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

March 31, 2022 updated by: Ylva Trolle Lagerros, Karolinska Institutet

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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
158

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Change in Physical activity level
Time Frame: Before surgery and 18 weeks, 6 months, 1 year, and 2 years after surgery.
counts/min from accelerometers
Before surgery and 18 weeks, 6 months, 1 year, and 2 years after surgery.

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Body Mass Index
Time Frame: Before surgery, 6 weeks(intervention start) and 18 weeks, 6 months and 1 year after surgery.
BMI, kg/m2
Before surgery, 6 weeks(intervention start) and 18 weeks, 6 months and 1 year after surgery.
Body weight
Time Frame: Before surgery, 6 weeks(intervention start) and 18 weeks, 6 months, 1 year, and 2 years after surgery.
kg
Before surgery, 6 weeks(intervention start) and 18 weeks, 6 months, 1 year, and 2 years after surgery.
Percent Body Fat
Time Frame: Before surgery, 6 weeks(intervention start) and 18 weeks, 6 months and 1 year after surgery.
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
Time Frame: Before surgery, 6 weeks(intervention start) and 18 weeks, 6 months and 1 year after surgery.
kg
Before surgery, 6 weeks(intervention start) and 18 weeks, 6 months and 1 year after surgery.
Muscle mass
Time Frame: Before surgery, 6 weeks(intervention start) and 18 weeks, 6 months and 1 year after surgery.
kg
Before surgery, 6 weeks(intervention start) and 18 weeks, 6 months and 1 year after surgery.
Total body water
Time Frame: Before surgery, 6 weeks(intervention start) and 18 weeks, 6 months and 1 year after surgery.
kg
Before surgery, 6 weeks(intervention start) and 18 weeks, 6 months and 1 year after surgery.
Hand grip
Time Frame: Before surgery, 6 weeks(intervention start) and 18 weeks, 6 months and 1 year after surgery.
kg
Before surgery, 6 weeks(intervention start) and 18 weeks, 6 months and 1 year after surgery.
Self registered physical activity in the app
Time Frame: 12 weeks, 6 to 18 weeks after surgery
minutes/day and minutes/week
12 weeks, 6 to 18 weeks after surgery

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change in eating behavior using the TFEQ-R21 questionnaire
Time Frame: Before surgery and 18 weeks, 6 months, 1 year, and 2 years after surgery.
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
Time Frame: Before surgery and 18 weeks, 6 months, 1 year, and 2 years after surgery.
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.
Time Frame: Before and 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
Time Frame: 18 weeks (after surgery) and 1 year after surgery
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
Time Frame: 18 weeks (after surgery) and 1 year after surgery
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
Time Frame: 18 weeks (after surgery) and 1 year after surgery
Total BMQ-score, 10 items, 5-point Likert-scale
18 weeks (after surgery) and 1 year after surgery
Change in sleeping habits
Time Frame: Before surgery and 18 weeks, 6 months, 1 year, and 2 years after surgery.
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
Time Frame: 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)
Before surgery and 6 months, 1 year, and 2 years after surgery.
Change in symptoms related to urinary incontinence or prolapse
Time Frame: 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
Before surgery and 18 weeks, 6 months, 1 year, and 2 years after surgery.
Hemoglobin (Hb)
Time Frame: Before surgery and 1 year after surgery
g/L
Before surgery and 1 year after surgery
Iron status
Time Frame: Before surgery and 1 year after surgery
µmol/L
Before surgery and 1 year after surgery
s-folate
Time Frame: Before surgery and 1 year after surgery
nmol/L
Before surgery and 1 year after surgery
p-calcium
Time Frame: Before surgery and 1 year after surgery
mmol/L
Before surgery and 1 year after surgery
s-albumin
Time Frame: Before surgery and 1 year after surgery
g/L
Before surgery and 1 year after surgery
s-cobolamin
Time Frame: Before surgery and 1 year after surgery
pmol/L
Before surgery and 1 year after surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Karolinska Institutet

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Linkoeping University
Vrinnevi Hospital

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Ylva Trolle Lagerros, Md,PhD, Karolinska Institutet

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 16, 2017

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 30, 2021

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 30, 2021

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 6, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 21, 2018

First Posted (ACTUAL)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 29, 2018

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 1, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 31, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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