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Completed

NCT Number: NCT03480464

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

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.

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Key information

Conditions

Obesity Bariatric Surgery Behavior Behavior, Animal Body Fat Distribution Body Weight Body Weight Changes Eating Behavior Exercise Feeding Behavior Motor Activity Nutrition Disorders Nutritional and Metabolic Diseases Overnutrition Overweight Pathological Conditions, Signs and Symptoms Quality of Life Signs and Symptoms

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Vrinnevi Hospital

Norrköping, 603 79, Sweden

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

App-technology to increase physical activity

Behavioral

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

Primary outcomes

  1. 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

Secondary outcomes

  1. Body Mass Index

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

    BMI, kg/m2

  2. Body weight

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

    kg

  3. 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

  4. Fat free mass

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

    kg

  5. Muscle mass

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

    kg

  6. Total body water

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

    kg

  7. Hand grip

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

    kg

  8. Self registered physical activity in the app

    Time frame: 12 weeks, 6 to 18 weeks after surgery

    minutes/day and minutes/week

Other outcomes

  1. 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

  2. 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

  3. 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

  4. 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

  5. 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

  6. 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

  7. 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)

  8. 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)

  9. 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

  10. Hemoglobin (Hb)

    Time frame: Before surgery and 1 year after surgery

    g/L

  11. Iron status

    Time frame: Before surgery and 1 year after surgery

    µmol/L

  12. s-folate

    Time frame: Before surgery and 1 year after surgery

    nmol/L

  13. p-calcium

    Time frame: Before surgery and 1 year after surgery

    mmol/L

  14. s-albumin

    Time frame: Before surgery and 1 year after surgery

    g/L

  15. s-cobolamin

    Time frame: Before surgery and 1 year after surgery

    pmol/L

Sponsors and collaborators

Lead sponsor

Karolinska Institutet

Other

Collaborators

  • Linkoeping University
  • Vrinnevi Hospital

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2021
Study completion
2021
First posted
Mar 29, 2018
Registry last updated
Apr 1, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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