Clinical trial NCT03480464: App-technology to Improve the Level of Physical Activity After Bariatric Surgery
Official title: App-technology to Increase Physical Activity After Bariatric Surgery: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity
Bariatric Surgery
Exercise
Quality of Life
Eating Behavior
Body Fat Distribution
Body Weight Changes
Lead sponsor: Karolinska Institutet
Sponsor class: OTHER
Collaborators: name: Vrinnevi Hospital
name: Linkoeping University
First posted: 2018-03-29
Enrollment: 158
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.


Eligibility criteria: Inclusion Criteria:

* Accepted to bariatric surgery due to national guidelines, BMI\>35 kg/m2
* 18 years of age or older
* Informed consent
* Ability to read and understand Swedish
* Own and use a smartphone

Exclusion Criteria:

* Disability preventing daily walking

Primary outcomes:
measure: Change in Physical activity level
timeFrame: Before surgery and 18 weeks, 6 months, 1 year, and 2 years after surgery.
Secondary outcomes:
measure: Body Mass Index
timeFrame: Before surgery, 6 weeks(intervention start) and 18 weeks, 6 months and 1 year after surgery.
measure: Body weight
timeFrame: Before surgery, 6 weeks(intervention start) and 18 weeks, 6 months, 1 year, and 2 years after surgery.
measure: Percent Body Fat
timeFrame: Before surgery, 6 weeks(intervention start) and 18 weeks, 6 months and 1 year after surgery.
measure: Fat free mass
timeFrame: Before surgery, 6 weeks(intervention start) and 18 weeks, 6 months and 1 year after surgery.
measure: Muscle mass
timeFrame: Before surgery, 6 weeks(intervention start) and 18 weeks, 6 months and 1 year after surgery.
measure: Total body water
timeFrame: Before surgery, 6 weeks(intervention start) and 18 weeks, 6 months and 1 year after surgery.
measure: Hand grip
timeFrame: Before surgery, 6 weeks(intervention start) and 18 weeks, 6 months and 1 year after surgery.
measure: Self registered physical activity in the app
timeFrame: 12 weeks, 6 to 18 weeks after surgery
Other outcomes:
measure: Change in eating behavior using the TFEQ-R21 questionnaire
timeFrame: Before surgery and 18 weeks, 6 months, 1 year, and 2 years after surgery.
measure: Change in Quality of life using the SF35 questionnaire
timeFrame: Before surgery and 18 weeks, 6 months, 1 year, and 2 years after surgery.
measure: Change in co morbidity, before surgery compared to 1 year and 2 years after surgery.
timeFrame: Before and 1 year and 2 years after surgery
measure: Change in supplementary vitamin intake adherence according to to the MARS-5 scale
timeFrame: 18 weeks (after surgery) and 1 year after surgery
measure: Change in supplementary vitamin intake adherence using registry data
timeFrame: 18 weeks (after surgery) and 1 year after surgery
measure: Change in beliefs and attitude to medication according to the Brief Medication Questionnaire
timeFrame: 18 weeks (after surgery) and 1 year after surgery
measure: Change in sleeping habits
timeFrame: Before surgery and 18 weeks, 6 months, 1 year, and 2 years after surgery.
measure: Change in dietary intake and eating habits
timeFrame: Before surgery and 6 months, 1 year, and 2 years after surgery.
measure: Change in symptoms related to urinary incontinence or prolapse
timeFrame: Before surgery and 18 weeks, 6 months, 1 year, and 2 years after surgery.
measure: Hemoglobin (Hb)
timeFrame: Before surgery and 1 year after surgery
measure: Iron status
timeFrame: Before surgery and 1 year after surgery
measure: s-folate
timeFrame: Before surgery and 1 year after surgery
measure: p-calcium
timeFrame: Before surgery and 1 year after surgery
measure: s-albumin
timeFrame: Before surgery and 1 year after surgery
measure: s-cobolamin
timeFrame: Before surgery and 1 year after surgery
Locations:
city: Norrköping
country: Sweden
facility: Vrinnevi Hospital
Study officials:
affiliation: Karolinska Institutet
name: Ylva Trolle Lagerros, Md,PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Spetz 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.
citation: Bonn 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.