Lifestyle Intervention on Patients With Overweight or Obesity (NCT06829862) | Clinical Trial Compass
CompletedNot Applicable
Lifestyle Intervention on Patients With Overweight or Obesity
Spain115 participantsStarted 2025-02-11
Plain-language 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.
Who can participate
Age range
18 Years – 65 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Body Mass Index
Timeframe: Baseline (pre-intervention) and immediately post-intervention (3 months).