Bariatric Surgery, Body Fat Distribution, Body Weight Changes, Eating Behavior, Exercise, Obesity, Quality of Life
Conditions
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.
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
Sponsors
Vrinnevi Hospital
Linkoeping University
Karolinska Institutet
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Physical activity level | Before surgery and 18 weeks, 6 months, 1 year, and 2 years after surgery. | counts/min from accelerometers |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Body weight | Before surgery, 6 weeks(intervention start) and 18 weeks, 6 months, 1 year, and 2 years after surgery. | kg |
| Percent Body Fat | Before surgery, 6 weeks(intervention start) and 18 weeks, 6 months and 1 year after surgery. | Percent body fat of total body weight |
| Fat free mass | Before surgery, 6 weeks(intervention start) and 18 weeks, 6 months and 1 year after surgery. | kg |
| Body Mass Index | Before surgery, 6 weeks(intervention start) and 18 weeks, 6 months and 1 year after surgery. | BMI, kg/m2 |
| Total body water | Before surgery, 6 weeks(intervention start) and 18 weeks, 6 months and 1 year after surgery. | kg |
| Hand grip | Before surgery, 6 weeks(intervention start) and 18 weeks, 6 months and 1 year after surgery. | kg |
| Self registered physical activity in the app | 12 weeks, 6 to 18 weeks after surgery | minutes/day and minutes/week |
| Muscle mass | Before surgery, 6 weeks(intervention start) and 18 weeks, 6 months and 1 year after surgery. | kg |
Other
| Measure | Time frame | Description |
|---|---|---|
| Hemoglobin (Hb) | Before surgery and 1 year after surgery | g/L |
| Iron status | Before surgery and 1 year after surgery | µmol/L |
| s-folate | Before surgery and 1 year after surgery | nmol/L |
| Change in eating behavior using the TFEQ-R21 questionnaire | Before surgery and 18 weeks, 6 months, 1 year, and 2 years after surgery. | Eating behavior |
| s-albumin | Before surgery and 1 year after surgery | g/L |
| s-cobolamin | Before surgery and 1 year after surgery | pmol/L |
| p-calcium | Before surgery and 1 year after surgery | mmol/L |
| Change in Quality of life using the SF35 questionnaire | Before surgery and 18 weeks, 6 months, 1 year, and 2 years after surgery. | Health related Quality of LIfe |
| Change in co morbidity, before surgery compared to 1 year and 2 years after surgery. | Before and 1 year and 2 years after surgery | Number of co morbidities |
| Change in supplementary vitamin intake adherence according to to the MARS-5 scale | 18 weeks (after surgery) and 1 year after surgery | Total MARS-5 score, 5-items, 5-point Likert-scale |
| Change in supplementary vitamin intake adherence using registry data | 18 weeks (after surgery) and 1 year after surgery | Medication possession ratio, i.e. proportion of fulfilled prescriptions |
| Change in beliefs and attitude to medication according to the Brief Medication Questionnaire | 18 weeks (after surgery) and 1 year after surgery | Total BMQ-score, 10 items, 5-point Likert-scale |
| Change in sleeping habits | Before surgery and 18 weeks, 6 months, 1 year, and 2 years after surgery. | Assessed using a modified 13-item Karolinska Sleep questionnaire (KSQ) |
| Change in dietary intake and eating habits | Before surgery and 6 months, 1 year, and 2 years after surgery. | Macro- and micro-nutrient intake assessed using a 94 item food frequency questionnaire (FFQ) |
| Change in symptoms related to urinary incontinence or prolapse | Before surgery and 18 weeks, 6 months, 1 year, and 2 years after surgery. | Assessed using six questions based on the International Consultation on Incontinence Questionnaire |
Countries
Sweden
Outcome results
None listed