Lifestyle Internet-Based Intervention On Hypertensive Patients With Overweight Or Obesity

NCT04426877 | Completed

• 1 other identifier: UNIVERSITY CARDENAL HERRERA-85
• Study Type: interventional
• Target: 135
• Locations: 1 country
• Sites: 1

Brief 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. 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

Keywords

Hypertension; Obesity; Internet; Exercise; Nutrition

Outcome Measures

Primary Outcomes (1)

• BMI

  Body mass index

  At three months

Secondary Outcomes (3)

• Blood Pressure (BP)

  At three months

• Physical activity

  At three months

• Fall risk

  At three months

Study Arms (2)

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.

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.

Behavioral: Control group

Interventions

Experimental group BEHAVIORAL

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 group

Control group BEHAVIORAL

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.

Control Group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Hypertension
• Overweight or obesity (25 ≤ BMI ≤ 35 kg/m2)
• Aged between 18-75 years

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.

Sponsors & Collaborators

• Cardenal Herrera University: lead

Study Sites (1)

Enrique Rodilla Sala

Sagunto, Valencia, 46520, Spain

Location

Related Publications (2)

• 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: 32286232 RESULT

• Muzquiz-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.

  PMID: 36998287 DERIVED

MeSH Terms

Conditions

Hypertension; Obesity; Motor Activity

Interventions

Control Groups

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Study Officials

• JUAN FRANCISCO L PÁRRAGA, PhD

  Cardenal Herrera University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of Medicine

Study Record Dates

• First Submitted: June 5, 2020
• First Posted: June 11, 2020
• Study Start: January 1, 2021
• Primary Completion: June 1, 2021
• Study Completion: June 5, 2021
• Last Updated: June 29, 2021

Record last verified: 2021-06

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)