Lifestyle Internet-Based Intervention On Hypertensive Patients With Overweight Or Obesity (IBI-HTA)

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.

Study Overview

• Status: Completed
• Conditions: Hypertension; Obesity
• Intervention / Treatment: Behavioral: Experimental group; Behavioral: Control group

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 Type: Interventional
• Enrollment (Actual): 135
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Spain
  • Valencia
    • Sagunt, Valencia, Spain, 46520
      • Enrique Rodilla Sala

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Experimental group; 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.	Behavioral: Experimental group; 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.
Experimental: Control Group; 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.	Behavioral: Control group; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
BMI	Body mass index	At three months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Blood Pressure (BP)	Systolic and diastolic blood pressure	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.	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).	At three months

Collaborators and Investigators

• Sponsor: Cardenal Herrera University
• Investigators: Principal Investigator: JUAN FRANCISCO L PÁRRAGA, PhD, Cardenal Herrera University

Publications and helpful links

General 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.

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2021
• Primary Completion (Actual): June 1, 2021
• Study Completion (Actual): June 5, 2021

Study Registration Dates

• First Submitted: June 5, 2020
• First Submitted That Met QC Criteria: June 8, 2020
• First Posted (Actual): June 11, 2020

Study Record Updates

• Last Update Posted (Actual): June 29, 2021
• Last Update Submitted That Met QC Criteria: June 27, 2021
• Last Verified: June 1, 2021

More Information

Terms related to this study

• Keywords: Exercise; Obesity; Hypertension; Nutrition; Internet
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Overnutrition; Nutrition Disorders; Body Weight; Hypertension; Obesity; Overweight
• Other Study ID Numbers: UNIVERSITY CARDENAL HERRERA-85

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No