Lifestyle Internet-Based Intervention On Hypertensive Patients With Overweight Or Obesity (IBI-HTA)
Primary Purpose
Hypertension, Obesity
Status
Completed
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Experimental group
Control group
Sponsored by

About this trial
This is an interventional treatment trial for Hypertension focused on measuring Hypertension, Obesity, Internet, Exercise, Nutrition
Eligibility Criteria
Inclusion Criteria:
- Hypertension
- Overweight or obesity (25 ≤ BMI ≤ 35 kg/m2)
- Aged between 18-75 years
Exclusion Criteria:
- Not having access to the Internet or lack of information about it.
- Treatment with more than 3 antihypertensive drugs.
- Meet the criteria of the DSM-IV-TR of a Food Disorder.
- Presenting some type of severe psychiatric disorder.
- Disability that prevents or hinders physical exercise.
- Receiving some treatment for weight loss.
Sites / Locations
- Enrique Rodilla Sala
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Experimental group
Control Group
Arm 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.
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.
Outcomes
Primary Outcome Measures
BMI
Body mass index
Secondary Outcome Measures
Blood Pressure (BP)
Systolic and diastolic blood pressure
Physical activity
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.
Fall risk
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).
Full Information
NCT ID
NCT04426877
First Posted
June 5, 2020
Last Updated
June 27, 2021
Sponsor
Cardenal Herrera University
1. Study Identification
Unique Protocol Identification Number
NCT04426877
Brief Title
Lifestyle Internet-Based Intervention On Hypertensive Patients With Overweight Or Obesity
Acronym
IBI-HTA
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.
Study Type
Interventional
2. Study Status
Record Verification Date
June 2021
Overall Recruitment Status
Completed
Study Start Date
January 1, 2021 (Actual)
Primary Completion Date
June 1, 2021 (Actual)
Study Completion Date
June 5, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cardenal Herrera University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
Detailed Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypertension, Obesity
Keywords
Hypertension, Obesity, Internet, Exercise, Nutrition
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
135 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Experimental group
Arm Type
Experimental
Arm 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 Title
Control Group
Arm Type
Experimental
Arm 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(s)
Experimental group
Intervention 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.
Intervention Type
Behavioral
Intervention Name(s)
Control group
Intervention 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.
Primary Outcome Measure Information:
Title
BMI
Description
Body mass index
Time Frame
At three months
Secondary Outcome Measure Information:
Title
Blood Pressure (BP)
Description
Systolic and diastolic blood pressure
Time Frame
At three months
Title
Physical activity
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.
Time Frame
At three months
Title
Fall risk
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).
Time Frame
At three months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Hypertension
Overweight or obesity (25 ≤ BMI ≤ 35 kg/m2)
Aged between 18-75 years
Exclusion Criteria:
Not having access to the Internet or lack of information about it.
Treatment with more than 3 antihypertensive drugs.
Meet the criteria of the DSM-IV-TR of a Food Disorder.
Presenting some type of severe psychiatric disorder.
Disability that prevents or hinders physical exercise.
Receiving some treatment for weight loss.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
JUAN FRANCISCO L PÁRRAGA, PhD
Organizational Affiliation
Cardenal Herrera University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Enrique Rodilla Sala
City
Sagunt
State/Province
Valencia
ZIP/Postal Code
46520
Country
Spain
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
32286232
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.
Results Reference
result
Learn more about this trial
Lifestyle Internet-Based Intervention On Hypertensive Patients With Overweight Or Obesity
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