NCT03396302

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
105

participants targeted

Target at P50-P75 for not_applicable obesity

Timeline
Completed

Started Jan 2018

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 5, 2018

Completed
5 days until next milestone

First Posted

Study publicly available on registry

January 10, 2018

Completed
12 days until next milestone

Study Start

First participant enrolled

January 22, 2018

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 22, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 22, 2019

Completed
Last Updated

July 5, 2019

Status Verified

July 1, 2019

Enrollment Period

1.2 years

First QC Date

January 5, 2018

Last Update Submit

July 3, 2019

Conditions

ObesityHypertension

Keywords

ExerciseNutritionInternetObesityHypertension

Outcome Measures

Primary Outcomes (1)

  • BMI

    Body mass index

    At three months

Secondary Outcomes (3)

  • Blood Pressure (BP)

    At three months

  • Glucose metabolism

    At three months

  • Physical activity

    At three months

Study Arms (2)

Experimental

EXPERIMENTAL

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

Other: Educational intervention

Control

NO INTERVENTION

The control group will receive Hospital treatment as usual.

Interventions

Educational interventionOTHER

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
Experimental

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

JF Lisón

Alfara del Patriarca, Valencia, 46113, 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: 32286232DERIVED

MeSH Terms

Conditions

ObesityHypertensionMotor Activity

Interventions

Early Intervention, Educational

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsVascular DiseasesCardiovascular DiseasesBehavior

Intervention Hierarchy (Ancestors)

Child Health ServicesCommunity Health ServicesHealth ServicesHealth Care Facilities Workforce and ServicesPreventive Health Services

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Head of Medicine

Study Record Dates

First Submitted

January 5, 2018

First Posted

January 10, 2018

Study Start

January 22, 2018

Primary Completion

March 22, 2019

Study Completion

March 22, 2019

Last Updated

July 5, 2019

Record last verified: 2019-07

Data Sharing

IPD Sharing
Will not share

Locations

ES(1)