Lifestyle Online Re-Intervention On Blood Pressure, BMI, And Physical Activity On Obese Hypertensive Patients
IBI-HTA
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.
1 other identifier
interventional
30
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable hypertension
Started Oct 2020
Shorter than P25 for not_applicable hypertension
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 25, 2020
CompletedFirst Posted
Study publicly available on registry
October 1, 2020
CompletedStudy Start
First participant enrolled
October 1, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
January 7, 2021
CompletedJune 30, 2021
June 1, 2021
3 months
September 25, 2020
June 27, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Blood Pressure (BP)
Systolic and diastolic blood pressure
3 months
Secondary Outcomes (2)
BMI
3 months
Physical activity
3 months
Study Arms (1)
Experimental group
EXPERIMENTALAll participants will receive access to the same web-based lifestyle intervention (exercise and nutritional education)
Interventions
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.
Eligibility Criteria
You may qualify if:
- Hypertension
- Overweight or obesity (25 ≤ BMI ≤ 35 kg/m2)
- Aged between 18-65 years
- Have participated in the same program 3 years ago
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Juan Francisco Lisón Párraga
Valencia, 46006, Spain
Related Publications (1)
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: 32286232RESULT
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
JUAN FRANCISCO L Lisón Párraga, PhD
Cardenal Herrera University
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor of the Deparment of Biomedical Sciences
Study Record Dates
First Submitted
September 25, 2020
First Posted
October 1, 2020
Study Start
October 1, 2020
Primary Completion
January 1, 2021
Study Completion
January 7, 2021
Last Updated
June 30, 2021
Record last verified: 2021-06
Data Sharing
- IPD Sharing
- Will not share