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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.

ABSTRACT: 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.

SUBMITTER: Brandt CJ

PROVIDER: S-EPMC7380992 | biostudies-literature | 2020 Jun

REPOSITORIES: biostudies-literature

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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.

Brandt Carl J CJ Christensen Jeanette Reffstrup JR Lauridsen Jørgen T JT Nielsen Jesper Bo JB Søndergaard Jens J Sortsø Camilla C

JMIR research protocols 20200625 6

<h4>Background</h4>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.<h4>Objective</h4>This study protocol is for a 2-year randomized controlled trial that aims to evaluate the clinical and ...[more]

PMID: 32584260

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Project description:BackgroundFor chronic disease management, self-management strategies are essential to achieve sustained improvement.ObjectiveOur study evaluated the efficacy of health coaching and a self-management strategy-based electronic program on self-management strategies for patients with osteoporosis, chronic respiratory disease, or arthritis.DesignThree-arm randomized controlled trial, pilot study PARTICIPANTS: Fifty-four participants INTERVENTIONS: The first intervention group (n = 53) received a self-management strategy-based electronic program and 12 weeks of health coaching (20 sessions). The second intervention group received the information and communications technology (ICT) program; the control group received usual care and an educational booklet about self-management of chronic diseases.Main measuresThe primary outcome was the difference in the change of the mean of self-management strategy scores. Secondary outcomes included depression (PHQ-9), physical activity (Godin Leisure Exercise Questionnaire), and health habit maintenance (transtheoretical model) after 12 weeks in the program.Key resultsThe combination of health coaching and ICT was superior to control group (change 18.5 vs. - 2.6, adjusted difference = 24.5, p < 0.001); however, the ICT alone group was not superior to the control group (change 8.0 vs. - 2.6, adjusted difference = 8.0, p = 0.156). As a result of evaluating the change in the percentage of people with positive stage changes in the transtheoretical model of health habits, regular exercise (p = 0.008), a balanced diet (p = 0.005), helping others (p = 0.001), and living with loved ones (p = 0.038) showed significant differences. There was no significant difference in the changes in percentage of patients with depressive symptoms in comparison with control group; however, there was in comparison with control group among groups (p = 0.033). Compared to the control group, the proportion of patients who achieved an exercise amount of 12.5 MET or higher was significantly higher (p = 0.028) in the health coaching and ICT group.ConclusionsThe combination of ICT + health coaching led to improvement in self-management as well as in increasing exercise, and several healthy behaviors.Trial registrationhttps://clinicaltrials.gov/ct2/show/NCT03294057.

Project description:Background:Stress and obesity are interrelated and common among low-income adults. Mind-body interventions have been shown to reduce psychological distress and have been incorporated into many weight loss interventions. However, few of these programs have incorporated a telephone coaching component. Objective:We designed and piloted a novel weight loss telephone coaching intervention for this population and examined its effectiveness on weight loss and improvements in health behaviors in obese community health center patients. Methods:This was a 6-month, single-arm, prospective, pre-post pilot study. The study took place at a community health center near Boston, Massachusetts. Participants were 27 overweight and obese community health center patients. The intervention consisted of one in-person intake with the registered dietitian, trained in mind-body approaches, and approximately 1 phone coaching session every 2 weeks for 6 consecutive months. Anthropometric data consisted of weight, body mass index (BMI), and blood pressure. Questionnaires consisted of the Perceived Stress Scale-10 item, the CIGNA Healthy Eating Survey, Section H: Behavioral Eating, a physical activity questionnaire, and a nutritional habits questionnaire. We used paired samples t tests to assess pre-post changes in weight, BMI, blood pressure, perceived stress, behavioral eating, and physical activity. We also conducted semistructured exit interviews to learn about participants' experiences in this program. Results:There was a trend toward weight reduction (P?<?.1, Cohen's d?=?0.33) and significant improvements in systolic blood pressure (P?=?.001, Cohen's d?=?0.72), perceived stress (P?=?.001, Cohen's d?=?0.75), and behavioral eating (P?=?.009, Cohen's d?=?0.54). Improvements in weight were sustained 6 months after completion of the intervention. Conclusion:Results suggest that a telephone nutrition health coaching intervention is feasible and may facilitate weight loss in obese community health center patients. Future randomized-controlled studies are warranted to better understand these improvements. Clinicaltrialsgov registration:NCT03025217.

Project description:BackgroundPhysical inactivity and unhealthy dietary habits are known to be disadvantageous for the development of late adverse effects in survivors of childhood, adolescent, and young adult cancer. To make interventions, aimed at improving lifestyle, fit into the daily life of survivors, interventions should be designed and delivered in a person-centred way with a limited time burden. As part of the European PanCareFollowUp project, an eHealth intervention was developed to support sustainable changes to physical activity levels and/or diet of childhood, adolescent, and young adult cancer survivors. This feasibility study aims to gain insight into the feasibility and potential effect sizes of the PanCareFollowUp lifestyle intervention.MethodsThe PanCareFollowUp lifestyle intervention consists of person-centred 3-6 screen-to-screen sessions with a certified lifestyle coach. The intervention will be evaluated with a single-arm pre-post feasibility study conducted at two survivorship care clinics in the Netherlands. A total of 60 participants who are (i) diagnosed with cancer <25 years, (ii) ≥ 5 years post-treatment, (iii) aged 16-55 years, and (iv) have a low physical activity level and/or unhealthy dietary intake manifested by overweight will be recruited. Using reports, hospital records, and questionnaires for survivors, coaches, and late effect doctors, feasibility will be based on (i) adherence to intervention, (ii) acceptability, (iii) practicality, (iv) integration/implementation, (v) demand, and (vi) attrition. The potential effect sizes of the intervention will be explored by determining the percentage of survivors that reach the personalized lifestyle goals that were set with the coach. Physical activity level, dietary intake, BMI, general self-efficacy, self-management, and motivation level will be assessed at three time points with questionnaires, reports, and/or an accelerometer.DiscussionData of this study will be gathered to assess the feasibility and potential effect sizes. This will allow for further intervention refinement as needed as well as to inform a future large-scale intervention study and a manual for implementation at other centres.Trial registrationInternational Clinical Trial Registry Platform (ICTRP) number: NL8932 (ICTRP Search Portal (who.int)). Registered on September 29, 2020.

Project description:BACKGROUND:Workplace Health Promotion Programs (WHPP) have been shown to be an efficient way of improving workers' health. These programs can be incorporated in the worker's daily schedule and improve their productivity at work. Improving employees' health also benefits the employers by increasing their return on investment and lowering healthcare costs. The Activate Your Health program, created by Capsana in 2015, is a WHPP targeting multiple lifestyle habits for a three-year period. This WHPP includes tailored web-based interventions and the support of different health professionals throughout the years. We hypothesize that this approach will yield long-term lifestyle changes. The objective of the current paper is to describe the Activate Your Health program's design. METHODS/DESIGN:Eleven companies are taking part in this WHPP and had to choose among five different options of this program and all their employees were encouraged to participate. Each option differs by the number and type of interventions included. The limited option, which is considered the control group, only consists in completing a questionnaire regarding their health status, lifestyle habits and behaviors. On the other end, the extensive option receives a combination of multiple interventions: online menus, health challenges, support in creating a healthy work environment, coaching by health professionals (nurse, nutritionist, and kinesiologist), health screening and flexibility assessment, online resources, social health platform, and activity tracking. The remaining options are in between these options and vary by the amount of intervention. Baseline data are already gathered; two other data collection periods will take place after one and 2 years into the program. The primary outcomes of the current program are physical activity and fitness measures, nutritional data, smoking habits, stress and intention to change. DISCUSSION:The Activate Your Health program will allow us to compare which combinations of interventions are the most effective. It is expected that the extensive option will be the most advantageous to improve lifestyle habits. The results will indicate the strength and weakness of each intervention and how it could be improved. TRIAL REGISTRATION:Clinicaltrails.gov, registration number: NCT02933385 (updated on the 26th of March 2019, initially registered on the 5th of October 2016).

Project description:INTRODUCTION:Low back pain is one of the most common and burdensome chronic conditions worldwide. Lifestyle factors, such as excess weight, physical inactivity, poor diet and smoking, are linked to low back pain chronicity and disability. There are few high-quality randomised controlled trials that investigate the effects of targeting lifestyle risk factors in people with chronic low back pain. METHODS AND ANALYSIS:The aim of this study is to determine the effectiveness of a Healthy Lifestyle Program (HeLP) for low back pain targeting weight, physical activity, diet and smoking to reduce disability in patients with chronic low back pain compared with usual care. This is a randomised controlled trial, with participants stratified by body mass index, allocated 1:1 to the HeLP intervention or usual physiotherapy care. HeLP involves three main components: (1) clinical consultations with a physiotherapist and dietitian; (2) educational resources; and (3) telephone-based health coaching support for lifestyle risk factors. The primary outcome is disability (Roland Morris Disability Questionnaire) at 26 weeks. Secondary outcomes include pain intensity, weight, quality of life and smoking status. Data will be collected at baseline, and at weeks 6, 12, 26 and 52. Patients with chronic low back pain who have at least one health risk factor (are overweight or obese, are smokers and have inadequate physical activity or fruit and vegetable consumption) will be recruited from primary or secondary care, or the community. Primary outcome data will be analysed by intention to treat using linear mixed-effects regression models. We will conduct three supplementary analyses: causal mediation analysis, complier average causal effects analysis and economic analysis. ETHICS AND DISSEMINATION:This study was approved by the Hunter New England Research Ethics Committee (Approval No 17/02/15/4.05), and the University of Newcastle Human Research Ethics Committee (Ref No H-2017-0222). Outcomes of this trial and supplementary analyses will be disseminated through publications in peer-reviewed journals and conference presentations. TRIAL REGISTRATION NUMBER:ACTRN12617001288314.

Project description:BackgroundCombined lifestyle interventions (CLIs) are designed to help people who are overweight or obese maintain a healthy new lifestyle. The CooL intervention is a CLI in the Netherlands, in which lifestyle coaches counsel adults and children (and/or their parents) who are obese or at high risk of obesity to achieve a sustained healthier lifestyle. The intervention consists of coaching on lifestyle in group and individual sessions, addressing the topics of physical activity, dietary behaviours, sleep, stress management and behavioural change. The aim of this study was to evaluate the implementation process of the Coaching on Lifestyle (CooL) intervention and its facilitating and impeding factors.MethodsMixed methods were used in this action-oriented study. Both quantitative (number of referrals, attendance lists of participants and questionnaires) and qualitative (group and individual interviews, observations, minutes and open questions) data were collected among participants, lifestyle coaches, project group members and other stakeholders. The Consolidated Framework for Implementation Research was used to analyse the data.ResultsCooL was evaluated by stakeholders and participants as an accessible and useful programme, because of its design and content and the lifestyle coaches' approach. However, stakeholders indicated that the lifestyle coaches need to become more familiar in the health care network and public sectors in the Netherlands. Lifestyle coaching is a novel profession and the added value of the lifestyle coach is not always acknowledged by all health care providers. Lifestyle coaches play a crucial role in ensuring the impact of CooL by actively networking, using clear communication materials and creating stakeholders' support and understanding.ConclusionThe implementation process needs to be strengthened in terms of creating support for and providing clear information about lifestyle coaching. The CooL intervention was implemented in multiple regions, thanks to the efforts of many stakeholders. Lifestyle coaches should engage in networking activities and entrepreneurship to boost the implementation process. It takes considerable time for a lifestyle coach to become fully incorporated in primary care.Trial registrationNTR6208 ; date registered: 13-01-2017; retrospectively registered; Netherlands Trial Register.

Dataset Information

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.

Publications

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.

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