The goal of this study is to investigate the feasibility of distant, internet-based follow-up and monitoring of the weigth of 20 gastric bypass patients. Our research results will determine whether or not the use of the Youw8 weight scale is…
ID
Source
Brief title
Condition
- Appetite and general nutritional disorders
- Gastrointestinal therapeutic procedures
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Percentage of 'measured weeks' during the first postoperative year, calculated
as a minumum of 1 available measurement per week/52 weeks. Feasibility of
telemonitoring, i.e., success, will be defined as weight measurements for 80%
of 52 postoperative weeks (42 *week* measurements).
Secondary outcome
-Percentage of measured days in the first postoperative year, calculated as
number of weigh days divided by 365 days
-Percentages of weight loss and excess weight loss from moment of inclusion to
surgery
-Percentages of weight loss and excess weight loss from surgery to 1 year
postoperatively
-Patient satisfaction based on responses to satisfaction questions
-Health worker satisfaction based on responses to satisfaction questions
Successful excess weight loss is defined as at least 50% excess weight loss 1
year after surgery
Background summary
Bariatric surgery is the most effective treatment option for patients with
extreme obesity and has become increasingly popular. Successful bariatric
surgery is defined as at least 50% excess weight loss 1 year after surgery. One
of the most important factors that contribute to success is postoperative
follow-up. Patient weight loss should be monitored closely since weigth regain
is the most important long-term threat for these patients.
Study objective
The goal of this study is to investigate the feasibility of distant,
internet-based follow-up and monitoring of the weigth of 20 gastric bypass
patients. Our research results will determine whether or not the use of the
Youw8 weight scale is attainable and desirable in the contact of the
preoperative and postoperative follow-up of gastric bypass patients.
Study design
Prospective intervention study
Study burden and risks
After informed consent has been obtained by the researcher, treating physician
and/or specialised nurse, the patient will receive the weight scale with user's
manual. Patients are requested to install the program and weigh themselves with
this system from this moment on, preferably daily, but at least once a week.
The period of hospital admission will be excepted from measurements. After
dismissal, the weighing frequency of at least once a week is resumed and the
patient will be invited to visit the out patient clinic according to the
protocolled frequencies of 6 weeks, 3 months, 6 months and 12 months
postoperatively. The 12-month visit will be the study end point.
Included patients will be asked to fill in satisfaction-related questions on
the following time points:
1) after installation of the program (possible answers: very dissatisfied,
somewhat unsatisfied, neutral, somewhat satisfied, very satisfied)
2) after the end of the study 12 months after surgery
a) on satisfaction with regard to the program (mogelijke antwoorden: erg
ontevreden, enigszins ontevreden, neutraal, enigszins tevreden, zeer tevreden)
b) whether they would recommend the weight scale to others ( possible answers:
definitely not, probably not, maybe not, maybe yes, probably yes, surely yes)
The risk associated with participation in this study is considered negligible.
Vondellaan 12
1942 LE Beverwijk
NL
Vondellaan 12
1942 LE Beverwijk
NL
Listed location countries
Age
Inclusion criteria
-age 18 years and older
-maximum weight of 150 kg (measured on the weigth scale at the out patient clinic)
-patient is planned for laparoscopic or open gastric bypass surgery (or similar procedure) or gastric sleeve procedure
-consent for surgery by Dutch Obesity Clinic
-consent for surgery by anaesthesiologist
-available internet connection
-sufficient knowledge of the Dutch language in order to comply to weighing instructions
Exclusion criteria
-adolescents and children
-gastric banding surgery
-no available internet connection
-insufficient knowledge of the Dutch language
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL34902.094.10 |