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Obesity & OverweightFAMVIVSALNCT07893717

Motivational Interviewing Intervention for Families With Overweight and Obesity

A study testing Motivational interviewing to reduce obesity and Traditional nutritional counseling in people with Obesity & Overweight, run by Universidad Autonoma de Baja California at 1 site in Mexico.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Obesity & Overweight
What is being tested?
Motivational interviewing to reduce obesity and Traditional nutritional counseling
Could I receive a placebo?
No, everyone receives an active treatment
How many people
120 participants
Where
1 siteMexico
Study dates
1 Oct 2023to 30 Jun 2027
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Being overweight or obese

Who cannot join

  • Limitations on physical activity
  • Mental disorders
  • Weight-loss surgeries in recent months

Trial locations and contacts

1 site in 1 country.

Mexico1 site
  • Facultad de Medicina y Nutrición. Universidad Autónoma de Baja California.

    Mexicali, Estado de Baja California, 21000

Other trials in Mexico

About this study

Official title: Intervention Program Using Motivational Interviewing to Promote Healthy Behaviors Improving the Physical and Emotional Health of Families in Northwestern Mexico Following the COVID-19 Lockdown

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.

Read the detailed description

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.

Being tested
Motivational interviewing to reduce obesity, Traditional nutritional counseling
Keywords
Obesity, Motivational interviewing, Intervention, Diet, Physical activity, Emotional well-being
Medical subject headings
Obesity, Overweight, Motor Activity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Motivational interviewing to reduce obesityBehavioural

    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 counselingBehavioural

    Traditional nutritional consulting

Study groups in NCT07893717
Study groupRoleWhat they receive
Intervention group. Motivational interviewing.ExperimentalIntervention group receiving nutritional and emotional guidance based on the motivational interviewing approach.
Receives: Behavioral: Motivational interviewing to reduce obesity
Control group. Traditional nutritional counseling.Active comparatorA group receiving nutritional guidance in the traditional manner-that is, the approach commonly taken by any nutritionist during a consultation.
Receives: Behavioral: Traditional nutritional counseling

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: At the beginning, at the midpoint of the intervention (at 5 months), and at the end-that is, at 10 months.

Secondary outcomes (4)
  1. 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.

    Measured: At the beginning, at 5 months (the midpoint), and at the end-that is, at 10 months-when the intervention concludes.

  2. 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.

    Measured: At the beginning, at 5 months (the midpoint), and at the end-that is, at 10 months-when the intervention concludes.

  3. 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.

    Measured: At the beginning, at 5 months (the midpoint), and at the end-that is, at 10 months-when the intervention concludes.

  4. 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.

    Measured: At the beginning, at 5 months (the midpoint), and at the end-that is, at 10 months-when the intervention concludes.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted26 Oct 2026
  2. Study start1 Oct 2023
  3. Primary completion31 Mar 2027 (estimated)
  4. Study completion30 Jun 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Participant
Enrolment
120 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07893717
Sponsor's protocol ID
FMM/CEI-FMM/017/2023-2
Acronym
FAMVIVSAL
Status last verified
Oct 2026
First submitted
18 Sep 2026
Last updated
26 Oct 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
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.

Publications

  • Perez-Herrera A, Cruz-Lopez M. [Childhood obesity: current situation in Mexico]. Nutr Hosp. 2019 Apr 10;36(2):463-469. doi: 10.20960/nh.2116. Spanish.

    PubMed 30866635
  • Barquera S, Hernandez-Barrera L, Trejo-Valdivia B, Shamah T, Campos-Nonato I, Rivera-Dommarco J. [Obesity in Mexico, prevalence andtrends in adults. Ensanut 2018-19.]. Salud Publica Mex. 2020 Nov-Dec;62(6):682-692. doi: 10.21149/11630. Spanish.

    PubMed 33620965
  • Michalopoulou M, Ferrey AE, Harmer G, Goddard L, Kebbe M, Theodoulou A, Jebb SA, Aveyard P. Effectiveness of Motivational Interviewing in Managing Overweight and Obesity : A Systematic Review and Meta-analysis. Ann Intern Med. 2022 Jun;175(6):838-850. doi: 10.7326/M21-3128. Epub 2022 Mar 29.

    PubMed 35344379
  • Armstrong MJ, Mottershead TA, Ronksley PE, Sigal RJ, Campbell TS, Hemmelgarn BR. Motivational interviewing to improve weight loss in overweight and/or obese patients: a systematic review and meta-analysis of randomized controlled trials. Obes Rev. 2011 Sep;12(9):709-23. doi: 10.1111/j.1467-789X.2011.00892.x. Epub 2011 Jun 21.

    PubMed 21692966

Questions about this trial

What is this clinical trial studying?

A study testing Motivational interviewing to reduce obesity and Traditional nutritional counseling in people with Obesity & Overweight, run by Universidad Autonoma de Baja California at 1 site in Mexico.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 26 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Mexico. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Body composition (time frame: At the beginning, at the midpoint of the intervention (at 5 months), and at the end-that is, at 10 months.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07893717, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Oct 2026.

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