase in knowledge of DR’. Multivariate logistic regression model was used to identify significant predictors of compliance to referral. Results A total of nine participants dropped and 290 completed the post intervention survey. The compliance rate in intervention group was found to be significantly higher than the control group (64.3% vs 28.2%; OR 4.73; 95% CI 2.87–7.79; p<0.001). Participants in the intervention group acquired better knowledge on DR (p<0.05). Apart from intervention, referral compliance rate was also found to be significantly associated with participants’ self-perception of vision problem (OR 2.02; 95% CI 1.02–4.01; p = 0.045) and participants’ income (OR 1.24; 95% CI 1.06–1.44; p = 0.008). Discussion Our results suggest that intensive health education on DR should be integrated with diabetes education as it may result in significantly improved referral compliance. Outcomes may be sustainable if interventions are institutionalized at referral point. Trial registration Clinical Trials.gov (Registration # NCT03658980); https://clinicaltrials.gov/ct2/show/NCT03658980.

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.

scholarly journals A Smartphone App to Restore Optimal Weight (SPAROW) in Women With Recent Gestational Diabetes Mellitus: Randomized Controlled Trial

10.2196/22147 ◽  
2021 ◽  
Vol 9 (3) ◽  
pp. e22147
Author(s):  
Karen Lim ◽  
Shiao-Yng Chan ◽  
Su Lin Lim ◽  
Bee Choo Tai ◽  
Cammy Tsai ◽  
...  
Keyword(s):  
Diabetes Mellitus ◽  
Weight Loss ◽  
Controlled Trial ◽  
Intervention Group ◽  
Caloric Intake ◽  
First Trimester ◽  
Control Group ◽  
Optimal Weight ◽  
Randomized Controlled

Background Women with a history of gestational diabetes mellitus (GDM) are at an increased risk of developing type 2 diabetes mellitus (T2DM). Lifestyle interventions aimed at postpartum weight loss to reduce T2DM risk have been reported, but poor compliance remains a barrier. Smartphone-based interventions may improve compliance, but data on its use in women with recent GDM are limited. Objective This trial aimed to investigate the efficacy of a smartphone app in restoring optimal weight following delivery in women with GDM, in the setting of a population with high rates of GDM and type 2 diabetes. Methods In this unblinded randomized controlled trial, 200 women with GDM were randomized to receive the intervention or standard care following delivery. The intervention enabled logging of weight, meals, and activity, with web-based interaction with a team comprising dieticians, a physiotherapist, and an occupational therapist. The primary outcome was an achievement of optimal weight (defined as the restoration of first trimester weight if first trimester BMI≤23 kg/m2 or weight loss of at least 5% from first trimester weight if first trimester BMI>23 kg/m2) at 4 months post partum. Secondary outcome measures included absolute weight loss, serum metabolic markers, self-reported nutritional intake, health education, and quality of life via questionnaires and user engagement in the intervention group. Results In total, 40% (38/96) of women in the intervention group achieved optimal weight at 4 months post delivery compared with 32% (28/93) in the control group (P=.27). Compared with the control group, women in the intervention group reported significantly reduced caloric intake at 4 months after delivery (P<.001) and higher health-directed behavior scores (P=.045). The intervention group also reported increased emotional distress scores (P=.01). At 4 months, participant engagement with the intervention was maintained at 60.8% (SD 33.9%). Conclusions Although a statistically significant increase in women achieving healthy weight was not observed, this app remains promising, as women in the intervention group reported improved health behaviors and lower caloric intake. Importantly, the high retention rates suggest that a larger study with a longer follow-up period might confirm the effectiveness of this app for weight management. Trial Registration ClinicalTrials.gov NCT03324737; https://clinicaltrials.gov/ct2/show/NCT03324737 International Registered Report Identifier (IRRID) RR2-10.1186/s12889-019-7691-3

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