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

Obesity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03480464
• Other study ID #: Dnr: 2016/1259-31/4
• Status: Completed
• Phase: N/A
• Start date: November 16, 2017
• Est. completion date: September 30, 2021

Study information

• Verified date: March 2022
• Source: Karolinska Institutet
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 158
• Est. completion date: September 30, 2021
• Est. primary completion date: September 30, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

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

Intervention

Behavioral:
• App-technology to increase physical activity
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

Locations

Country	Name	City	State
Sweden	Vrinnevi Hospital	Norrköping

Sponsors (3)

Lead Sponsor	Collaborator
Karolinska Institutet	Linkoeping University, Vrinnevi Hospital

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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.
Other	Change in Quality of life using the SF35 questionnaire	Health related Quality of LIfe	Before surgery and 18 weeks, 6 months, 1 year, and 2 years after surgery.
Other	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
Other	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
Other	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
Other	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
Other	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.
Other	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.
Other	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.
Other	Hemoglobin (Hb)	g/L	Before surgery and 1 year after surgery
Other	Iron status	µmol/L	Before surgery and 1 year after surgery
Other	s-folate	nmol/L	Before surgery and 1 year after surgery
Other	p-calcium	mmol/L	Before surgery and 1 year after surgery
Other	s-albumin	g/L	Before surgery and 1 year after surgery
Other	s-cobolamin	pmol/L	Before surgery and 1 year after surgery
Primary	Change in Physical activity level	counts/min from accelerometers	Before surgery and 18 weeks, 6 months, 1 year, and 2 years after surgery.
Secondary	Body Mass Index	BMI, kg/m2	Before surgery, 6 weeks(intervention start) and 18 weeks, 6 months and 1 year after surgery.
Secondary	Body weight	kg	Before surgery, 6 weeks(intervention start) and 18 weeks, 6 months, 1 year, and 2 years after surgery.
Secondary	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.
Secondary	Fat free mass	kg	Before surgery, 6 weeks(intervention start) and 18 weeks, 6 months and 1 year after surgery.
Secondary	Muscle mass	kg	Before surgery, 6 weeks(intervention start) and 18 weeks, 6 months and 1 year after surgery.
Secondary	Total body water	kg	Before surgery, 6 weeks(intervention start) and 18 weeks, 6 months and 1 year after surgery.
Secondary	Hand grip	kg	Before surgery, 6 weeks(intervention start) and 18 weeks, 6 months and 1 year after surgery.
Secondary	Self registered physical activity in the app	minutes/day and minutes/week	12 weeks, 6 to 18 weeks after surgery