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

Primary Purpose

Obesity, Bariatric Surgery, Exercise

Status
Completed
Phase
Not Applicable
Locations
Sweden
Study Type
Interventional
Intervention
App-technology to increase physical activity
Sponsored by
Karolinska Institutet
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Obesity

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Vrinnevi Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

App-technology group

Control group

Arm Description

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.

The control group will receive standard information about the benefit of physical activity after surgery.

Outcomes

Primary Outcome Measures

Change in Physical activity level
counts/min from accelerometers

Secondary Outcome Measures

Body Mass Index
BMI, kg/m2
Body weight
kg
Percent Body Fat
Percent body fat of total body weight
Fat free mass
kg
Muscle mass
kg
Total body water
kg
Hand grip
kg
Self registered physical activity in the app
minutes/day and minutes/week

Full Information

First Posted
September 6, 2017
Last Updated
March 31, 2022
Sponsor
Karolinska Institutet
Collaborators
Vrinnevi Hospital, Linkoeping University
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1. Study Identification

Unique Protocol Identification Number
NCT03480464
Brief Title
App-technology to Improve the Level of Physical Activity After Bariatric Surgery
Official Title
App-technology to Increase Physical Activity After Bariatric Surgery: A Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
March 2022
Overall Recruitment Status
Completed
Study Start Date
November 16, 2017 (Actual)
Primary Completion Date
September 30, 2021 (Actual)
Study Completion Date
September 30, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Karolinska Institutet
Collaborators
Vrinnevi Hospital, Linkoeping University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity, Bariatric Surgery, Exercise, Quality of Life, Eating Behavior, Body Fat Distribution, Body Weight Changes

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
158 (Actual)

8. Arms, Groups, and Interventions

Arm Title
App-technology group
Arm Type
Experimental
Arm Description
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.
Arm Title
Control group
Arm Type
No Intervention
Arm Description
The control group will receive standard information about the benefit of physical activity after surgery.
Intervention Type
Behavioral
Intervention Name(s)
App-technology to increase physical activity
Other Intervention Name(s)
PromMera
Intervention Description
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
Primary Outcome Measure Information:
Title
Change in Physical activity level
Description
counts/min from accelerometers
Time Frame
Before surgery and 18 weeks, 6 months, 1 year, and 2 years after surgery.
Secondary Outcome Measure Information:
Title
Body Mass Index
Description
BMI, kg/m2
Time Frame
Before surgery, 6 weeks(intervention start) and 18 weeks, 6 months and 1 year after surgery.
Title
Body weight
Description
kg
Time Frame
Before surgery, 6 weeks(intervention start) and 18 weeks, 6 months, 1 year, and 2 years after surgery.
Title
Percent Body Fat
Description
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.
Title
Fat free mass
Description
kg
Time Frame
Before surgery, 6 weeks(intervention start) and 18 weeks, 6 months and 1 year after surgery.
Title
Muscle mass
Description
kg
Time Frame
Before surgery, 6 weeks(intervention start) and 18 weeks, 6 months and 1 year after surgery.
Title
Total body water
Description
kg
Time Frame
Before surgery, 6 weeks(intervention start) and 18 weeks, 6 months and 1 year after surgery.
Title
Hand grip
Description
kg
Time Frame
Before surgery, 6 weeks(intervention start) and 18 weeks, 6 months and 1 year after surgery.
Title
Self registered physical activity in the app
Description
minutes/day and minutes/week
Time Frame
12 weeks, 6 to 18 weeks after surgery
Other Pre-specified Outcome Measures:
Title
Change in eating behavior using the TFEQ-R21 questionnaire
Description
Eating behavior
Time Frame
Before surgery and 18 weeks, 6 months, 1 year, and 2 years after surgery.
Title
Change in Quality of life using the SF35 questionnaire
Description
Health related Quality of LIfe
Time Frame
Before surgery and 18 weeks, 6 months, 1 year, and 2 years after surgery.
Title
Change in co morbidity, before surgery compared to 1 year and 2 years after surgery.
Description
Number of co morbidities
Time Frame
Before and 1 year and 2 years after surgery
Title
Change in supplementary vitamin intake adherence according to to the MARS-5 scale
Description
Total MARS-5 score, 5-items, 5-point Likert-scale
Time Frame
18 weeks (after surgery) and 1 year after surgery
Title
Change in supplementary vitamin intake adherence using registry data
Description
Medication possession ratio, i.e. proportion of fulfilled prescriptions
Time Frame
18 weeks (after surgery) and 1 year after surgery
Title
Change in beliefs and attitude to medication according to the Brief Medication Questionnaire
Description
Total BMQ-score, 10 items, 5-point Likert-scale
Time Frame
18 weeks (after surgery) and 1 year after surgery
Title
Change in sleeping habits
Description
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.
Title
Change in dietary intake and eating habits
Description
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.
Title
Change in symptoms related to urinary incontinence or prolapse
Description
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.
Title
Hemoglobin (Hb)
Description
g/L
Time Frame
Before surgery and 1 year after surgery
Title
Iron status
Description
µmol/L
Time Frame
Before surgery and 1 year after surgery
Title
s-folate
Description
nmol/L
Time Frame
Before surgery and 1 year after surgery
Title
p-calcium
Description
mmol/L
Time Frame
Before surgery and 1 year after surgery
Title
s-albumin
Description
g/L
Time Frame
Before surgery and 1 year after surgery
Title
s-cobolamin
Description
pmol/L
Time Frame
Before surgery and 1 year after surgery

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ylva Trolle Lagerros, Md,PhD
Organizational Affiliation
Karolinska Institutet
Official's Role
Principal Investigator
Facility Information:
Facility Name
Vrinnevi Hospital
City
Norrköping
ZIP/Postal Code
603 79
Country
Sweden

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
36050801
Citation
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.
Results Reference
derived
PubMed Identifier
32795990
Citation
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.
Results Reference
derived

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

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