Lifestyle Intervention on Patients With Overweight or Obesity

NCT ID: NCT06829862

Last Updated: 2025-07-30

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 115 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-02-11
• Study Completion Date: 2025-05-11

Brief Summary

This study aims to analyze the effects of a 3-month self-applied online program, focused on promoting healthy lifestyle habits (healthy eating and increased physical activity), on adults with obesity. Participants will be recruited by 8 doctors from 6 public Health Centers. These patients will be randomized allocated into two interventional groups: the experimental group will receive audiovisual instructions from their specialist doctor, and the control group from a doctor outside the patient. Assessment will include sociodemographic variables, body mass index, blood pressure, glycemic and lipid metabolism variables, physical activity level, adherence to the Mediterranean diet, therapeutic alliance, and health-related quality of life. The randomization process will be stratified according to BMI, therapeutic alliance, age, and sex.

Detailed Description

Obesity or being overweight, even other associated comorbidities, involve a worrying public health problem. The evidence shows that healthy eating and regular physical exercise, monitored by different means (internet, face to face, exercise diaries), play an important prevention role to maintain health while ageing. In this way, Information and Communication Technologies (ICTs) have been demonstrated as a useful tool to promote health, working on barriers at the same time, such as low motivation and difficulties maintaining regular exercise and/or healthy eating habits. ICTs also allows to reach a wider audience at a lower cost, due to their good cost-benefit relationship and the possibility of increasing the efficiency of interventions. Therefore, this study aims to analyze the effects of a 3-month self-applied online program, focused on promoting healthy lifestyle habits (healthy eating and increased physical activity), on adults with obesity. Participants will be recruited by 8 doctors from 6 public Health Centers. These patients will be randomized allocated into two interventional groups: the experimental group will receive audiovisual instructions from their specialist doctor, and the control group from a doctor outside the patient. Assessment will include sociodemographic variables, body mass index, blood pressure, glycemic and lipid metabolism variables, physical activity level, adherence to the Mediterranean diet, therapeutic alliance, and health-related quality of life. The randomization process will be stratified according to BMI, therapeutic alliance, age, and sex.

Conditions

Obesity; Physical Activity; Eating Behavior; Therapeutic Alliance

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Own Doctor Group

The experimental group will receive access to audiovisual instructions (exercise and nutritional education) given by their specialist doctor.

Group Type: EXPERIMENTAL

Own Doctor Education

Intervention Type: OTHER

The self-applied online program will comprise a 3-month behavioural intervention seeking to develop gradually achieving the goals of changing eating and physical activity habits, supported by audiovisual instructions. This group will receive access to the internet-based lifestyle intervention (exercise and nutritional education), supported by audiovisual instructions given by their specialist doctor.

Unknown Doctor Group

The control group will receive access to audiovisual instructions (exercise and nutritional education) given by an unknown doctor.

Group Type: ACTIVE_COMPARATOR

Unknown Doctor Education

Intervention Type: OTHER

The self-applied online program will comprise a 3-month behavioural intervention seeking to develop gradually achieving the goals of changing eating and physical activity habits, supported by audiovisual instructions. This group will receive the same intervention, but in this case supported by audiovisual instructions given by a doctor outside the patient.

Interventions

Own Doctor Education

The self-applied online program will comprise a 3-month behavioural intervention seeking to develop gradually achieving the goals of changing eating and physical activity habits, supported by audiovisual instructions. This group will receive access to the internet-based lifestyle intervention (exercise and nutritional education), supported by audiovisual instructions given by their specialist doctor.

Intervention Type: OTHER

Unknown Doctor Education

The self-applied online program will comprise a 3-month behavioural intervention seeking to develop gradually achieving the goals of changing eating and physical activity habits, supported by audiovisual instructions. This group will receive the same intervention, but in this case supported by audiovisual instructions given by a doctor outside the patient.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Overweight or grade I obesity (BMI > 25 and < 35).

Exclusion Criteria

• No access to the Internet or a smartphone.
• Not having visited their doctor at least once in the last 2 years.
• Meeting DSM-IV-TR criteria for an Eating Disorder.
• Having a diagnosed serious psychological disorder (psychosis, bipolar disorder, major depressive disorder, substance abuse disorder, etc.).
• Having any disability that prevents or hinders exercise and physical activity.
• Receiving any weight loss treatment at another center.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Cardenal Herrera University

OTHER

Sponsor Role: lead

Responsible Party

Juan F. Lisón Párraga, Dr

Chair Profesor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Juan Fco. Lisón

Valencia, Valencia-valència, Spain

Countries

Spain

Other Identifiers

UNIVERSITY CARDENAL HERRERA-99

Identifier Type: -

Identifier Source: org_study_id