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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 : May 5, 2017
Sponsor:
Collaborators:
Katholieke Universiteit Leuven
iMinds
Brand New Health
Yorbody
Delhaize
Information provided by (Responsible Party):
Christophe Matthys, PhD, Universitaire Ziekenhuizen Leuven

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.

Condition or disease Intervention/treatment Phase
Obesity Other: Digital Super Coach Other: Conventional face to face PA & dietitian Other: Digital Super Coach + minimal coaching Other: Waiting Group Not Applicable

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 : Interventional  (Clinical Trial)
Actual Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Supportive Care
Official Title: B-slim, a Multi-source Digital Super Coach for Sustainable Weight Loss
Study Start Date : September 2015
Actual Primary Completion Date : January 2016
Actual Study Completion Date : April 2016

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
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.
Other: Waiting Group
Receive Digital Super Coach during 12 weeks, after 12 weeks of no treatment
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.
Other: Conventional face to face PA & dietitian
Receive 7 face-to-face contacts (dietary and physical activity advice)
Active Comparator: Digital Super Coach
Only receive coaching via digital super coach.
Other: Digital Super Coach
Receive Digital Super Coach during 12 weeks
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.
Other: Digital Super Coach
Receive Digital Super Coach during 12 weeks
Other: Digital Super Coach + minimal coaching
Receive 3 face-to-face contacts (dietary and physical activity advice)



Primary Outcome Measures :
  1. Weight Loss (Omron Weight Balance) [ Time Frame: 12 weeks ]
    Weight loss measured pre & post intervenion


Secondary Outcome Measures :
  1. Physical Activity - self evaluated [ Time Frame: 12 weeks ]
    Physical activity measured by International Physical Activity Questionnaire

  2. Physical Activity - objective measurement [ Time Frame: 12 weeks ]
    Physical activity measured by ActiGraph

  3. Food Litteracy [ Time Frame: 12 weeks ]
    Food Litteracy measured by questionnaire

  4. Dietary Pattern [ Time Frame: 12 weeks ]
    Dietary pattern measured by the use of a Food Frequency Questionnaire

  5. Body Composition - BIA [ Time Frame: 12 weeks ]
    Using Bio-impediance Assessment to determine the fat and fatfree mass

  6. Body Composition - 3D Scan [ Time Frame: 12 weeks ]
    A 3D-scan will be used to evaluate phenotypic changes

  7. Body Composition - Waist [ Time Frame: 12 weeks ]
    Waist circumference measurement

  8. Physical fitness [ Time Frame: 12 weeks ]
    Use of the 6 minute walking test to evaluate the level of fitness of the participants

  9. Motivation [ Time Frame: 12 weeks ]
    Motivation to change lifestyle by use of a questionnaire

  10. Social Support [ Time Frame: 12 weeks ]
    social support will be measured by a questionnaire

  11. Demographic factors [ Time Frame: 12 weeks ]
    demographic factors will be measured by a questionnaire

  12. Program adherence (24h food recall, compliance food pictures) [ Time Frame: 12 weeks ]
    Adherence to the prescribed physical activity plan and dietary pattern

  13. Shopping behavior [ Time Frame: 12 weeks ]
    Shopping behavior (and potential changes) will be measured by use of the grocery fidelty card


Other Outcome Measures:
  1. The usability experience [ Time Frame: 3 months ]
    Usability and overall user experience of the Super Coach application



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

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): NCT02595671


Locations
Belgium
University Hospital Leuven
Leuven, Vlaams Brabant, Belgium, 3000
Sponsors and Collaborators
Universitaire Ziekenhuizen Leuven
Katholieke Universiteit Leuven
iMinds
Brand New Health
Yorbody
Delhaize
Investigators
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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Christophe Matthys, PhD, Prof. Christophe Matthys, Universitaire Ziekenhuizen Leuven
ClinicalTrials.gov Identifier: NCT02595671     History of Changes
Other Study ID Numbers: S57538
First Posted: November 3, 2015    Key Record Dates
Last Update Posted: May 5, 2017
Last Verified: May 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: IPD will be discussed in the next steering committee

Keywords provided by Christophe Matthys, PhD, Universitaire Ziekenhuizen Leuven:
Digital coaching
Sustainable weight loss
Self-determination theory
Obesity
Overweight
Diet
Physical activity

Additional relevant MeSH terms:
Weight Loss
Body Weight Changes
Body Weight
Signs and Symptoms