Clinical trial NCT06829862: Lifestyle Intervention on Patients With Overweight or Obesity
Official title: Video-Guided Lifestyle Intervention Led by Patients' Own Doctor in Overweight and Obese Adult
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Obesity
Physical Activity
Eating Behavior
Therapeutic Alliance
Lead sponsor: Cardenal Herrera University
Sponsor class: OTHER
First posted: 2025-02-17
Enrollment: 115
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Body Mass Index
timeFrame: Baseline (pre-intervention) and immediately post-intervention (3 months).
Secondary outcomes:
measure: Blood Pressure
timeFrame: Baseline (pre-intervention) and immediately post-intervention (3 months).
measure: Physical Activity Level
timeFrame: Baseline (pre-intervention) and immediately post-intervention (3 months).
measure: Adherence to the Mediterranean diet
timeFrame: Baseline (pre-intervention) and immediately post-intervention (3 months).
measure: Therapeutic Alliance
timeFrame: Baseline (pre-intervention) and immediately post-intervention (3 months).
measure: Health-related Quality of Life
timeFrame: Baseline (pre-intervention) and immediately post-intervention (3 months).
Other outcomes:
Locations:
city: València
country: Spain
facility: Juan Fco. Lisón
state: Valencia-valència
Study officials:
References: