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| Name | Class |
|---|---|
| Vrinnevi Hospital | OTHER |
| Linkoeping University | OTHER_GOV |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| App-technology group | Experimental | 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. |
|
| Control group | No Intervention | The control group will receive standard information about the benefit of physical activity after surgery. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| App-technology to increase physical activity | Behavioral | 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 |
| 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. |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Change in eating behavior using the TFEQ-R21 questionnaire | Eating behavior | Before surgery and 18 weeks, 6 months, 1 year, and 2 years after surgery. |
| Change in Quality of life using the SF35 questionnaire |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ylva Trolle Lagerros, Md,PhD | Karolinska Institutet | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Vrinnevi Hospital | Norrköping | 603 79 | Sweden |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37500930 | Derived | 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. | |
| 36050801 | Derived |
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| ID | Term |
|---|---|
| D009765 | Obesity |
| D009043 | Motor Activity |
| D005247 | Feeding Behavior |
| D001836 | Body Weight Changes |
| ID | Term |
|---|---|
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
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|
| 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 |
Health related Quality of LIfe
| 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 | 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 | 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 | 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 | 18 weeks (after surgery) and 1 year after surgery |
| Change in sleeping habits | Assessed using a modified 13-item Karolinska Sleep questionnaire (KSQ) | 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) | 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 | Before surgery and 18 weeks, 6 months, 1 year, and 2 years after surgery. |
| Hemoglobin (Hb) | g/L | Before surgery and 1 year after surgery |
| Iron status | µmol/L | Before surgery and 1 year after surgery |
| s-folate | nmol/L | Before surgery and 1 year after surgery |
| p-calcium | mmol/L | Before surgery and 1 year after surgery |
| s-albumin | g/L | Before surgery and 1 year after surgery |
| s-cobolamin | pmol/L | Before surgery and 1 year after surgery |
| 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. |
| 32795990 | Derived | 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. |
| D001835 |
| Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001519 | Behavior |
| D001522 | Behavior, Animal |