HypertensionIBI-HTANCT04426877
Lifestyle Internet-Based Intervention On Hypertensive Patients With Overweight Or Obesity
A study testing Experimental group in people with Hypertension and Obesity, run by Cardenal Herrera University at 1 site in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Hypertension, Obesity
- What is being tested?
- Experimental group
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 135 participants
- Where
- 1 siteSpain
- Study dates
- 1 Jan 2021to 5 Jun 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Hypertension
- Overweight or obesity (25 ≤ BMI ≤ 35 kg/m2)
- Aged between 18-75 years
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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.
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.
Read the 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.
- Conditions
- Hypertension, Obesity
- Being tested
- Experimental group, Control group
- Keywords
- Hypertension, Obesity, Internet, Exercise, Nutrition
- Medical subject headings
- Hypertension, Obesity, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Experimental groupBehavioural
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.
Control groupBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Experimental group | Experimental | 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. Receives: Behavioral: Experimental group |
| Control Group | Experimental | 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. Receives: Behavioral: Control group |
What is being measured
The primary outcome is the main question the study is designed to answer.
BMI
Body mass index
Measured: At three months
Secondary outcomes (3)
Blood Pressure (BP)
Systolic and diastolic blood pressure
Measured: At three months
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.
Measured: At three months
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).
Measured: At three months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jun 2020
- Study start1 Jan 2021
- Primary completion1 Jun 2021
- Study completion5 Jun 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for HypertensionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 135 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cardenal Herrera University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Juan F. Lisón Párraga, Dr, Cardenal Herrera University
- Investigators
- JUAN FRANCISCO L PÁRRAGA, PhD, Principal investigator, Cardenal Herrera University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04426877
- Sponsor's protocol ID
- UNIVERSITY CARDENAL HERRERA-85
- Acronym
- IBI-HTA
- Status last verified
- Jun 2021
- First submitted
- 5 Jun 2020
- Last updated
- 29 Jun 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 32286232Muzquiz-Barbera P, Ruiz-Cortes M, Herrero R, Vara MD, Escriva-Martinez T, Banos RM, Rodilla E, Lison JF. "Own doctor" presence in a web-based lifestyle intervention for adults with obesity and hypertension: A randomized controlled trial. Front Public Health. 2023 Mar 14;11:1115711. doi: 10.3389/fpubh.2023.1115711. eCollection 2023.
PubMed 36998287
Study at a glance
From the registry record, last updated by the sponsor on 29 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT04426877
- Acronym / sponsor ID
- IBI-HTA / UNIVERSITY CARDENAL HERRERA-85
- Conditions
- Hypertension, Obesity
- Keywords
- Hypertension, Obesity, Internet, Exercise, Nutrition
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 135 participants (actual)
- Lead sponsor
- Cardenal Herrera UniversityUniversity, hospital or other
- Study start
- 1 Jan 2021 (actual)
- Primary completion
- 1 Jun 2021 (actual)
- Study completion
- 5 Jun 2021 (actual)
- First posted
- 11 Jun 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental group | Experimental | Behavioral: Experimental groupThe 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. |
| Control Group | Experimental | Behavioral: Control groupThe 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. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Hypertension
- Overweight or obesity (25 ≤ BMI ≤ 35 kg/m2)
- Aged between 18-75 years
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Experimental groupThe 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. | Behavioural | Experimental group |
| Control groupThe 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. | Behavioural | Control Group |
Primary outcome
BMI
Time frame: At three months
Body mass index
3 secondary outcomes
Blood Pressure (BP)
Time frame: At three months
Physical activity
Time frame: At three months
Fall risk
Time frame: At three months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jun 2021.
- Results publication: PubMed 32286232Lison 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.
- Derived from this study: PubMed 36998287Muzquiz-Barbera P, Ruiz-Cortes M, Herrero R, Vara MD, Escriva-Martinez T, Banos RM, Rodilla E, Lison JF. "Own doctor" presence in a web-based lifestyle intervention for adults with obesity and hypertension: A randomized controlled trial. Front Public Health. 2023 Mar 14;11:1115711. doi: 10.3389/fpubh.2023.1115711. eCollection 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
JUAN FRANCISCO L PÁRRAGA, PhD principal investigator
Cardenal Herrera University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Experimental group in people with Hypertension and Obesity, run by Cardenal Herrera University at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Jun 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
BMI (time frame: At three months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04426877, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jun 2021.