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Completed

NCT Number: NCT06829862

Lifestyle Intervention on Patients With Overweight or Obesity

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.

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Key information

Conditions

Obesity Behavior Behavior, Animal Body Weight Eating Behavior Feeding Behavior Motor Activity Nutrition Disorders Nutritional and Metabolic Diseases Overnutrition Overweight Pathological Conditions, Signs and Symptoms Physical Activity Signs and Symptoms Therapeutic Alliance

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Juan Fco. Lisón

Valencia, Valencia-valència, 46006, Spain

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Own Doctor Education

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 Education

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.

Primary outcomes

  1. Body Mass Index

    Time frame: Baseline (pre-intervention) and immediately post-intervention (3 months).

    Body Mass Index (BMI) is a measure of body weight relative to height, calculated by dividing a person's weight in kilograms by the square of their height in meters.

Secondary outcomes

  1. Blood Pressure

    Time frame: Baseline (pre-intervention) and immediately post-intervention (3 months).

    Blood Pressure (BP) is the force exerted by circulating blood on the walls of the arteries. It is measured in millimeters of mercury (mmHg) and recorded as two values: systolic pressure (the pressure during heart contraction) over diastolic pressure (the pressure during heart relaxation).

  2. Physical Activity Level

    Time frame: Baseline (pre-intervention) and immediately post-intervention (3 months).

    Levels of Physical Activity will be assessed using the Short International Physical Activity Questionnaire (Short-IPAQ). This tool evaluates the frequency, duration, and intensity of physical activity, as well as sedentary behavior, in daily life. It estimates total physical activity in MET-min/week and records time spent sitting, providing a standardized measure of physical activity levels.

  3. Adherence to the Mediterranean diet

    Time frame: Baseline (pre-intervention) and immediately post-intervention (3 months).

    Adherence to the Mediterranean Diet will be assessed using the MEDAS (Mediterranean Diet Adherence Screener) from the PREDIMED study. This 14-item questionnaire evaluates adherence based on 12 questions about food consumption frequency and 2 questions on dietary habits associated with the Mediterranean diet. Each item is scored 0 or 1 point, with a total possible score ranging from 0 to 14 points. Higher scores indicate greater adherence.

  4. Therapeutic Alliance

    Time frame: Baseline (pre-intervention) and immediately post-intervention (3 months).

    Therapeutic Alliance will be assessed using the Working Alliance Inventory (WAI) questionnaire. This tool evaluates the relationship between a patient and their therapist across three key dimensions: (1) therapeutic goals, (2) tasks, and (3) therapeutic bond. Each item is scored on a Likert scale, with a total possible score ranging from low to high alliance strength. Higher scores indicate a stronger therapeutic alliance, which is associated with better treatment outcomes.

  5. Health-related Quality of Life

    Time frame: Baseline (pre-intervention) and immediately post-intervention (3 months).

    Health-Related Quality of Life (HRQoL) will be assessed using the EuroQol-5D (EQ-5D) questionnaire. This tool evaluates five dimensions of health: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression, each rated on a multi-level scale. A health index score will be generated based on these dimensions. The visual analog scale (VAS) will not be used in this study.

Sponsors and collaborators

Lead sponsor

Cardenal Herrera University

Other

Registry information

Official study title

Video-Guided Lifestyle Intervention Led by Patients' Own Doctor in Overweight and Obese Adult

Acronym: LIO

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Feb 17, 2025
Registry last updated
Jul 30, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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