Lifestyle Online Re-Intervention On Blood Pressure, BMI, And Physical Activity On Obese Hypertensive Patients (IBI-HTA)
Primary Purpose
Hypertension, Overweight and Obesity
Status
Completed
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Reintervention
Sponsored by

About this trial
This is an interventional treatment trial for Hypertension focused on measuring Hypertension, Obesity, Internet, Exercise, Nutrition, Reintervention
Eligibility Criteria
Inclusion Criteria:
- Hypertension
- Overweight or obesity (25 ≤ BMI ≤ 35 kg/m2)
- Aged between 18-65 years
- Have participated in the same program 3 years ago
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
- Juan Francisco Lisón Párraga
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Experimental group
Arm Description
All participants will receive access to the same web-based lifestyle intervention (exercise and nutritional education)
Outcomes
Primary Outcome Measures
Blood Pressure (BP)
Systolic and diastolic blood pressure
Secondary Outcome Measures
BMI
Body Mass Index
Physical activity
Levels of physical activity (measured with SHORT-IPAQ Questionnaire). This Questionnaire 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.
Full Information
NCT ID
NCT04571450
First Posted
September 25, 2020
Last Updated
June 27, 2021
Sponsor
Cardenal Herrera University
1. Study Identification
Unique Protocol Identification Number
NCT04571450
Brief Title
Lifestyle Online Re-Intervention On Blood Pressure, BMI, And Physical Activity On Obese Hypertensive Patients
Acronym
IBI-HTA
Official Title
Effects On Blood Pressure And Body Composition Of A Self-Applied Online Re-Intervention Focused On Healthy Eating And Increased Physical Activity 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
October 1, 2020 (Actual)
Primary Completion Date
January 1, 2021 (Actual)
Study Completion Date
January 7, 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 research will constitute a 3 years follow-up which includes a re-assessment and re-intervention of obese or overweight adults with hypertension, recruited from a hypertension unit of a public hospital, that already participated in a similar program 3 years ago. At the same time, the aim of the study is to analyze the effects of the current program, which will take 3 months and promotes lifestyle changes focusing on healthy eating and increased physical activity in their 9 modules, comparing the results obtained in 2018. These patients will be allocated into one experimental group. Assessment will include: Blood Pressure, Body Mass Index, Physical Activity levels, and adherence to the Mediterranean diet.
Detailed Description
Hypertension incidence and overweight or obesity related, constitute a worrying public health problem nowadays. In this sense, healthy eating and regular physical activity have demonstrated a relevant role maintaining health while ageing. Information and Communication Technologies (ICTs) have been shown as a useful way to promote health, improving motivation and overcoming difficulties to maintain a healthy lifestyle. ICTs also reach a wider audience at a lower cost, due to their good cost-benefit relationship and the possibility of increasing the efficiency of interventions.
This research will constitute a 3 years follow-up which includes a re-assessment and re-intervention of obese or overweight adults with hypertension, recruited from a hypertension unit of a public hospital, that already participated in a similar program 3 years ago. At the same time, the aim of the study is to analyze the effects of the current program, which will take 3 months and promotes lifestyle changes focusing on healthy eating and increased physical activity in their 9 modules, comparing the results obtained in 2018. These patients will be allocated into one experimental group. Assessment will include: Blood Pressure, Body Mass Index, Physical Activity levels, and adherence to the Mediterranean diet.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypertension, Overweight and Obesity
Keywords
Hypertension, Obesity, Internet, Exercise, Nutrition, Reintervention
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Experimental group
Arm Type
Experimental
Arm Description
All participants will receive access to the same web-based lifestyle intervention (exercise and nutritional education)
Intervention Type
Behavioral
Intervention Name(s)
Reintervention
Intervention Description
This self-applied online program will take three months and comprise 9 behavioural modules developed gradually, achieving the changes needed on eating and physical activity habits, supported by audiovisual instructions given by an hypertension specialist doctor.
Primary Outcome Measure Information:
Title
Blood Pressure (BP)
Description
Systolic and diastolic blood pressure
Time Frame
3 months
Secondary Outcome Measure Information:
Title
BMI
Description
Body Mass Index
Time Frame
3 months
Title
Physical activity
Description
Levels of physical activity (measured with SHORT-IPAQ Questionnaire). This Questionnaire 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
3 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Hypertension
Overweight or obesity (25 ≤ BMI ≤ 35 kg/m2)
Aged between 18-65 years
Have participated in the same program 3 years ago
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 Lisón Párraga, PhD
Organizational Affiliation
Cardenal Herrera University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Juan Francisco Lisón Párraga
City
Valencia
ZIP/Postal Code
46006
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 Online Re-Intervention On Blood Pressure, BMI, And Physical Activity On Obese Hypertensive Patients
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