App-technology to Improve the Level of Physical Activity After Bariatric Surgery

Study Overview
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Brief Summary
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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.

Official Title
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App-technology to Increase Physical Activity After Bariatric Surgery: A Randomized Controlled Trial

Conditions
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Obesity, Bariatric Surgery, Exercise, Quality of Life, Eating Behavior, Body Fat Distribution, Body Weight Changes

Intervention / Treatment
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* Behavioral: App-technology to increase physical activity


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: App-technology group<br>App-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. | Behavioral: App-technology to increase physical activity<br>* 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<br>* Other names: PromMera;|
| No Intervention: Control group<br>The control group will receive standard information about the benefit of physical activity after surgery. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Physical activity level | counts/min from accelerometers | Before surgery and 18 weeks, 6 months, 1 year, and 2 years after surgery. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Body Mass Index | BMI, kg/m2 | Before surgery, 6 weeks(intervention start) and 18 weeks, 6 months and 1 year after surgery. | 
| Body weight | kg | Before surgery, 6 weeks(intervention start) and 18 weeks, 6 months, 1 year, and 2 years after surgery. | 
| Percent Body Fat | Percent body fat of total body weight | Before surgery, 6 weeks(intervention start) and 18 weeks, 6 months and 1 year after surgery. | 
| Fat free mass | kg | Before surgery, 6 weeks(intervention start) and 18 weeks, 6 months and 1 year after surgery. | 
| Muscle mass | kg | Before surgery, 6 weeks(intervention start) and 18 weeks, 6 months and 1 year after surgery. | 
| Total body water | kg | Before surgery, 6 weeks(intervention start) and 18 weeks, 6 months and 1 year after surgery. | 
| Hand grip | kg | Before surgery, 6 weeks(intervention start) and 18 weeks, 6 months and 1 year after surgery. | 
| Self registered physical activity in the app | minutes/day and minutes/week | 12 weeks, 6 to 18 weeks after surgery |