ClinicalTrials.gg
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

Where this study stands

Counted across the records on this site · 2026-11-12

Among 387 studies in Obesity with a site in Spain — 92 open to participants now, 131 under way, 43 of them phase 3. Obesity · Spain.

Enrollment
188th of 329
105 · median 123
Started
2018
with 25 others
No phase
219 of 387
40 open now
Registered
100th of 387
by date
Lead sponsor
9 of 387
Cardenal Herrera University

Among the 387 studies in Obesity with a site in Spain, this one is the 188th largest by enrollment of the 329 interventional ones that give a count, is one of 26 that started in 2018, is one of 219 with no phase, and was the 100th registered.

Obesity

11,522 studies on the registry are indexed under Obesity; 2,033 are open to participants now.

Browse Obesity studies →

Open to participants now

92 of the 387 studies in Obesity with a site in Spain are open now. Recruiting first, the newest first:

87 more — sign in →

All 92 open studies →

A study can be open while its sites in Spain have not opened yet or have stopped. Only those recruiting at a site in Spain →

Who these studies take

Of the 1,336 Obesity studies recruiting now, 377 (28%) set no upper age limit and 856 (64%) stop at 75 or younger; 168 take children under 18; 491 take healthy volunteers.

This study: 18 Years to 65 Years · all sexes · no healthy volunteers.

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02

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).

03

Conditions studied

  • Obesity
  • Hypertension

Keywords

  • Exercise
  • Nutrition
  • Internet
  • Obesity
  • Hypertension
04

Who can participate

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

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Overweight or obesity (= 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 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.
Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

BMI (body mass index)

Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.

What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.

DSM diagnostic criteria

The American Psychiatric Association’s manual of mental health diagnoses. DSM-5 (2013, revised as DSM-5-TR in 2022) replaced DSM-IV, and some studies still name the older edition. “Meets DSM criteria for …” means diagnosed by that edition’s diagnostic criteria, usually by a clinician in an interview.

05

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

06

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

07

Study locations

1 site
  • JF Lisón
    Alfara del Patriarca, Valencia 46113, Spain
08

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

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Jan 2018 to primary completion in Mar 2019, 14 months.

Of 3,680 non-industry interventional studies with no phase under Obesity, half reached primary completion within 23 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 43. This study's 14 months is below that.

Counting every sponsor, half of 3,843 studies reached it within 22 months; a quarter within 10 and three quarters within 42.

How these figures are worked out, and which studies are left out of them.

Registered
Jan 5, 2018
First posted
Jan 10, 2018
StartActual
Jan 22, 2018
Primary completionActual
Mar 22, 2019
CompletionActual
Mar 22, 2019
Last update
Jul 5, 2019
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jul 5, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03396302
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 ↗

Not currently enrolling

This study is completed, as verified in Jul 2019. You cannot join it, but the record below documents what was studied.

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