B-slim, a Multi-source Digital Super Coach for Sustainable Weight Loss
1 other identifier
interventional
120
1 country
1
Brief Summary
The purpose of this study is to carry out a field trial to evaluate the effectiveness and added value of the b-SLIM digital Super Coach in a convenient sample of overweight and obese adults.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable obesity
Started Oct 2015
Shorter than P25 for not_applicable obesity
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 18, 2015
CompletedStudy Start
First participant enrolled
October 1, 2015
CompletedFirst Posted
Study publicly available on registry
November 3, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2016
CompletedFebruary 8, 2019
February 1, 2019
3 months
June 18, 2015
February 6, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Weight Loss (Omron Weight Balance)
Weight loss measured pre \& post intervenion
12 weeks
Secondary Outcomes (13)
Physical Activity - self evaluated
12 weeks
Physical Activity - objective measurement
12 weeks
Food Litteracy
12 weeks
Dietary Pattern
12 weeks
Body Composition - BIA
12 weeks
- +8 more secondary outcomes
Other Outcomes (1)
The usability experience
3 months
Study Arms (4)
Waiting Group
ACTIVE COMPARATORPatients will not receive a treatment during the actual intervention. This group will receive the digital super coach as an incentive at the end of the trial.
Conventional face to face PA & dietitian
ACTIVE COMPARATORParticipants will receive both dietary and physical activity advice. The advice is provided my medical trained staff (eg. dieticia, physiotherapist) according to a standardised protocol. The number of consultations are respectively three and four for diet and physcial activity.
Digital Super Coach
ACTIVE COMPARATOROnly receive coaching via digital super coach.
Digital Super Coach + minimal coaching
ACTIVE COMPARATORReceive digital super coach and only have a few appointments with a physical activity coach and a dietitian.
Interventions
Receive Digital Super Coach during 12 weeks
Receive 7 face-to-face contacts (dietary and physical activity advice)
Receive 3 face-to-face contacts (dietary and physical activity advice)
Receive Digital Super Coach during 12 weeks, after 12 weeks of no treatment
Eligibility Criteria
You may qualify if:
- Living in the region of Leuven
- Middle-aged (from 18 to 65 years)
- Having a body mass index between 29-34 kg/m²
- Having an e-mail address
- Having a personal computer
You may not qualify if:
- Suffering from a known physical (e.g., orthopedic limitations, stroke, etc.) and/or psychological (e.g., anorexia, bulimia, depression, etc.) disease or co-morbidity
- Intake of any medication with possible impact on body weight, endurance capacity
- Currently treated for diabetes (both Type 1 \& 2).
- No sleepapneu has been determined during the last year.
- Having a history of systematic strength or endurance training (moderate to high intensity training more than once a week) in the year before the beginning of the trial
- Having a history of following a supervised dietary advice in the year before the beginning of the trial
- Having a history of bariatric surgery or any other malabsorption-related disease.
- Pregnancy
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Universitaire Ziekenhuizen KU Leuvenlead
- KU Leuvencollaborator
- iMindscollaborator
- Brand New Healthcollaborator
- Yorbodycollaborator
- Delhaizecollaborator
Study Sites (1)
University Hospital Leuven
Leuven, Vlaams Brabant, 3000, Belgium
Related Publications (2)
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: 38375882DERIVEDHurkmans E, Matthys C, Bogaerts A, Scheys L, Devloo K, Seghers J. Face-to-Face Versus Mobile Versus Blended Weight Loss Program: Randomized Clinical Trial. JMIR Mhealth Uhealth. 2018 Jan 11;6(1):e14. doi: 10.2196/mhealth.7713.
PMID: 29326093DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Christophe Matthys, Prof. Dr.
Department of Clinical and Experimental Medicine, KU Leuven
- STUDY CHAIR
Jan Seghers, Prof. Dr.
Physical Activity, Sports & Health (PASH) Research Group
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Prof. Christophe Matthys
Study Record Dates
First Submitted
June 18, 2015
First Posted
November 3, 2015
Study Start
October 1, 2015
Primary Completion
January 1, 2016
Study Completion
April 1, 2016
Last Updated
February 8, 2019
Record last verified: 2019-02