Assessing the Value of eHealth for Bariatric Surgery

NCT03394638 | Unknown

• 1 other identifier: NL56992.100.16
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

Brief 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. 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

Keywords

eHealth; Bariatric surgery; Obesity; Telemedicine

Outcome Measures

Primary Outcomes (1)

• Body Mass Index (BMI)

  The BMI in kg/m2 at 2 years postoperatively.

  2 years after the operation

Secondary Outcomes (8)

• Quality of Life

  At 1 and 2 years after the operation

• Evolution of obesity related comorbidities

  At 1 and 2 years after the operation

• Program commitment

  At 1 and 2 years after the operation

• Technical errors biometric devices

  At 2 years after the operation

• Length of hospitalization

  At 2 years after the operation

Study Arms (3)

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

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

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

Other: Access to online eLearning module; Other: Access to measurement devices; Procedure: Conventional group

Interventions

Access to online eLearning module OTHER

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.

Device group; Online group

Access to measurement devices OTHER

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.

Device group

Conventional group PROCEDURE

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.

Conventional group; Device group; Online group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

Sponsors & Collaborators

• Catharina Ziekenhuis Eindhoven: lead

Study Sites (1)

Catharina Hospital

Eindhoven, North Brabant, 5623EJ, Netherlands

RECRUITING

Related Publications (16)

• 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.

  PMID: 20158617 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

• 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.

  PMID: 23819903 BACKGROUND

• Mundi 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.

  PMID: 25702141 BACKGROUND

• Bond 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.

  PMID: 26331982 BACKGROUND

• Kim 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.

  PMID: 24464545 BACKGROUND

• Sysko 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.

  PMID: 25066443 BACKGROUND

• Haggerty 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.

  PMID: 26644265 BACKGROUND

• Skoyen 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.

  PMID: 25697133 BACKGROUND

• Azar 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.

  PMID: 25729451 BACKGROUND

• Steinberg 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.

  PMID: 24780934 BACKGROUND

• Luley 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.

  PMID: 25105874 BACKGROUND

• Ahrendt 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.

  PMID: 24112223 BACKGROUND

• Uhlig 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.

  PMID: 23922064 BACKGROUND

• McKee 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.

  PMID: 23767689 BACKGROUND

• Versteegden DPA, Van Himbeeck MJJ, Luyer MD, van Montfort G, de Zoete JJGM, Smulders JF, Nienhuijs SW. A randomized clinical trial evaluating eHealth in bariatric surgery. Surg Endosc. 2023 Oct;37(10):7625-7633. doi: 10.1007/s00464-023-10211-w. Epub 2023 Jul 20.

  PMID: 37474829 DERIVED

MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Simon Nienhuijs, MD, PhD

  Department of Surgery, Catharina Hospital Eindhoven

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Dirk Versteegden, MD

CONTACT

003140 239 9850; dirk.versteegden@catharinaziekenhuis.nl

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: December 6, 2017
• First Posted: January 9, 2018
• Study Start: February 21, 2017
• Primary Completion: December 15, 2019
• Study Completion: December 15, 2019
• Last Updated: January 11, 2018

Record last verified: 2018-01

Locations

NL (1)