Lifestyle On-line Intervention in Patients With Obesity a... | NCT03396302

Studies
Lifestyle On-line Intervention in Patients With Obesity and Hypertension

NCT03396302

Sponsor

Cardenal Herrera University

Status

Completed

Last Update Posted

Jul 5, 2019Actual

Enrollment

105Actual

Phase

Not Applicable

Conditions

Obesity
Hypertension

Interventions

Educational intervention

Countries

Spain

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2019

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 22, 2018Actual

Primary Completion Date

Mar 22, 2019Actual

Completion Date

Mar 22, 2019Actual

First Submitted Date

Jan 5, 2018

First Submission Date that Met QC Criteria

Jan 9, 2018

First Posted Date

Jan 10, 2018Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 3, 2019

Last Update Posted Date

Jul 5, 2019Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Juan F. Lisón Párraga, Dr, Head of Medicine, Cardenal Herrera UniversityPrincipal Investigator

Lead Sponsor

Cardenal Herrera UniversityOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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).

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

105Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
Educational intervention	Other	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.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
BMI	Body mass index	At three months

Secondary Outcomes

Measure	Description	Time Frame
Blood Pressure (BP)	Systolic and diastolic blood pressure	At three months
Glucose metabolism	Levels of glucose (mg/dL) and insulin (mg/dL)

Other Outcomes

Not provided

Eligibility Module

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

65 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
JF Lisón		Alfara del Patriarca	Valencia	46113	Spain

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
32286232	Derived	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.

ID	Term
D009765	Obesity
D006973	Hypertension
D009043	Motor Activity

ID	Term
D050177	Overweight
D044343	Overnutrition
D009748	Nutrition Disorders
D009750	Nutritional and Metabolic Diseases

ID	Term
D002662	Child Health Services
D003153	Community Health Services
D006296	Health Services
D005159	Health Care Facilities Workforce and Services