Clinical trial NCT02595671: B-slim, a Multi-source Digital Super Coach for Sustainable Weight Loss
Official title: B-slim, a Multi-source Digital Super Coach for Sustainable Weight Loss
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity
Keywords: Digital coaching
Sustainable weight loss
Self-determination theory
Obesity
Overweight
Diet
Physical activity
Lead sponsor: Universitaire Ziekenhuizen KU Leuven
Sponsor class: OTHER
Collaborators: name: KU Leuven
name: iMinds
name: Brand New Health
name: Yorbody
name: Delhaize
First posted: 2015-11-03
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility 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

Primary outcomes:
measure: Weight Loss (Omron Weight Balance)
timeFrame: 12 weeks
Secondary outcomes:
measure: Physical Activity - self evaluated
timeFrame: 12 weeks
measure: Physical Activity - objective measurement
timeFrame: 12 weeks
measure: Food Litteracy
timeFrame: 12 weeks
measure: Dietary Pattern
timeFrame: 12 weeks
measure: Body Composition - BIA
timeFrame: 12 weeks
measure: Body Composition - 3D Scan
timeFrame: 12 weeks
measure: Body Composition - Waist
timeFrame: 12 weeks
measure: Physical fitness
timeFrame: 12 weeks
measure: Motivation
timeFrame: 12 weeks
measure: Social Support
timeFrame: 12 weeks
measure: Demographic factors
timeFrame: 12 weeks
measure: Program adherence (24h food recall, compliance food pictures)
timeFrame: 12 weeks
measure: Shopping behavior
timeFrame: 12 weeks
Other outcomes:
measure: The usability experience
timeFrame: 3 months
Locations:
city: Leuven
country: Belgium
facility: University Hospital Leuven
state: Vlaams Brabant
Study officials:
affiliation: Department of Clinical and Experimental Medicine, KU Leuven
name: Christophe Matthys, Prof. Dr.
role: STUDY_CHAIR
affiliation: Physical Activity, Sports & Health (PASH) Research Group
name: Jan Seghers, Prof. Dr.
role: STUDY_CHAIR
References:
citation: 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.