Lifestyle Intervention on Patients With Overweight or Obesity

NCT06829862 | Completed

• 1 other identifier: UNIVERSITY CARDENAL HERRERA-99
• Study Type: interventional
• Target: 115
• Locations: 1 country
• Sites: 1

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.

Conditions

Obesity; Physical Activity; Eating Behavior; Therapeutic Alliance

Outcome Measures

Primary Outcomes (1)

• Body Mass Index

  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.

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

Secondary Outcomes (5)

• Blood Pressure

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

• Physical Activity Level

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

• Adherence to the Mediterranean diet

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

• Therapeutic Alliance

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

• Health-related Quality of Life

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

Study Arms (2)

Own Doctor Group

EXPERIMENTAL

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

Other: Own Doctor Education

Unknown Doctor Group

ACTIVE COMPARATOR

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

Other: Unknown Doctor Education

Interventions

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.

Own Doctor Group

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.

Unknown Doctor Group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Cardenal Herrera University: lead

Study Sites (1)

Juan Fco. Lisón

Valencia, Valencia-valència, 46006, Spain

Location

MeSH Terms

Conditions

Obesity; Motor Activity; Feeding Behavior

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Behavior; Behavior, Animal

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chair Profesor

Study Record Dates

• First Submitted: February 11, 2025
• First Posted: February 17, 2025
• Study Start: February 11, 2025
• Primary Completion: May 11, 2025
• Study Completion: May 11, 2025
• Last Updated: July 30, 2025

Record last verified: 2025-07

Locations

ES (1)