Bariatric SurgeryBePATIENTNCT03394638
Assessing the Value of eHealth for Bariatric Surgery
A study testing Access to online eLearning module, Access to measurement devices and Conventional group in people with Bariatric Surgery and Obesity, run by Catharina Ziekenhuis Eindhoven at 1 site in Netherlands.
Trial summary
Bariatric surgery is the only treatment with long standing effect of morbid obesity. The key elements to success are the patient-selection, an experienced bariatric team and a completed follow-up program. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Bariatric Surgery, Obesity, Telemedicine
- What is being tested?
- Access to online eLearning module, Access to measurement devices and Conventional group
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteNetherlands
- Study dates
- 21 Feb 2017to 15 Dec 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Completed the questionnaire online
- Having ongoing access to internet
- Ability to use a model of mobile device (smartphone or tablet) with any version of the Android or iOS platform
- A body mass index above 40 kg/m2 or above 35 kg/m2 with related comorbidity (hypertension, diabetes type 2, hyperlipidaemia, obstructive sleep apnea syndrome or joint arthritis of lower limbs)
- A primary gastric sleeve or bypass planned
- Age of 18 years or more
- Ability to read and write the Dutch language
- Signed informed consent
Who cannot join
- 1. Patients not meeting the inclusion criteria
Trial locations and contacts
1 site in 1 country.
Netherlands1 site, 1 recruiting
- Recruiting
Catharina Hospital
Eindhoven, North Brabant, 5623EJ
Dirk PA Versteegden, MD, 040 239 9111, dirk.versteegden@catharinaziekenhuis.nl
About this study
Bariatric surgery is the only treatment with long standing effect of morbid obesity. The key elements to success are the patient-selection, an experienced bariatric team and a completed follow-up program. Follow-up programs can consist of, for example, providing social support in support groups, teaching psychological skills, such as coping with the body change or teaching self-regulation of body weight. Furthermore, follow-up is important for dietary and sports counselling. The experience of the team members and coaching skills are essential in indicating the suitable procedure if necessary and guide the patients through the process. Various studies showed a significant positive effect of a completed follow-up program after bariatric surgery on maintaining weight loss. There is a burden for this on site provided care as organizational and financial resources are not unlimited. Especially as the follow-up period is an obligatory 5 years or if possible life long. Even if this aftercare is provided, not all patients complete the complete program. Various reasons are possible for an increasing no-show-rate, the loss of enthusiasm for onsite visits could be one of them. Analogue to other chronic diseases, the addition of telehealth could be useful. Telehealth is the delivery of health-related services and information via telecommunications technologies. It encompasses preventative, promotive and curative aspects. Examples are exchanging health services or education via videoconference, transmission of medical data for disease management (remote monitoring) and advice on prevention of diseases and promotion of good health by patient monitoring and follow-up. The participation of eHealth has been investigated and considered useful in the treatment of obesity. In a systematic review self-measured blood pressure monitoring was associated with better control of hypertension at least in the first year. Its value in a bariatric tract has not been investigated. It can be hypothesized that self-control by eHealth could enhance clinical outcome as more weight loss and comorbidity reduction. Long-term realistic goals setting, consistent use of routines and self-monitoring has been proven effective for weight loss maintenance. Patients with higher self-control are more certain regarding their abilities, which cause higher commitment and adherence to the program. This eventually leads to more weight loss. For this purpose an online monitoring program was designed for our Obesity Centre (BePATIENT) to provide preoperative information as well as aids in the post-bariatric phase by self-control wireless devices for registration of biometric outcomes, teleconference opportunities and access to additional information. In a prospective trial the implementation in several degrees is evaluated.
- Conditions
- Bariatric Surgery, Obesity, Telemedicine
- Being tested
- Access to online eLearning module, Access to measurement devices, Conventional group
- Keywords
- eHealth, Bariatric surgery, Obesity, Telemedicine
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Access to online eLearning moduleOther
Patients enrolled in the Online group have access to an online platform called BePatient. Patients are given the ability to access the platform and do eLearnings; watch videos about the operation and recovery; do quizzes, see dietary advices; see news about obesity and our department; read patients' stories. They are also able to chat with other patients.
Access to measurement devicesOther
Patients in the device group have, in addition to patients in the Online group, access to 4 measuring devices, including: weight scale, oximeter, activity bracelet and blood pressure device. Those devices are connectable to their mobile phones where patients can view their own progress.
Conventional groupProcedure or surgery
All patients undergo the standard of care which included: the bariatric procedure and several outpatient visits including consultation with their surgeon, obesity nurses, dieticians and (if indicated) psychologists.
| Study group | Role | What they receive |
|---|---|---|
| Conventional group | Active comparator | Treatment includes:
1. 10 individual and 3 group consultations at the outpatient department by several disciplines in the first postoperative year.
2. Additional visits if necessary
3. No further access to the BePATIENT website Receives: Procedure: Conventional group |
| Online group | Experimental | Treatment includes:
Added to conventional group: Continuation of access to the BePATIENT website with:
1. eLearning programs
2. Informative videos
3. Patient network
4. Video consulting Receives: Other: Access to online eLearning module; Procedure: Conventional group |
| Device group | Experimental | Added to Online group:Four wireless devices, which are
1. Weight Scale
2. Blood Pressure
3. Oximeter
4. Activity Tracker Receives: Other: Access to online eLearning module; Other: Access to measurement devices; Procedure: Conventional group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Body Mass Index (BMI)
The BMI in kg/m2 at 2 years postoperatively.
Measured: 2 years after the operation
Secondary outcomes (8)
Quality of Life
Quality of Life assessment using the RAND36-questionnaire. The RAND36 questionnaire consists of 36 questions about health related quality of life. The RAND36 scores are divided in 9 subscales: vitality, physical functioning, bodily pain, general health perceptions, physical role functioning, emotional role functioning, social role functioning, mental health and health change. Scores for each subscale are transformed to a linear 0 - 100 score. A higher score indicates a better quality of life in that domain.
Measured: At 1 and 2 years after the operation
Evolution of obesity related comorbidities
Status of comorbidities are recorded at 1 and 2 years postoperatively and classified as either: cured (no medication and no complaints), improved (less medication needed and/or less complaints), unchanged (no alterations in medication use and no change in complaints), worsened (more medication needed and/or more complaints) or de novo (development of a comorbidity which was not present at inclusion). The reviewed comorbidities include: hypertension, diabetes mellitus, Arthralgia, obstructive sleep apnea syndrome, dyslipidemia and gastro-esophageal reflux disease.
Measured: At 1 and 2 years after the operation
Program commitment
A 6-item questionnaire to assess program commitment (Neubert \& Cady 2001).
Measured: At 1 and 2 years after the operation
Technical errors biometric devices
Number of technical issues reported by patients or health care professionals
Measured: At 2 years after the operation
Length of hospitalization
Length of stay in hospital (days)
Measured: At 2 years after the operation
Return to work (days)
Number of days patients start working again after operation
Measured: At 1 year after the operation.
Patients' satisfaction
Satisfactory assessment patients (Numeric Rate Scale 0-10)
Measured: At 1 and 2 years after the operation
Health care suppliers' satisfaction
Satisfactory assessment health care professional (Numeric Rate Scale 0-10)
Measured: At 1 and 2 years after the operation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jan 2018
- Study start21 Feb 2017
- Primary completion15 Dec 2019 (estimated)
- Study completion15 Dec 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (16)Papers the sponsor has linked to this study.
- Other trials for Bariatric SurgeryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Catharina Ziekenhuis Eindhoven
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dirk Versteegden, Catharina Ziekenhuis Eindhoven
- Investigators
- Simon Nienhuijs, MD, PhD, Principal investigator, Department of Surgery, Catharina Hospital Eindhoven
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03394638
- Sponsor's protocol ID
- NL56992.100.16
- Acronym
- BePATIENT
- Status last verified
- Jan 2018
- First submitted
- 6 Dec 2017
- Last updated
- 11 Jan 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Livhits M, Mercado C, Yermilov I, Parikh JA, Dutson E, Mehran A, Ko CY, Shekelle PG, Gibbons MM. Is social support associated with greater weight loss after bariatric surgery?: a systematic review. Obes Rev. 2011 Feb;12(2):142-8. doi: 10.1111/j.1467-789X.2010.00720.x.
PubMed 20158617[2] Lyons K, Meisner B, Sockalingam S, Cassin S.. Body image after bariatric surgery: A qualitative study. Bariatric Surgical Practice and Patient Care. March 2014, 9(1): 41-49.
Petasne Nijamkin M, Campa A, Samiri Nijamkin S, Sosa J. Comprehensive behavioral-motivational nutrition education improves depressive symptoms following bariatric surgery: a randomized, controlled trial of obese Hispanic Americans. J Nutr Educ Behav. 2013 Nov-Dec;45(6):620-6. doi: 10.1016/j.jneb.2013.04.264. Epub 2013 Jun 29.
PubMed 23819903Mundi MS, Lorentz PA, Grothe K, Kellogg TA, Collazo-Clavell ML. Feasibility of Smartphone-Based Education Modules and Ecological Momentary Assessment/Intervention in Pre-bariatric Surgery Patients. Obes Surg. 2015 Oct;25(10):1875-81. doi: 10.1007/s11695-015-1617-7.
PubMed 25702141Bond DS, Thomas JG. Measurement and Intervention on Physical Activity and Sedentary Behaviours in Bariatric Surgery Patients: Emphasis on Mobile Technology. Eur Eat Disord Rev. 2015 Nov;23(6):470-8. doi: 10.1002/erv.2394. Epub 2015 Sep 2.
PubMed 26331982Kim HJ, Madan A, Fenton-Lee D. Does patient compliance with follow-up influence weight loss after gastric bypass surgery? A systematic review and meta-analysis. Obes Surg. 2014 Apr;24(4):647-51. doi: 10.1007/s11695-014-1178-1.
PubMed 24464545Sysko R, Hildebrandt TB, Kaplan S, Brewer SK, Zitsman JL, Devlin MJ. Predictors and correlates of follow-up visit adherence among adolescents receiving laparoscopic adjustable gastric banding. Surg Obes Relat Dis. 2014 Sep-Oct;10(5):914-20. doi: 10.1016/j.soard.2014.03.012. Epub 2014 Mar 28.
PubMed 25066443Haggerty AF, Huepenbecker S, Sarwer DB, Spitzer J, Raggio G, Chu CS, Ko E, Allison KC. The use of novel technology-based weight loss interventions for obese women with endometrial hyperplasia and cancer. Gynecol Oncol. 2016 Feb;140(2):239-44. doi: 10.1016/j.ygyno.2015.11.033. Epub 2015 Nov 28.
PubMed 26644265Skoyen JA, Rutledge T, Wiese JA, Woods GN. Evaluation of TeleMOVE: a Telehealth Weight Reduction Intervention for Veterans with Obesity. Ann Behav Med. 2015 Aug;49(4):628-33. doi: 10.1007/s12160-015-9690-7.
PubMed 25697133Azar KM, Aurora M, Wang EJ, Muzaffar A, Pressman A, Palaniappan LP. Virtual small groups for weight management: an innovative delivery mechanism for evidence-based lifestyle interventions among obese men. Transl Behav Med. 2015 Mar;5(1):37-44. doi: 10.1007/s13142-014-0296-6.
PubMed 25729451Steinberg DM, Levine EL, Lane I, Askew S, Foley PB, Puleo E, Bennett GG. Adherence to self-monitoring via interactive voice response technology in an eHealth intervention targeting weight gain prevention among Black women: randomized controlled trial. J Med Internet Res. 2014 Apr 29;16(4):e114. doi: 10.2196/jmir.2996.
PubMed 24780934Luley C, Blaik A, Gotz A, Kicherer F, Kropf S, Isermann B, Stumm G, Westphal S. Weight loss by telemonitoring of nutrition and physical activity in patients with metabolic syndrome for 1 year. J Am Coll Nutr. 2014;33(5):363-74. doi: 10.1080/07315724.2013.875437. Epub 2014 Aug 8.
PubMed 25105874Ahrendt AD, Kattelmann KK, Rector TS, Maddox DA. The effectiveness of telemedicine for weight management in the MOVE! Program. J Rural Health. 2014 Winter;30(1):113-9. doi: 10.1111/jrh.12049. Epub 2013 Sep 24.
PubMed 24112223Uhlig K, Patel K, Ip S, Kitsios GD, Balk EM. Self-measured blood pressure monitoring in the management of hypertension: a systematic review and meta-analysis. Ann Intern Med. 2013 Aug 6;159(3):185-94. doi: 10.7326/0003-4819-159-3-201308060-00008.
PubMed 23922064McKee H, Ntoumanis N, Smith B. Weight maintenance: self-regulatory factors underpinning success and failure. Psychol Health. 2013;28(10):1207-23. doi: 10.1080/08870446.2013.799162. Epub 2013 Jun 14.
PubMed 23767689
Study at a glance
From the registry record, last updated by the sponsor on 11 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessing the Value of eHealth for Bariatric Surgery
- ClinicalTrials.gov ID
- NCT03394638
- Acronym / sponsor ID
- BePATIENT / NL56992.100.16
- Conditions
- Bariatric Surgery, Obesity, Telemedicine
- Keywords
- eHealth, Bariatric surgery, Obesity, Telemedicine
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Catharina Ziekenhuis EindhovenUniversity, hospital or other
- Study start
- 21 Feb 2017 (actual)
- Primary completion
- 15 Dec 2019 (estimated)
- Study completion
- 15 Dec 2019 (estimated)
- First posted
- 9 Jan 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Bariatric surgery is the only treatment with long standing effect of morbid obesity. The key elements to success are the patient-selection, an experienced bariatric team and a completed follow-up program. Follow-up programs can consist of, for example, providing social support in support groups, teaching psychological skills, such as coping with the body change or teaching self-regulation of body weight. Furthermore, follow-up is important for dietary and sports counselling. The experience of the team members and coaching skills are essential in indicating the suitable procedure if necessary and guide the patients through the process. Various studies showed a significant positive effect of a completed follow-up program after bariatric surgery on maintaining weight loss. There is a burden for this on site provided care as organizational and financial resources are not unlimited. Especially as the follow-up period is an obligatory 5 years or if possible life long. Even if this aftercare is provided, not all patients complete the complete program. Various reasons are possible for an increasing no-show-rate, the loss of enthusiasm for onsite visits could be one of them. Analogue to other chronic diseases, the addition of telehealth could be useful. Telehealth is the delivery of health-related services and information via telecommunications technologies. It encompasses preventative, promotive and curative aspects. Examples are exchanging health services or education via videoconference, transmission of medical data for disease management (remote monitoring) and advice on prevention of diseases and promotion of good health by patient monitoring and follow-up. The participation of eHealth has been investigated and considered useful in the treatment of obesity. In a systematic review self-measured blood pressure monitoring was associated with better control of hypertension at least in the first year. Its value in a bariatric tract has not been investigated. It can be hypothesized that self-control by eHealth could enhance clinical outcome as more weight loss and comorbidity reduction. Long-term realistic goals setting, consistent use of routines and self-monitoring has been proven effective for weight loss maintenance. Patients with higher self-control are more certain regarding their abilities, which cause higher commitment and adherence to the program. This eventually leads to more weight loss. For this purpose an online monitoring program was designed for our Obesity Centre (BePATIENT) to provide preoperative information as well as aids in the post-bariatric phase by self-control wireless devices for registration of biometric outcomes, teleconference opportunities and access to additional information. In a prospective trial the implementation in several degrees is evaluated.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Conventional group | Active comparator | Procedure: Conventional groupTreatment includes: 1. 10 individual and 3 group consultations at the outpatient department by several disciplines in the first postoperative year. 2. Additional visits if necessary 3. No further access to the BePATIENT website |
| Online group | Experimental | Other: Access to online eLearning module, Procedure: Conventional groupTreatment includes: Added to conventional group: Continuation of access to the BePATIENT website with: 1. eLearning programs 2. Informative videos 3. Patient network 4. Video consulting |
| Device group | Experimental | Other: Access to online eLearning module, Other: Access to measurement devices, Procedure: Conventional groupAdded to Online group:Four wireless devices, which are 1. Weight Scale 2. Blood Pressure 3. Oximeter 4. Activity Tracker |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Completed the questionnaire online
- Having ongoing access to internet
- Ability to use a model of mobile device (smartphone or tablet) with any version of the Android or iOS platform
- A body mass index above 40 kg/m2 or above 35 kg/m2 with related comorbidity (hypertension, diabetes type 2, hyperlipidaemia, obstructive sleep apnea syndrome or joint arthritis of lower limbs)
- A primary gastric sleeve or bypass planned
Key exclusion criteria (1 listed)
- 1. Patients not meeting the inclusion criteria
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Access to online eLearning modulePatients enrolled in the Online group have access to an online platform called BePatient. Patients are given the ability to access the platform and do eLearnings; watch videos about the operation and recovery; do quizzes, see dietary advices; see news about obesity and our department; read patients' stories. They are also able to chat with other patients. | Other | Device group, Online group |
| Access to measurement devicesPatients in the device group have, in addition to patients in the Online group, access to 4 measuring devices, including: weight scale, oximeter, activity bracelet and blood pressure device. Those devices are connectable to their mobile phones where patients can view their own progress. | Other | Device group |
| Conventional groupAll patients undergo the standard of care which included: the bariatric procedure and several outpatient visits including consultation with their surgeon, obesity nurses, dieticians and (if indicated) psychologists. | Procedure or surgery | Conventional group, Device group, Online group |
Primary outcome
Body Mass Index (BMI)
Time frame: 2 years after the operation
The BMI in kg/m2 at 2 years postoperatively.
8 secondary outcomes
Quality of Life
Time frame: At 1 and 2 years after the operation
Evolution of obesity related comorbidities
Time frame: At 1 and 2 years after the operation
Program commitment
Time frame: At 1 and 2 years after the operation
Technical errors biometric devices
Time frame: At 2 years after the operation
Length of hospitalization
Time frame: At 2 years after the operation
Return to work (days)
Time frame: At 1 year after the operation.
Patients' satisfaction
Time frame: At 1 and 2 years after the operation
Health care suppliers' satisfaction
Time frame: At 1 and 2 years after the operation
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jan 2018.
- Background: PubMed 20158617Livhits M, Mercado C, Yermilov I, Parikh JA, Dutson E, Mehran A, Ko CY, Shekelle PG, Gibbons MM. Is social support associated with greater weight loss after bariatric surgery?: a systematic review. Obes Rev. 2011 Feb;12(2):142-8. doi: 10.1111/j.1467-789X.2010.00720.x.
- Background[2] Lyons K, Meisner B, Sockalingam S, Cassin S.. Body image after bariatric surgery: A qualitative study. Bariatric Surgical Practice and Patient Care. March 2014, 9(1): 41-49.
- Background: PubMed 23819903Petasne Nijamkin M, Campa A, Samiri Nijamkin S, Sosa J. Comprehensive behavioral-motivational nutrition education improves depressive symptoms following bariatric surgery: a randomized, controlled trial of obese Hispanic Americans. J Nutr Educ Behav. 2013 Nov-Dec;45(6):620-6. doi: 10.1016/j.jneb.2013.04.264. Epub 2013 Jun 29.
- Background: PubMed 25702141Mundi MS, Lorentz PA, Grothe K, Kellogg TA, Collazo-Clavell ML. Feasibility of Smartphone-Based Education Modules and Ecological Momentary Assessment/Intervention in Pre-bariatric Surgery Patients. Obes Surg. 2015 Oct;25(10):1875-81. doi: 10.1007/s11695-015-1617-7.
- Background: PubMed 26331982Bond DS, Thomas JG. Measurement and Intervention on Physical Activity and Sedentary Behaviours in Bariatric Surgery Patients: Emphasis on Mobile Technology. Eur Eat Disord Rev. 2015 Nov;23(6):470-8. doi: 10.1002/erv.2394. Epub 2015 Sep 2.
- Background: PubMed 24464545Kim HJ, Madan A, Fenton-Lee D. Does patient compliance with follow-up influence weight loss after gastric bypass surgery? A systematic review and meta-analysis. Obes Surg. 2014 Apr;24(4):647-51. doi: 10.1007/s11695-014-1178-1.
- Background: PubMed 25066443Sysko R, Hildebrandt TB, Kaplan S, Brewer SK, Zitsman JL, Devlin MJ. Predictors and correlates of follow-up visit adherence among adolescents receiving laparoscopic adjustable gastric banding. Surg Obes Relat Dis. 2014 Sep-Oct;10(5):914-20. doi: 10.1016/j.soard.2014.03.012. Epub 2014 Mar 28.
- Background: PubMed 26644265Haggerty AF, Huepenbecker S, Sarwer DB, Spitzer J, Raggio G, Chu CS, Ko E, Allison KC. The use of novel technology-based weight loss interventions for obese women with endometrial hyperplasia and cancer. Gynecol Oncol. 2016 Feb;140(2):239-44. doi: 10.1016/j.ygyno.2015.11.033. Epub 2015 Nov 28.
- Background: PubMed 25697133Skoyen JA, Rutledge T, Wiese JA, Woods GN. Evaluation of TeleMOVE: a Telehealth Weight Reduction Intervention for Veterans with Obesity. Ann Behav Med. 2015 Aug;49(4):628-33. doi: 10.1007/s12160-015-9690-7.
- Background: PubMed 25729451Azar KM, Aurora M, Wang EJ, Muzaffar A, Pressman A, Palaniappan LP. Virtual small groups for weight management: an innovative delivery mechanism for evidence-based lifestyle interventions among obese men. Transl Behav Med. 2015 Mar;5(1):37-44. doi: 10.1007/s13142-014-0296-6.
- Background: PubMed 24780934Steinberg DM, Levine EL, Lane I, Askew S, Foley PB, Puleo E, Bennett GG. Adherence to self-monitoring via interactive voice response technology in an eHealth intervention targeting weight gain prevention among Black women: randomized controlled trial. J Med Internet Res. 2014 Apr 29;16(4):e114. doi: 10.2196/jmir.2996.
- Background: PubMed 25105874Luley C, Blaik A, Gotz A, Kicherer F, Kropf S, Isermann B, Stumm G, Westphal S. Weight loss by telemonitoring of nutrition and physical activity in patients with metabolic syndrome for 1 year. J Am Coll Nutr. 2014;33(5):363-74. doi: 10.1080/07315724.2013.875437. Epub 2014 Aug 8.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Simon Nienhuijs, MD, PhD principal investigator
Department of Surgery, Catharina Hospital Eindhoven
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Access to online eLearning module, Access to measurement devices and Conventional group in people with Bariatric Surgery and Obesity, run by Catharina Ziekenhuis Eindhoven at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 11 Jan 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Dirk Versteegden, MD (003140 239 9850, dirk.versteegden@catharinaziekenhuis.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Body Mass Index (BMI) (time frame: 2 years after the operation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03394638, which also lists 16 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jan 2018.