<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/NCT04426877</url>
  </required_header>
  <id_info>
    <org_study_id>UNIVERSITY CARDENAL HERRERA-85</org_study_id>
    <nct_id>NCT04426877</nct_id>
  </id_info>
  <brief_title>Lifestyle Internet-Based Intervention On Hypertensive Patients With Overweight Or Obesity</brief_title>
  <acronym>IBI-HTA</acronym>
  <official_title>Impact Of An Exercise And Nutritional Education Self-Applied Online Intervention On Body Composition And Blood Pressure On Hypertensive Adults With Overweight Or Obesity.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Cardenal Herrera University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Cardenal Herrera University</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>
      This study aims to analyze the effects of a 3 months duration self-applied online program,&#xD;
      composed of 9 modules focused on promoting healthy lifestyle habits (healthy eating and&#xD;
      increased physical activity), on obese or overweight adults with hypertension. Participants&#xD;
      will be recruited from a hypertension unit of a public hospital. These patients will be&#xD;
      randomized allocated into two interventional groups: experimental group will receive&#xD;
      audiovisual instructions from their hypertension specialist doctor, and the control group&#xD;
      from a doctor outside the patient. Assessment will include: body composition (BMI), blood&#xD;
      pressure, levels of physical activity, functional capacity, fall risk, and quality of life.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Hypertension and obesity or overweight related, even other associated comorbidities, involve&#xD;
      a worrying public health problem. The evidence shows that healthy eating and regular physical&#xD;
      exercise, monitored by different means (internet, face to face, exercise diaries), play an&#xD;
      important prevention role to maintain health while ageing. In this way, Information and&#xD;
      Communication Technologies (ICTs) have been demonstrated as a useful tool to promote health,&#xD;
      working on barriers at the same time, such as low motivation and difficulties to maintain&#xD;
      regular exercise or healthy eating habits. ICTs also allows to reach a wider audience at a&#xD;
      lower cost, due to their good cost-benefit relationship and the possibility of increasing the&#xD;
      efficiency of interventions. Therefore, this study aims to analyze the effects of a 3 months&#xD;
      duration self-applied online program, composed of 9 modules focused on promoting healthy&#xD;
      lifestyle habits (healthy eating and increased physical activity), on obese or overweight&#xD;
      adults with hypertension. Participants will be recruited from a hypertension unit of a public&#xD;
      hospital. These patients will be randomized allocated into two interventional groups:&#xD;
      experimental group will receive audiovisual instructions from their hypertension specialist&#xD;
      doctor, and the control group from a doctor outside the patient. Assessment will include:&#xD;
      body composition (BMI), blood pressure, levels of physical activity, functional capacity,&#xD;
      fall risk, and quality of life.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 1, 2021</start_date>
  <completion_date type="Actual">June 5, 2021</completion_date>
  <primary_completion_date type="Actual">June 1, 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>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Double (Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>BMI</measure>
    <time_frame>At three months</time_frame>
    <description>Body mass index</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Blood Pressure (BP)</measure>
    <time_frame>At three months</time_frame>
    <description>Systolic and diastolic blood pressure</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Physical activity</measure>
    <time_frame>At three months</time_frame>
    <description>Levels of physical activity (measured with SHORT-IPAQ Questionnaire). This Questionnaire measure assesses the types of intensity of physical activity and sitting time that people do as part of their daily lives are considered to estimate total physical activity in MET-min/week and time spent sitting.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Fall risk</measure>
    <time_frame>At three months</time_frame>
    <description>Fall risk perception (measured with FES Questionnaire). The 'Falls Efficacy Scale' (FES) directly evaluate the impact of fear of falling on social life. This scale has excellent reliability, is correlated with measures of balance and gait, and predicts future falls and decline in functional capacity. The 16 items of the FES are rated according to &quot;how concerned you are about the possibility of falling&quot;, using the following responses (score in parentheses): not at all (1), somewhat (2), fairly (3), and very concerned (4). Thus, the total score ranges from 16 to 64 points. Higher values indicate less fall-related self-efficacy (and more concern about falling).</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">135</enrollment>
  <condition>Hypertension</condition>
  <condition>Obesity</condition>
  <arm_group>
    <arm_group_label>Experimental group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The experimental group will receive access to the web-based lifestyle intervention (exercise and nutritional education), supported by audiovisual instructions given by their hypertension specialist doctor.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control Group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The control group will receive the same web-based lifestyle intervention (exercise and nutritional education), but in this case supported by audiovisual instructions given by a doctor outside the patient.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Experimental group</intervention_name>
    <description>The self-applied online program will comprise a three months behavioural intervention composed by 9 modules seeking to develop gradually achieving the goals of changing eating and physical activity habits, supported by audiovisual instructions. This group will receive access to the web-based lifestyle intervention (exercise and nutritional education), supported by audiovisual instructions given by their hypertension specialist doctor.</description>
    <arm_group_label>Experimental group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Control group</intervention_name>
    <description>The self-applied online program will comprise a three months behavioural intervention composed by 9 modules seeking to develop gradually achieving the goals of changing eating and physical activity habits, supported by audiovisual instructions. This group will receive the same web-based lifestyle intervention (exercise and nutritional education), but in this case supported by audiovisual instructions given by a doctor outside the patient.</description>
    <arm_group_label>Control Group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Hypertension&#xD;
&#xD;
          -  Overweight or obesity (25 ≤ BMI ≤ 35 kg/m2)&#xD;
&#xD;
          -  Aged between 18-75 years&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Not having access to the Internet or lack of information about it.&#xD;
&#xD;
          -  Treatment with more than 3 antihypertensive drugs.&#xD;
&#xD;
          -  Meet the criteria of the DSM-IV-TR of a Food Disorder.&#xD;
&#xD;
          -  Presenting some type of severe psychiatric disorder.&#xD;
&#xD;
          -  Disability that prevents or hinders physical exercise.&#xD;
&#xD;
          -  Receiving some treatment for weight loss.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>75 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>JUAN FRANCISCO L PÁRRAGA, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Cardenal Herrera University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Enrique Rodilla Sala</name>
      <address>
        <city>Sagunt</city>
        <state>Valencia</state>
        <zip>46520</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Spain</country>
  </location_countries>
  <results_reference>
    <citation>Lison JF, Palomar G, Mensorio MS, Banos RM, Cebolla-Marti A, Botella C, Benavent-Caballer V, Rodilla E. Impact of a Web-Based Exercise and Nutritional Education Intervention in Patients Who Are Obese With Hypertension: Randomized Wait-List Controlled Trial. J Med Internet Res. 2020 Apr 14;22(4):e14196. doi: 10.2196/14196.</citation>
    <PMID>32286232</PMID>
  </results_reference>
  <verification_date>June 2021</verification_date>
  <study_first_submitted>June 5, 2020</study_first_submitted>
  <study_first_submitted_qc>June 8, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 11, 2020</study_first_posted>
  <last_update_submitted>June 27, 2021</last_update_submitted>
  <last_update_submitted_qc>June 27, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">June 29, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Cardenal Herrera University</investigator_affiliation>
    <investigator_full_name>Juan F. Lisón Párraga, Dr</investigator_full_name>
    <investigator_title>Head of Medicine</investigator_title>
  </responsible_party>
  <keyword>Hypertension</keyword>
  <keyword>Obesity</keyword>
  <keyword>Internet</keyword>
  <keyword>Exercise</keyword>
  <keyword>Nutrition</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Hypertension</mesh_term>
    <mesh_term>Obesity</mesh_term>
    <mesh_term>Overweight</mesh_term>
  </condition_browse>
  <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/NCT04426877
org study id: UNIVERSITY CARDENAL HERRERA-85
nct id: NCT04426877
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This study aims to analyze the effects of a 3 months duration self-applied online program,
      composed of 9 modules focused on promoting healthy lifestyle habits (healthy eating and
      increased physical activity), on obese or overweight adults with hypertension. Participants
      will be recruited from a hypertension unit of a public hospital. These patients will be
      randomized allocated into two interventional groups: experimental group will receive
      audiovisual instructions from their hypertension specialist doctor, and the control group
      from a doctor outside the patient. Assessment will include: body composition (BMI), blood
      pressure, levels of physical activity, functional capacity, fall risk, and quality of life.
Hypertension and obesity or overweight related, even other associated comorbidities, involve
      a worrying public health problem. The evidence shows that healthy eating and regular physical
      exercise, monitored by different means (internet, face to face, exercise diaries), play an
      important prevention role to maintain health while ageing. In this way, Information and
      Communication Technologies (ICTs) have been demonstrated as a useful tool to promote health,
      working on barriers at the same time, such as low motivation and difficulties to maintain
      regular exercise or healthy eating habits. ICTs also allows to reach a wider audience at a
      lower cost, due to their good cost-benefit relationship and the possibility of increasing the
      efficiency of interventions. Therefore, this study aims to analyze the effects of a 3 months
      duration self-applied online program, composed of 9 modules focused on promoting healthy
      lifestyle habits (healthy eating and increased physical activity), on obese or overweight
      adults with hypertension. Participants will be recruited from a hypertension unit of a public
      hospital. These patients will be randomized allocated into two interventional groups:
      experimental group will receive audiovisual instructions from their hypertension specialist
      doctor, and the control group from a doctor outside the patient. Assessment will include:
      body composition (BMI), blood pressure, levels of physical activity, functional capacity,
      fall risk, and quality of life.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Investigator, Outcomes Assessor)
measure: BMI
time frame: At three months
description: Body mass index
measure: Blood Pressure (BP)
time frame: At three months
description: Systolic and diastolic blood pressure
measure: Physical activity
time frame: At three months
description: Levels of physical activity (measured with SHORT-IPAQ Questionnaire). This Questionnaire measure assesses the types of intensity of physical activity and sitting time that people do as part of their daily lives are considered to estimate total physical activity in MET-min/week and time spent sitting.
measure: Fall risk
time frame: At three months
description: Fall risk perception (measured with FES Questionnaire). The 'Falls Efficacy Scale' (FES) directly evaluate the impact of fear of falling on social life. This scale has excellent reliability, is correlated with measures of balance and gait, and predicts future falls and decline in functional capacity. The 16 items of the FES are rated according to "how concerned you are about the possibility of falling", using the following responses (score in parentheses): not at all (1), somewhat (2), fairly (3), and very concerned (4). Thus, the total score ranges from 16 to 64 points. Higher values indicate less fall-related self-efficacy (and more concern about falling).
arm group label: Experimental group
arm group type: Experimental
description: The experimental group will receive access to the web-based lifestyle intervention (exercise and nutritional education), supported by audiovisual instructions given by their hypertension specialist doctor.
arm group label: Control Group
arm group type: Experimental
description: The control group will receive the same web-based lifestyle intervention (exercise and nutritional education), but in this case supported by audiovisual instructions given by a doctor outside the patient.
intervention type: Behavioral
intervention name: Experimental group
description: The self-applied online program will comprise a three months behavioural intervention composed by 9 modules seeking to develop gradually achieving the goals of changing eating and physical activity habits, supported by audiovisual instructions. This group will receive access to the web-based lifestyle intervention (exercise and nutritional education), supported by audiovisual instructions given by their hypertension specialist doctor.
arm group label: Experimental group
intervention type: Behavioral
intervention name: Control group
description: The self-applied online program will comprise a three months behavioural intervention composed by 9 modules seeking to develop gradually achieving the goals of changing eating and physical activity habits, supported by audiovisual instructions. This group will receive the same web-based lifestyle intervention (exercise and nutritional education), but in this case supported by audiovisual instructions given by a doctor outside the patient.
arm group label: Control Group
criteria: 
gender: All
minimum age: 18 Years
maximum age: 75 Years
healthy volunteers: No
last name: JUAN FRANCISCO L PÁRRAGA, PhD
role: Principal Investigator
affiliation: Cardenal Herrera University
facility: 
country: Spain
citation: Lison JF, Palomar G, Mensorio MS, Banos RM, Cebolla-Marti A, Botella C, Benavent-Caballer V, Rodilla E. Impact of a Web-Based Exercise and Nutritional Education Intervention in Patients Who Are Obese With Hypertension: Randomized Wait-List Controlled Trial. J Med Internet Res. 2020 Apr 14;22(4):e14196. doi: 10.2196/14196.
PMID: 32286232
responsible party type: Principal Investigator
investigator affiliation: Cardenal Herrera University
investigator full name: Juan F. Lisón Párraga, Dr
investigator title: Head of Medicine
mesh term: Hypertension
mesh term: Obesity
mesh term: Overweight
sharing ipd: No