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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Obesity

Intervention / Treatment
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* Other: Digital Super Coach
* Other: Conventional face to face PA & dietitian
* Other: Digital Super Coach + minimal coaching
* Other: Waiting Group


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Waiting Group<br>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<br>* Receive Digital Super Coach during 12 weeks, after 12 weeks of no treatment<br>|
| Active Comparator: Conventional face to face PA & dietitian<br>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<br>* Receive 7 face-to-face contacts (dietary and physical activity advice)<br>|
| Active Comparator: Digital Super Coach<br>Only receive coaching via digital super coach. | Other: Digital Super Coach<br>* Receive Digital Super Coach during 12 weeks<br>|
| Active Comparator: Digital Super Coach + minimal coaching<br>Receive digital super coach and only have a few appointments with a physical activity coach and a dietitian. | Other: Digital Super Coach<br>* Receive Digital Super Coach during 12 weeks<br>Other: Digital Super Coach + minimal coaching<br>* Receive 3 face-to-face contacts (dietary and physical activity advice)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Weight Loss (Omron Weight Balance) | Weight loss measured pre & post intervenion | 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Digital coaching, Sustainable weight loss, Self-determination theory, Obesity, Overweight, Diet, Physical activity