NCT04580264

Brief Summary

This research will constitute a 3-year follow-up that includes a re-evaluation and re-intervention of overweight or obese adults suffering from hypertension, who already participated in a similar programme with the same objectives 3 years ago. Patients will be recruited in the Hypertension Unit of a public hospital and assigned to a experimental group. The evaluation will include: eating behaviour, body mass index (BMI) and physical activity levels.

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 Jan 2021

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 2, 2020

Completed
6 days until next milestone

First Posted

Study publicly available on registry

October 8, 2020

Completed
3 months until next milestone

Study Start

First participant enrolled

January 15, 2021

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 15, 2021

Completed
4 days until next milestone

Study Completion

Last participant's last visit for all outcomes

April 19, 2021

Completed
Last Updated

June 29, 2021

Status Verified

June 1, 2021

Enrollment Period

3 months

First QC Date

October 2, 2020

Last Update Submit

June 27, 2021

Conditions

HypertensionOverweight and Obesity

Keywords

HypertensionObesityInternetRe-interventionEating BehaviourPhysical Activity

Outcome Measures

Primary Outcomes (1)

  • Eating Behaviour

    Eating Behaviour will be measured with the DEBQ (Dutch Eating Behaviour Questionnaire). DEBQ evaluates eating behaviour that may contribute to or mitigate the development of overweight. It consists of 33 items, with a 5-point Likert scale, which 89 evaluate three eating styles. The Emotional Eating Scale has 13 items (e.g. "Do you have a desire to eat when you are angry?"), the External Eating Scale has 10 items (e.g. "Do you eat more than usual when you see others eating?"), and the Restrictive Eating Scale has 10 items (e.g. "Do you eat less deliberately so that you don't gain weight?").

    3 months

Secondary Outcomes (2)

  • BMI

    3 Month

  • 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.
  • Being a participant of the 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)

Enrique Rodilla Sala

Sagunto, Valencia, 46520, 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: 32286232BACKGROUND

MeSH Terms

Conditions

HypertensionOverweightObesityFeeding BehaviorMotor Activity

Condition Hierarchy (Ancestors)

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

Study Officials

  • JUAN FRANCISCO L 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

October 2, 2020

First Posted

October 8, 2020

Study Start

January 15, 2021

Primary Completion

April 15, 2021

Study Completion

April 19, 2021

Last Updated

June 29, 2021

Record last verified: 2021-06

Data Sharing

IPD Sharing
Will not share

Locations

ES(1)