Lifestyle On-line Intervention in Patients With Obesity and Hypertension

Impact of An Exercise and Nutritional Education Based Intervention Through New Technologies on Body Composition and Blood Pressure in Hypertensive People With Overweight and Obesity

This study aims to describe a totally self-applied online program to promote healthy lifestyles (nutritional education and exercise practice) for obese participants with hypertension. Participants will be recruited from users of a hypertension unit of a public hospital and will be randomized into two groups: experimental group and control group (treatment as usual). The experimental program (3 months) will be composed by 8 modules aimed for promoting healthy eating habits and increase physical activity. Assessment will include: body composition (BMI), blood pressure, glucose metabolism variables, and physical activity level (measured with accelerometers).

Design: Randomized Controlled Trial.

Study Overview

• Status: Completed
• Conditions: Hypertension; Obesity
• Intervention / Treatment: Other: Educational intervention

Detailed Description

Healthy eating and regular exercise play an important role to maintain health while ageing. Nutritional education and exercise practice could be monitored by different means, such as Internet, face to face and/or through exercise diaries. Information and Communication Technologies (ICTs) could be a useful tool to promote health, and could be used to work on barriers, such as low motivation and difficulties to maintain exercise or diet. ICTs also have other important advantages, especially their good cost-benefit relationship and the possibility of increasing the efficiency of interventions, allowing them to reach a wider audience at a lower cost. This study aims to describe a totally self-applied online program to promote healthy lifestyles (nutritional education and exercise practice) for obese participants with hypertension. Participants will be recruited from users of a hypertension unit of a public hospital and will be randomized into two groups: experimental group and control group (treatment as usual). The experimental program (3 months) will be composed by 8 modules aimed for promoting healthy eating habits and increase physical activity. Assessment will include: body composition (BMI), blood pressure, glucose metabolism variables, and physical activity level (measured with accelerometers).

• Study Type: Interventional
• Enrollment (Actual): 105
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Spain
  • Valencia
    • Alfara del Patriarca, Valencia, Spain, 46113
      • JF Lisón

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Overweight or obesity (BMI= 25-35 kg/m2)
• Hypertension

Exclusion Criteria:

• Not having access to the Internet or lack of information about it.
• Treatment with more than 3 antihypertensive drugs.
• Diabetes Mellitus Diagnosis.
• 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.
• Be receiving some treatment for weight loss in another center.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Experimental; The experimental group will receive access to the web-based lifestyle intervention (exercise and nutritional education).	Other: Educational intervention; The self-applied on-line intervention will comprise a three months behavioural intervention composed by 8 modules seeking to develop gradually achieving the goals of changing eating and physical activity habits.; Other Names: ICT intervention
No Intervention: Control; The control group will receive Hospital treatment as usual.

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
Glucose metabolism	Levels of glucose (mg/dL) and insulin (mg/dL)	At three months
Physical activity	Levels of physical activity (measured with accelerometers)	At three months

Collaborators and Investigators

• Sponsor: 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 22, 2018
• Primary Completion (Actual): March 22, 2019
• Study Completion (Actual): March 22, 2019

Study Registration Dates

• First Submitted: January 5, 2018
• First Submitted That Met QC Criteria: January 9, 2018
• First Posted (Actual): January 10, 2018

Study Record Updates

• Last Update Posted (Actual): July 5, 2019
• Last Update Submitted That Met QC Criteria: July 3, 2019
• Last Verified: July 1, 2019

More Information

Terms related to this study

• Keywords: Exercise; Obesity; Hypertension; Nutrition; Internet
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Overnutrition; Nutrition Disorders; Overweight; Body Weight; Hypertension; Obesity
• Other Study ID Numbers: CEU-UCH 2017-18

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