<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT04413812</url>
  </required_header>
  <id_info>
    <org_study_id>FREEBASE</org_study_id>
    <nct_id>NCT04413812</nct_id>
  </id_info>
  <brief_title>Fostering Exercise After Bariatric Surgery</brief_title>
  <acronym>FREEBASE</acronym>
  <official_title>Fostering Exercise After Bariatric Surgery</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Lia Bally</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Insel Gruppe AG, University Hospital Bern</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      While the benefits of engagement in regular physical activity after bariatric surgery has&#xD;
      been established in various studies, little is known about the effectiveness of an&#xD;
      interdisciplinary intervention including nutritional and psychological advice, hands-on&#xD;
      training experience and motivational education to promote long-term adherence to a&#xD;
      self-motivated active lifestyle in the bariatric surgery population.&#xD;
&#xD;
      This randomized pilot intervention study called Fostering Exercise After Bariatric Surgery&#xD;
      (FREEBASE) explores the efficacy of an interdisciplinary approach to promote physical&#xD;
      activity-related health competence and an active lifestyle after bariatric surgery.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Bariatric surgery is quickly emerging as a standard treatment for people with obesity stage&#xD;
      II and III (BMI ≥35 kg/m2) because of its beneficial long-term effects on body weight and&#xD;
      obesity-related comorbidities. In Switzerland, approximately 5,000 bariatric surgeries are&#xD;
      performed every year. There is a growing body of evidence demonstrating that engagement in&#xD;
      physical activity benefits the bariatric surgery population in many aspects. These entail the&#xD;
      prevention of surgery-induced metabolic complications such as sarcopenia and osteopenia on&#xD;
      the one hand, but also the mitigation against the commonly observed weight regain and relapse&#xD;
      of metabolic comorbidities. Despite these obvious health benefits, inactivity and poor health&#xD;
      literacy are common problems amongst people who underwent bariatric surgery. Although the&#xD;
      Swiss healthcare system offers well designed post-operative follow-up programmes, exercise is&#xD;
      currently not to being considered. Additionally the lower educational level of bariatric&#xD;
      surgery patients is a well known problem. Addressing physical activity-related health&#xD;
      competence and self-empowerment in this population currently remains an unmet need.&#xD;
&#xD;
      Previous studies investigating exercise interventions in the bariatric surgery population&#xD;
      have demonstrated efficacy on metabolic outcomes but also indicated that adherence wanes over&#xD;
      time. To overcome the challenge of changing lifestyle in a sustainable way, individuals need&#xD;
      to have a complex set of abilities, skills, knowledge, motivation and willingness. In&#xD;
      Germany, diverse models have been developed to describe this specific set of competences, all&#xD;
      inspired by the concept of health literacy, which is internationally recognised in research&#xD;
      and clinical practice.&#xD;
&#xD;
      Physical activity-related health competence comprises three components: (1) Movement&#xD;
      competence, enabling individuals to meet the movement-related requirements of physical&#xD;
      activities (e.g. motor abilities, motor skills for cycling or gymnastics) (2) control&#xD;
      competence for physical activity enabling people to gear their own activity to achieve&#xD;
      positive effects in health and well-being, and (3) physical activity-specific self-regulation&#xD;
      competence enabling individuals to be regularly active, which involves both motivational and&#xD;
      volitional factors. The relevance of physical activity-related health competence for the&#xD;
      promotion of an active lifestyle has been demonstrated in various studies in healthy and&#xD;
      physical inactive adults at metabolic risk. However, the concept has not yet been addressed&#xD;
      in the bariatric surgery population. The investigators therefore hypothesize, that targeting&#xD;
      the various components of physical activity-related health competence by means of a&#xD;
      comprehensive exercise programme has the potential to result in a more effective promotion of&#xD;
      physical activity in the bariatric surgery population, thereby benefitting their long-term&#xD;
      health and well-being.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">July 1, 2020</start_date>
  <completion_date type="Actual">April 23, 2021</completion_date>
  <primary_completion_date type="Actual">January 17, 2021</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <intervention_model_description>Randomized single-centre open-label clinical trial with two parallel groups. The randomization will be stratified according to age, sex, current BMI, surgical procedure, and educational level using a dedicated software.</intervention_model_description>
    <primary_purpose>Prevention</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change from baseline in physical activity-related health competence.</measure>
    <time_frame>The questionnaires will be completed at baseline, after completion of the exercise program (visit 2, at 10-12 weeks) and at the follow-up (visit 3, at 16-18 weeks).</time_frame>
    <description>The physical activity-related health competence will be assessed using items from different areas (self-efficacy, self-control, emotional attitudes, cognitive attitudes, motivational competence, control of physical load, affect regulation). A composite score will be calculated as the mean score of the individual areas. For each area, the mean score of its items assessed on a 5-point Likert scale ranging from 1 (does not apply at all) to 5 (does apply exactly) will be calculated.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Relative change from baseline in physical activity level.</measure>
    <time_frame>Physical activity will be measured during one week at baseline and during one week at follow-up (visit 3, at 16-18 weeks).</time_frame>
    <description>Physical activity level will be assessed using accelerometry and is defined as the overall daily mean acceleration (mg).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from baseline in self-reported physical activity.</measure>
    <time_frame>The questionnaires will be completed at baseline, after completion of the exercise program (visit 2, at 10-12 weeks) and at the follow-up (visit 3, at 16-18 weeks).</time_frame>
    <description>Self-reported physical activity will be assessed using the German Physical Activity, Exercise, and Sport Questionnaire &quot;Bewegungs- und Sportaktivität Fragebogen; BSA-F&quot;. This questionnaire asks for frequency and duration of daily physical activities such as walking, cycling, garden work, house work, caring for others in the last four weeks. The frequency and duration for each question are multiplied and the products are added up in an overall physical activity index (in minutes/week).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from baseline in self-reported sport and exercise activity.</measure>
    <time_frame>The questionnaires will be completed at baseline, after completion of the exercise program (visit 2, at 10-12 weeks) and at the follow-up (visit 3, at 16-18 weeks).</time_frame>
    <description>Self-reported sport and exercise activity will be assessed using the German Physical Activity, Exercise, and Sport Questionnaire &quot;Bewegungs- und Sportaktivität Fragebogen; BSA-F&quot;. This questionnaire includes questions about regular exercise and sport activities. People can indicate up to three exercise and sport activities and indicate frequency and duration in the last four weeks. The frequency and duration for the named exercise and sport activity are multiplied and the products are added up to an exercise and sport activity index (in minutes/week).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Absolute change in 6-min walking distance (m)</measure>
    <time_frame>The test will be conducted at baseline and at visit 2 (after 10-12 weeks).</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Absolute change in Time (s) in the &quot;Timed up and go&quot; test.</measure>
    <time_frame>The test will be conducted at baseline and at visit 2 (after 10-12 weeks).</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Absolute change in Time (s) in the &quot;Unilateral hip bridge&quot; test</measure>
    <time_frame>The test will be conducted at baseline and at visit 2 (after 10-12 weeks).</time_frame>
  </secondary_outcome>
  <other_outcome>
    <measure>Change from baseline in health status</measure>
    <time_frame>The questionnaires will be completed at baseline, after completion of the exercise program (visit 2, at 10-12 weeks) and at the follow-up (visit 3, at 16-18 weeks).</time_frame>
    <description>The health status will be assessed using the German questionnaire for health status assessment &quot;Allgemeiner Gesundheitszustand&quot;</description>
  </other_outcome>
  <other_outcome>
    <measure>Change from baseline in vitality.</measure>
    <time_frame>The questionnaires will be completed at baseline, after completion of the exercise program (visit 2, at 10-12 weeks) and at the follow-up (visit 3, at 16-18 weeks).</time_frame>
    <description>Vitality will be assessed using the German questionnaire &quot;Vitalitätsskala&quot; (&quot;subjective vitality scale&quot;) on a 7-point Likert scale ranging vom 1 (not applicable at all) to 7 (very applicable).</description>
  </other_outcome>
  <other_outcome>
    <measure>Change from baseline in self-concordance.</measure>
    <time_frame>The questionnaires will be completed at baseline, after completion of the exercise program (visit 2, at 10-12 weeks) and at the follow-up (visit 3, at 16-18 weeks).</time_frame>
    <description>The self-concordance will be assessed on a 6-point Likert scale ranging from 1 (does not apply at all) to 6 (applies exactly).</description>
  </other_outcome>
  <other_outcome>
    <measure>Change from baseline in the intention to perform physical activity.</measure>
    <time_frame>The questionnaires will be completed at baseline, after completion of the exercise program (visit 2, at 10-12 weeks) and at the follow-up (visit 3, at 16-18 weeks).</time_frame>
    <description>The intention to perform physical activity will be assessed on a 10-point Likert scale ranging from 1 (I have no such intention) to 10 (I have this intention very strongly).</description>
  </other_outcome>
  <other_outcome>
    <measure>Participant satisfaction.</measure>
    <time_frame>Within the first week after completion of the exercise program.</time_frame>
    <description>The satisfaction will be assessed using a self-designed feedback questionnaire. The overall satisfaction is assessed on a 5-point Likert scale ranging from 1 (not satisfied at all) to 5 (very satisfied).</description>
  </other_outcome>
  <other_outcome>
    <measure>Perception of usefulness of the program.</measure>
    <time_frame>Within the first week after completion of the exercise program.</time_frame>
    <description>The usefulness will be assessed on a 5-point Likert scale ranging from 1 (not useful at all) to 5 (very useful).</description>
  </other_outcome>
  <other_outcome>
    <measure>Change from baseline in self-regulation competence.</measure>
    <time_frame>The questionnaire will be completed at baseline, after completion of the exercise program (at 10-12 weeks) and at follow-up (at 16-18 weeks).</time_frame>
    <description>The self-regulation competence will be calculated as the mean score of the items &quot;self-efficacy&quot;, &quot;self-control&quot;, &quot;emotional attitudes&quot;, &quot;cognitive attitudes&quot;, and &quot;motivational competence&quot;. Each item is assessed on a 5-point Likert scale ranging from 1 (does not apply at all) to 5 (applies exactly).</description>
  </other_outcome>
  <other_outcome>
    <measure>Change from baseline in control competence</measure>
    <time_frame>The questionnaire will be completed at baseline, after completion of the exercise program (visit 2, at 10-12 weeks) and at follow-up (visit 3, at 16-18 weeks).</time_frame>
    <description>The control competence will be calculated as a mean score of the items &quot;control of physical load&quot; and &quot;affect regulation&quot;. Each item is assessed on a 5-point Likert scale ranging from 1 (does not apply at all) to 5 (applies exactly).</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">40</enrollment>
  <condition>Bariatric Surgery</condition>
  <condition>Physical Activity</condition>
  <arm_group>
    <arm_group_label>Experimental Group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The experimental group will participate in a 3-months training programme focusing on health competence related outcomes.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control Group</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>The control group does not participate in the exercise programme but undergoes identical outcome assessments.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>FREEBASE exercise programme</intervention_name>
    <description>The exercise programme will be initialized 1-10 months following bariatric surgery and last for 3 months. The programme will be mainly delivered in two groups consisting of 10-12 subjects each and will be held in the facilities of a fitness studio and remotely at home. The programme consists of 24 units (two per week, the lesson in the fitness studio lasting for 75 minutes and the remote lesson lasting for 45 minutes.This is due to the COVID-19-related social distancing restrictions. The intervention combines the following elements: a) exercise training in a group, b) interactive workshops on basic knowledge of training sciences and techniques of behavior change and c) an individual exercise counselling session.&#xD;
The programme will be medically supervised and the content will be taught and instructed by members of the research team qualified in exercise science and sports physiology.</description>
    <arm_group_label>Experimental Group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Aged ≥18 years&#xD;
&#xD;
          -  Bariatric surgery within the past 1-6 months according to the guidelines of the Swiss&#xD;
             Society for the Study of Morbid Obesity and Metabolic Disorders (SMOB)&#xD;
&#xD;
          -  Willingness to comply with study-related activities&#xD;
&#xD;
          -  Literate in German&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Incapacity to give informed consent&#xD;
&#xD;
          -  Contraindication to participation in the study exercise programme as judged by the&#xD;
             clinical investigator or treating physical&#xD;
&#xD;
          -  Physical or physiological condition likely to interfere with the normal conduct of the&#xD;
             study and interpretation of the study results as judged by the clinical investigator&#xD;
             or treating physical&#xD;
&#xD;
          -  Evidence of malnutrition as judged by the clinical investigator or treating physician&#xD;
&#xD;
          -  Pregnancy, planned pregnancy, or breast feeding (females of childbearing potential are&#xD;
             advice to use safe-contraception for up to 18 months post-bariatric surgery as part of&#xD;
             usual care)&#xD;
&#xD;
          -  Illicit or prescription drug abuse&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Lia Bally, MD, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University Hospital Bern &amp; University of Bern, Bern, Switzerland</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Department of Diabetes, Endocrinology, Clinical Nutrition and Metabolism, Inselspital, Bern University Hospital</name>
      <address>
        <city>Bern</city>
        <zip>3010</zip>
        <country>Switzerland</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Switzerland</country>
  </location_countries>
  <verification_date>April 2021</verification_date>
  <study_first_submitted>April 16, 2020</study_first_submitted>
  <study_first_submitted_qc>May 28, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 4, 2020</study_first_posted>
  <last_update_submitted>April 26, 2021</last_update_submitted>
  <last_update_submitted_qc>April 26, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">April 28, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>Insel Gruppe AG, University Hospital Bern</investigator_affiliation>
    <investigator_full_name>Lia Bally</investigator_full_name>
    <investigator_title>Professor</investigator_title>
  </responsible_party>
  <keyword>Training Intervention</keyword>
  <keyword>Health Competence</keyword>
  <keyword>Active Lifestyle</keyword>
  <keyword>Bariatric Surgery</keyword>
  <keyword>Lifestyle Modification</keyword>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT04413812
org study id: FREEBASE
nct id: NCT04413812
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
While the benefits of engagement in regular physical activity after bariatric surgery has
      been established in various studies, little is known about the effectiveness of an
      interdisciplinary intervention including nutritional and psychological advice, hands-on
      training experience and motivational education to promote long-term adherence to a
      self-motivated active lifestyle in the bariatric surgery population.

      This randomized pilot intervention study called Fostering Exercise After Bariatric Surgery
      (FREEBASE) explores the efficacy of an interdisciplinary approach to promote physical
      activity-related health competence and an active lifestyle after bariatric surgery.
Bariatric surgery is quickly emerging as a standard treatment for people with obesity stage
      II and III (BMI ≥35 kg/m2) because of its beneficial long-term effects on body weight and
      obesity-related comorbidities. In Switzerland, approximately 5,000 bariatric surgeries are
      performed every year. There is a growing body of evidence demonstrating that engagement in
      physical activity benefits the bariatric surgery population in many aspects. These entail the
      prevention of surgery-induced metabolic complications such as sarcopenia and osteopenia on
      the one hand, but also the mitigation against the commonly observed weight regain and relapse
      of metabolic comorbidities. Despite these obvious health benefits, inactivity and poor health
      literacy are common problems amongst people who underwent bariatric surgery. Although the
      Swiss healthcare system offers well designed post-operative follow-up programmes, exercise is
      currently not to being considered. Additionally the lower educational level of bariatric
      surgery patients is a well known problem. Addressing physical activity-related health
      competence and self-empowerment in this population currently remains an unmet need.

      Previous studies investigating exercise interventions in the bariatric surgery population
      have demonstrated efficacy on metabolic outcomes but also indicated that adherence wanes over
      time. To overcome the challenge of changing lifestyle in a sustainable way, individuals need
      to have a complex set of abilities, skills, knowledge, motivation and willingness. In
      Germany, diverse models have been developed to describe this specific set of competences, all
      inspired by the concept of health literacy, which is internationally recognised in research
      and clinical practice.

      Physical activity-related health competence comprises three components: (1) Movement
      competence, enabling individuals to meet the movement-related requirements of physical
      activities (e.g. motor abilities, motor skills for cycling or gymnastics) (2) control
      competence for physical activity enabling people to gear their own activity to achieve
      positive effects in health and well-being, and (3) physical activity-specific self-regulation
      competence enabling individuals to be regularly active, which involves both motivational and
      volitional factors. The relevance of physical activity-related health competence for the
      promotion of an active lifestyle has been demonstrated in various studies in healthy and
      physical inactive adults at metabolic risk. However, the concept has not yet been addressed
      in the bariatric surgery population. The investigators therefore hypothesize, that targeting
      the various components of physical activity-related health competence by means of a
      comprehensive exercise programme has the potential to result in a more effective promotion of
      physical activity in the bariatric surgery population, thereby benefitting their long-term
      health and well-being.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: Randomized single-centre open-label clinical trial with two parallel groups. The randomization will be stratified according to age, sex, current BMI, surgical procedure, and educational level using a dedicated software.
primary purpose: Prevention
masking: None (Open Label)
measure: Change from baseline in physical activity-related health competence.
time frame: The questionnaires will be completed at baseline, after completion of the exercise program (visit 2, at 10-12 weeks) and at the follow-up (visit 3, at 16-18 weeks).
description: The physical activity-related health competence will be assessed using items from different areas (self-efficacy, self-control, emotional attitudes, cognitive attitudes, motivational competence, control of physical load, affect regulation). A composite score will be calculated as the mean score of the individual areas. For each area, the mean score of its items assessed on a 5-point Likert scale ranging from 1 (does not apply at all) to 5 (does apply exactly) will be calculated.
measure: Relative change from baseline in physical activity level.
time frame: Physical activity will be measured during one week at baseline and during one week at follow-up (visit 3, at 16-18 weeks).
description: Physical activity level will be assessed using accelerometry and is defined as the overall daily mean acceleration (mg).
measure: Change from baseline in self-reported physical activity.
time frame: The questionnaires will be completed at baseline, after completion of the exercise program (visit 2, at 10-12 weeks) and at the follow-up (visit 3, at 16-18 weeks).
description: Self-reported physical activity will be assessed using the German Physical Activity, Exercise, and Sport Questionnaire "Bewegungs- und Sportaktivität Fragebogen; BSA-F". This questionnaire asks for frequency and duration of daily physical activities such as walking, cycling, garden work, house work, caring for others in the last four weeks. The frequency and duration for each question are multiplied and the products are added up in an overall physical activity index (in minutes/week).
measure: Change from baseline in self-reported sport and exercise activity.
time frame: The questionnaires will be completed at baseline, after completion of the exercise program (visit 2, at 10-12 weeks) and at the follow-up (visit 3, at 16-18 weeks).
description: Self-reported sport and exercise activity will be assessed using the German Physical Activity, Exercise, and Sport Questionnaire "Bewegungs- und Sportaktivität Fragebogen; BSA-F". This questionnaire includes questions about regular exercise and sport activities. People can indicate up to three exercise and sport activities and indicate frequency and duration in the last four weeks. The frequency and duration for the named exercise and sport activity are multiplied and the products are added up to an exercise and sport activity index (in minutes/week).
measure: Absolute change in 6-min walking distance (m)
time frame: The test will be conducted at baseline and at visit 2 (after 10-12 weeks).
measure: Absolute change in Time (s) in the "Timed up and go" test.
time frame: The test will be conducted at baseline and at visit 2 (after 10-12 weeks).
measure: Absolute change in Time (s) in the "Unilateral hip bridge" test
time frame: The test will be conducted at baseline and at visit 2 (after 10-12 weeks).
measure: Change from baseline in health status
time frame: The questionnaires will be completed at baseline, after completion of the exercise program (visit 2, at 10-12 weeks) and at the follow-up (visit 3, at 16-18 weeks).
description: The health status will be assessed using the German questionnaire for health status assessment "Allgemeiner Gesundheitszustand"
measure: Change from baseline in vitality.
time frame: The questionnaires will be completed at baseline, after completion of the exercise program (visit 2, at 10-12 weeks) and at the follow-up (visit 3, at 16-18 weeks).
description: Vitality will be assessed using the German questionnaire "Vitalitätsskala" ("subjective vitality scale") on a 7-point Likert scale ranging vom 1 (not applicable at all) to 7 (very applicable).
measure: Change from baseline in self-concordance.
time frame: The questionnaires will be completed at baseline, after completion of the exercise program (visit 2, at 10-12 weeks) and at the follow-up (visit 3, at 16-18 weeks).
description: The self-concordance will be assessed on a 6-point Likert scale ranging from 1 (does not apply at all) to 6 (applies exactly).
measure: Change from baseline in the intention to perform physical activity.
time frame: The questionnaires will be completed at baseline, after completion of the exercise program (visit 2, at 10-12 weeks) and at the follow-up (visit 3, at 16-18 weeks).
description: The intention to perform physical activity will be assessed on a 10-point Likert scale ranging from 1 (I have no such intention) to 10 (I have this intention very strongly).
measure: Participant satisfaction.
time frame: Within the first week after completion of the exercise program.
description: The satisfaction will be assessed using a self-designed feedback questionnaire. The overall satisfaction is assessed on a 5-point Likert scale ranging from 1 (not satisfied at all) to 5 (very satisfied).
measure: Perception of usefulness of the program.
time frame: Within the first week after completion of the exercise program.
description: The usefulness will be assessed on a 5-point Likert scale ranging from 1 (not useful at all) to 5 (very useful).
measure: Change from baseline in self-regulation competence.
time frame: The questionnaire will be completed at baseline, after completion of the exercise program (at 10-12 weeks) and at follow-up (at 16-18 weeks).
description: The self-regulation competence will be calculated as the mean score of the items "self-efficacy", "self-control", "emotional attitudes", "cognitive attitudes", and "motivational competence". Each item is assessed on a 5-point Likert scale ranging from 1 (does not apply at all) to 5 (applies exactly).
measure: Change from baseline in control competence
time frame: The questionnaire will be completed at baseline, after completion of the exercise program (visit 2, at 10-12 weeks) and at follow-up (visit 3, at 16-18 weeks).
description: The control competence will be calculated as a mean score of the items "control of physical load" and "affect regulation". Each item is assessed on a 5-point Likert scale ranging from 1 (does not apply at all) to 5 (applies exactly).
arm group label: Experimental Group
arm group type: Experimental
description: The experimental group will participate in a 3-months training programme focusing on health competence related outcomes.
arm group label: Control Group
arm group type: No Intervention
description: The control group does not participate in the exercise programme but undergoes identical outcome assessments.
intervention type: Behavioral
intervention name: FREEBASE exercise programme
description: The exercise programme will be initialized 1-10 months following bariatric surgery and last for 3 months. The programme will be mainly delivered in two groups consisting of 10-12 subjects each and will be held in the facilities of a fitness studio and remotely at home. The programme consists of 24 units (two per week, the lesson in the fitness studio lasting for 75 minutes and the remote lesson lasting for 45 minutes.This is due to the COVID-19-related social distancing restrictions. The intervention combines the following elements: a) exercise training in a group, b) interactive workshops on basic knowledge of training sciences and techniques of behavior change and c) an individual exercise counselling session.
The programme will be medically supervised and the content will be taught and instructed by members of the research team qualified in exercise science and sports physiology.
arm group label: Experimental Group
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Lia Bally, MD, PhD
role: Principal Investigator
affiliation: University Hospital Bern & University of Bern, Bern, Switzerland
facility: 
country: Switzerland
responsible party type: Sponsor-Investigator
investigator affiliation: Insel Gruppe AG, University Hospital Bern
investigator full name: Lia Bally
investigator title: Professor
sharing ipd: No