Clinical trial NCT03396302: Lifestyle On-line Intervention in Patients With Obesity and Hypertension
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity
Hypertension
Keywords: Exercise
Nutrition
Internet
Obesity
Hypertension
Lead sponsor: Cardenal Herrera University
Sponsor class: OTHER
First posted: 2018-01-10
Enrollment: 105
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

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).

Eligibility criteria: 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.

Primary outcomes:
measure: BMI
timeFrame: At three months
Secondary outcomes:
measure: Blood Pressure (BP)
timeFrame: At three months
measure: Glucose metabolism
timeFrame: At three months
measure: Physical activity
timeFrame: At three months
Other outcomes:
Locations:
city: Alfara del Patriarca
country: Spain
facility: JF Lisón
state: Valencia
Study officials:
References:
citation: 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.