An interventional study of Motivational interviewing to reduce obesity and Traditional nutritional counseling in Obesity & Overweight, sponsored by Universidad Autonoma de Baja California. Active, not recruiting at 1 site in Mexico. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-26.
Sponsored by Universidad Autonoma de Baja California · Not applicable, Interventional, and Prevention
The COVID-19 lockdown fostered unhealthy eating habits and reduced physical activity levels, leading to weight gain, sedentary behavior, and increased anxiety and sleep disorders. Consequently, this study aims to evaluate the efficacy of an intervention using motivational interviewing to promote healthy diet and physical activity, improve body weight, reduce anxiety and depression, and enhance sleep quality and overall quality of life among families in Baja California and Sonora, Mexico, following the COVID-19 lockdown. This randomized controlled trial will include 60 individuals and their families in an intervention group receiving the motivational interviewing approach, and another 60 individuals and their families in a comparison group receiving traditional nutritional counseling; both groups will receive the same information but through different strategies. The intervention will be conducted using the motivational interviewing approach, delivered by professionals trained in this strategy. During each session, families will receive information regarding a nutritional plan and healthy physical activity. The project will involve physicians, nutritionists, and psychologists, as well as interns from medical and nutrition academic programs. Following the information sessions-which will take place in person within the comfort of each family's home-participants will be asked if they wish to set individual or family goals to be achieved over the subsequent 15-day periods during the first five months, or 30-day periods during the final five months. The information shared with participants will be based on practical guidelines for chronic disease prevention issued by the Ministry of Health. Topics will include the importance of consuming fruits, vegetables, and fiber-rich foods; strategies to reduce the intake of high-fat foods and sugary beverages; and the physical and emotional health benefits of physical activity. At the start of the study, anthropometric measurements will be taken, and assessments will be conducted regarding diet, physical activity levels, anxiety, depression, sleep quality, and quality of life; upon completion of the 10-month intervention, all assessment tools will be administered again to evaluate potential differences in the variables of interest. It is expected that, by the end of the intervention, participants will be able to modify their dietary and physical activity habits to achieve and maintain a healthy body weight, and that the strategies employed over the 10 months will enable them to develop a long-term healthy lifestyle, helping to prevent physical and mental illnesses among the children, adolescents, and adults in each family.
Introduction: Many countries, including Mexico, have been facing health issues stemming from citizens' lack of adherence to healthy lifestyles. This is reflected in significant year-over-year increases in overweight, obesity, diabetes, hypertension, and other conditions. The fast-paced lifestyle in many countries often prevents people from maintaining a healthy diet and engaging in physical activity. During the COVID-19 lockdown, physical activity became more difficult due to measures implemented to prevent the virus's spread; furthermore, as emotional well-being was affected by the pandemic's complications, many people adopted unhealthy eating patterns.
Objective: To evaluate the efficacy of an intervention using motivational interviewing to promote healthy diets and physical activity, improve body weight, reduce anxiety and depression levels, and enhance sleep quality and quality of life among families in Baja California and Sonora, Mexico, following the COVID-19 lockdown.
Methodology: The study design is a randomized controlled trial. It will include a total of 60 families per group. The sample size calculation was based on expected body weight reduction, referencing the study by Cofre-Lizama (2017). Inclusion criteria require that at least one family member be overweight or obese and that the families reside in Mexicali or Tijuana (Baja California) or Hermosillo, Ciudad Obregón, or Navojoa (Sonora). Exclusion criteria include all family members having a Body Mass Index (BMI) of 20, the presence of heart problems, high-risk pregnancies, seizure-inducing disorders, electronic implants or pacemakers, or heart rhythm disturbances. The program will last 10 months. The first visit will take place at baseline, involving the administration of a questionnaire regarding inclusion criteria; if these are met, the informed consent form will be signed, followed by the collection of anthropometric and blood measurements. During this same visit, the dietary questionnaire and the psychological and physical activity questionnaires will be administered. Subsequently, the intervention-based on Motivational Interviewing-will begin with in-person sessions held every two weeks for the first five months and monthly for the final five months. Upon completion of the intervention, anthropometric measurements and the dietary, psychological, and physical activity questionnaires will be repeated. Additionally, for participants found to be overweight or obese at baseline, the HOMA index will be calculated to explore potential alterations in glucose metabolism.
To evaluate the project's variables of interest, the following methods will be used: A 5 mL peripheral blood sample will be collected from participants identified as overweight or obese during the baseline assessment.
Body weight will be measured using a portable scale (AND FG-150K with 0.05 kg precision). Height will be measured using a portable stadiometer. Body composition will be assessed using electrical bioimpedance equipment.
Dietary assessment will involve a duplicate 24-hour dietary recall, while physical activity will be assessed using a seven-day physical activity diary.
Anxiety will be evaluated using the State-Trait Anxiety Inventory. Depression will be analyzed using the Beck Depression Inventory. Sleep quality will be assessed using the Pittsburgh Sleep Quality Index, and quality of life will be evaluated using the WHOQOL-BREF questionnaire.
The researchers participating in this study are affiliated with the Mexicali School of Medicine and the Tijuana School of Medicine and Psychology at the Autonomous University of Baja California, as well as the Department of Psychology (Navojoa Unit) at the Sonora Institute of Technology.
The research outcomes will include a book chapter, an undergraduate psychology thesis from the Sonora Institute of Technology, participation in an international conference, and a book on tools for promoting healthy lifestyles. An undergraduate thesis in nutrition from the Autonomous University of Baja California and an approved thesis by a student from the nutrition graduate program at the Mexicali School of Medicine of the Autonomous University of Baja California.
6,583 studies on the registry are indexed under Obesity; 1,718 are open to participants now.
This study's planned enrollment of 120 is above the median of 77 across 5,091 interventional studies indexed under Obesity.
Browse Obesity studies →Universidad Autonoma de Baja California is the lead sponsor of 33 studies on the registry; 12 are open to participants now.
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Exclusion Criteria:
Intervention group receiving nutritional and emotional guidance based on the motivational interviewing approach.
Behavioral: Motivational interviewing to reduce obesity
A group receiving nutritional guidance in the traditional manner-that is, the approach commonly taken by any nutritionist during a consultation.
Behavioral: Traditional nutritional counseling
A randomized controlled trial to test the efficacy of motivational interviewing in families with overweight and obesity. The aim is for them to adopt healthy habits that enable them to maintain a healthy body weight and prevent future diseases.
Traditional nutritional consulting
Body composition
Participants' body weight will be assessed via direct measurement and expressed in kilograms. Body mass index will be calculated from body weight and height and expressed in kg/m². Waist circumference will be measured and expressed in centimeters. Body fat percentage will be determined using the InBody 270 and expressed as a percentage. Muscle mass percentage will be determined using the InBody 270 and expressed as a percentage.
Time frame: At the beginning, at the midpoint of the intervention (at 5 months), and at the end-that is, at 10 months.
Depression
Depression symptoms will be assessed using the Beck Depression Inventory-II (BDI-II). The result will be expressed as the total score obtained on the questionnaire, where a higher score indicates a greater presence of depressive symptoms.
Time frame: At the beginning, at 5 months (the midpoint), and at the end-that is, at 10 months-when the intervention concludes.
State anxiety
State anxiety will be assessed using the State-Trait Anxiety Inventory (STAI), specifically the state anxiety scale. The result will be expressed as the total score obtained on the scale, with a higher score indicating a higher level of state anxiety.
Time frame: At the beginning, at 5 months (the midpoint), and at the end-that is, at 10 months-when the intervention concludes.
Quality life
Quality of life will be assessed using the WHOQOL-BREF (World Health Organization Quality of Life-BREF), which consists of 26 questions. Results will be expressed in terms of the scores obtained across the instrument's dimensions and the overall quality of life score.
Time frame: At the beginning, at 5 months (the midpoint), and at the end-that is, at 10 months-when the intervention concludes.
Sleep quality
Sleep quality will be assessed using the Pittsburgh Sleep Quality Index (PSQI). The result will be expressed as the global score obtained on the questionnaire, where a higher score indicates poorer sleep quality.
Time frame: At the beginning, at 5 months (the midpoint), and at the end-that is, at 10 months-when the intervention concludes.
Plan to share: No — No se compartirán porque debe salvaguardarse la privacidad de los datos. Sin embargo, si en algún momento se requiere alguna base de datos, cartas de aprobación de comités de investigación o de ética o lo que sea necesario, se podrá poner a disposición de quien lo requiera previo una solicitud que lo justifique.
Started Oct 2023 (actual). Primary completion is estimated for Mar 2027, 41 months after the start.
Of 2,256 non-industry interventional studies with no phase under Obesity, half reached primary completion within 26 months of starting (the median), counting those still running; a quarter within 11 and three quarters within 50. This study's planned 41 months is above that.
Counting every sponsor, half of 2,355 studies reached it within 25 months; a quarter within 11 and three quarters within 48.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is active, not recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.
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Universidad Autonoma de Baja California