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ObesityNCT03480464

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

A study testing App-technology to increase physical activity in people with Obesity and Bariatric Surgery, run by Karolinska Institutet at 1 site in Sweden.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 18 to 60 years
Conditions the study is for
Obesity, Bariatric Surgery, Exercise
What is being tested?
App-technology to increase physical activity
Could I receive a placebo?
No, everyone receives an active treatment
How many people
158 participants
Where
1 siteSweden
Study dates
16 Nov 2017to 30 Sep 2021
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 60 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

  • 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

Who cannot join

  • Disability preventing daily walking

Trial locations and contacts

1 site in 1 country.

Sweden1 site

  • Vrinnevi Hospital

    Norrköping, 603 79

Other trials in Sweden

About this study

Official title: 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.

Being tested
App-technology to increase physical activity
Medical subject headings
Obesity, Motor Activity, Feeding Behavior, Body Weight Changes

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • App-technology to increase physical activityBehavioural

    Also called PromMera

    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

Study groups in NCT03480464
Study groupRoleWhat they receive
App-technology groupExperimentalApp-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.
Receives: Behavioral: App-technology to increase physical activity
Control groupNo interventionThe control group will receive standard information about the benefit of physical activity after surgery.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in Physical activity level

    counts/min from accelerometers

    Measured: Before surgery and 18 weeks, 6 months, 1 year, and 2 years after surgery.

Secondary outcomes (8)

  1. Body Mass Index

    BMI, kg/m2

    Measured: Before surgery, 6 weeks(intervention start) and 18 weeks, 6 months and 1 year after surgery.

  2. Body weight

    kg

    Measured: Before surgery, 6 weeks(intervention start) and 18 weeks, 6 months, 1 year, and 2 years after surgery.

  3. Percent Body Fat

    Percent body fat of total body weight

    Measured: Before surgery, 6 weeks(intervention start) and 18 weeks, 6 months and 1 year after surgery.

  4. Fat free mass

    kg

    Measured: Before surgery, 6 weeks(intervention start) and 18 weeks, 6 months and 1 year after surgery.

  5. Muscle mass

    kg

    Measured: Before surgery, 6 weeks(intervention start) and 18 weeks, 6 months and 1 year after surgery.

  6. Total body water

    kg

    Measured: Before surgery, 6 weeks(intervention start) and 18 weeks, 6 months and 1 year after surgery.

  7. Hand grip

    kg

    Measured: Before surgery, 6 weeks(intervention start) and 18 weeks, 6 months and 1 year after surgery.

  8. Self registered physical activity in the app

    minutes/day and minutes/week

    Measured: 12 weeks, 6 to 18 weeks after surgery

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 Mar 2018
  2. Study start16 Nov 2017
  3. Primary completion30 Sep 2021
  4. Study completion30 Sep 2021

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
158 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03480464
Sponsor's protocol ID
Dnr: 2016/1259-31/4
Status last verified
Mar 2022
First submitted
6 Sep 2017
Last updated
1 Apr 2022
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 37500930

  • 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.

    PubMed 36050801

  • 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.

    PubMed 32795990

Questions about this trial

What is this clinical trial studying?

A study testing App-technology to increase physical activity in people with Obesity and Bariatric Surgery, run by Karolinska Institutet at 1 site in Sweden.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 1 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in Physical activity level (time frame: Before surgery and 18 weeks, 6 months, 1 year, and 2 years after surgery.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03480464, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Apr 2022.

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