NCT03788915

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
340

participants targeted

Target at P75+ for not_applicable obesity

Timeline
Completed

Started Apr 2018

Typical duration for not_applicable obesity

Geographic Reach
1 country

2 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 16, 2015

Completed
2.8 years until next milestone

Study Start

First participant enrolled

April 16, 2018

Completed
9 months until next milestone

First Posted

Study publicly available on registry

December 28, 2018

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2019

Completed
1.9 years until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2021

Completed
Last Updated

December 28, 2018

Status Verified

December 1, 2018

Enrollment Period

12 months

First QC Date

June 16, 2015

Last Update Submit

December 24, 2018

Conditions

Obesity

Keywords

obesityinternet communitytreatment; preventive medicinerisk perceptionlifestyle counseling

Outcome Measures

Primary Outcomes (1)

  • Weight change

    kg

    Baseline, 6, 12, and 24 months

Secondary Outcomes (1)

  • HbA1C change

    Baseline, 6, 12 and 24 months

Other Outcomes (3)

  • Medicine usage change

    Baseline, 6, 12 and 24 months

  • SF-12 Quality of life change

    Baseline, 6, 12, and 24 months

  • Retention rate change

    Baseline, 6, 12 and 24 months

Study Arms (2)

Online dietician lifestyle counseling

ACTIVE COMPARATOR

Online dietetic lifestyle counseling

Behavioral: Online dietetic lifestyle counseling

Usual care

PLACEBO COMPARATOR

Usual care

Behavioral: Usual care

Interventions

Online dietetic lifestyle counselingBEHAVIORAL

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).

Online dietician lifestyle counseling
Usual careBEHAVIORAL

Patients randomized to the control group will be offered to receive usual municipal secondary or tertiary preventive offers.

Usual care

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Research Unit for General Practice, Department for Public Health, University of Southern Denmark

Odense, Region Syddanmark, Denmark

RECRUITING

Lægehuset i Stenstrup

Stenstrup, 5700, Denmark

RECRUITING

Related Publications (9)

  • 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.

    PMID: 27581172BACKGROUND

  • Johansen 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.

    PMID: 28810024BACKGROUND

  • Lean 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.

    PMID: 29221645BACKGROUND

  • 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.].

    BACKGROUND

  • 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.

    PMID: 30291100BACKGROUND

  • Metzendorf 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.

    PMID: 38375882DERIVED

  • Hesseldal 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.

    PMID: 36149735DERIVED

  • Imeraj 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.

    PMID: 36047606DERIVED

  • Brandt 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.

    PMID: 32584260DERIVED

Related Links

MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Jens Søndergaard, Professor

    University of Southern Denmark

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD, PhD, Principal investigator

Study Record Dates

First Submitted

June 16, 2015

First Posted

December 28, 2018

Study Start

April 16, 2018

Primary Completion

April 1, 2019

Study Completion

March 1, 2021

Last Updated

December 28, 2018

Record last verified: 2018-12

Data Sharing

IPD Sharing
Will share

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.

Shared Documents
STUDY PROTOCOL, SAP, 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

Locations

DK(2)