App-technology to Improve the Level of Physical Activity After Bariatric Surgery
App-technology to Increase Physical Activity After Bariatric Surgery: A Randomized Controlled Trial
1 other identifier
interventional
158
1 country
1
Brief Summary
The aim of this study is to investigate the effect of using new app-based technology to increase the level of physical activity, compared to conventional postoperative information given to patients undergoing bariatric surgery. The hypothesis is that the intervention, i.e. using the new technology, will have a greater positive effect on levels of physical activity and outcomes of weight loss than conventional postoperative information.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable obesity
Started Nov 2017
Longer than P75 for not_applicable obesity
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 6, 2017
CompletedStudy Start
First participant enrolled
November 16, 2017
CompletedFirst Posted
Study publicly available on registry
March 29, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 30, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
September 30, 2021
CompletedApril 1, 2022
March 1, 2022
3.9 years
September 6, 2017
March 31, 2022
Conditions
Outcome Measures
Primary Outcomes (1)
Change in Physical activity level
counts/min from accelerometers
Before surgery and 18 weeks, 6 months, 1 year, and 2 years after surgery.
Secondary Outcomes (8)
Body Mass Index
Before surgery, 6 weeks(intervention start) and 18 weeks, 6 months and 1 year after surgery.
Body weight
Before surgery, 6 weeks(intervention start) and 18 weeks, 6 months, 1 year, and 2 years after surgery.
Percent Body Fat
Before surgery, 6 weeks(intervention start) and 18 weeks, 6 months and 1 year after surgery.
Fat free mass
Before surgery, 6 weeks(intervention start) and 18 weeks, 6 months and 1 year after surgery.
Muscle mass
Before surgery, 6 weeks(intervention start) and 18 weeks, 6 months and 1 year after surgery.
- +3 more secondary outcomes
Other Outcomes (15)
Change in eating behavior using the TFEQ-R21 questionnaire
Before surgery and 18 weeks, 6 months, 1 year, and 2 years after surgery.
Change in Quality of life using the SF35 questionnaire
Before surgery and 18 weeks, 6 months, 1 year, and 2 years after surgery.
Change in co morbidity, before surgery compared to 1 year and 2 years after surgery.
Before and 1 year and 2 years after surgery
- +12 more other outcomes
Study Arms (2)
App-technology group
EXPERIMENTALApp-technology to increase physical activity Participants in the intervention group (App-technology) will use a newly developed smartphone application ("app") in which the participants are able to register their daily physical activity in bouts of 10 min and their intake if supplementary vitamins. They will also be able to set personal goals every week for the level (minutes) of physical activity and get feedback every week in whether they fulfilled the goal or not. They will also get feedback on the intake of supplementary vitamin intake.
Control group
NO INTERVENTIONThe control group will receive standard information about the benefit of physical activity after surgery.
Interventions
The application will send daily reminders to register and notices with information about the health benefit of physical activity, medication, supplementary vitamins and diet after surgery
Eligibility Criteria
You may qualify if:
- Accepted to bariatric surgery due to national guidelines, BMI\>35 kg/m2
- years of age or older
- Informed consent
- Ability to read and understand Swedish
- Own and use a smartphone
You may not qualify if:
- Disability preventing daily walking
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Karolinska Institutetlead
- Vrinnevi Hospitalcollaborator
- Linkoeping Universitycollaborator
Study Sites (1)
Vrinnevi Hospital
Norrköping, 603 79, Sweden
Related Publications (3)
Bonn SE, Hult M, Spetz K, Eke H, Andersson E, Wiren M, Lof M, Trolle Lagerros Y. Effect of a Smartphone Application on Physical Activity and Weight Loss After Bariatric Surgery-Results from a Randomized Controlled Trial. Obes Surg. 2023 Sep;33(9):2841-2850. doi: 10.1007/s11695-023-06753-6. Epub 2023 Jul 27.
PMID: 37500930DERIVEDSpetz K, Hult M, Olbers T, Bonn S, Svedjeholm S, Lagerros YT, Andersson E. A smartphone application to improve adherence to vitamin and mineral supplementation after bariatric surgery. Obesity (Silver Spring). 2022 Oct;30(10):1973-1982. doi: 10.1002/oby.23536. Epub 2022 Sep 1.
PMID: 36050801DERIVEDBonn SE, Hult M, Spetz K, Lof M, Andersson E, Wiren M, Trolle Lagerros Y. App Technology to Support Physical Activity and Intake of Vitamins and Minerals After Bariatric Surgery (the PromMera Study): Protocol of a Randomized Controlled Clinical Trial. JMIR Res Protoc. 2020 Aug 14;9(8):e19624. doi: 10.2196/19624.
PMID: 32795990DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Ylva Trolle Lagerros, Md,PhD
Karolinska Institutet
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- MD, Associate Professor
Study Record Dates
First Submitted
September 6, 2017
First Posted
March 29, 2018
Study Start
November 16, 2017
Primary Completion
September 30, 2021
Study Completion
September 30, 2021
Last Updated
April 1, 2022
Record last verified: 2022-03
Data Sharing
- IPD Sharing
- Will not share