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Completed

NCT Number: NCT02595671

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.

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University Hospital Leuven

Leuven, Vlaams Brabant, 3000, Belgium

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Digital Super Coach

Other

Receive Digital Super Coach during 12 weeks

Conventional face to face PA & dietitian

Other

Receive 7 face-to-face contacts (dietary and physical activity advice)

Digital Super Coach + minimal coaching

Other

Receive 3 face-to-face contacts (dietary and physical activity advice)

Waiting Group

Other

Receive Digital Super Coach during 12 weeks, after 12 weeks of no treatment

Primary outcomes

  1. Weight Loss (Omron Weight Balance)

    Time frame: 12 weeks

    Weight loss measured pre & post intervenion

Secondary outcomes

  1. Physical Activity - self evaluated

    Time frame: 12 weeks

    Physical activity measured by International Physical Activity Questionnaire

  2. Physical Activity - objective measurement

    Time frame: 12 weeks

    Physical activity measured by ActiGraph

  3. Food Litteracy

    Time frame: 12 weeks

    Food Litteracy measured by questionnaire

  4. Dietary Pattern

    Time frame: 12 weeks

    Dietary pattern measured by the use of a Food Frequency Questionnaire

  5. Body Composition - BIA

    Time frame: 12 weeks

    Using Bio-impediance Assessment to determine the fat and fatfree mass

  6. Body Composition - 3D Scan

    Time frame: 12 weeks

    A 3D-scan will be used to evaluate phenotypic changes

  7. Body Composition - Waist

    Time frame: 12 weeks

    Waist circumference measurement

  8. Physical fitness

    Time frame: 12 weeks

    Use of the 6 minute walking test to evaluate the level of fitness of the participants

  9. Motivation

    Time frame: 12 weeks

    Motivation to change lifestyle by use of a questionnaire

  10. Social Support

    Time frame: 12 weeks

    social support will be measured by a questionnaire

  11. Demographic factors

    Time frame: 12 weeks

    demographic factors will be measured by a questionnaire

  12. Program adherence (24h food recall, compliance food pictures)

    Time frame: 12 weeks

    Adherence to the prescribed physical activity plan and dietary pattern

  13. Shopping behavior

    Time frame: 12 weeks

    Shopping behavior (and potential changes) will be measured by use of the grocery fidelty card

Other outcomes

  1. The usability experience

    Time frame: 3 months

    Usability and overall user experience of the Super Coach application

Sponsors and collaborators

Lead sponsor

Universitaire Ziekenhuizen KU Leuven

Other

Collaborators

  • Brand New Health
  • Delhaize
  • KU Leuven
  • Yorbody
  • iMinds

Registry information

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Nov 3, 2015
Registry last updated
Feb 8, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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