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

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

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.

Study Overview

• Status: Completed
• Conditions: Quality of Life; Obesity; Body Weight Changes; Exercise; Eating Behavior; Bariatric Surgery; Body Fat Distribution
• Intervention / Treatment: Behavioral: App-technology to increase physical activity

• Study Type: Interventional
• Enrollment (Actual): 158
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Sweden
  • Norrköping, Sweden, 603 79
    • Vrinnevi Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: SUPPORTIVE_CARE
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: App-technology group; 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 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; Other Names: PromMera
NO_INTERVENTION: Control group; The control group will receive standard information about the benefit of physical activity after surgery.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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.

Secondary Outcome Measures

Outcome Measure	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	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

Other Outcome Measures

Outcome Measure	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	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

Collaborators and Investigators

• Sponsor: Karolinska Institutet
• Collaborators: Linkoeping University; Vrinnevi Hospital
• Investigators: Principal Investigator: Ylva Trolle Lagerros, Md,PhD, Karolinska Institutet

Publications and helpful links

General Publications

• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (ACTUAL): November 16, 2017
• Primary Completion (ACTUAL): September 30, 2021
• Study Completion (ACTUAL): September 30, 2021

Study Registration Dates

• First Submitted: September 6, 2017
• First Submitted That Met QC Criteria: March 21, 2018
• First Posted (ACTUAL): March 29, 2018

Study Record Updates

• Last Update Posted (ACTUAL): April 1, 2022
• Last Update Submitted That Met QC Criteria: March 31, 2022
• Last Verified: March 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Body Weight; Body Weight Changes
• Other Study ID Numbers: Dnr: 2016/1259-31/4

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No