跳至主要内容
临床试验/NCT02595671
NCT02595671已完成不适用

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

Universitaire Ziekenhuizen KU Leuven2 个研究点 分布在 1 个国家目标入组 120 人开始时间: 2015年10月最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
120
试验地点
2
主要终点
Weight Loss (Omron Weight Balance)

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
Single (Participant)

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

  • 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

研究组 & 干预措施

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.

干预措施: Waiting Group (Other)

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.

干预措施: Conventional face to face PA & dietitian (Other)

Digital Super Coach

Active Comparator

Only receive coaching via digital super coach.

干预措施: Digital Super Coach (Other)

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.

干预措施: Digital Super Coach (Other)

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.

干预措施: Digital Super Coach + minimal coaching (Other)

结局指标

主要结局

Weight Loss (Omron Weight Balance)

时间窗: 12 weeks

Weight loss measured pre \& post intervenion

次要结局

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

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Christophe Matthys, PhD

Prof. Christophe Matthys

Universitaire Ziekenhuizen KU Leuven

研究点 (2)

Loading locations...

相似试验