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

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.

Study Overview

• Status: Completed
• Conditions: Obesity
• Intervention / Treatment: Other: Waiting Group; Other: Conventional face to face PA & dietitian; Other: Digital Super Coach; Other: Digital Super Coach + minimal coaching

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.

• Study Type: Interventional
• Enrollment (Actual): 120
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Belgium
  • Vlaams Brabant
    • Leuven, Vlaams Brabant, Belgium, 3000
      • University Hospital Leuven

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

4

Arms and Interventions

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

What is the study measuring?

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
The usability experience	Usability and overall user experience of the Super Coach application	3 months

Collaborators and Investigators

• Sponsor: Universitaire Ziekenhuizen KU Leuven
• Collaborators: KU Leuven; iMinds; Brand New Health; Yorbody; Delhaize
• Investigators: Study Chair: 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

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: October 1, 2015
• Primary Completion (Actual): January 1, 2016
• Study Completion (Actual): April 1, 2016

Study Registration Dates

• First Submitted: June 18, 2015
• First Submitted That Met QC Criteria: November 2, 2015
• First Posted (Estimate): November 3, 2015

Study Record Updates

• Last Update Posted (Actual): February 8, 2019
• Last Update Submitted That Met QC Criteria: February 6, 2019
• Last Verified: February 1, 2019

More Information

Terms related to this study

• Keywords: Obesity; Overweight; Physical activity; Diet; Digital coaching; Sustainable weight loss; Self-determination theory
• Additional Relevant MeSH Terms: Body Weight; Body Weight Changes; Weight Loss
• Other Study ID Numbers: S57538

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided
• IPD Plan Description: IPD will be discussed in the next steering committee

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No