xml: <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/NCT05997771</url>
    </required_header>
    <id_info>
      <org_study_id>PNA-ORIGINATE</org_study_id>
      <nct_id>NCT05997771</nct_id>
    </id_info>
    <brief_title>A Personal Nutrition Advisor to Assist Remote Dietary Counselling for Weight Loss and Maintenance</brief_title>
    <acronym>PNA-ORIGINATE</acronym>
    <official_title>A Personal Nutrition Advisor to Assist Remote Dietary Counselling for Weight Loss and Maintenance</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>
        The purpose of the study is to assess the usability of the PNA and satisfaction with the&#xD;
        treatment within the framework of usual care remote nutritional counselling for&#xD;
        GLP-1-supported weight management and collect pilot data on its potential to support weight&#xD;
        loss.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        The global prevalence of obesity and overweight is increasing and persistently drives global&#xD;
        mortality and morbidity.As overweight and obesity are the result of an imbalance between&#xD;
        energy intake and energy use, achieving a negative energy balance build the foundation for&#xD;
        weight loss. Whilst dietary modification as a standalone procedure often fail in achieving or&#xD;
        maintaining weight loss, the recent advent of supportive Glucagon-like Peptide-1 (GLP-1)&#xD;
        based pharmacotherapies have greatly changed the landscape.Dietary counselling help people on&#xD;
        GLP-1 based treatment reaching their individual weight goals and continued reimbursement of&#xD;
        medication costs. However, nutritional advice provided by dietitians is often generic, not&#xD;
        sufficiently aligned to individual weight loss trajectories.&#xD;
  &#xD;
        The &quot;Personal Nutrition Advisor&quot; (PNA) is a decision support tool which is built upon an&#xD;
        interpretable weight prediction model based on the energy balance equation (energy intake is&#xD;
        a function of recorded dietary intake and a latent part dependent on observed weight changes,&#xD;
        whereas energy expenditure is a function of weight and physical activity). Food, weight- and&#xD;
        activity records captured using a smartphone application represent input data to the model.&#xD;
        Output of the model is the predicted body weight trajectory alongside with personalized&#xD;
        recommendations to reach a pre-defined target weight.&#xD;
  &#xD;
        Integrating the PNA into a remote dietary counselling programme, in which certified&#xD;
        dietitians deliver nutritional and lifestyle coaching via an application, has the potential&#xD;
        to improve treatment satisfaction and efficacy. Therefore, the purpose of the study assess&#xD;
        the usability of the PNA and satisfaction with the treatment within the framework of usual&#xD;
        care remote nutritional counselling for GLP-1-supported weight management and collect pilot&#xD;
        data on its potential to support weight loss.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">August 25, 2023</start_date>
    <completion_date type="Anticipated">January 31, 2024</completion_date>
    <primary_completion_date type="Anticipated">January 31, 2024</primary_completion_date>
    <phase>N/A</phase>
    <study_type>Interventional</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <allocation>N/A</allocation>
      <intervention_model>Single Group Assignment</intervention_model>
      <intervention_model_description>The evaluation of the usability will be done using a prospective single arm design (n=80). In addition, we will collect data regarding the efficacy of the intervention by comparing results of the study participants to results of historical controls (n=80). Historical controls are patients receiving the same usual care dietary counselling as the study participants but without assistance by the personal nutrition advisor.</intervention_model_description>
      <primary_purpose>Supportive Care</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Change in the overall mean satisfaction score of the Nutritional and Dietetic Patient Outcomes Questionnaire (NDPOQ)</measure>
      <time_frame>From baseline to 3 months of the respective study period</time_frame>
      <description>This outcome will evaluate the patient treatment satisfaction with the counselling of the &quot;Personal Nutrition Advisor&quot; (PNA) -assisted remote nutritional counselling. The NDPOQ includes a 5 point likert scale of agreement (5 points=strongly agree, 1 point= strongly disagree) of 15 questions.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>The overall mean score of the &quot;perceived impact&quot; section from the user version of the mobile application scale (uMARS )</measure>
      <time_frame>Post intervention visit (3 months after baseline)</time_frame>
      <description>This outcome will evaluate patient satisfaction with the counselling of the &quot;Personal Nutrition Advisor&quot; (PNA) -assisted remote nutritional counselling. The uMARS includes a 5 point likert scale of agreement (5 points=strongly agree, 1 point= strongly disagree) of 5 questions.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>The overall mean score of the Healthcare Systems Usability Scale (HSUS)</measure>
      <time_frame>Post intervention visit (3 months after baseline)</time_frame>
      <description>This outcome will evaluate dietitian reported usability of the &quot;Personal Nutrition Advisor&quot; (PNA)- assisted remote nutritional counselling. HSUS includes a 5 point likert scale of agreement (5 points=strongly agree, 1 point= strongly disagree) of 20 questions.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Change in self reported weight (%)</measure>
      <time_frame>From baseline to 3 months of the respective study period</time_frame>
      <description>This outcome will evaluate the potential to support weight loss by PNA-assisted remote nutritional counselling (self-reported weight closest to start and end of the study period).</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Proportion of patients reaching &gt;5% weight loss</measure>
      <time_frame>At start of the GLP-1 based pharmacotherapy to 3 months of the respective study period</time_frame>
      <description>This outcome will evaluate the potential to support weight loss by PNA-assisted remote nutritional counselling (calculated from the initial weight, measured in-clinic at start of the GLP-1 based pharmacotherapy)</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Proportion of patients reaching &gt;10% weight loss</measure>
      <time_frame>At start of the GLP-1 based pharmacotherapy to 3 months of the respective study period</time_frame>
      <description>This outcome will evaluate the potential to support weight loss by PNA-assisted remote nutritional counselling (calculated from the initial weight, measured in-clinic at start of the GLP-1 based pharmacotherapy)</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Proportion of patients reaching &gt;15% weight loss</measure>
      <time_frame>At start of the GLP-1 based pharmacotherapy to 3 months of the respective study period</time_frame>
      <description>This outcome will evaluate the potential to support weight loss by PNA-assisted remote nutritional counselling (calculated from the initial weight, measured in-clinic at start of the GLP-1 based pharmacotherapy)</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change in daily number of logged meals and beverages</measure>
      <time_frame>From the first day of the respective study period to 3 months thereafter</time_frame>
      <description>This outcome will evaluate the impact of PNA-assisted remote nutritional counselling on frequency of dietary self-monitoring (manual entries of pictures, text tags and food/beverage tags per day)</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change in energy intake (kcal/day)</measure>
      <time_frame>From the first day of the respective study period to 3 months thereafter</time_frame>
      <description>This outcome will evaluate the impact of PNA-assisted remote nutritional counselling on PNA derived dietary intake, calculated by the energy balance model embedded in the PNA using manual entries of weight logs, meal logs and activity logs.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change in energy expenditure (kcal/day)</measure>
      <time_frame>From the first day of the respective study period to 3 months thereafter</time_frame>
      <description>This outcome will evaluate the impact of PNA-assisted remote nutritional counselling on PNA derived dietary expenditure, calculated by the energy balance model embedded in the PNA using manual entries of weight logs, meal logs and activity logs.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change in relative carbohydrate content (%)</measure>
      <time_frame>From the first day of the respective study period to 3 months thereafter</time_frame>
      <description>This outcome will evaluate the impact of PNA-assisted remote nutritional counselling on PNA derived nutrient distribution, calculated by the energy balance model embedded in the PNA using manual entries of weight logs, meal logs and activity logs.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change in relative protein content (%)</measure>
      <time_frame>From the first day of the respective study period to 3 months thereafter</time_frame>
      <description>This outcome will evaluate the impact of PNA-assisted remote nutritional counselling on PNA derived nutrient distribution, calculated by the energy balance model embedded in the PNA using manual entries of weight logs, meal logs and activity logs.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change in relative fat content (%)</measure>
      <time_frame>From the first day of the respective study period to 3 months thereafter</time_frame>
      <description>This outcome will evaluate the impact of PNA-assisted remote nutritional counselling on PNA derived nutrient distribution, calculated by the energy balance model embedded in the PNA using manual entries of weight logs, meal logs and activity logs.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change in relative fiber content (%)</measure>
      <time_frame>From the first day of the respective study period to 3 months thereafter</time_frame>
      <description>This outcome will evaluate the impact of PNA-assisted remote nutritional counselling on PNA derived nutrient distribution, calculated by the energy balance model embedded in the PNA using manual entries of weight logs, meal logs and activity logs.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change in self-reported exercise engagement per week (hours/week)</measure>
      <time_frame>At baseline and at 3 months of study intervention</time_frame>
      <description>This outcome will evaluate the impact of PNA-assisted remote nutritional counselling on self-reported physical activity using manual entries of activity logs.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change in the overall mean score of the General Self-efficacy Scale (GSE) from Imperial College London</measure>
      <time_frame>From baseline to 3 months of the respective study period</time_frame>
      <description>This outcome will evaluate the impact of PNA-assisted remote nutritional counselling on self-efficacy. GSE includes a 5 point Likert scale of confidence (Not at all confident =1 point, Extremely confident=5 points) of 6 questions.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Collection of open ended PNA specific feedback questionnaires</measure>
      <time_frame>Post intervention visit (3 months after baseline)</time_frame>
      <description>This qualitative outcome will collect opinions from patients and dietitians regarding the components of the PNA with the aim to further optimise its perceived usefulness.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Qualitative collection of patient reported PNA specific feedback.</measure>
      <time_frame>Post intervention visit (3 months after baseline)</time_frame>
      <description>This qualitative outcome will be assessed by an semi structured remote patient group interview addressing the patient's perspective on the utility of the dietitians' advice, discrepancy from expectations, general feedback and suggestions for PNA improvement.</description>
    </secondary_outcome>
    <number_of_arms>1</number_of_arms>
    <enrollment type="Anticipated">80</enrollment>
    <condition>Obesity</condition>
    <arm_group>
      <arm_group_label>Study Intervention Group</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>The study intervention group will be undergoing 3 months of Personalized Nutrition Advisor (PNA)-assisted remote nutritional counselling.The PNA data analysis tool will be used by the dietitians during remote nutritional counselling sessions.The service will be delivered to patients undergoing GLP-1 based obesity treatment as part of their usual care. The study intervention group will report treatment-satisfaction and self-efficacy via questionnaires at baseline, 1.5 - and 3 months.&#xD;
  Patients who expressed their interest in participating in a focus group at the time of study inclusion, will be invited for a 60 min online interview session chaired by an experienced moderator. The focus group will consists of a maximum of 10 participants and address the patient's perspective on the utility of the dietitians' advice, discrepancy from expectations, general feedback and suggestions for PNA improvement using a semi structured discussion guide held in an open and spontaneous format</description>
    </arm_group>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Personal Nutrition Advisor</intervention_name>
      <description>The study intervention will be the use of the PNA data analysis tool during remote nutritional counselling sessions delivered by certified dietitians, also referred to as PNA-assisted remote nutritional counselling.</description>
      <arm_group_label>Study Intervention Group</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Written informed consent&#xD;
  &#xD;
            -  Receiving GLP-1-based pharmacotherapy in combination with remote nutritional&#xD;
               counselling&#xD;
  &#xD;
            -  Achieved weight loss of ≥5 (for baseline BMI 28-35 kg/m2) or ≥7% (for baseline&#xD;
               BMI≥35kg/m2) after 4 months of GLP-1 based therapy (1st milestone)&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Inability to give written informed consent&#xD;
  &#xD;
            -  Any physical or psychological disease or condition likely to interfere with the normal&#xD;
               conduct of the study and interpretation of the study results&#xD;
  &#xD;
            -  Self-reported pregnancy, planed pregnancy within next 3 months or breast-feeding&#xD;
  &#xD;
            -  Concomitant participation in another trial that interferes with the normal conduct of&#xD;
               the study and interpretation of the study results&#xD;
  &#xD;
            -  Not proficient in German&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Lia Bally, MD-PhD</last_name>
      <role>Principal Investigator</role>
      <affiliation>Inselspital University Hospital Bern, University of Bern</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Lia Bally, MD-PhD</last_name>
      <phone>+41 31 63 2 36 77</phone>
      <email>lia.bally@insel.ch</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Freya Orban, MSc</last_name>
      <phone>41 31 664 30 57</phone>
      <email>freya.orban@extern.insel.ch</email>
    </overall_contact_backup>
    <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>
      <status>Recruiting</status>
      <contact>
        <last_name>Lia Bally</last_name>
        <phone>+41316323677</phone>
        <phone_ext>+41316323677</phone_ext>
        <email>lia.bally@insel.ch</email>
      </contact>
    </location>
    <location_countries>
      <country>Switzerland</country>
    </location_countries>
    <verification_date>September 2023</verification_date>
    <study_first_submitted>June 15, 2023</study_first_submitted>
    <study_first_submitted_qc>August 11, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 18, 2023</study_first_posted>
    <last_update_submitted>September 11, 2023</last_update_submitted>
    <last_update_submitted_qc>September 11, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 13, 2023</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>Prof. Dr.med. et Dr. phil.</investigator_title>
    </responsible_party>
    <keyword>Nutritional counselling</keyword>
    <keyword>Personalised nutrition</keyword>
    <keyword>Dietary advice</keyword>
    <keyword>Usability</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Weight Loss</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>Yes</sharing_ipd>
      <ipd_description>Anonymised individual participant data will be shared after inquiry via a validated sharing platform (yet to be defined). Anonymised data packages will be available once the final study results are published in a peer-reviewed journal.</ipd_description>
      <ipd_info_type>Study Protocol</ipd_info_type>
      <ipd_time_frame>After publication of the study results in a peer-reviewed journal</ipd_time_frame>
      <ipd_access_criteria>Contact with an approval by the corresponding author</ipd_access_criteria>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT05997771
  org study id: PNA-ORIGINATE
  nct id: NCT05997771
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  The purpose of the study is to assess the usability of the PNA and satisfaction with the
        treatment within the framework of usual care remote nutritional counselling for
        GLP-1-supported weight management and collect pilot data on its potential to support weight
        loss.
  The global prevalence of obesity and overweight is increasing and persistently drives global
        mortality and morbidity.As overweight and obesity are the result of an imbalance between
        energy intake and energy use, achieving a negative energy balance build the foundation for
        weight loss. Whilst dietary modification as a standalone procedure often fail in achieving or
        maintaining weight loss, the recent advent of supportive Glucagon-like Peptide-1 (GLP-1)
        based pharmacotherapies have greatly changed the landscape.Dietary counselling help people on
        GLP-1 based treatment reaching their individual weight goals and continued reimbursement of
        medication costs. However, nutritional advice provided by dietitians is often generic, not
        sufficiently aligned to individual weight loss trajectories.
  
        The "Personal Nutrition Advisor" (PNA) is a decision support tool which is built upon an
        interpretable weight prediction model based on the energy balance equation (energy intake is
        a function of recorded dietary intake and a latent part dependent on observed weight changes,
        whereas energy expenditure is a function of weight and physical activity). Food, weight- and
        activity records captured using a smartphone application represent input data to the model.
        Output of the model is the predicted body weight trajectory alongside with personalized
        recommendations to reach a pre-defined target weight.
  
        Integrating the PNA into a remote dietary counselling programme, in which certified
        dietitians deliver nutritional and lifestyle coaching via an application, has the potential
        to improve treatment satisfaction and efficacy. Therefore, the purpose of the study assess
        the usability of the PNA and satisfaction with the treatment within the framework of usual
        care remote nutritional counselling for GLP-1-supported weight management and collect pilot
        data on its potential to support weight loss.
  allocation: N/A
  intervention model: Single Group Assignment
  intervention model description: The evaluation of the usability will be done using a prospective single arm design (n=80). In addition, we will collect data regarding the efficacy of the intervention by comparing results of the study participants to results of historical controls (n=80). Historical controls are patients receiving the same usual care dietary counselling as the study participants but without assistance by the personal nutrition advisor.
  primary purpose: Supportive Care
  masking: None (Open Label)
  measure: Change in the overall mean satisfaction score of the Nutritional and Dietetic Patient Outcomes Questionnaire (NDPOQ)
  time frame: From baseline to 3 months of the respective study period
  description: This outcome will evaluate the patient treatment satisfaction with the counselling of the "Personal Nutrition Advisor" (PNA) -assisted remote nutritional counselling. The NDPOQ includes a 5 point likert scale of agreement (5 points=strongly agree, 1 point= strongly disagree) of 15 questions.
  measure: The overall mean score of the "perceived impact" section from the user version of the mobile application scale (uMARS )
  time frame: Post intervention visit (3 months after baseline)
  description: This outcome will evaluate patient satisfaction with the counselling of the "Personal Nutrition Advisor" (PNA) -assisted remote nutritional counselling. The uMARS includes a 5 point likert scale of agreement (5 points=strongly agree, 1 point= strongly disagree) of 5 questions.
  measure: The overall mean score of the Healthcare Systems Usability Scale (HSUS)
  time frame: Post intervention visit (3 months after baseline)
  description: This outcome will evaluate dietitian reported usability of the "Personal Nutrition Advisor" (PNA)- assisted remote nutritional counselling. HSUS includes a 5 point likert scale of agreement (5 points=strongly agree, 1 point= strongly disagree) of 20 questions.
  measure: Change in self reported weight (%)
  time frame: From baseline to 3 months of the respective study period
  description: This outcome will evaluate the potential to support weight loss by PNA-assisted remote nutritional counselling (self-reported weight closest to start and end of the study period).
  measure: Proportion of patients reaching >5% weight loss
  time frame: At start of the GLP-1 based pharmacotherapy to 3 months of the respective study period
  description: This outcome will evaluate the potential to support weight loss by PNA-assisted remote nutritional counselling (calculated from the initial weight, measured in-clinic at start of the GLP-1 based pharmacotherapy)
  measure: Proportion of patients reaching >10% weight loss
  time frame: At start of the GLP-1 based pharmacotherapy to 3 months of the respective study period
  description: This outcome will evaluate the potential to support weight loss by PNA-assisted remote nutritional counselling (calculated from the initial weight, measured in-clinic at start of the GLP-1 based pharmacotherapy)
  measure: Proportion of patients reaching >15% weight loss
  time frame: At start of the GLP-1 based pharmacotherapy to 3 months of the respective study period
  description: This outcome will evaluate the potential to support weight loss by PNA-assisted remote nutritional counselling (calculated from the initial weight, measured in-clinic at start of the GLP-1 based pharmacotherapy)
  measure: Change in daily number of logged meals and beverages
  time frame: From the first day of the respective study period to 3 months thereafter
  description: This outcome will evaluate the impact of PNA-assisted remote nutritional counselling on frequency of dietary self-monitoring (manual entries of pictures, text tags and food/beverage tags per day)
  measure: Change in energy intake (kcal/day)
  time frame: From the first day of the respective study period to 3 months thereafter
  description: This outcome will evaluate the impact of PNA-assisted remote nutritional counselling on PNA derived dietary intake, calculated by the energy balance model embedded in the PNA using manual entries of weight logs, meal logs and activity logs.
  measure: Change in energy expenditure (kcal/day)
  time frame: From the first day of the respective study period to 3 months thereafter
  description: This outcome will evaluate the impact of PNA-assisted remote nutritional counselling on PNA derived dietary expenditure, calculated by the energy balance model embedded in the PNA using manual entries of weight logs, meal logs and activity logs.
  measure: Change in relative carbohydrate content (%)
  time frame: From the first day of the respective study period to 3 months thereafter
  description: This outcome will evaluate the impact of PNA-assisted remote nutritional counselling on PNA derived nutrient distribution, calculated by the energy balance model embedded in the PNA using manual entries of weight logs, meal logs and activity logs.
  measure: Change in relative protein content (%)
  time frame: From the first day of the respective study period to 3 months thereafter
  description: This outcome will evaluate the impact of PNA-assisted remote nutritional counselling on PNA derived nutrient distribution, calculated by the energy balance model embedded in the PNA using manual entries of weight logs, meal logs and activity logs.
  measure: Change in relative fat content (%)
  time frame: From the first day of the respective study period to 3 months thereafter
  description: This outcome will evaluate the impact of PNA-assisted remote nutritional counselling on PNA derived nutrient distribution, calculated by the energy balance model embedded in the PNA using manual entries of weight logs, meal logs and activity logs.
  measure: Change in relative fiber content (%)
  time frame: From the first day of the respective study period to 3 months thereafter
  description: This outcome will evaluate the impact of PNA-assisted remote nutritional counselling on PNA derived nutrient distribution, calculated by the energy balance model embedded in the PNA using manual entries of weight logs, meal logs and activity logs.
  measure: Change in self-reported exercise engagement per week (hours/week)
  time frame: At baseline and at 3 months of study intervention
  description: This outcome will evaluate the impact of PNA-assisted remote nutritional counselling on self-reported physical activity using manual entries of activity logs.
  measure: Change in the overall mean score of the General Self-efficacy Scale (GSE) from Imperial College London
  time frame: From baseline to 3 months of the respective study period
  description: This outcome will evaluate the impact of PNA-assisted remote nutritional counselling on self-efficacy. GSE includes a 5 point Likert scale of confidence (Not at all confident =1 point, Extremely confident=5 points) of 6 questions.
  measure: Collection of open ended PNA specific feedback questionnaires
  time frame: Post intervention visit (3 months after baseline)
  description: This qualitative outcome will collect opinions from patients and dietitians regarding the components of the PNA with the aim to further optimise its perceived usefulness.
  measure: Qualitative collection of patient reported PNA specific feedback.
  time frame: Post intervention visit (3 months after baseline)
  description: This qualitative outcome will be assessed by an semi structured remote patient group interview addressing the patient's perspective on the utility of the dietitians' advice, discrepancy from expectations, general feedback and suggestions for PNA improvement.
  arm group label: Study Intervention Group
  arm group type: Experimental
  description: The study intervention group will be undergoing 3 months of Personalized Nutrition Advisor (PNA)-assisted remote nutritional counselling.The PNA data analysis tool will be used by the dietitians during remote nutritional counselling sessions.The service will be delivered to patients undergoing GLP-1 based obesity treatment as part of their usual care. The study intervention group will report treatment-satisfaction and self-efficacy via questionnaires at baseline, 1.5 - and 3 months.
  Patients who expressed their interest in participating in a focus group at the time of study inclusion, will be invited for a 60 min online interview session chaired by an experienced moderator. The focus group will consists of a maximum of 10 participants and address the patient's perspective on the utility of the dietitians' advice, discrepancy from expectations, general feedback and suggestions for PNA improvement using a semi structured discussion guide held in an open and spontaneous format
  intervention type: Other
  intervention name: Personal Nutrition Advisor
  description: The study intervention will be the use of the PNA data analysis tool during remote nutritional counselling sessions delivered by certified dietitians, also referred to as PNA-assisted remote nutritional counselling.
  arm group label: Study Intervention Group
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: No
  last name: Lia Bally, MD-PhD
  role: Principal Investigator
  affiliation: Inselspital University Hospital Bern, University of Bern
  last name: Lia Bally, MD-PhD
  phone: +41 31 63 2 36 77
  email: lia.bally@insel.ch
  last name: Freya Orban, MSc
  phone: 41 31 664 30 57
  email: freya.orban@extern.insel.ch
  facility: 
  status: Recruiting
  contact: 
  country: Switzerland
  responsible party type: Sponsor-Investigator
  investigator affiliation: Insel Gruppe AG, University Hospital Bern
  investigator full name: Lia Bally
  investigator title: Prof. Dr.med. et Dr. phil.
  mesh term: Weight Loss
  sharing ipd: Yes
  ipd description: Anonymised individual participant data will be shared after inquiry via a validated sharing platform (yet to be defined). Anonymised data packages will be available once the final study results are published in a peer-reviewed journal.
  ipd info type: Study Protocol
  ipd time frame: After publication of the study results in a peer-reviewed journal
  ipd access criteria: Contact with an approval by the corresponding author