NCT04571450

Brief Summary

This research will constitute a 3 years follow-up which includes a re-assessment and re-intervention of obese or overweight adults with hypertension, recruited from a hypertension unit of a public hospital, that already participated in a similar program 3 years ago. At the same time, the aim of the study is to analyze the effects of the current program, which will take 3 months and promotes lifestyle changes focusing on healthy eating and increased physical activity in their 9 modules, comparing the results obtained in 2018. These patients will be allocated into one experimental group. Assessment will include: Blood Pressure, Body Mass Index, Physical Activity levels, and adherence to the Mediterranean diet.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
30

participants targeted

Target at below P25 for not_applicable hypertension

Timeline
Completed

Started Oct 2020

Shorter than P25 for not_applicable hypertension

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

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 25, 2020

Completed
6 days until next milestone

First Posted

Study publicly available on registry

October 1, 2020

Completed
Same day until next milestone

Study Start

First participant enrolled

October 1, 2020

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2021

Completed
6 days until next milestone

Study Completion

Last participant's last visit for all outcomes

January 7, 2021

Completed
Last Updated

June 30, 2021

Status Verified

June 1, 2021

Enrollment Period

3 months

First QC Date

September 25, 2020

Last Update Submit

June 27, 2021

Conditions

Keywords

HypertensionObesityInternetExerciseNutritionReintervention

Outcome Measures

Primary Outcomes (1)

  • Blood Pressure (BP)

    Systolic and diastolic blood pressure

    3 months

Secondary Outcomes (2)

  • BMI

    3 months

  • Physical activity

    3 months

Study Arms (1)

Experimental group

EXPERIMENTAL

All participants will receive access to the same web-based lifestyle intervention (exercise and nutritional education)

Behavioral: Reintervention

Interventions

ReinterventionBEHAVIORAL

This self-applied online program will take three months and comprise 9 behavioural modules developed gradually, achieving the changes needed on eating and physical activity habits, supported by audiovisual instructions given by an hypertension specialist doctor.

Experimental group

Eligibility Criteria

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

You may qualify if:

  • Hypertension
  • Overweight or obesity (25 ≤ BMI ≤ 35 kg/m2)
  • Aged between 18-65 years
  • Have participated in the same program 3 years ago

You may not qualify if:

  • Not having access to the Internet or lack of information about it.
  • Treatment with more than 3 antihypertensive drugs.
  • 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.
  • Receiving some treatment for weight loss.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Juan Francisco Lisón Párraga

Valencia, 46006, 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.

MeSH Terms

Conditions

HypertensionOverweightObesityMotor Activity

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular DiseasesOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsBehavior

Study Officials

  • JUAN FRANCISCO L Lisón Párraga, PhD

    Cardenal Herrera University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of the Deparment of Biomedical Sciences

Study Record Dates

First Submitted

September 25, 2020

First Posted

October 1, 2020

Study Start

October 1, 2020

Primary Completion

January 1, 2021

Study Completion

January 7, 2021

Last Updated

June 30, 2021

Record last verified: 2021-06

Data Sharing

IPD Sharing
Will not share

Locations