Lifestyle Online Intervention On EB and BMI On Obese Hypertensive Adults

NCT04739033 | Completed

• 1 other identifier: UCH-86
• Study Type: interventional
• Target: 135
• Locations: 1 country
• Sites: 1

Brief Summary

This study aims to analyze the effects of a online program 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, and eating behaviour.

Conditions

Hypertension; Obesity

Keywords

Hypertension; Obesity; Internet; Exercise; Nutrition; Eating Behaviour

Outcome Measures

Primary Outcomes (1)

• Eating Behaviour, as measured with the DEBQ (Dutch Eating Behaviour Questionnaire).

  The Dutch Eating Behaviour Questionnaire has 33 items, 13 of which refer to the emotional eating scale (eg, 'Desire to eat when irritated') and 10 of which refer to the external (eg, 'Eating when you feel lonely') and restrictive (eg, 'Difficult to resist delicious food') scales. The items can be rated on a five-point Likert-type scale, with a score of 1 indicating 'never' and 5 indicating 'very often (range 33-165). The lower the scores are, the lower the problematic eating behaviours are.

  3 months

Secondary Outcomes (1)

• BMI

  3 months

Study Arms (2)

Experimental group

EXPERIMENTAL

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. 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.

Behavioral: VIVIR MEJOR EXPERIMENTAL

Control Group

ACTIVE COMPARATOR

The control group will receive the same webbased lifestyle intervention (exercise and nutritional education), but in this case supported by audiovisual instructions given by a doctor outside the patient.

Behavioral: VIVIR MEJOR EXPERIMENTAL

Interventions

VIVIR MEJOR EXPERIMENTAL BEHAVIORAL

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. 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 Group; Experimental 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
• Being a participant of the program 5 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.

Sponsors & Collaborators

• Cardenal Herrera University: lead

Study Sites (1)

Juan Francisco Lisón Párraga

Valencia, 46006, Spain

Location

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: 32286232 BACKGROUND

MeSH Terms

Conditions

Hypertension; Obesity; Motor Activity; Feeding Behavior

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; Behavior, Animal

Study Officials

• JUAN FRANCISCO L PÁRRAGA

  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: Professor of the Deparment of Biomedical Sciences

Study Record Dates

• First Submitted: January 31, 2021
• First Posted: February 4, 2021
• Study Start: February 3, 2021
• Primary Completion: June 3, 2021
• Study Completion: June 10, 2021
• Last Updated: June 29, 2021

Record last verified: 2021-06

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)