Weight Reduction by the Low-Insulin-Method—A Randomized Controlled Trial

Continuous high insulin levels are associated with weight gain and lead to cardiometabolic diseases. Therefore, we have developed the Low-Insulin-Method and integrated it into the multi-component, occupational healthcare program SHAPE-AND-MOTION-Medical-Accompanied-Slimming (SAMMAS) to reduce daily insulin levels for long-term weight reduction in overweight or obesity. Employees were randomized into a starting intervention group (SI, n = 15) or waiting list control group (WL, n = 15). SAMMAS consisted of group-based seminars, low-carbohydrate nutrition including formula diet, continuous glucose monitoring, telemetric monitoring, and telemedical coaching. Both groups received telemetric devices at baseline. Intention-to-treat analyses were performed after 12, 26, and 52 weeks. The estimated treatment difference in weight reduction after 12 weeks, which is the primary endpoint of the study, showed a pronounced effect in favour of SI (−6.3 kg with (95% confidence interval) (−7.4; −4.5) (p < 0.001)) after 12 weeks. Furthermore, SI improved fasting blood glucose, HbA1c, quality of life, fasting insulin, blood pressure, and eating behaviour (all p < 0.05) in the within-group analysis, while WL did not. After 26 and 52 weeks, weight reduction could be maintained in the whole group (both groups together) by −6.7 kg (−9.5; −3.8) (p < 0.001) and −6.1 kg (−9.2; −2.7) (p < 0.01). SAMMAS supports clinically relevant weight reduction and long-term weight loss maintenance in individuals with overweight or obesity.

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Impact of a 12-month web and smartphone-based intervention initiated during spa therapy to improve long-term physical activity of patients with chronic diseases: randomized controlled trial. (Preprint)

10.2196/preprints.29640 ◽

2021 ◽

Author(s):

Florie FILLOL ◽

Ludivine PARIS ◽

Sébastien PASCAL ◽

Aurélien MULLIEZ ◽

Christian-François ROQUES ◽

...

Keyword(s):

Quality Of Life ◽

Physical Activity ◽

Waist Circumference ◽

Controlled Trial ◽

Intervention Group ◽

Group Versus ◽

Control Group ◽

Spa Therapy

BACKGROUND Lack of physical activity (PA) and sedentary behaviors are leading risk factors for non-communicable diseases (NCD). Web-based interventions are effective in increasing PA in older adults and in NCD patients. In many countries a course of spa therapy is commonly prescribed to NCD patients and represents an ideal context to initiating lifestyle changes. OBJECTIVE The main objective of this study was to evaluate in NCD patients the effectiveness of an intervention combining an individual face-to-face coaching during spa therapy and, when returning home, a web- and smartphone-based PA program including a connected wrist pedometer and a connected weighing scale, on the achievement of physical activity guidelines (PAG) 12 months after the end of spa therapy. METHODS This was a 12-month, prospective, parallel-group, randomized controlled trial. Patients were enrolled during spa therapy and randomized 1:1 to intervention or control group who received usual advices about PA. From the end of spa therapy, PA, weight, waist circumference, and quality of life of the participants in both groups, were assessed by phone every 2 months. Primary outcome was meeting PAG (PA≥600 METs) at 12 months after the end of spa therapy. Secondary outcomes were: meeting current PAG at 6 months of follow-up; sedentary time, weight and waist circumference, PA and quality of life, at 6 and 12 months. Objective use data of the web-and smartphone-based PA program were collected. Analytic methods include intention-to-treat and constrained longitudinal data analyses. RESULTS The study sample was 228 patients (female : 77.2% (176/228), mean age: 62.4 years (SD 6.7), retired: 53.9% (123/228), mean BMI = 28.2 kg.m-2 (SD 4.2)). No group differences were found for any baseline variable. At 12 months, the proportion of patients achieving PAG was significantly higher in intervention group versus control group (81% vs 67% respectively, OR = 2.34 (95% CI 1.02- 5.38; P=.045). No difference between intervention and control group was found neither in achieving PAG at 6 months nor for sedentary time, weight and waist circumference, at 6 and 12 months. Regarding quality of life, the physical component subscale score was significantly higher at 12 months in intervention group versus control group (mean difference: 4.1 (95% CI 1.9-6.3; P<.001). The mean duration use of the program was 7.1 months (SD 4.5). Attrition rate during the first 2 months of the program was 20.4% (23/113) whereas 39.8% (45/113) of the participants used the program for at least 10 months. CONCLUSIONS The results showed significantly more participants meeting PAG at one year in the intervention group compared to controls. A course of spa therapy offers the ideal time and setting to implement education in PA. Digital coaching seems to be more efficient than usual coaching for increasing the level of PA and decreasing sedentariness on the long term. CLINICALTRIAL ClinicalTrials.gov NCT02694796; https://clinicaltrials.gov/ct2/show/NCT02694796.

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One Shot—No Hit? Evaluation of a Stress-Prevention Workshop for Adolescent Soccer Players in a Randomized Controlled Trial

The Sport Psychologist ◽

10.1123/tsp.2019-0106 ◽

2020 ◽

Vol 34 (2) ◽

pp. 132-142

Author(s):

Johanna Belz ◽

Jens Kleinert ◽

Moritz Anderten

Keyword(s):

Controlled Trial ◽

Intervention Group ◽

Perceived Quality ◽

Soccer Players ◽

Control Group ◽

Stress Coping ◽

Quality Of Results ◽

Stress Prevention

Adolescent soccer players experience many stressors and negative stress-related outcomes. Short-term stress-prevention programs are frequently implemented in youth sports, although there is limited evidence of their usefulness and effectiveness. Thus, the present study evaluated the usefulness and effectiveness of a stress-prevention workshop for adolescent soccer players. Ninety-two soccer players (age: M = 15.5 years, SD = 1.43; 31.5% female) were randomly allocated to either an intervention group or an intervention control group. To evaluate effectiveness, stress, coping, and depression were assessed at baseline (t1) and 4 weeks postworkshop (t2). To investigate usefulness, the perceived quality of results was assessed at t2. No intervention effects on stress, coping, and depression emerged, but both groups exhibited high values regarding perceived quality of results. Although one workshop might not be enough to modify stress-related parameters, it may be useful for adolescent soccer players and pave the way for long-term interventions.

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Long-term efficacy of indicated prevention of depression in non-professional caregivers: randomized controlled trial

Psychological Medicine ◽

10.1017/s0033291714002505 ◽

2014 ◽

Vol 45 (7) ◽

pp. 1401-1412 ◽

Cited By ~ 15

Author(s):

P. Otero ◽

F. Smit ◽

P. Cuijpers ◽

A. Torres ◽

V. Blanco ◽

...

Keyword(s):

Randomized Controlled Trial ◽

Caregiver Burden ◽

Controlled Trial ◽

Intervention Group ◽

Control Group ◽

Indicated Prevention ◽

Randomized Controlled ◽

Term Efficacy

BackgroundAlthough depression is a common problem among non-professional caregivers, only one trial has evaluated the efficacy of indicated prevention targeting this population and the long-term efficacy is unknown. The aim of this study was to evaluate the long-term efficacy of a brief intervention for the indicated prevention of depression in a sample of female caregivers.MethodA randomized controlled trial was conducted involving 173 participants (mean age 53.9 years) who were allocated to the intervention (n = 89) or the usual-care control group (n = 84). Blinded interviewers conducted assessments at 1, 3, 6 and 12 months of follow-up. The main outcome measure was the incidence of major depression and the secondary outcomes were compliance with treatment, depressive symptoms, emotional distress and caregiver burden.ResultsAt the 12-month follow-up, a lower incidence of depression as evaluated using the Structured Clinical Interview for Axis I Disorders of the DSM-IV was found in the intervention group compared with the control group (10.1%v.25.0%). The relative risk was 0.40 and statistically significant [χ2 = 6.68, degrees of freedom = 1,p = 0.010, 95% confidence interval (CI) 0.20–0.81], and the number needed to treat was 7 (95% CI 4–27). There was a significant delay in the onset of depression in the intervention group (p = 0.008). The good complier caregivers had a lower incidence of depression. The intervention effect on depressive symptoms, emotional distress and caregiver burden were maintained for 12 months.ConclusionsThis is the first study to demonstrate that a brief problem-solving intervention can prevent the onset of depression among non-professional caregivers over the longer term.

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Long-Term Effects of Financial Incentives for General Practitioners on Quality Indicators in the Treatment of Patients With Diabetes Mellitus in Primary Care—A Follow-Up Analysis of a Cluster Randomized Parallel Controlled Trial

Frontiers in Medicine ◽

10.3389/fmed.2021.664510 ◽

2021 ◽

Vol 8 ◽

Author(s):

Rahel Meier ◽

Corinne Chmiel ◽

Fabio Valeri ◽

Leander Muheim ◽

Oliver Senn ◽

...

Keyword(s):

Diabetes Mellitus ◽

Medical Records ◽

Financial Incentives ◽

Controlled Trial ◽

Intervention Group ◽

Routine Data ◽

Control Group ◽

Long Term Effects ◽

Patients With Diabetes

Background: The effect of financial incentives on the quality of primary care is of high interest, and so is its sustainability after financial incentives are withdrawn.Objective: To assess both long-term effects and sustainability of financial incentives for general practitioners (GPs) in the treatment of patients with diabetes mellitus based on quality indicators (QIs) calculated from routine data from electronic medical records.Design/Participants: Randomized controlled trial using routine data from electronic medical records of patients with diabetes mellitus of Swiss GPs.Intervention: During the study period of 24 months, all GPs received bimonthly feedback reports with information on their actual treatment as reflected in QIs. In the intervention group, the reports were combined with financial incentives for quality improvement. The incentive was stopped after 12 months.Measurements: Proportion of patients meeting the process QI of annual HbA1c measurements and the clinical QI of blood pressure levels below 140/85 mmHg.Results: A total of 71 GPs from 43 different practices were included along with 3,854 of their patients with diabetes mellitus. Throughout the study, the proportion of patients with annual HbA1c measurements was stable in the intervention group (78.8–78.9%) and decreased slightly in the control group (81.5–80.2%) [odds ratio (OR): 1.21; 95% CI: 1.04–1.42, p < 0.05]. The proportion of patients achieving blood pressure levels below 140/85 mmHg decreased in the control group (51.2–47.2%) and increased in the intervention group (49.7–51.9%) (OR: 1.18; 95% CI: 1.04–1.35, p < 0.05) where it peaked at 54.9% after 18 months and decreased steadily over the last 6 months.Conclusion: After the withdrawal of financial incentives for the GPs after 12 months, some QIs still improved, indicating that 1 year might be too short to observe the full effect of such interventions. The decrease in QI achievement rates after 18 months suggests that the positive effects of time-limited financial incentives eventually wane.

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Nutrition information system (SISFORNUTRIMIL) application With Online Food Record for Indonesia Pregnant Women: Protocol for Randomized Controlled Trial

10.21203/rs.3.rs-634069/v1 ◽

2021 ◽

Author(s):

Mira Trisyani Koeryaman ◽

Saseendran Pallikadavath ◽

Isobel Ryder ◽

Ngianga Kandala

Keyword(s):

Randomized Controlled Trial ◽

Pregnant Women ◽

Dietary Diversity ◽

Controlled Trial ◽

Intervention Group ◽

Eating Behaviour ◽

Control Group ◽

Food Record ◽

Randomized Controlled ◽

The Impact

Abstract Background: The pregnant women and family may not have the necessary knowledge and skills to estimate nutrient value in food in line with dietary targets and the guidelines, i.e. they do not know whether or not they are consuming the right amount of nutrition needed during pregnancy. The aims of this randomized controlled trial (RCT) is to examine the impact of SISFORNUTRIMIL application on maternal eating behaviour and associated maternal factors such as weight gain, blood pressure, biochemical measurement, and pregnancy outcome.Methods: The study recruits 112 participants with eligible criteria during December 2019 to January 2020. The allocation of participants is 1:1 to the SISFORNUTRIMIL application user and non-user application, with criteria: singleton pregnancy (22-26 weeks), mother age between 20-35 years), have monthly income and literate. Both groups will receive 12-week standard health services from health professionals and received information about dietary diversity and food record. Particularly, intervention group could be access the SISFORNUTRIMIL on their devices, which provide necessary information about nutrition in pregnancy, food record and food choice includes total serving size calculation. In contrast, the control group only receive food information and food intake record by paper-based, and they should record and calculate the nutrition intake by traditionally. Discussion: This is the first randomized controlled trial to examine the SISFORNUTIMIL application. This mandate reflects keen interest and motivation for the proposed research study. This is in addition to the researcher’s personal efforts to reduce morbidity and mortality rate as well as a general focus on pregnancy complication prevention than nutrition treatment. Thus, an investigation of eating behaviour and associated maternal needed to address this issue. Firstly, the results could extend the scope of knowledge about nutrition intervention to include the Indonesia pregnant women context as well as the Indonesia health ministry context. Secondly, this research could help to change individual health behaviour and activity undertaken by an individual who believes her-self to be healthy.Trial registration: ISRCTN Registry: ISRCTN42690828. Date of registration: 22 October 2019.

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Cost-effectiveness of a stepwise cardiometabolic disease prevention program: results of a randomized controlled trial in primary care

BMC Medicine ◽

10.1186/s12916-021-01933-6 ◽

2021 ◽

Vol 19 (1) ◽

Author(s):

Daphne M. Stol ◽

Eelco A. B. Over ◽

Ilse F. Badenbroek ◽

Monika Hollander ◽

Mark M. J. Nielen ◽

...

Keyword(s):

Risk Assessment ◽

Primary Care ◽

Cost Effectiveness ◽

Prevention Program ◽

Healthcare Costs ◽

Controlled Trial ◽

Intervention Group ◽

Control Group

Abstract Background Cardiometabolic diseases (CMD) are the major cause of death worldwide and are associated with a lower quality of life and high healthcare costs. To prevent a further rise in CMD and related healthcare costs, early detection and adequate management of individuals at risk could be an effective preventive strategy. The objective of this study was to determine long-term cost-effectiveness of stepwise CMD risk assessment followed by individualized treatment if indicated compared to care as usual. A computer-based simulation model was used to project long-term health benefits and cost-effectiveness, assuming the prevention program was implemented in Dutch primary care. Methods A randomized controlled trial in a primary care setting in which 1934 participants aged 45–70 years without recorded CMD or CMD risk factors participated. The intervention group was invited for stepwise CMD risk assessment through a risk score (step 1), additional risk assessment at the practice in case of increased risk (step 2) and individualized follow-up treatment if indicated (step 3). The control group was not invited for risk assessment, but completed a health questionnaire. Results of the effectiveness analysis on systolic blood pressure (− 2.26 mmHg; 95% CI − 4.01: − 0.51) and total cholesterol (− 0.15 mmol/l; 95% CI − 0.23: − 0.07) were used in this analysis. Outcome measures were the costs and benefits after 1-year follow-up and long-term (60 years) cost-effectiveness of stepwise CMD risk assessment compared to no assessment. A computer-based simulation model was used that included data on disability weights associated with age and disease outcomes related to CMD. Analyses were performed taking a healthcare perspective. Results After 1 year, the average costs in the intervention group were 260 Euro higher than in the control group and differences were mainly driven by healthcare costs. No meaningful change was found in EQ 5D-based quality of life between the intervention and control groups after 1-year follow-up (− 0.0154; 95% CI − 0.029: 0.004). After 60 years, cumulative costs of the intervention were 41.4 million Euro and 135 quality-adjusted life years (QALY) were gained. Despite improvements in blood pressure and cholesterol, the intervention was not cost-effective (ICER of 306,000 Euro/QALY after 60 years). Scenario analyses did not allow for a change in conclusions with regard to cost-effectiveness of the intervention. Conclusions Implementation of this primary care-based CMD prevention program is not cost-effective in the long term. Implementation of this program in primary care cannot be recommended. Trial registration Dutch Trial Register NTR4277, registered on 26 November 2013

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Impact of virtual reality anatomy training on ultrasound competency development: A randomized controlled trial

PLoS ONE ◽

10.1371/journal.pone.0242731 ◽

2020 ◽

Vol 15 (11) ◽

pp. e0242731

Author(s):

Kai-Chun Hu ◽

Daniel Salcedo ◽

Yi-No Kang ◽

Che-Wei Lin ◽

Chin-Wang Hsu ◽

...

Keyword(s):

Virtual Reality ◽

Controlled Trial ◽

Group Analysis ◽

Intervention Group ◽

Spatial Relationship ◽

Control Group ◽

Psychomotor Skills ◽

Anatomical Structures ◽

Image Identification ◽

The Impact

Purpose The use of Virtual Reality (VR) in health professions education has increased dramatically in recent years, yet there is limited evidence of its impact on educational outcomes. The purpose of the study was to assess the impact of VR anatomy instruction on the ultrasound competency of novice learners participating in a ultrasonography workshop. Method We designed a VR-enhanced ultrasonography training program and utilized a plane transection tool to interact with a three-dimensional (3D) VR model of the human body which facilitated the 3D conceptualization of the spatial relationship of anatomical structures, leading to faster and better development of ultrasonographic competency. This was a randomized control study which enrolled third-year medical students (n = 101) without previous exposure to formal or informal ultrasonography training. The participants were randomly divided into an intervention and control group. We assessed participants’ competency through ultrasound performance stations on live subjects, we also measured anatomical and ultrasound image identification ability using multiple choice tests. Result Participants in the intervention group (median = 16; interquartile 13 to 19) had significantly higher scores in ultrasonography task performance tests than the control group (median = 10; interquartile 7 to 14; Mann-Whitney U = 595; P < 0.01). In sub-group analysis, the intervention group performed significantly better in the six out of ten ultrasound tasks. Participants in the intervention group also had greater improvement in ultrasonographic image identification MCQ tests than the control group (Mann-Whitney U = 914; P < 0.05). Conclusion This study suggests that VR-enhanced anatomical training could be of significant benefit in ultrasonography training by promoting a better understanding of the spatial relationships of anatomical structures and the development of early psychomotor skills transferable to the handling of ultrasonographic probes.

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A Long-Term Follow-Up Programme for Maintenance of Motor Function after Stroke: Protocol of the life after Stroke—The LAST Study

Stroke Research and Treatment ◽

10.1155/2012/392101 ◽

2012 ◽

Vol 2012 ◽

pp. 1-7 ◽

Cited By ~ 8

Author(s):

Torunn Askim ◽

Birgitta Langhammer ◽

Hege Ihle-Hansen ◽

Jon Magnussen ◽

Torgeir Engstad ◽

...

Keyword(s):

Motor Function ◽

Controlled Trial ◽

Intervention Group ◽

Control Group ◽

Stroke Severity ◽

Stroke Patients ◽

Long Term Follow Up ◽

Randomised Controlled

Background. There are no evidence-based strategies that have been shown to be superior in maintaining motor function for months to years after the stroke. The LAST study therefore intends to assess the effect of a long-term follow-up program for stroke patients compared to standard care on function, disability and health.Design. This is a prospective, multi-site randomised controlled trial, with blinded assessment 18 months after inclusion. A total of 390 patients will be recruited and randomised to a control group, receiving usual care, or to an intervention group 10 to 16 weeks after onset of stroke. Patients will be stratified according to stroke severity, age above 80, and recruitment site. The intervention group will receive monthly coaching on physical activity by a physiotherapist for 18 consecutive months after inclusion.Outcomes. The primary outcome is motor function (Motor Assessment Scale) 18 months after inclusion. Secondary outcomes are: dependency, balance, endurance, health-related quality of life, fatigue, anxiety and depression, cognitive function, burden on caregivers, and health costs. Adverse events and compliance to the intervention will be registered consecutively during follow-up.

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Effects of Long-Term Use of Insoles with a Toe-Grip Bar on the Balance, Walking, and Running of Preschool Children: A Randomized Controlled Trial

BioMed Research International ◽

10.1155/2020/1940954 ◽

2020 ◽

Vol 2020 ◽

pp. 1-6

Author(s):

Hideki Nakano ◽

Shin Murata ◽

Teppei Abiko ◽

Nozomi Mitsumaru ◽

Atsuko Kubo ◽

...

Keyword(s):

Preschool Children ◽

Controlled Trial ◽

Intervention Group ◽

Step Length ◽

Controlled Study ◽

Control Group ◽

Randomized Controlled ◽

Before And After ◽

Length Step

This randomized controlled study is aimed at investigating the effects of long-term use of insoles with a toe-grip bar on the balance, walking, and running of preschool children. Fifty-two preschool children were randomly assigned to an intervention group or control group. Children included in the intervention group wore shoes with insoles that had a toe-grip bar, and those in the control group wore shoes with regular insoles without a toe-grip bar for 4 weeks while they were at school. The center of gravity sway (total trajectory length and envelope area), walking parameters (walking speed, cadence, stride length, step length, stance time, and swing time), and time to run 25 m were measured before and after the intervention. The 25 m running time of the intervention group was significantly improved after the intervention (F=5.66; p<0.05). This study suggests that insoles with a toe-grip bar may contribute to improvements in the running of preschool children.

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The effect on length of sickness absence by recognition of undetected psychiatric disorder in long-term sickness absence. A randomized controlled trial

Scandinavian Journal of Public Health ◽

10.1177/1403494809347551 ◽

2009 ◽

Vol 37 (8) ◽

pp. 864-871 ◽

Cited By ~ 13

Author(s):

Hans Jørgen Søgaard ◽

Per Bech

Keyword(s):

Randomized Controlled Trial ◽

Mental Disorders ◽

Return To Work ◽

Sickness Absence ◽

Controlled Trial ◽

Intervention Group ◽

Rate Of Return ◽

Control Group ◽

Randomized Controlled

Background: The burden caused by psychiatric disorders on the individual and society has resulted in more studies examining interventions aimed at reducing sickness absence. Aims: To examine if detection of undetected psychiatric disorders in long-term sickness absence (LSA) would improve the rate of return to work. Methods: Over one year all 2,414 incident persons on LSA in a well-defined population were within one week after eight weeks of continuous sickness absence posted the Common Mental Disorders Screening Questionnaire (CMD-SQ) to screen for mental disorders. In a randomized controlled trial (RCT), of 1,121 responding participants, persons with a minimum level of psychiatric symptoms 420 were allocated to the intervention group and 416 to the control group. The intervention was a psychiatric examination including diagnostics with Present State Examination and feedback regarding treatment and rehabilitation to the participants themselves, general practitioners and the social service taking care of the participants’ rehabilitation back to work. Of the 420 in the intervention group 329 (78.3%) participated in the intervention. The outcomes measure was in an intention treat analysis the rate of return to work. Results: The rate of return to work was non-significantly lower for the intervention group than for the control group, except for persons without a psychiatric sick-leave diagnosis who were sick-listed from full time work, who showed a significantly higher rate of return to work in the intervention group. Conclusions: The effect of interventions for return to work depends on socio-demographic characteristics. Further studies are needed regarding interventions to improve return to work.

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