HypertensionIBI-HTANCT04571450
Lifestyle Online Re-Intervention On Blood Pressure, BMI, And Physical Activity On Obese Hypertensive Patients
A study testing Reintervention in people with Hypertension and Overweight and Obesity, run by Cardenal Herrera University at 1 site in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Hypertension, Overweight and Obesity
- What is being tested?
- Reintervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteSpain
- Study dates
- 1 Oct 2020to 7 Jan 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 65 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 18-65 years
- Have participated in the same program 3 years ago
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: 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.
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.
Read the 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.
- Conditions
- Hypertension, Overweight and Obesity
- Being tested
- Reintervention
- Keywords
- Hypertension, Obesity, Internet, Exercise, Nutrition, Reintervention
- Medical subject headings
- Hypertension, Overweight, Obesity, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ReinterventionBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Experimental group | Experimental | All participants will receive access to the same web-based lifestyle intervention (exercise and nutritional education) Receives: Behavioral: Reintervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Blood Pressure (BP)
Systolic and diastolic blood pressure
Measured: 3 months
Secondary outcomes (2)
BMI
Body Mass Index
Measured: 3 months
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.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Oct 2020
- Study start1 Oct 2020
- Primary completion1 Jan 2021
- Study completion7 Jan 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 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 Lisón Párraga, PhD, Principal investigator, Cardenal Herrera University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04571450
- Sponsor's protocol ID
- UNIVERSITY CARDENAL HERRERA-26
- Acronym
- IBI-HTA
- Status last verified
- Jun 2021
- First submitted
- 25 Sep 2020
- Last updated
- 30 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 32286232
Study at a glance
From the registry record, last updated by the sponsor on 30 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT04571450
- Acronym / sponsor ID
- IBI-HTA / UNIVERSITY CARDENAL HERRERA-26
- Conditions
- Hypertension, Overweight and Obesity
- Keywords
- Hypertension, Obesity, Internet, Exercise, Nutrition, Reintervention
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Cardenal Herrera UniversityUniversity, hospital or other
- Study start
- 1 Oct 2020 (actual)
- Primary completion
- 1 Jan 2021 (actual)
- Study completion
- 7 Jan 2021 (actual)
- First posted
- 1 Oct 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 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Experimental group | Experimental | Behavioral: ReinterventionAll participants will receive access to the same web-based lifestyle intervention (exercise and nutritional education) |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Hypertension
- Overweight or obesity (25 ≤ BMI ≤ 35 kg/m2)
- Aged between 18-65 years
- Have participated in the same program 3 years ago
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 |
|---|---|---|
| ReinterventionThis 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. | Behavioural | Experimental group |
Primary outcome
Blood Pressure (BP)
Time frame: 3 months
Systolic and diastolic blood pressure
2 secondary outcomes
BMI
Time frame: 3 months
Physical activity
Time frame: 3 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 30 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.
- 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 Lisón 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 Reintervention in people with Hypertension and Overweight 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 4 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 30 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?
Blood Pressure (BP) (time frame: 3 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 NCT04571450, which also lists 1 linked publication.
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 30 Jun 2021.