Table 1 WHO trial registration dataset – structured summary
Data category | Information |
|---|---|
Primary registry and trial identifying number | Nederlands trial register - NTR6827 |
Date of registration in primary registry | 19 November 2017 |
Secondary identifying numbers | Clinicaltrials.gov: NCT03394638 Protocol number: NL56992.100.16 |
Source(s) of monetary or material support | N/A |
Sponsor | N/A |
Contact for public/scientific queries | Obesity Center, Catharina Hospital Eindhoven, The Netherlands |
Public title | BePatient trial |
Scientific title | Assessing the value of eHealth for bariatric surgery (BePatient trial): study protocol for a randomized controlled trial |
Country of recruitment | The Netherlands |
Health condition(s) or problem(s) studied | Morbid obesity |
Intervention(s) | Standard care vs eHealth platform vs eHealth platform + self-monitoring devices |
Key inclusion and exclusion criteria | Age > 18 years; eligible for bariatric surgery; BMI > 40 kg/m2 or > 35 kg/m2 with related co-morbidity; ongoing access to the Internet; ability to use smartphone or tablet; ability to understand Dutch language; signed informed consent |
Study type | Open randomized controlled trial |
Date of first enrollment | 21 February 2017 |
Sample size | 200 |
Recruitment status | Recruiting |
Primary outcome(s) | BMI |
Key secondary outcomes | Sociodemographics, weight, co-morbidity status, quality of life, return to work, satisfaction and commitment, inventory of use of additional support, devices and data-traffic |
Ethics review | Reviewed and approved by Institutional Review Board on 15 August 2016 |
Summary results | Planned to be released in 2020 |
IPD sharing statement | Undecided |