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CompletedNCT03396302Updated Jul 5, 2019

Lifestyle On-line Intervention in Patients With Obesity and Hypertension

An interventional study of Educational intervention in Obesity and Hypertension, sponsored by Cardenal Herrera University. Completed at 1 site in Spain. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2019-07-05.

Sponsored by Cardenal Herrera University · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
105
Allocation
Randomized
Ages
18 Years to 65 Years
Sex
All
01

Study summary

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.

Read the 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).

02

Conditions studied

  • Obesity
  • Hypertension

Keywords

  • Exercise
  • Nutrition
  • Internet
  • Obesity
  • Hypertension
03

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

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.
04

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
105 participants (actual)

Study arms

  • Experimental
    Experimental

    The experimental group will receive access to the web-based lifestyle intervention (exercise and nutritional education).

    Other: Educational intervention

  • No intervention
    Control

    The control group will receive Hospital treatment as usual.

Interventions

  • OtherEducational 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.

    Also known as: ICT intervention

05

What researchers measure

Primary outcomes

  1. BMI

    Body mass index

    Time frame: At three months

Secondary outcomes

  1. Blood Pressure (BP)

    Systolic and diastolic blood pressure

    Time frame: At three months

  2. Glucose metabolism

    Levels of glucose (mg/dL) and insulin (mg/dL)

    Time frame: At three months

  3. Physical activity

    Levels of physical activity (measured with accelerometers)

    Time frame: At three months

06

Study locations

1 site
  • JF Lisón
    Alfara del Patriarca, Valencia 46113, Spain
07

References and documents

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. PubMed 32286232 ↗

Individual participant data

Plan to share: No

08

Registry details

Key details

Study ID
NCT03396302
Lead sponsor
Cardenal Herrera University
Responsible party
Juan F. Lisón Párraga, Dr (Head of Medicine, Cardenal Herrera University) — Principal investigator
First posted
Jan 10, 2018
Start date
Jan 22, 2018
Primary completion
Mar 22, 2019
Completion
Mar 22, 2019
Last update
Jul 5, 2019

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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