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
|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|
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|
|Intervention Model:||Parallel Assignment|
|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|
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 weeksOther: Digital Super Coach + minimal coaching
Receive 3 face-to-face contacts (dietary and physical activity advice)
- Weight Loss (Omron Weight Balance) [ Time Frame: 12 weeks ]Weight loss measured pre & post intervenion
- 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
- The usability experience [ Time Frame: 3 months ]Usability and overall user experience of the Super Coach application
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
|University Hospital Leuven|
|Leuven, Vlaams Brabant, Belgium, 3000|
|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|