ObesityLIVANCT03788915
Weight Loss and Reversing T2D Through eHealth Coaching
A study testing Online dietetic lifestyle counseling in people with Obesity, run by University of Southern Denmark at 2 sites in Denmark.
Trial summary
Background: Systematic reviews conclude that Internet and mobile interventions can significantly change lifestyle in a short time span. The applicant has developed a collaborative eHealth tool (LIVA) that has led to a significant and clinically relevant weight loss of 5.4 to 7.0 kg over 12 to 20 months in primary care… Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Obesity
- What is being tested?
- Online dietetic lifestyle counseling
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 340 participants
- Where
- 2 sitesDenmark
- Study dates
- 16 Apr 2018to Mar 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- BMI ≥ 30 kg/m2 and < 45 kg/m2
- Aged 18 -70 years
Who cannot join
- Fails to provide informed consent
- Fails to complete the initial questionnaire
- No Internet access in own home through computer or smartphone
- Is pregnant or actively trying to get pregnant
- Experiences serious or life-threatening disease
Trial locations and contacts
2 sites in 1 country.
Denmark2 sites, 2 recruiting
- Recruiting
Research Unit for General Practice, Department for Public Health, University of Southern Denmark
Odense, Region Syddanmark
Carl J Brandt, MD, +45 2014 1566, cbrandt@health.sdu.dk
Jens Søndergaard, PhD, +45 6550 3830, jsoendergaard@health.sdu.dk
- Recruiting
Lægehuset i Stenstrup
Stenstrup, 5700
Jacob B Madsen, MD, 63621015, info@laegehusetistenstrup.dk
Cees Stauvenuiter, MD, 63621015, info@laegehusetistenstrup.dk
About this study
Official title: Facilitating Weight Loss and Reversing Type 2 Diabetes (T2D) by Means of a Collaborative eHealth Lifestyle Coaching Intervention in Primary Care - A 2-year Randomised Controlled Trial
Background: Systematic reviews conclude that Internet and mobile interventions can significantly change lifestyle in a short time span. The applicant has developed a collaborative eHealth tool (LIVA) that has led to a significant and clinically relevant weight loss of 5.4 to 7.0 kg over 12 to 20 months in primary care settings. The objective of this study is to develop and evaluate a model targeting long-term effects using eHealth coaching assisted by machine learning-generated advice intervention for overweight patients at risk of developing diabetes as well as current type 2 diabetes (T2D) patients in a primary care setting.
Methods and analysis: Randomized controlled trial with 1-year intervention and 1-year maintenance. The primary outcome is weight loss and the secondary outcome is reduced HbA1c level. The study will comprise 340 overweight patients of which 170 will have T2D. Individual data will be obtained from clinical measurements, questionnaire data, registered from the collaborative eHealth tool, as well as other registry data at baseline and at 6, 12 and 24 months. The core of the intervention is the establishment of an empathic relationship and ongoing real-life coaching using the LIVA app (working together with native iOS and Android) and Internet for patients combined with an effective coaching module supported by machine learning methods. The intervention will be compared with usual care.
Read the detailed description
- Introduction With diseases such as Type 2 diabetes (T2D), adiposity and cardiovascular diseases rapidly increasing, cost effective management is needed (World Health Organization, 2017). Lifestyle improvements such as weight loss, diet and exercise managed in a primary care setting has shown significant impact on reduced risk of cardiovascular disease and reversing T2D for 46-56% of patients with T2D (Lean et al., 2017, Johansen et al., 2017). Based on these findings, weight loss among overweight patients with T2D and patients at risk of developing T2D has important clinical and societal effects. Traditional lifestyle interventions are mostly ineffective and expensive long-term. Internet and mobile technology-based interventions aiming at promoting healthy lifestyles have shown potential for scalability, accessibility, and cost effective use in primary care settings both for overweight patients and T2D patients (Brandt et al, 2011, Haste et al., 2017, Komkova et al 2018). However, there is only sparse knowledge about whether the beneficial effects are long-term (Afshin et al., 2016, Levine et al., 2015). Qualitative research studies comprising patients, general practitioners and the healthcare professionals' perspectives suggest that the establishment of an empathic relationship is key to long-term lifestyle change (Brandt et al., 2018a, 2018b and 2018c). An observational study among 103 diabetes patients using the collaborative eHealth tool (LIVA) demonstrated a clinically significant self-reported weight loss of 4.7 kg among users who had been on the platform for 90+ days (Komkova et al., 2018). Modelling the association between weight reduction and decreased health care costs, the same study estimated that the program will save 2,667€ annually for every patient and be cost effective from a municipal perspective even with only 1 year of implementation data for T2D patients (Mukherjee et al., 2016, Nichols et al., 2016, Bell et al., 2014). In the present study, the model to be tested is a lifestyle intervention using a cost-effective eHealth coaching tool (LIVA) model: following an initial meeting, frequent digital communication is established between health coach and patient, supplemented by machine learning. Machine learning is performed using data automatically gathered from patients' relevant daily lifestyle registrations such as activity level, step count, diet goals fulfilment, sleep, etc. Data will be analysed to predict attrition and outcome. The developed algorithms and models will then be used to increase outcome and decrease dropout by supporting the health coaches with information and guidance how to deliver better coaching directly and indirectly. This intervention will be compared with standard lifestyle interventions in a municipality setting.
- Study objectives and hypothesis The aim of this study is to evaluate the clinical efficacy of the LIVA intervention for overweight patients at risk of developing a chronic disease and overweight type 2 diabetes patients in a primary care setting. We hypothesize that the LIVA intervention will lead to significant weight loss, reduced HbA1C, and reduced need for medication compared to usual care.
- Methods and analysis Study design and setting The study is a randomized controlled trial with one year of intervention and one year of subsequent maintenance, with continued collection of clinical and questionnaire data, where the primary endpoint is weight loss and the secondary endpoint is HbA1c. The intervention is conducted in a real life setting; all data management will be at the Research Unit for General Practice, Department of Public Health, Primary trial sponsor, J.B. Winsløwsvej 9A, 5000 Odense C, Denmark. Recruitment of patients to the study is in 8-10 municipalities within the Region of Southern Denmark and the Capitol Region of Denmark. The study has been registered at https://register.clinicaltrials.gov. On-boarding of patients began in March 2018 and the results are expected to be accessible during 2021. Study population and inclusion criteria Flow of patients is described in figure 1. In each municipality, advertising through social media will be used to recruit eligible patients for municipal preventive offers, fulfilling the inclusion criteria in the study (Table 1). These patients will be contacted by phone and/ or email, and informed about the study and asked to register if they accept the offer to participate. Table 1. Inclusion and exclusion criteria Inclusion criteria: BMI 45 ≥ 30 kg/m2 Aged 18 -70 years Exclusion criteria: Fails to provide informed consent Fails to complete the initial questionnaire or understand Danish No Internet access in own home through computer or smartphone Is pregnant or actively trying to get pregnant Experiences mental or serious life-threatening disease The 340 eligible patients will be invited to an introduction meeting with an healthcare professional with a master's in human nutrition or a clinical dietician. This introductory appointment is scheduled within 7-14 days after the information material is received by the patient. The patient is weighed and measured according to defined clinical indicators. Blood indicators are measured through a finger prick blood sample. The patient is then instructed to use a web link to complete a standard quality of life questionnaire (SF-12) combined with registration of medication intake and questions concerning the patient's sociodemographic characteristics, such as educational level, labour market affiliation, questions concerning work performance, and disease history. Randomization: After patients have successfully completed the web questionnaire, they will be randomized via an automated computer algorithm. This procedure ensures that drop-out characteristics can be recorded. Patients are randomized in a 60:40 sequencing, where 60% of recruited patients are randomized for the intervention group while the remaining 40% will constitute the control group, based on sample size calculations (Please see Sample size calculations, below). Randomization is controlled to ensure that 50% of intervention group and controls will be overweight patients at risk of developing chronic disease and the other 50% of intervention group and controls will be overweight diabetes patients. Intervention: The intervention is summarised in Table 2. Based on results in the applicant's PhD thesis, the core of the intervention is the initial establishment of an empathic relationship with a healthcare professional who is a clinical dietician by profession and has been working with eHealth lifestyle coaching for more than 2 years (referred to as the health coach) and who delivers effective remote and/or digital coaching responsive to the users' own data registrations (Brandt et al, 2018a). Patients in the intervention group receive a login to the eHealth tool at a personal meeting (either physical or digital) during which the health coach introduces the program. Together, the patient and the health coach agree on goals for diet, physical exercise, sleep, etc. (Brandt et al, 2018b). Using the app, patients fill in a daily record as well as their comments, concerns and questions for the health coach, who will have access to patient profiles. The health coach provides individual asynchronous advice according to the patients' needs based on the patients' own real-time registrations (Brandt et al, 2018c); the health coach's advice is supported by artificial intelligence predictions using machine learning (Holzinger A. et al, 2017). The coach advises on goal setting based on the SMART model: Specific, Measurable, Attainable, Relevant, Timely, and according to a predefined guideline structure (Ryan et al, 2009). Asynchronous advice will be provided on a weekly basis during the first 6 months. Subsequently, advice will be given monthly for 6 months. After 12 months, the participant enters maintenance for 12 months, where the coach will still follow patients' registrations and may give four to twelve coaching sessions during that year. Patients can also participate in usual municipally provided preventive medicine offerings, such as "diabetes school", to the extent that the municipalities normally provide such offers. Conventional care (control group): Patients randomized to the control group will be offered standard municipal secondary or tertiary preventive offers. Study endpoints and assessment: Measurement of endpoints (weight, HbA1c etc.) will be conducted by the health coach at baseline and at 6, 12 and 24 months' follow-up. Primary outcome: Weight loss from baseline to 12 months' follow-up. Secondary outcome Reduction in HbA1c for all patients from baseline to 12 months for patients with T2D. Other outcomes The following tertiary outcomes will be measured at baseline and at 12 months:
- Retention rates among users
- Patient waist circumference
- Blood pressure
- Total cholesterol, LDL, HDL and TG
- Patients' quality of life
- Changes in patterns of medication Apart from these outcomes, patient demographic characteristics (gender, age, highest educational level) will be measured at baseline. Analysis strategy Primary analyses will be performed blinded by statisticians and comprise subgroup analyses based on stratification according to patient characteristics and experiences. Statistical significance will be inferred at a two-tailed and p<0.05 significance level. All data will be accessible on the Internet in anonymised form to allow full peer scrutiny and facilitate secondary research. Sample size calculations The primary objective of this study is measurement of changes in body weight and waist circumference. Weight loss in the intervention group and control group will be analysed using appropriate statistical procedures. Based on a recent study by Haste and colleagues evaluating a web-based weight loss intervention among men with diabetes, we expect a weight loss of at least 4.5 kg at 12 months in the intervention group, compared to 2.5 kg in the control group, as well as dropout rates of 39% among the intervention group and 57% among control group at 12 months (Haste et al., 2017). A power calculation based on the standard deviations observed in the study performed by Haste et al shows that to detect a difference in weight loss of 2 kg with a power of 0.95% requires 55 patients in the intervention group and 32 in the control group. To be able to stratify analyses according to overweight patients at risk of developing chronic disease and overweight diabetes patients we will therefore recruit 200 (100+100) in the intervention groups and 140 (70+70) controls.
- Ethics The intervention is not expected to cause any side effects or discomfort except for the ones a change in lifestyle can bring. The only recognized risk is in relation to eating disorders (pre-existing or developing during the study) and the dieticians and nurses involved in the study will specifically look out for indications of this. The Regional Ethical Committee (Regional Videnskabsetisk Komité) have accepted the study in according to Danish law. Participant data will be handled and stored in accordance with rules approved by the Danish Data Inspectorate (Datatilsynet). Permission to handle individual patient data from the national registries will be obtained from patients and the Danish Data Inspectorate. All data will be analysed in anonymous form.
- Publication The results of the studies will be published in international journals in accordance with the Vancouver rules. Furthermore, participants will be invited to a presentation of results at the end of the study and news media will be informed.
- Conflict of Interests Carl J. Brandt has co-founded and works as a medical consultant for LIVA Healthcare A/S, the company that has developed parts of the technical platform and will host some of it during the study. Carl J. Brandt works at the Research Unit for General Practice and CIMT at SDU. Camilla Sortsø is working for LIVA Healthcare A/S, Jens Søndergaard, Jesper B. Nielsen and Jørgen T. Lauridsen have no financial interest in LIVA Healthcare A/S or any other aspects of this study.
- Conditions
- Obesity
- Being tested
- Online dietetic lifestyle counseling, Usual care
- Keywords
- obesity, internet community, treatment; preventive medicine, risk perception, lifestyle counseling
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Online dietetic lifestyle counselingBehavioural
The certified clinical dieticians provide individual therapy online and offline according to their patients' needs and based on information supplied via the website "www.livalife.dk". The dietician generates a daily caloric reduction plan of approximately 1600-4800 KJ based on the patients' diet record. The dietary advice will be standardized and follow the dietary guidelines given at "www.livalife.dk" and the Danish Health Administration (Sundhedsstyrelsen).
Usual careBehavioural
Patients randomized to the control group will be offered to receive usual municipal secondary or tertiary preventive offers.
| Study group | Role | What they receive |
|---|---|---|
| Online dietician lifestyle counseling | Active comparator | Online dietetic lifestyle counseling Receives: Behavioral: Online dietetic lifestyle counseling |
| Usual care | Placebo comparator | Usual care Receives: Behavioral: Usual care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Weight change
kg
Measured: Baseline, 6, 12, and 24 months
Secondary outcomes (1)
HbA1C change
mmol/mol
Measured: Baseline, 6, 12 and 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Dec 2018
- Study start16 Apr 2018
- Primary completionApr 2019 (estimated)
- Study completionMar 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for ObesityStudies of the same condition, open and under way.
- More trials run by University of Southern DenmarkThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 340 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Southern Denmark
- Sponsor type
- University, hospital or other
- Collaborators
- Odense University Hospital
- Responsible party
- Principal investigator, Carl J. Brandt, University of Southern Denmark
- Investigators
- Jens Søndergaard, Professor, Study director, University of Southern Denmark
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03788915
- Sponsor's protocol ID
- LIVA USouthernDenmark
- Acronym
- LIVA
- Status last verified
- Dec 2018
- First submitted
- 16 Jun 2015
- Last updated
- 28 Dec 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The study protocol along with the statistical analysis plan (SAP) will be published and all data from the study will be made available in a clinical study report.
Publications
Afshin A, Babalola D, Mclean M, Yu Z, Ma W, Chen CY, Arabi M, Mozaffarian D. Information Technology and Lifestyle: A Systematic Evaluation of Internet and Mobile Interventions for Improving Diet, Physical Activity, Obesity, Tobacco, and Alcohol Use. J Am Heart Assoc. 2016 Aug 31;5(9):e003058. doi: 10.1161/JAHA.115.003058.
PubMed 27581172Johansen MY, MacDonald CS, Hansen KB, Karstoft K, Christensen R, Pedersen M, Hansen LS, Zacho M, Wedell-Neergaard AS, Nielsen ST, Iepsen UW, Langberg H, Vaag AA, Pedersen BK, Ried-Larsen M. Effect of an Intensive Lifestyle Intervention on Glycemic Control in Patients With Type 2 Diabetes: A Randomized Clinical Trial. JAMA. 2017 Aug 15;318(7):637-646. doi: 10.1001/jama.2017.10169.
PubMed 28810024Lean ME, Leslie WS, Barnes AC, Brosnahan N, Thom G, McCombie L, Peters C, Zhyzhneuskaya S, Al-Mrabeh A, Hollingsworth KG, Rodrigues AM, Rehackova L, Adamson AJ, Sniehotta FF, Mathers JC, Ross HM, McIlvenna Y, Stefanetti R, Trenell M, Welsh P, Kean S, Ford I, McConnachie A, Sattar N, Taylor R. Primary care-led weight management for remission of type 2 diabetes (DiRECT): an open-label, cluster-randomised trial. Lancet. 2018 Feb 10;391(10120):541-551. doi: 10.1016/S0140-6736(17)33102-1. Epub 2017 Dec 5.
PubMed 29221645Brandt V, Brandt CJ, Glintborg D, Arendal C, Toubro S, Brandt K. Sustained weight loss during 20 months using a personalized interactive internet based dietician advice program in a general practice setting. International Journal on Advances in Life Sciences [Internet]. 2011; 3(1&2):[23-8 pp.].
Haste A, Adamson AJ, McColl E, Araujo-Soares V, Bell R. Web-Based Weight Loss Intervention for Men With Type 2 Diabetes: Pilot Randomized Controlled Trial. JMIR Diabetes. 2017 Jul 7;2(2):e14. doi: 10.2196/diabetes.7430.
PubMed 30291100Metzendorf MI, Wieland LS, Richter B. Mobile health (m-health) smartphone interventions for adolescents and adults with overweight or obesity. Cochrane Database Syst Rev. 2024 Feb 20;2(2):CD013591. doi: 10.1002/14651858.CD013591.pub2.
PubMed 38375882Hesseldal L, Christensen JR, Olesen TB, Olsen MH, Jakobsen PR, Laursen DH, Lauridsen JT, Nielsen JB, Sondergaard J, Brandt CJ. Long-term Weight Loss in a Primary Care-Anchored eHealth Lifestyle Coaching Program: Randomized Controlled Trial. J Med Internet Res. 2022 Sep 23;24(9):e39741. doi: 10.2196/39741.
PubMed 36149735Imeraj A, Olesen TB, Laursen DH, Sondergaard J, Brandt CJ. Agreement Between Clinically Measured Weight and Self-reported Weight Among Patients With Type 2 Diabetes Through an mHealth Lifestyle Coaching Program in Denmark: Secondary Analysis of a Randomized Controlled Trial. JMIR Form Res. 2022 Sep 14;6(9):e40739. doi: 10.2196/40739.
PubMed 36047606Brandt CJ, Christensen JR, Lauridsen JT, Nielsen JB, Sondergaard J, Sortso C. 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. JMIR Res Protoc. 2020 Jun 25;9(6):e19172. doi: 10.2196/19172.
PubMed 32584260
Study at a glance
From the registry record, last updated by the sponsor on 28 Dec 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Facilitating Weight Loss and Reversing Type 2 Diabetes (T2D) by Means of a Collaborative eHealth Lifestyle Coaching Intervention in Primary Care - A 2-year Randomised Controlled Trial
- ClinicalTrials.gov ID
- NCT03788915
- Acronym / sponsor ID
- LIVA / LIVA USouthernDenmark
- Conditions
- Obesity
- Keywords
- obesity, internet community, treatment; preventive medicine, risk perception, lifestyle counseling
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 340 participants (estimated)
- Lead sponsor
- University of Southern DenmarkUniversity, hospital or other
- Collaborators
- Odense University Hospital
- Study start
- 16 Apr 2018 (actual)
- Primary completion
- Apr 2019 (estimated)
- Study completion
- Mar 2021 (estimated)
- First posted
- 28 Dec 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Background: Systematic reviews conclude that Internet and mobile interventions can significantly change lifestyle in a short time span. The applicant has developed a collaborative eHealth tool (LIVA) that has led to a significant and clinically relevant weight loss of 5.4 to 7.0 kg over 12 to 20 months in primary care settings. The objective of this study is to develop and evaluate a model targeting long-term effects using eHealth coaching assisted by machine learning-generated advice intervention for overweight patients at risk of developing diabetes as well as current type 2 diabetes (T2D) patients in a primary care setting.
Methods and analysis: Randomized controlled trial with 1-year intervention and 1-year maintenance. The primary outcome is weight loss and the secondary outcome is reduced HbA1c level. The study will comprise 340 overweight patients of which 170 will have T2D. Individual data will be obtained from clinical measurements, questionnaire data, registered from the collaborative eHealth tool, as well as other registry data at baseline and at 6, 12 and 24 months. The core of the intervention is the establishment of an empathic relationship and ongoing real-life coaching using the LIVA app (working together with native iOS and Android) and Internet for patients combined with an effective coaching module supported by machine learning methods. The intervention will be compared with usual care.
Detailed description
- Introduction With diseases such as Type 2 diabetes (T2D), adiposity and cardiovascular diseases rapidly increasing, cost effective management is needed (World Health Organization, 2017). Lifestyle improvements such as weight loss, diet and exercise managed in a primary care setting has shown significant impact on reduced risk of cardiovascular disease and reversing T2D for 46-56% of patients with T2D (Lean et al., 2017, Johansen et al., 2017). Based on these findings, weight loss among overweight patients with T2D and patients at risk of developing T2D has important clinical and societal effects. Traditional lifestyle interventions are mostly ineffective and expensive long-term. Internet and mobile technology-based interventions aiming at promoting healthy lifestyles have shown potential for scalability, accessibility, and cost effective use in primary care settings both for overweight patients and T2D patients (Brandt et al, 2011, Haste et al., 2017, Komkova et al 2018). However, there is only sparse knowledge about whether the beneficial effects are long-term (Afshin et al., 2016, Levine et al., 2015). Qualitative research studies comprising patients, general practitioners and the healthcare professionals' perspectives suggest that the establishment of an empathic relationship is key to long-term lifestyle change (Brandt et al., 2018a, 2018b and 2018c). An observational study among 103 diabetes patients using the collaborative eHealth tool (LIVA) demonstrated a clinically significant self-reported weight loss of 4.7 kg among users who had been on the platform for 90+ days (Komkova et al., 2018). Modelling the association between weight reduction and decreased health care costs, the same study estimated that the program will save 2,667€ annually for every patient and be cost effective from a municipal perspective even with only 1 year of implementation data for T2D patients (Mukherjee et al., 2016, Nichols et al., 2016, Bell et al., 2014). In the present study, the model to be tested is a lifestyle intervention using a cost-effective eHealth coaching tool (LIVA) model: following an initial meeting, frequent digital communication is established between health coach and patient, supplemented by machine learning. Machine learning is performed using data automatically gathered from patients' relevant daily lifestyle registrations such as activity level, step count, diet goals fulfilment, sleep, etc. Data will be analysed to predict attrition and outcome. The developed algorithms and models will then be used to increase outcome and decrease dropout by supporting the health coaches with information and guidance how to deliver better coaching directly and indirectly. This intervention will be compared with standard lifestyle interventions in a municipality setting.
- Study objectives and hypothesis The aim of this study is to evaluate the clinical efficacy of the LIVA intervention for overweight patients at risk of developing a chronic disease and overweight type 2 diabetes patients in a primary care setting. We hypothesize that the LIVA intervention will lead to significant weight loss, reduced HbA1C, and reduced need for medication compared to usual care.
- Methods and analysis Study design and setting The study is a randomized controlled trial with one year of intervention and one year of subsequent maintenance, with continued collection of clinical and questionnaire data, where the primary endpoint is weight loss and the secondary endpoint is HbA1c. The intervention is conducted in a real life setting; all data management will be at the Research Unit for General Practice, Department of Public Health, Primary trial sponsor, J.B. Winsløwsvej 9A, 5000 Odense C, Denmark. Recruitment of patients to the study is in 8-10 municipalities within the Region of Southern Denmark and the Capitol Region of Denmark. The study has been registered at https://register.clinicaltrials.gov. On-boarding of patients began in March 2018 and the results are expected to be accessible during 2021. Study population and inclusion criteria Flow of patients is described in figure 1. In each municipality, advertising through social media will be used to recruit eligible patients for municipal preventive offers, fulfilling the inclusion criteria in the study (Table 1). These patients will be contacted by phone and/ or email, and informed about the study and asked to register if they accept the offer to participate. Table 1. Inclusion and exclusion criteria Inclusion criteria: BMI 45 ≥ 30 kg/m2 Aged 18 -70 years Exclusion criteria: Fails to provide informed consent Fails to complete the initial questionnaire or understand Danish No Internet access in own home through computer or smartphone Is pregnant or actively trying to get pregnant Experiences mental or serious life-threatening disease The 340 eligible patients will be invited to an introduction meeting with an healthcare professional with a master's in human nutrition or a clinical dietician. This introductory appointment is scheduled within 7-14 days after the information material is received by the patient. The patient is weighed and measured according to defined clinical indicators. Blood indicators are measured through a finger prick blood sample. The patient is then instructed to use a web link to complete a standard quality of life questionnaire (SF-12) combined with registration of medication intake and questions concerning the patient's sociodemographic characteristics, such as educational level, labour market affiliation, questions concerning work performance, and disease history. Randomization: After patients have successfully completed the web questionnaire, they will be randomized via an automated computer algorithm. This procedure ensures that drop-out characteristics can be recorded. Patients are randomized in a 60:40 sequencing, where 60% of recruited patients are randomized for the intervention group while the remaining 40% will constitute the control group, based on sample size calculations (Please see Sample size calculations, below). Randomization is controlled to ensure that 50% of intervention group and controls will be overweight patients at risk of developing chronic disease and the other 50% of intervention group and controls will be overweight diabetes patients. Intervention: The intervention is summarised in Table 2. Based on results in the applicant's PhD thesis, the core of the intervention is the initial establishment of an empathic relationship with a healthcare professional who is a clinical dietician by profession and has been working with eHealth lifestyle coaching for more than 2 years (referred to as the health coach) and who delivers effective remote and/or digital coaching responsive to the users' own data registrations (Brandt et al, 2018a). Patients in the intervention group receive a login to the eHealth tool at a personal meeting (either physical or digital) during which the health coach introduces the program. Together, the patient and the health coach agree on goals for diet, physical exercise, sleep, etc. (Brandt et al, 2018b). Using the app, patients fill in a daily record as well as their comments, concerns and questions for the health coach, who will have access to patient profiles. The health coach provides individual asynchronous advice according to the patients' needs based on the patients' own real-time registrations (Brandt et al, 2018c); the health coach's advice is supported by artificial intelligence predictions using machine learning (Holzinger A. et al, 2017). The coach advises on goal setting based on the SMART model: Specific, Measurable, Attainable, Relevant, Timely, and according to a predefined guideline structure (Ryan et al, 2009). Asynchronous advice will be provided on a weekly basis during the first 6 months. Subsequently, advice will be given monthly for 6 months. After 12 months, the participant enters maintenance for 12 months, where the coach will still follow patients' registrations and may give four to twelve coaching sessions during that year. Patients can also participate in usual municipally provided preventive medicine offerings, such as "diabetes school", to the extent that the municipalities normally provide such offers. Conventional care (control group): Patients randomized to the control group will be offered standard municipal secondary or tertiary preventive offers. Study endpoints and assessment: Measurement of endpoints (weight, HbA1c etc.) will be conducted by the health coach at baseline and at 6, 12 and 24 months' follow-up. Primary outcome: Weight loss from baseline to 12 months' follow-up. Secondary outcome Reduction in HbA1c for all patients from baseline to 12 months for patients with T2D. Other outcomes The following tertiary outcomes will be measured at baseline and at 12 months:
- Retention rates among users
- Patient waist circumference
- Blood pressure
- Total cholesterol, LDL, HDL and TG
- Patients' quality of life
- Changes in patterns of medication Apart from these outcomes, patient demographic characteristics (gender, age, highest educational level) will be measured at baseline. Analysis strategy Primary analyses will be performed blinded by statisticians and comprise subgroup analyses based on stratification according to patient characteristics and experiences. Statistical significance will be inferred at a two-tailed and p<0.05 significance level. All data will be accessible on the Internet in anonymised form to allow full peer scrutiny and facilitate secondary research. Sample size calculations The primary objective of this study is measurement of changes in body weight and waist circumference. Weight loss in the intervention group and control group will be analysed using appropriate statistical procedures. Based on a recent study by Haste and colleagues evaluating a web-based weight loss intervention among men with diabetes, we expect a weight loss of at least 4.5 kg at 12 months in the intervention group, compared to 2.5 kg in the control group, as well as dropout rates of 39% among the intervention group and 57% among control group at 12 months (Haste et al., 2017). A power calculation based on the standard deviations observed in the study performed by Haste et al shows that to detect a difference in weight loss of 2 kg with a power of 0.95% requires 55 patients in the intervention group and 32 in the control group. To be able to stratify analyses according to overweight patients at risk of developing chronic disease and overweight diabetes patients we will therefore recruit 200 (100+100) in the intervention groups and 140 (70+70) controls.
- Ethics The intervention is not expected to cause any side effects or discomfort except for the ones a change in lifestyle can bring. The only recognized risk is in relation to eating disorders (pre-existing or developing during the study) and the dieticians and nurses involved in the study will specifically look out for indications of this. The Regional Ethical Committee (Regional Videnskabsetisk Komité) have accepted the study in according to Danish law. Participant data will be handled and stored in accordance with rules approved by the Danish Data Inspectorate (Datatilsynet). Permission to handle individual patient data from the national registries will be obtained from patients and the Danish Data Inspectorate. All data will be analysed in anonymous form.
- Publication The results of the studies will be published in international journals in accordance with the Vancouver rules. Furthermore, participants will be invited to a presentation of results at the end of the study and news media will be informed.
- Conflict of Interests Carl J. Brandt has co-founded and works as a medical consultant for LIVA Healthcare A/S, the company that has developed parts of the technical platform and will host some of it during the study. Carl J. Brandt works at the Research Unit for General Practice and CIMT at SDU. Camilla Sortsø is working for LIVA Healthcare A/S, Jens Søndergaard, Jesper B. Nielsen and Jørgen T. Lauridsen have no financial interest in LIVA Healthcare A/S or any other aspects of this study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Online dietician lifestyle counseling | Active comparator | Behavioral: Online dietetic lifestyle counselingOnline dietetic lifestyle counseling |
| Usual care | Placebo comparator | Behavioral: Usual careUsual care |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- BMI ≥ 30 kg/m2 and < 45 kg/m2
- Aged 18 -70 years
Key exclusion criteria (5 listed)
- Fails to provide informed consent
- Fails to complete the initial questionnaire
- No Internet access in own home through computer or smartphone
- Is pregnant or actively trying to get pregnant
- Experiences serious or life-threatening disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Online dietetic lifestyle counselingThe certified clinical dieticians provide individual therapy online and offline according to their patients' needs and based on information supplied via the website "www.livalife.dk". The dietician generates a daily caloric reduction plan of approximately 1600-4800 KJ based on the patients' diet record. The dietary advice will be standardized and follow the dietary guidelines given at "www.livalife.dk" and the Danish Health Administration (Sundhedsstyrelsen). | Behavioural | Online dietician lifestyle counseling |
| Usual carePatients randomized to the control group will be offered to receive usual municipal secondary or tertiary preventive offers. | Behavioural | Usual care |
Primary outcome
Weight change
Time frame: Baseline, 6, 12, and 24 months
kg
1 secondary outcome
HbA1C change
Time frame: Baseline, 6, 12 and 24 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Dec 2018.
- Background: PubMed 27581172Afshin A, Babalola D, Mclean M, Yu Z, Ma W, Chen CY, Arabi M, Mozaffarian D. Information Technology and Lifestyle: A Systematic Evaluation of Internet and Mobile Interventions for Improving Diet, Physical Activity, Obesity, Tobacco, and Alcohol Use. J Am Heart Assoc. 2016 Aug 31;5(9):e003058. doi: 10.1161/JAHA.115.003058.
- Background: PubMed 28810024Johansen MY, MacDonald CS, Hansen KB, Karstoft K, Christensen R, Pedersen M, Hansen LS, Zacho M, Wedell-Neergaard AS, Nielsen ST, Iepsen UW, Langberg H, Vaag AA, Pedersen BK, Ried-Larsen M. Effect of an Intensive Lifestyle Intervention on Glycemic Control in Patients With Type 2 Diabetes: A Randomized Clinical Trial. JAMA. 2017 Aug 15;318(7):637-646. doi: 10.1001/jama.2017.10169.
- Background: PubMed 29221645Lean ME, Leslie WS, Barnes AC, Brosnahan N, Thom G, McCombie L, Peters C, Zhyzhneuskaya S, Al-Mrabeh A, Hollingsworth KG, Rodrigues AM, Rehackova L, Adamson AJ, Sniehotta FF, Mathers JC, Ross HM, McIlvenna Y, Stefanetti R, Trenell M, Welsh P, Kean S, Ford I, McConnachie A, Sattar N, Taylor R. Primary care-led weight management for remission of type 2 diabetes (DiRECT): an open-label, cluster-randomised trial. Lancet. 2018 Feb 10;391(10120):541-551. doi: 10.1016/S0140-6736(17)33102-1. Epub 2017 Dec 5.
- BackgroundBrandt V, Brandt CJ, Glintborg D, Arendal C, Toubro S, Brandt K. Sustained weight loss during 20 months using a personalized interactive internet based dietician advice program in a general practice setting. International Journal on Advances in Life Sciences [Internet]. 2011; 3(1&2):[23-8 pp.].
- Background: PubMed 30291100Haste A, Adamson AJ, McColl E, Araujo-Soares V, Bell R. Web-Based Weight Loss Intervention for Men With Type 2 Diabetes: Pilot Randomized Controlled Trial. JMIR Diabetes. 2017 Jul 7;2(2):e14. doi: 10.2196/diabetes.7430.
- Derived from this study: PubMed 38375882Metzendorf MI, Wieland LS, Richter B. Mobile health (m-health) smartphone interventions for adolescents and adults with overweight or obesity. Cochrane Database Syst Rev. 2024 Feb 20;2(2):CD013591. doi: 10.1002/14651858.CD013591.pub2.
- Derived from this study: PubMed 36149735Hesseldal L, Christensen JR, Olesen TB, Olsen MH, Jakobsen PR, Laursen DH, Lauridsen JT, Nielsen JB, Sondergaard J, Brandt CJ. Long-term Weight Loss in a Primary Care-Anchored eHealth Lifestyle Coaching Program: Randomized Controlled Trial. J Med Internet Res. 2022 Sep 23;24(9):e39741. doi: 10.2196/39741.
- Derived from this study: PubMed 36047606Imeraj A, Olesen TB, Laursen DH, Sondergaard J, Brandt CJ. Agreement Between Clinically Measured Weight and Self-reported Weight Among Patients With Type 2 Diabetes Through an mHealth Lifestyle Coaching Program in Denmark: Secondary Analysis of a Randomized Controlled Trial. JMIR Form Res. 2022 Sep 14;6(9):e40739. doi: 10.2196/40739.
- Derived from this study: PubMed 32584260Brandt CJ, Christensen JR, Lauridsen JT, Nielsen JB, Sondergaard J, Sortso C. 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. JMIR Res Protoc. 2020 Jun 25;9(6):e19172. doi: 10.2196/19172.
- Liva Healthcare Collaborative eHealth solutionLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. The study protocol along with the statistical analysis plan (SAP) will be published and all data from the study will be made available in a clinical study report.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Research Unit for General Practice, Department for Public Health, University of Southern Denmark
Odense, Denmark
Jens Søndergaard, Professor study director
University of Southern Denmark
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Online dietetic lifestyle counseling in people with Obesity, run by University of Southern Denmark at 2 sites in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 28 Dec 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Weight change (time frame: Baseline, 6, 12, and 24 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03788915, which also lists 9 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Dec 2018; AzTrials last refreshed its copy on 4 Nov 2026.