An interventional study of App-technology to increase physical activity in Obesity, Bariatric Surgery and Exercise, sponsored by Karolinska Institutet. Completed at 1 site in Sweden. Open to participants aged 18 Years to 60 Years. Per ClinicalTrials.gov, last updated 2022-04-01.
Sponsored by Karolinska Institutet · Not applicable, Interventional, and Supportive care
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.
11,522 studies on the registry are indexed under Obesity; 2,033 are open to participants now.
This study's enrollment of 158 is above the median of 67 across 9,006 interventional studies indexed under Obesity.
Browse Obesity studies →Karolinska Institutet is the lead sponsor of 1,148 studies on the registry; 276 are open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
The control group will receive standard information about the benefit of physical activity after surgery.
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
Also known as: PromMera
Change in Physical activity level
counts/min from accelerometers
Time frame: Before surgery and 18 weeks, 6 months, 1 year, and 2 years after surgery.
Body Mass Index
BMI, kg/m2
Time frame: Before surgery, 6 weeks(intervention start) and 18 weeks, 6 months and 1 year after surgery.
Body weight
kg
Time frame: 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
Time frame: Before surgery, 6 weeks(intervention start) and 18 weeks, 6 months and 1 year after surgery.
Fat free mass
kg
Time frame: Before surgery, 6 weeks(intervention start) and 18 weeks, 6 months and 1 year after surgery.
Muscle mass
kg
Time frame: Before surgery, 6 weeks(intervention start) and 18 weeks, 6 months and 1 year after surgery.
Total body water
kg
Time frame: Before surgery, 6 weeks(intervention start) and 18 weeks, 6 months and 1 year after surgery.
Hand grip
kg
Time frame: 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
Time frame: 12 weeks, 6 to 18 weeks after surgery
Change in eating behavior using the TFEQ-R21 questionnaire
Eating behavior
Time frame: Before surgery and 18 weeks, 6 months, 1 year, and 2 years after surgery.
Change in Quality of life using the SF35 questionnaire
Health related Quality of LIfe
Time frame: 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.
Number of co morbidities
Time frame: Before and 1 year and 2 years after surgery
Change in supplementary vitamin intake adherence according to to the MARS-5 scale
Total MARS-5 score, 5-items, 5-point Likert-scale
Time frame: 18 weeks (after surgery) and 1 year after surgery
Change in supplementary vitamin intake adherence using registry data
Medication possession ratio, i.e. proportion of fulfilled prescriptions
Time frame: 18 weeks (after surgery) and 1 year after surgery
Change in beliefs and attitude to medication according to the Brief Medication Questionnaire
Total BMQ-score, 10 items, 5-point Likert-scale
Time frame: 18 weeks (after surgery) and 1 year after surgery
Change in sleeping habits
Assessed using a modified 13-item Karolinska Sleep questionnaire (KSQ)
Time frame: Before surgery and 18 weeks, 6 months, 1 year, and 2 years after surgery.
Change in dietary intake and eating habits
Macro- and micro-nutrient intake assessed using a 94 item food frequency questionnaire (FFQ)
Time frame: Before surgery and 6 months, 1 year, and 2 years after surgery.
Change in symptoms related to urinary incontinence or prolapse
Assessed using six questions based on the International Consultation on Incontinence Questionnaire
Time frame: Before surgery and 18 weeks, 6 months, 1 year, and 2 years after surgery.
Hemoglobin (Hb)
g/L
Time frame: Before surgery and 1 year after surgery
Iron status
µmol/L
Time frame: Before surgery and 1 year after surgery
s-folate
nmol/L
Time frame: Before surgery and 1 year after surgery
p-calcium
mmol/L
Time frame: Before surgery and 1 year after surgery
s-albumin
g/L
Time frame: Before surgery and 1 year after surgery
s-cobolamin
pmol/L
Time frame: Before surgery and 1 year after surgery
Plan to share: No
This study is completed, as verified in Mar 2022. You cannot join it, but the record below documents what was studied.
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