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

Primary Purpose

Obesity

Status
Completed
Phase
Not Applicable
Locations
Belgium
Study Type
Interventional
Intervention
Digital Super Coach
Conventional face to face PA & dietitian
Digital Super Coach + minimal coaching
Waiting Group
Sponsored by
Universitaire Ziekenhuizen KU Leuven
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Obesity focused on measuring Digital coaching, Sustainable weight loss, Self-determination theory, Obesity, Overweight, Diet, Physical activity

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • University Hospital Leuven

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Active Comparator

Active Comparator

Active Comparator

Active Comparator

Arm Label

Waiting Group

Conventional face to face PA & dietitian

Digital Super Coach

Digital Super Coach + minimal coaching

Arm Description

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.

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.

Only receive coaching via digital super coach.

Receive digital super coach and only have a few appointments with a physical activity coach and a dietitian.

Outcomes

Primary Outcome Measures

Weight Loss (Omron Weight Balance)
Weight loss measured pre & post intervenion

Secondary Outcome Measures

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

Full Information

First Posted
June 18, 2015
Last Updated
February 6, 2019
Sponsor
Universitaire Ziekenhuizen KU Leuven
Collaborators
KU Leuven, iMinds, Brand New Health, Yorbody, Delhaize
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1. Study Identification

Unique Protocol Identification Number
NCT02595671
Brief Title
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

2. Study Status

Record Verification Date
February 2019
Overall Recruitment Status
Completed
Study Start Date
October 2015 (undefined)
Primary Completion Date
January 2016 (Actual)
Study Completion Date
April 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universitaire Ziekenhuizen KU Leuven
Collaborators
KU Leuven, iMinds, Brand New Health, Yorbody, Delhaize

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity
Keywords
Digital coaching, Sustainable weight loss, Self-determination theory, Obesity, Overweight, Diet, Physical activity

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
120 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Waiting Group
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Conventional face to face PA & dietitian
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Digital Super Coach
Arm Type
Active Comparator
Arm Description
Only receive coaching via digital super coach.
Arm Title
Digital Super Coach + minimal coaching
Arm Type
Active Comparator
Arm Description
Receive digital super coach and only have a few appointments with a physical activity coach and a dietitian.
Intervention Type
Other
Intervention Name(s)
Digital Super Coach
Intervention Description
Receive Digital Super Coach during 12 weeks
Intervention Type
Other
Intervention Name(s)
Conventional face to face PA & dietitian
Intervention Description
Receive 7 face-to-face contacts (dietary and physical activity advice)
Intervention Type
Other
Intervention Name(s)
Digital Super Coach + minimal coaching
Intervention Description
Receive 3 face-to-face contacts (dietary and physical activity advice)
Intervention Type
Other
Intervention Name(s)
Waiting Group
Intervention Description
Receive Digital Super Coach during 12 weeks, after 12 weeks of no treatment
Primary Outcome Measure Information:
Title
Weight Loss (Omron Weight Balance)
Description
Weight loss measured pre & post intervenion
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
Physical Activity - self evaluated
Description
Physical activity measured by International Physical Activity Questionnaire
Time Frame
12 weeks
Title
Physical Activity - objective measurement
Description
Physical activity measured by ActiGraph
Time Frame
12 weeks
Title
Food Litteracy
Description
Food Litteracy measured by questionnaire
Time Frame
12 weeks
Title
Dietary Pattern
Description
Dietary pattern measured by the use of a Food Frequency Questionnaire
Time Frame
12 weeks
Title
Body Composition - BIA
Description
Using Bio-impediance Assessment to determine the fat and fatfree mass
Time Frame
12 weeks
Title
Body Composition - 3D Scan
Description
A 3D-scan will be used to evaluate phenotypic changes
Time Frame
12 weeks
Title
Body Composition - Waist
Description
Waist circumference measurement
Time Frame
12 weeks
Title
Physical fitness
Description
Use of the 6 minute walking test to evaluate the level of fitness of the participants
Time Frame
12 weeks
Title
Motivation
Description
Motivation to change lifestyle by use of a questionnaire
Time Frame
12 weeks
Title
Social Support
Description
social support will be measured by a questionnaire
Time Frame
12 weeks
Title
Demographic factors
Description
demographic factors will be measured by a questionnaire
Time Frame
12 weeks
Title
Program adherence (24h food recall, compliance food pictures)
Description
Adherence to the prescribed physical activity plan and dietary pattern
Time Frame
12 weeks
Title
Shopping behavior
Description
Shopping behavior (and potential changes) will be measured by use of the grocery fidelty card
Time Frame
12 weeks
Other Pre-specified Outcome Measures:
Title
The usability experience
Description
Usability and overall user experience of the Super Coach application
Time Frame
3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Christophe Matthys, Prof. Dr.
Organizational Affiliation
Department of Clinical and Experimental Medicine, KU Leuven
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Jan Seghers, Prof. Dr.
Organizational Affiliation
Physical Activity, Sports & Health (PASH) Research Group
Official's Role
Study Chair
Facility Information:
Facility Name
University Hospital Leuven
City
Leuven
State/Province
Vlaams Brabant
ZIP/Postal Code
3000
Country
Belgium

12. IPD Sharing Statement

Plan to Share IPD
Undecided
IPD Sharing Plan Description
IPD will be discussed in the next steering committee
Citations:
PubMed Identifier
29326093
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. Erratum In: JMIR Mhealth Uhealth. 2018 Mar 15;6(3):e10159.
Results Reference
derived

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

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