What a weight loss programme should contain if people with obesity were asked - a qualitative analysis within the DO:IT study.

BACKGROUND: Currently 1.9 billion adults worldwide are estimated to be overweight or obese. In Denmark the municipalities hold the responsibility to deliver weight loss programmes to overweight and obese citizens. There is a tendency to assume that weight loss programmes that show positive effects in specialized hospital settings are directly transferrable to municipal settings. However, municipality-based weight loss programmes have not produced clinically significant reductions in body weight. One reason for this may be that much research evidence regarding obesity programming neglects the perspectives of people with obesity. The first step in developing a weight loss programme designed for municipal settings is to understand what people with obesity want and need from a programme. The aim of this study was to examine what people with obesity find important in a weight loss programme for weight loss and weight maintenance. METHODS: We used a qualitative, explorative, descriptive design with individual interviews. We included men and women age 17 and older with a BMI ≥ 25 kg/m2. Participants were recruited from the wait lists of 13 municipality programmes and through Facebook posts. Data were analyzed using content analysis. RESULTS: Thirty-four participants with overweight or obesity were individually interviewed (ages between 19 and 74). Findings suggest that weight loss programmes should; a) support participants in structuring days; b) consider the use of replacement activities to reduce cognitive and emotional burden; c) aide individuals to increase self-efficacy and; d) include family and friends as well as health professionals and peers in the weight loss process. Diet and exercise, while important, should be balanced with other meaningful activities in everyday life. CONCLUSION: Participants in this study wished to balance weight loss related activities with overall everyday life as well as finding the believe in their ability to lose weight in social relations.

Effectiveness of a comprehensive interactive eHealth intervention on patient-reported and clinical outcomes in patients with an implantable cardioverter defibrillator [ACQUIRE-ICD trial]: study protocol of a national Danish randomised controlled trial.

BACKGROUND: In Denmark and other countries, there has been a shift in the management of patients with an implantable cardioverter defibrillator (ICD) with remote device monitoring largely replacing in-hospital visits. Less patient-nurse and patient-physician interaction may lead to gaps in patients' quality of care and impede patients' adaptation to living successfully with the ICD. A comprehensive eHealth intervention that include goal-setting, monitoring of symptoms of depression, anxiety, and quality of life, psychological treatment, information provision, supportive tools, online dialogues with nursing staff and access to an online community network, may help fill these gaps and be particularly beneficial to patients who suffer from anxiety and depression. This study will evaluate the effectiveness of the ACQUIRE-ICD care innovation, a comprehensive and interactive eHealth intervention, on patient-reported and clinical outcomes. METHODS: The ACQUIRE-ICD study is a multicenter, prospective, two-arm, unblinded randomised controlled superiority trial that will enroll 478 patients implanted with a first-time ICD or ICD with cardiac synchronisation therapy (CRT-D) from the six implanting centers in Denmark. The trial will evaluate the clinical effectiveness and cost-effectiveness of the ACQUIRE-ICD care innovation, as add-on to usual care compared with usual care alone. The primary endpoint, device acceptance, assessed with the Florida Patient Acceptance Survey, is evaluated at 12 months' post implant. Secondary endpoints, evaluated at 12 and 24 months' post implant, include patient-reported outcomes, return to work, time to first ICD therapy and first hospitalisation, mortality and cost-effectiveness. DISCUSSION: The effectiveness of a comprehensive and interactive eHealth intervention that relies on patient-centred and personalised tools offered via a web-based platform targeted to patients with an ICD has not been assessed so far. The ACQUIRE-ICD care innovation promotes and facilitates that patients become active participants in the management of their disease, and as such addresses the need for a more patient-centered disease-management approach. If the care innovation proves to be beneficial to patients, it may not only increase patient empowerment and quality of life but also free up time for clinicians to care for more patients. TRIAL REGISTRATION: The trial has been registered on https://clinicaltrials.gov/ct2/show/NCT02976961 on November 30, 2016 with registration number [ NCT02976961 ].

The Impact of Education Level on Weight Loss in a Primary Care-Anchored eHealth Lifestyle Coaching Program in Denmark: A Randomized Controlled Trial.

In a randomized controlled trial including 340 people living with obesity, with and without type 2 diabetes, digital coaching has induced significant long-term weight loss compared to the usual methods of care. We investigated whether education level influenced this weight loss and which lifestyle changes supported the digital lifestyle coaching program. The intervention consisted of a 1 h face-to-face motivational interview followed by digital coaching using behavioral change techniques. At 6 months, the weight loss in the intervention group was significantly larger in participants with short education (6.0 vs. 2.2 kg, p < 0.01) (p = 0.006). Participants with long education experienced initially a modest weight loss, but the effect was maintained, leading to the largest weight loss at 24 months (5.06 [-11.98-1.86] kg), even though there were fewer coaching sessions in the maintenance period. In multiple regression analyses, the greater weight loss in the intervention group was associated with short education (ß = 1.81, p = 0.02), improvements in everyday physical activity (ß = 2.60, p = 0.014) and improvements in dietary habits (ß = 3.84, p = 0.013). In conclusion, at 6 months, the effect of the intervention was more pronounced in people with short education through improvements in everyday physical activity and dietary habits. However, participants with long education sustained their weight loss at 24 months.

A web-based intervention for patients with an implantable cardioverter defibrillator - A qualitative study of nurses' experiences (Data from the ACQUIRE-ICD study).

Objective: The aim of this study was to explore cardiac nurses' experiences with a comprehensive web-based intervention for patients with an implantable cardioverter defibrillator. Methods: We conducted an explorative qualitative study based on individual semi-structured interviews with 9 cardiac nurses from 5 Danish university hospitals. Results: We found one overall theme: "Between traditional nursing and modern eHealth". This theme was derived from the following six categories: (1) comprehensive content in the intervention, (2) patient-related differences in engagement, (3) following the protocol is a balancing act, (4) online communication challenges patient contact, (5) professional collaboration varies, and (6) an intervention with potential. Cardiac nurses were positive towards the web-based intervention and believe it holds a large potential. However, they felt challenged by not having in-person and face-to-face contact with patients, which they found valuable for assessing patients' wellbeing and psychological distress. Conclusion: Specific training in eHealth communication seems necessary as web-based care entails a shift in the nursing role and requires a different way of communication.InnovationFocusing on the user experience in web-based care from the perspective of cardiac nurses is innovative, and by applying implementation science this leads to new knowledge to consider when developing and implementing web-based care.

[Clinical applications of smartwatches].

Smartwatches can contribute to increased physical activity and weight loss in chronic patient groups, especially when included as a subcomponent in a bigger lifestyle intervention. ECGs from smartwatches can most likely be used to screen for atrial fibrillation in general practice. However, there is yet no definitive clinical validation and systematic studies on the possible consequences of using smartwatches. Access to more reliable health data in the patient's home may be the key to better health for chronic patients. Digital monitoring could become an important aspect of future health care, as argued in this review.

Preferred Content in Occupational Therapy-Based Weight Loss Interventions: A Survey.

Despite decades of attempts from doctors and dietitians to break the obesity curve, obesity rates are increasing in Denmark. To counteract this, municipal occupational therapy-based interventions are in development as part of the Danish Obesity Intervention Trial (DO: IT). The objective was to survey Danish adults on preferred content in an occupational therapy municipal weight loss intervention and determine if preferences differed by gender and age. A 21-item questionnaire was developed to explore preferences related to diet, physical activity, occupational balance, habits, and social relations. In all, 429 respondents were included. Chi-square statistics were performed to determine if preferences differed by gender and age. A total of 15 of the 21 items indicated gender-based differences in preferences. Two items indicated age-based differences. Notably, compared to men, women indicated significantly more interest in content relating to habit formation and occupational balance. Gender-based differences should be considered when developing a weight loss intervention.

Reversing Type 2 Diabetes in a Primary Care-Anchored eHealth Lifestyle Coaching Programme in Denmark: A Randomised Controlled Trial.

The goal of this trial was to investigate whether an eHealth lifestyle coaching programme led to significant weight loss and decreased Haemoglobin A1c (HbA1c) in patients with type 2 diabetes. In an RCT, 170 patients were enrolled from 2018 to 2019 for intervention or control. Inclusion criteria were diagnosed with type 2 diabetes, BMI 30−45 kg/m2, and aged 18−70 years. Exclusion criteria were lacks internet access, pregnant or planning a pregnancy, or has a serious disease. Primary and secondary outcomes were a reduction in body weight and HbA1c. At six months, 75 (75%) patients in the intervention group and 53 (76%) patients in the control group remained in the trial. The mean body weight loss was 4.2 kg (95% CI, −5.49; −2.98) in the intervention group and 1.5 kg (95% CI, −2.57; −0.48) in the control group (p = 0.005). In the intervention group, 24 out of 62 patients with elevated HbA1c at baseline (39%) had a normalized HbA1c < 6.5% at six months, compared to 8 out of 40 patients with elevated HbA1c at baseline (20%) in the control group (p = 0.047). The eHealth lifestyle coaching programme can lead to significant weight loss and decreased HbA1c among patients with type 2 diabetes, compared to standard care.

Long-term weight loss in a 24-month primary care-anchored telehealth lifestyle coaching program: Randomized controlled trial.

Long-term weight loss can reduce the risk of type 2 diabetes for people living with obesity and reduce complications for patients diagnosed with type 2 diabetes. We investigated whether a telehealth lifestyle-coaching program (Liva) leads to long-term (24 months) weight loss compared to usual care. In a randomized controlled trial, n = 340 participants living with obesity with or without type 2 diabetes were enrolled and randomized via an automated computer algorithm to an intervention group (n = 200) or to a control group (n = 140). The telehealth lifestyle-coaching program comprised of an initial one-hour face-to-face motivational interview followed by asynchronous telehealth coaching. The behavioural change techniques used were enabled by individual live monitoring. The primary outcome was a change in body weight from baseline to 24 months. Data were assessed for n = 136 participants (40%), n = 81 from the intervention group and n = 55 from the control group, who completed the 24-month follow-up. After 24 months mean body weight and body mass index were reduced significantly for completers in both groups, but almost twice as much was registered for those in the intervention group which was not significant between groups -4.4 (CI -6.1; -2.8) kg versus -2.5 (CI -3.9; -1.1) kg, P = 0.101. Haemoglobin A1c was significantly reduced in the intervention group -3.1 (CI -5.0; -1.2) mmol/mol, but not in the control group -0.2 (CI -2.4; -2.0) mmol/mol without a significant between group difference (P = 0.223). Low completion was partly due to coronavirus disease 2019. Telehealth lifestyle coaching improve long-term weight loss (> 24 months) for obese people with and without type 2 diabetes compared to usual care.

Identification of Important Factors Affecting Use of Digital Individualised Coaching and Treatment of Type 2 Diabetes in General Practice: A Qualitative Feasibility Study.

Most type 2 diabetes patients are treated in general practice and there is a need of developing and implementing efficient lifestyle interventions. eHealth interventions have shown to be effective in promoting a healthy lifestyle. The purpose of this study was to test the feasibility, including the identification of factors of importance, when offering digital lifestyle coaching to type 2 diabetes patients in general practice. We conducted a qualitative feasibility study with focus group interviews in four general practices. We identified two overall themes and four subthemes: (1) the distribution of roles and lifestyle interventions in general practice (subthemes: external and internal distribution of roles) and (2) the pros and cons for digital lifestyle interventions in general practice (subthemes: access to real life data and change in daily routines). We conclude that for digital lifestyle coaching to be feasible in a general practice setting, it was of great importance that the general practitioners and practice nurses knew the role and content of the intervention. In general, there was a positive attitude in the general practice setting towards referring type 2 diabetes patients to digital lifestyle intervention if it was easy to refer the patients and if easily understandable and accessible feedback was implemented into the electronic health record. It was important that the digital lifestyle intervention was flexible and offered healthcare providers in general practice an opportunity to follow the type 2 diabetes patient closely.

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.

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.

Long-Term Effect of Interactive Online Dietician Weight Loss Advice in General Practice (LIVA) Protocol for a Randomized Controlled Trial.

Background. Internet-based complex interventions aiming to promote weight loss and optimize healthy behaviors have attracted much attention. However, evidence for effect is lacking. Obesity is a growing problem, resulting in an increasing demand for cost efficient weight loss programs suitable for use on a large scale, for example, as part of standard primary care. In a previous pilot project by Brandt et al. (2011) without a control group, we examined the effects of online dietician counseling and found an average weight loss of 7.0 kg (95% CI: 4.6 to 9.3 kg) after 20 months. Aims and Methods. To analyze the effects of a complex intervention using trained dieticians in a general practice setting combined with internet-based interactive and personalized weight management support compared with conventional advice with a noninteractive internet support as placebo treatment in 340 overweight patients during a 2-year period. Primary endpoints are weight loss and lowering of cholesterol (LDL). We will also explore patients' sociodemographics and use of the intervention as well as the health professionals' views and perceptions of the intervention (their role and the advice and support that they provide). Perspective. The project will generate knowledge on the cost-effectiveness of a complex internet-based intervention in a general practice setting and on barriers and acceptability among professionals and patients.