ObesityNCT02595671

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

A study testing Digital Super Coach, Conventional face to face PA & dietitian and Digital Super Coach + minimal coaching in people with Obesity, run by Universitaire Ziekenhuizen KU Leuven at 1 site in Belgium.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial 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. Read more about this study

Who is it for?: Ages 18 to 65 yearsHealthy volunteers can take part
Conditions the study is for: Obesity
What is being tested?: Digital Super Coach, Conventional face to face PA & dietitian and Digital Super Coach + minimal coaching
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 120 participants
Where: 1 siteBelgium
Study dates: Oct 2015to Apr 2016
Phase: Interventional
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 65 years
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

Belgium1 site

University Hospital Leuven
Leuven, Vlaams Brabant, 3000

Other trials in Belgium

About this study

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.

Read the 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.

Conditions: Obesity
Being tested: Digital Super Coach, Conventional face to face PA & dietitian, Digital Super Coach + minimal coaching, Waiting Group
Keywords: Digital coaching, Sustainable weight loss, Self-determination theory, Obesity, Overweight, Diet, Physical activity
Medical subject headings: Obesity, Overweight, Motor Activity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Digital Super CoachOther
Receive Digital Super Coach during 12 weeks
Conventional face to face PA & dietitianOther
Receive 7 face-to-face contacts (dietary and physical activity advice)
Digital Super Coach + minimal coachingOther
Receive 3 face-to-face contacts (dietary and physical activity advice)
Waiting GroupOther
Receive Digital Super Coach during 12 weeks, after 12 weeks of no treatment

Study groups in NCT02595671
Study group	Role	What they receive
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. Receives: Other: Waiting Group
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. Receives: Other: Conventional face to face PA & dietitian
Digital Super Coach	Active comparator	Only receive coaching via digital super coach. Receives: Other: Digital Super Coach
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. Receives: Other: Digital Super Coach; Other: Digital Super Coach + minimal coaching

What is being measured

The primary outcome is the main question the study is designed to answer.

Weight Loss (Omron Weight Balance)
Weight loss measured pre \& post intervenion
Measured: 12 weeks

Secondary outcomes (13)

Physical Activity - self evaluated
Physical activity measured by International Physical Activity Questionnaire
Measured: 12 weeks
Physical Activity - objective measurement
Physical activity measured by ActiGraph
Measured: 12 weeks
Food Litteracy
Food Litteracy measured by questionnaire
Measured: 12 weeks
Dietary Pattern
Dietary pattern measured by the use of a Food Frequency Questionnaire
Measured: 12 weeks
Body Composition - BIA
Using Bio-impediance Assessment to determine the fat and fatfree mass
Measured: 12 weeks
Body Composition - 3D Scan
A 3D-scan will be used to evaluate phenotypic changes
Measured: 12 weeks
Body Composition - Waist
Waist circumference measurement
Measured: 12 weeks
Physical fitness
Use of the 6 minute walking test to evaluate the level of fitness of the participants
Measured: 12 weeks
Motivation
Motivation to change lifestyle by use of a questionnaire
Measured: 12 weeks
Social Support
social support will be measured by a questionnaire
Measured: 12 weeks
Demographic factors
demographic factors will be measured by a questionnaire
Measured: 12 weeks
Program adherence (24h food recall, compliance food pictures)
Adherence to the prescribed physical activity plan and dietary pattern
Measured: 12 weeks
Shopping behavior
Shopping behavior (and potential changes) will be measured by use of the grocery fidelty card
Measured: 12 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Oct 2015Apr 2016

First posted3 Nov 2015 (estimated)
Study startOct 2015
Primary completionJan 2016
Study completionApr 2016

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (2)Papers the sponsor has linked to this study.
Other trials for ObesityStudies of the same condition, open and under way.
More trials run by Universitaire Ziekenhuizen KU LeuvenThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Supportive care
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind
Who is masked: Participant
Enrolment: 120 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02595671
Sponsor's protocol ID: S57538
Status last verified: Feb 2019
First submitted: 18 Jun 2015
Last updated: 8 Feb 2019
Results posted: No
Data monitoring committee: Yes
Individual data sharing: Undecided: IPD will be discussed in the next steering committee

Publications

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.
PubMed 38375882
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.
PubMed 29326093

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Active, not recruiting
Comparing 150cm OAGB With 150cm Biliopancreatic Limb RYGB. A Non-inferiority Trial
Bariatric Surgery Candidate, Obesity
RecruitingPhase 3
Maridebart Cafraglutide in Heart Failure With Preserved or Mildly Reduced Ejection Fraction and Obesity
Heart Failure With Preserved Ejection Fraction, Heart Failure With Mildly Reduced Ejection Fraction
Not yet recruitingPhase 1
A Study of Safety of SUN-0864 and How it is Processed by and Affects the Body in Healthy Adults and Healthy Adults Who Are Overweight or Obese.
Healthy Participants
Not yet recruiting
Evaluation of the Axomove Therapy Medical Device to Facilitate Adapted Physical Activity for Patients With Obesity
Obese Adults
Not yet recruiting
Efficacy, Safety, and Treatment Satisfaction of Once-Weekly Tirzepatide in Obese Type 2 Diabetic Patients
Type 2 Diabetes Mellitus (T2DM), Obesity, Overweight

All Obesity trials

Study at a glance

From the registry record, last updated by the sponsor on 8 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: B-slim, a Multi-source Digital Super Coach for Sustainable Weight Loss
ClinicalTrials.gov ID: NCT02595671
Acronym / sponsor ID: S57538
Conditions: Obesity
Keywords: Digital coaching, Sustainable weight loss, Self-determination theory, Obesity, Overweight, Diet, Physical activity
Study type: Interventional
Recruitment status: Completed
Enrolment: 120 participants (actual)
Lead sponsor: Universitaire Ziekenhuizen KU LeuvenUniversity, hospital or other
Collaborators: KU Leuven, iMinds, Brand New Health, Yorbody, Delhaize
Study start: Oct 2015
Primary completion: Jan 2016 (actual)
Study completion: Apr 2016 (actual)
First posted: 3 Nov 2015 (estimated)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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

Study design

Primary purpose: Supportive care
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (participant)
Number of arms: 4

Arm	Type	Receives
Waiting Group	Active comparator	Other: Waiting GroupPatients 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	Other: Conventional face to face PA & dietitianParticipants 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	Other: Digital Super CoachOnly receive coaching via digital super coach.
Digital Super Coach + minimal coaching	Active comparator	Other: Digital Super Coach, Other: Digital Super Coach + minimal coachingReceive digital super coach and only have a few appointments with a physical activity coach and a dietitian.

Who may qualify

Ages: 18 to 65 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (5 listed)

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

Key exclusion criteria (8 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Digital Super CoachReceive Digital Super Coach during 12 weeks	Other	Digital Super Coach, Digital Super Coach + minimal coaching
Conventional face to face PA & dietitianReceive 7 face-to-face contacts (dietary and physical activity advice)	Other	Conventional face to face PA & dietitian
Digital Super Coach + minimal coachingReceive 3 face-to-face contacts (dietary and physical activity advice)	Other	Digital Super Coach + minimal coaching
Waiting GroupReceive Digital Super Coach during 12 weeks, after 12 weeks of no treatment	Other	Waiting Group

Primary outcome

Weight Loss (Omron Weight Balance)
Time frame: 12 weeks
Weight loss measured pre \& post intervenion

13 secondary outcomes

Physical Activity - self evaluated
Time frame: 12 weeks
Physical Activity - objective measurement
Time frame: 12 weeks
Food Litteracy
Time frame: 12 weeks
Dietary Pattern
Time frame: 12 weeks
Body Composition - BIA
Time frame: 12 weeks
Body Composition - 3D Scan
Time frame: 12 weeks
Body Composition - Waist
Time frame: 12 weeks
Physical fitness
Time frame: 12 weeks
Motivation
Time frame: 12 weeks
Social Support
Time frame: 12 weeks
Demographic factors
Time frame: 12 weeks
Program adherence (24h food recall, compliance food pictures)
Time frame: 12 weeks
Shopping behavior
Time frame: 12 weeks

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 8 Feb 2019.
Derived from this study: PubMed 38375882Metzendorf 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.
Derived from this study: PubMed 29326093Hurkmans 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.
Individual participant dataSharing planned: Undecided. IPD will be discussed in the next steering committee

Related trials for Obesity

Active, not recruiting
Comparing 150cm OAGB With 150cm Biliopancreatic Limb RYGB. A Non-inferiority Trial
Bariatric Surgery Candidate, Obesity
RecruitingPhase 3
Maridebart Cafraglutide in Heart Failure With Preserved or Mildly Reduced Ejection Fraction and Obesity
Heart Failure With Preserved Ejection Fraction, Heart Failure With Mildly Reduced Ejection Fraction
Not yet recruitingPhase 1
A Study of Safety of SUN-0864 and How it is Processed by and Affects the Body in Healthy Adults and Healthy Adults Who Are Overweight or Obese.
Healthy Participants
Not yet recruiting
Evaluation of the Axomove Therapy Medical Device to Facilitate Adapted Physical Activity for Patients With Obesity
Obese Adults
Not yet recruiting
Efficacy, Safety, and Treatment Satisfaction of Once-Weekly Tirzepatide in Obese Type 2 Diabetic Patients
Type 2 Diabetes Mellitus (T2DM), Obesity, Overweight

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Christophe Matthys, Prof. Dr. study chair

Department of Clinical and Experimental Medicine, KU Leuven

Jan Seghers, Prof. Dr. study chair

Physical Activity, Sports & Health (PASH) Research Group

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 8 Feb 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Weight Loss (Omron Weight Balance) (time frame: 12 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02595671, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Feb 2019.