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

Obesity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02595671
• Other study ID #: S57538
• Status: Completed
• Phase: N/A
• Start date: October 2015
• Est. completion date: April 2016

Study information

• Verified date: February 2019
• Source: Universitaire Ziekenhuizen Leuven
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: April 2016
• Est. primary completion date: January 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Obesity
• Weight Loss

Intervention

Other:
• Digital Super Coach
Receive Digital Super Coach during 12 weeks
• Conventional face to face PA & dietitian
Receive 7 face-to-face contacts (dietary and physical activity advice)
• Digital Super Coach + minimal coaching
Receive 3 face-to-face contacts (dietary and physical activity advice)
• Waiting Group
Receive Digital Super Coach during 12 weeks, after 12 weeks of no treatment

Locations

Country	Name	City	State
Belgium	University Hospital Leuven	Leuven	Vlaams Brabant

Sponsors (6)

Lead Sponsor	Collaborator
Universitaire Ziekenhuizen Leuven	Brand New Health, Delhaize, iMinds, KU Leuven, Yorbody

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	The usability experience	Usability and overall user experience of the Super Coach application	3 months
Primary	Weight Loss (Omron Weight Balance)	Weight loss measured pre & post intervenion	12 weeks
Secondary	Physical Activity - self evaluated	Physical activity measured by International Physical Activity Questionnaire	12 weeks
Secondary	Physical Activity - objective measurement	Physical activity measured by ActiGraph	12 weeks
Secondary	Food Litteracy	Food Litteracy measured by questionnaire	12 weeks
Secondary	Dietary Pattern	Dietary pattern measured by the use of a Food Frequency Questionnaire	12 weeks
Secondary	Body Composition - BIA	Using Bio-impediance Assessment to determine the fat and fatfree mass	12 weeks
Secondary	Body Composition - 3D Scan	A 3D-scan will be used to evaluate phenotypic changes	12 weeks
Secondary	Body Composition - Waist	Waist circumference measurement	12 weeks
Secondary	Physical fitness	Use of the 6 minute walking test to evaluate the level of fitness of the participants	12 weeks
Secondary	Motivation	Motivation to change lifestyle by use of a questionnaire	12 weeks
Secondary	Social Support	social support will be measured by a questionnaire	12 weeks
Secondary	Demographic factors	demographic factors will be measured by a questionnaire	12 weeks
Secondary	Program adherence (24h food recall, compliance food pictures)	Adherence to the prescribed physical activity plan and dietary pattern	12 weeks
Secondary	Shopping behavior	Shopping behavior (and potential changes) will be measured by use of the grocery fidelty card	12 weeks