Lifestyle Intervention on Patients With Overweight or Obesity (LIO)

Cardenal Herrera University

Status: Completed

Conditions: Physical Activity; Eating Behavior; Obesity; Therapeutic Alliance

Treatments: Other: Unknown Doctor Education; Other: Own Doctor Education

Study type: Interventional

Funder types: Other

Identifiers

NCT06829862

UNIVERSITY CARDENAL HERRERA-99

Details and patient eligibility

About

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.

Full 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.

Enrollment: 115 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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115 participants in 2 patient groups

Own Doctor Group

Experimental group

Description:

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

Treatment:

Other: Own Doctor Education

Unknown Doctor Group

Active Comparator group

Description:

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

Treatment:

Other: Unknown Doctor Education