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B-slim, a Multi-source Digital Super Coach for Sustainable Weight Loss

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ClinicalTrials.gov Identifier: NCT02595671
Recruitment Status : Completed
First Posted : November 3, 2015
Last Update Posted : February 8, 2019
Sponsor:
Collaborators:
KU Leuven
iMinds
Brand New Health
Yorbody
Delhaize
Information provided by (Responsible Party):
Christophe Matthys, PhD, Universitaire Ziekenhuizen Leuven

Tracking Information
First Submitted Date  ICMJE June 18, 2015
First Posted Date  ICMJE November 3, 2015
Last Update Posted Date February 8, 2019
Study Start Date  ICMJE October 2015
Actual Primary Completion Date January 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 2, 2017)
Weight Loss (Omron Weight Balance) [ Time Frame: 12 weeks ]
Weight loss measured pre & post intervenion
Original Primary Outcome Measures  ICMJE
 (submitted: November 2, 2015)
Weight Loss (Omron Weight Balance) [ Time Frame: 12 weeks ]
Change History Complete list of historical versions of study NCT02595671 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: November 3, 2015)
  • Physical Activity - self evaluated [ Time Frame: 12 weeks ]
    Physical activity measured by International Physical Activity Questionnaire
  • Physical Activity - objective measurement [ Time Frame: 12 weeks ]
    Physical activity measured by ActiGraph
  • Food Litteracy [ Time Frame: 12 weeks ]
    Food Litteracy measured by questionnaire
  • Dietary Pattern [ Time Frame: 12 weeks ]
    Dietary pattern measured by the use of a Food Frequency Questionnaire
  • Body Composition - BIA [ Time Frame: 12 weeks ]
    Using Bio-impediance Assessment to determine the fat and fatfree mass
  • Body Composition - 3D Scan [ Time Frame: 12 weeks ]
    A 3D-scan will be used to evaluate phenotypic changes
  • Body Composition - Waist [ Time Frame: 12 weeks ]
    Waist circumference measurement
  • Physical fitness [ Time Frame: 12 weeks ]
    Use of the 6 minute walking test to evaluate the level of fitness of the participants
  • Motivation [ Time Frame: 12 weeks ]
    Motivation to change lifestyle by use of a questionnaire
  • Social Support [ Time Frame: 12 weeks ]
    social support will be measured by a questionnaire
  • Demographic factors [ Time Frame: 12 weeks ]
    demographic factors will be measured by a questionnaire
  • Program adherence (24h food recall, compliance food pictures) [ Time Frame: 12 weeks ]
    Adherence to the prescribed physical activity plan and dietary pattern
  • Shopping behavior [ Time Frame: 12 weeks ]
    Shopping behavior (and potential changes) will be measured by use of the grocery fidelty card
Original Secondary Outcome Measures  ICMJE
 (submitted: November 2, 2015)
  • Physical Activity - self evaluated [ Time Frame: 12 weeks ]
    Physical activity measured by IPAQ
  • Physical Activity - objective measurement [ Time Frame: 12 weeks ]
    Physical activity measured by ActiGraph
  • Food Litteracy [ Time Frame: 12 weeks ]
    Food Litteracy measured by questionnaire
  • Dietary Pattern [ Time Frame: 12 weeks ]
    Dietary pattern measured by the use of a Food Frequency Questionnaire
  • Body Composition - BIA [ Time Frame: 12 weeks ]
    Using Bio-impediance Assessment to determine the fat and fatfree mass
  • Body Composition - 3D Scan [ Time Frame: 12 weeks ]
    A 3D-scan will be used to evaluate phenotypic changes
  • Body Composition - Waist [ Time Frame: 12 weeks ]
    Waist circumference measurement
  • Physical fitness [ Time Frame: 12 weeks ]
    Use of the 6 minute walking test to evaluate the level of fitness of the participants
  • Motivation [ Time Frame: 12 weeks ]
    Motivation to change lifestyle by use of a questionnaire
  • Social Support [ Time Frame: 12 weeks ]
    social support will be measured by a questionnaire
  • Demographic factors [ Time Frame: 12 weeks ]
    demographic factors will be measured by a questionnaire
  • Program adherence (24h food recall, compliance food pictures) [ Time Frame: 12 weeks ]
    Adherence to the prescribed physical activity plan and dietary pattern
  • Shopping behavior [ Time Frame: 12 weeks ]
    Shopping behavior (and potential changes) will be measured by use of the grocery fidelty card
Current Other Pre-specified Outcome Measures
 (submitted: November 2, 2015)
The usability experience [ Time Frame: 3 months ]
Usability and overall user experience of the Super Coach application
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title  ICMJE B-slim, a Multi-source Digital Super Coach for Sustainable Weight Loss
Official Title  ICMJE B-slim, a Multi-source Digital Super Coach for Sustainable Weight Loss
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.
Detailed Description

The purpose of this study is to carry out a field trial to evaluate the effectiveness of the b-SLIM digital Super Coach in a convenient sample of overweight and obese adults. The effectiveness will be evaluated at the individual level by means of a randomized trial. By combining or not combining the use of the b-SLIM digital Super Coach with a conventional physical activity and nutrition coaching, the effectiveness of the Super Coach of the (user-driven) 'Super Coach' compared to a conventional face to face weight loss program can be determined. Outcomes will be measured at the level of health behavior (i.e., physical activity and nutrition), body composition, physical fitness, psychosocial factors (e.g., motivation) and program adherence. The field trial will take place in Leuven (Belgium).

This study can be seen as a pilot trial. The central hypothesis of this field trial is that using the multi-source b-SLIM digital Super Coach will support and assist overweight and obese adults to change their health behavior (i.e., physical activity and nutrition) and to lose body weight by improving their self-control, self-determined motivation and attitude towards regular physical activity and healthy diet. The investigators will check if the Super Coach can be a valuable alternative for a conventional physical activity and nutrition coaching.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Supportive Care
Condition  ICMJE Obesity
Intervention  ICMJE
  • Other: Digital Super Coach
    Receive Digital Super Coach during 12 weeks
  • Other: Conventional face to face PA & dietitian
    Receive 7 face-to-face contacts (dietary and physical activity advice)
  • Other: Digital Super Coach + minimal coaching
    Receive 3 face-to-face contacts (dietary and physical activity advice)
  • Other: Waiting Group
    Receive Digital Super Coach during 12 weeks, after 12 weeks of no treatment
Study Arms  ICMJE
  • Active Comparator: Waiting Group
    Patients 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.
    Intervention: Other: Waiting Group
  • Active Comparator: Conventional face to face PA & dietitian
    Participants 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.
    Intervention: Other: Conventional face to face PA & dietitian
  • Active Comparator: Digital Super Coach
    Only receive coaching via digital super coach.
    Intervention: Other: Digital Super Coach
  • Active Comparator: Digital Super Coach + minimal coaching
    Receive digital super coach and only have a few appointments with a physical activity coach and a dietitian.
    Interventions:
    • Other: Digital Super Coach
    • Other: Digital Super Coach + minimal coaching
Publications * Hurkmans 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. Erratum in: JMIR Mhealth Uhealth. 2018 Mar 15;6(3):e10159.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: May 2, 2017)
120
Original Estimated Enrollment  ICMJE
 (submitted: November 2, 2015)
160
Actual Study Completion Date  ICMJE April 2016
Actual Primary Completion Date January 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Belgium
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02595671
Other Study ID Numbers  ICMJE S57538
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Plan Description: IPD will be discussed in the next steering committee
Responsible Party Christophe Matthys, PhD, Universitaire Ziekenhuizen Leuven
Study Sponsor  ICMJE Universitaire Ziekenhuizen Leuven
Collaborators  ICMJE
  • KU Leuven
  • iMinds
  • Brand New Health
  • Yorbody
  • Delhaize
Investigators  ICMJE
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
PRS Account Universitaire Ziekenhuizen Leuven
Verification Date February 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP