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Weight Loss and Reversing T2D Through eHealth Coaching (LIVA)

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ClinicalTrials.gov Identifier: NCT03788915
Recruitment Status : Recruiting
First Posted : December 28, 2018
Last Update Posted : December 28, 2018
Sponsor:
Collaborator:
Odense University Hospital
Information provided by (Responsible Party):
Carl J. Brandt, University of Southern Denmark

Brief 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 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.


Condition or disease Intervention/treatment Phase
Obesity Behavioral: Online dietetic lifestyle counseling Behavioral: Usual care Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 340 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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
Actual Study Start Date : April 16, 2018
Estimated Primary Completion Date : April 2019
Estimated Study Completion Date : March 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Online dietician lifestyle counseling
Online dietetic lifestyle counseling
Behavioral: Online dietetic lifestyle counseling
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).

Placebo Comparator: Usual care
Usual care
Behavioral: Usual care
Patients randomized to the control group will be offered to receive usual municipal secondary or tertiary preventive offers.




Primary Outcome Measures :
  1. Weight change [ Time Frame: Baseline, 6, 12, and 24 months ]
    kg


Secondary Outcome Measures :
  1. HbA1C change [ Time Frame: Baseline, 6, 12 and 24 months ]
    mmol/mol


Other Outcome Measures:
  1. Medicine usage change [ Time Frame: Baseline, 6, 12 and 24 months ]
    Registration of medicine usage by healthcare professional

  2. SF-12 Quality of life change [ Time Frame: Baseline, 6, 12, and 24 months ]
    Validated quality of life questionaire SF-12

  3. Retention rate change [ Time Frame: Baseline, 6, 12 and 24 months ]
    How many users are active in the collaborative eHealth tool/a usual care program



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion criteria:

  • BMI ≥ 30 kg/m2 and < 45 kg/m2
  • Aged 18 -70 years

Exclusion criteria:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03788915


Locations
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Denmark
Research Unit for General Practice, Department for Public Health, University of Southern Denmark Recruiting
Odense, Region Of Southern Denmark, Denmark
Contact: Carl J Brandt, MD    +45 2014 1566    cbrandt@health.sdu.dk   
Contact: Jens Søndergaard, PhD    +45 6550 3830    jsoendergaard@health.sdu.dk   
Principal Investigator: Jens Søndergaard, PhD         
Sub-Investigator: Jesper B Nielsen, PhD         
Sub-Investigator: Carl J Brandt, PhD         
Lægehuset i Stenstrup Recruiting
Stenstrup, Denmark, 5700
Contact: Jacob B Madsen, MD    63621015    info@laegehusetistenstrup.dk   
Contact: Cees Stauvenuiter, MD    63621015    info@laegehusetistenstrup.dk   
Principal Investigator: Jacob B Madsen, MD         
Sub-Investigator: Cees Stavenuiter, MD         
Sponsors and Collaborators
University of Southern Denmark
Odense University Hospital
Investigators
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Study Director: Jens Søndergaard, Professor University of Southern Denmark

Additional Information:
Publications:
Brandt 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.].

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Responsible Party: Carl J. Brandt, MD, PhD, Principal investigator, University of Southern Denmark
ClinicalTrials.gov Identifier: NCT03788915     History of Changes
Other Study ID Numbers: LIVA USouthernDenmark
First Posted: December 28, 2018    Key Record Dates
Last Update Posted: December 28, 2018
Last Verified: December 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: 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.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Clinical Study Report (CSR)
Time Frame:

The protocol along with SAP and some of the preliminary results after 6 months will be published within 18 months from start of study.

The clinical study report (CSR) will be published within 12 months of the end of the study.

Access Criteria: Study protocol and SAP will be published in international peer review journals and the CSR will at a minimum be made available via the internet through SDU and Researchgate

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Carl J. Brandt, University of Southern Denmark:
obesity
internet community
treatment; preventive medicine
risk perception
lifestyle counseling
Additional relevant MeSH terms:
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Weight Loss
Body Weight
Signs and Symptoms
Body Weight Changes