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| Name | Class |
|---|---|
| KU Leuven | OTHER |
| iMinds | INDUSTRY |
| Brand New Health | INDUSTRY |
| Yorbody |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Waiting Group | Active Comparator | 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. |
|
| Conventional face to face PA & dietitian | Active Comparator | 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. |
|
| Digital Super Coach | Active Comparator | Only receive coaching via digital super coach. |
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| Digital Super Coach + minimal coaching | Active Comparator | Receive digital super coach and only have a few appointments with a physical activity coach and a dietitian. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Digital Super Coach | Other | Receive Digital Super Coach during 12 weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| Weight Loss (Omron Weight Balance) | Weight loss measured pre & post intervenion | 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Physical Activity - self evaluated | Physical activity measured by International Physical Activity Questionnaire | 12 weeks |
| Physical Activity - objective measurement | Physical activity measured by ActiGraph |
| Measure | Description | Time Frame |
|---|---|---|
| The usability experience | Usability and overall user experience of the Super Coach application | 3 months |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| 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 Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Hospital Leuven | Leuven | Vlaams Brabant | 3000 | Belgium |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38375882 | Derived | 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. | |
| 29326093 | Derived | 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. |
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IPD will be discussed in the next steering committee
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| ID | Term |
|---|---|
| D009765 | Obesity |
| D050177 | Overweight |
| D009043 | Motor Activity |
| ID | Term |
|---|---|
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
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| ID | Term |
|---|---|
| D064686 | Nutritionists |
| ID | Term |
|---|---|
| D006282 | Health Personnel |
| D005159 | Health Care Facilities Workforce and Services |
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| Delhaize | INDUSTRY |
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| Conventional face to face PA & dietitian | Other | Receive 7 face-to-face contacts (dietary and physical activity advice) |
|
| Digital Super Coach + minimal coaching | Other | Receive 3 face-to-face contacts (dietary and physical activity advice) |
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| Waiting Group | Other | Receive Digital Super Coach during 12 weeks, after 12 weeks of no treatment |
|
| 12 weeks |
| Food Litteracy | Food Litteracy measured by questionnaire | 12 weeks |
| Dietary Pattern | Dietary pattern measured by the use of a Food Frequency Questionnaire | 12 weeks |
| Body Composition - BIA | Using Bio-impediance Assessment to determine the fat and fatfree mass | 12 weeks |
| Body Composition - 3D Scan | A 3D-scan will be used to evaluate phenotypic changes | 12 weeks |
| Body Composition - Waist | Waist circumference measurement | 12 weeks |
| Physical fitness | Use of the 6 minute walking test to evaluate the level of fitness of the participants | 12 weeks |
| Motivation | Motivation to change lifestyle by use of a questionnaire | 12 weeks |
| Social Support | social support will be measured by a questionnaire | 12 weeks |
| Demographic factors | demographic factors will be measured by a questionnaire | 12 weeks |
| Program adherence (24h food recall, compliance food pictures) | Adherence to the prescribed physical activity plan and dietary pattern | 12 weeks |
| Shopping behavior | Shopping behavior (and potential changes) will be measured by use of the grocery fidelty card | 12 weeks |
| D012816 |
| Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001519 | Behavior |