Obesity PreventionNCT07847645
Feasibility of a Healthy Lifestyle Program (Athletes for Life) in Mexicali, Baja California
A study testing Healthy lifestyle program in people with Obesity Prevention and Healthy Lifestyle Behaviors, run by Universidad Autonoma de Baja California at 1 site in Mexico.
Trial summary
Childhood obesity affects 36.6% of children in Mexico and nearly 50% in Baja California. Traditional weight-centered interventions yield modest and unsustainable results. In contrast, improving cardiorespiratory fitness provides broad health benefits independently of weight loss. Read more about this study
- Who is it for?
- Ages 6 to 12 yearsHealthy volunteers can take part
- Conditions the study is for
- Obesity Prevention, Healthy Lifestyle Behaviors
- What is being tested?
- Healthy lifestyle program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14 participants
- Where
- 1 siteMexico
- Study dates
- 23 May 2024to 3 Oct 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 6 to 12 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Parent or caregiver aged 18 years or older
- Child aged 6 to 12 years
- Residence within 4 km of one of the targeted community centers
Who cannot join
- Presence of a mental or physical condition that contraindicated participation in sports/exercise
- Participation in formal sports activities (e.g., baseball, karate, or soccer)
Trial locations and contacts
1 site in 1 country.
Mexico1 site
Universidad Autonoma de Baja California
Mexicali, Estado de Baja California
About this study
Official title: Impact of a Binational Healthy Lifestyle Program in Underserved Communities in Mexicali, Baja California: The Athletes for Life Program (AFL-Mexicali)
Childhood obesity affects 36.6% of children in Mexico and nearly 50% in Baja California. Traditional weight-centered interventions yield modest and unsustainable results. In contrast, improving cardiorespiratory fitness provides broad health benefits independently of weight loss. This quasi-experimental study assesses the feasibility and viability of Athletes for Life (AFL)-a community- and family-based behavioral program for parent-child dyads in Mexicali-comparing its overall impact against a control group.
Read the detailed description
The literature indicates that interventions addressing childhood overweight and obesity commonly integrate physical activity, nutrition, and behavioral change strategies; however, most evaluate their impact primarily through changes in body weight, yielding modest and poorly sustainable results. In contrast, improvements in cardiorespiratory fitness are associated with benefits in cardiometabolic health, prevention of premature cardiovascular disease, academic performance, and mental health in children and adolescents, even independently of weight loss. Furthermore, evidence highlights the role of parents and children as active agents in the adoption of healthy lifestyles and recognizes community centers as promising settings for implementing family-based programs. Athletes for Life (AFL), a multilevel, family-based behavioral healthy lifestyle program, emerges as a more viable alternative to weight-centered approaches, having demonstrated favorable outcomes in cardiovascular health, body fat reduction, and the home food environment across several pilot studies. To evaluate the feasibility of the Athletes for Life program on cardiorespiratory fitness, physical activity level, diet quality, and metabolic risk indicators among participating families from a community center in Mexicali, as well as its viability for long-term implementation. The study employed a two-group quasi-experimental design that incorporated both quantitative and qualitative methodologies. It was implemented and evaluated over a 12-month period divided into four phases: beginner, intermediate, advanced, and a final sustainability phase, in which nutrition and physical activity content and skills progressively increased. Two government-operated community centers participated in the study. One center received the intervention program, while the control center received monthly healthy lifestyle promotion sessions. A total of 14 parent-child dyads participated, and convenience non-probabilistic sampling was used. The project was structured into three major stages: 1) assessment of the contextual needs of the community centers and their members (administrators, staff, instructors, and users); 2) program implementation and impact evaluation through the assessment of physical fitness (YMCA 3-Minute Step Test and 1-mile run), physical activity level (accelerometry), anthropometry, cardiometabolic indicators, and diet quality; and 3) exploration of acceptability and the multilevel and organizational factors associated with effective program implementation. Outcome measurements were collected at baseline and at 4.5, 9, and 12 months. Data were analyzed using qualitative or quantitative methodologies according to data type, with Excel, QSR NVivo 14, SPSS v.24, and Prism software.
- Conditions
- Obesity Prevention, Healthy Lifestyle Behaviors
- Being tested
- Healthy lifestyle program, Control group
- Keywords
- Fitness, Physical Activity, Feasibility pilot study, Nutrition, Schoolchildren, Family, Healthy Lifestyle Program
- Medical subject headings
- Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Healthy lifestyle programBehavioural
The AFL program in Mexicali is a family-based healthy lifestyle behavioral program aimed at improving physical fitness, physical activity level, diet quality, and metabolic risk indicators.
Structure \& Phases: Features a 9-month active phase (biweekly 1.5-hour sessions progressing through beginner, intermediate, and advanced stages) followed by a 3-month sustainability phase with weekly remote check-ins.
- Behavioral Framework: Built on operant conditioning and socioecological models using goal setting, point/reward systems, positive reinforcement, and healthy food environments.
- Core Components:
Nutrition Education: Teaches portion sizes, food groups, and beverage choices (45 minutes for adults, 10 minutes for children).
Physical Exercise: Focuses on physical conditioning, motor skills, and sports like soccer, volleyball, and baseball (45 minutes for adults, 80 minutes for children).
Olympic Events: Celebratory family physical activity events held at the end of each stage.
Control groupOther
The control group did not receive any AFL program content throughout the study period. Instead, participating families received monthly 90-minute health-promotion sessions consisting of educational presentations and simple activities aimed at promoting healthy lifestyle behaviors, with a focus on physical activity and nutrition.
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Experimental | The Athletes for Life (AFL) program in Mexicali is adapted from the original AFL methodology (Crespo et al., 2015) using national and international nutrition and physical activity guidelines.
Program Structure
* Phases: The program is divided into four progressive stages: beginner, intermediate, advanced, and a final sustainability phase.
* Duration: The active phase lasts 9 months, featuring biweekly 1.5-hour sessions structured in both separate (parents/children) and joint family formats.
* Sustainability: A 3-month non-intensive follow-up period promotes family autonomy through weekly phone calls or messages.
* Theoretical Framework \& Strategies The curriculum integrates operant conditioning and the socioecological model to encourage healthy behavior changes across individual, interpersonal, and social levels. Key strategies include: positive reinforcement, a point/reward system, goal setting, self-monitoring, behavior modeling and social support. Receives: Behavioral: Healthy lifestyle program |
| Control group | Other | The control group did not receive any AFL program content throughout the study period. Instead, participating families received monthly 90-minute health-promotion sessions consisting of educational presentations and simple activities aimed at promoting healthy lifestyle behaviors, with a focus on physical activity and nutrition. Receives: Other: Control group |
What is being measured
The primary outcome is the main question the study is designed to answer.
1-Mile Run/Walk Test completition time (seconds)
Time required to complete a 1,605-meter (1-mile) run/walk test, recorded in minutes and seconds. The test was used as an indirect measure of cardiorespiratory fitness in adults and children. Unit of measure: seconds.
Measured: Baseline, 4.5, 9 and 12 months
Estimated VO₂max (mL/kg/min)
Maximum oxygen consumption (VO₂max) estimated using the Three-Minute Step Test (TMST). Adults and children stepped onto an 11-inch platform at a constant cadence of 96 beats per minute (BPM) for 3 minutes. Heart rate was monitored using a Polar FT1 device. Unit of measure: mL/kg/min
Measured: Baseline, 4.5, 9, and 12 months
Moderate-to-vigorous physical activity (MVPA) (minutes/day)
Daily time spent in moderate-to-vigorous physical activity, objectively assessed in adults and children using a waist-worn ActiGraph wGT3X-BT accelerometer during 7-day assessment periods. A minimum of 4 valid days, with at least 600 minutes of wear time per day, was required for inclusion in the analysis. Unit of measure: minutes/day.
Measured: Baseline, 9 and 12 months
Sedentary time (minutes/day)
Daily time spent in sedentary behavior, objectively assessed in adults and children using a waist-worn ActiGraph wGT3X-BT accelerometer during 7-day assessment periods. A minimum of 4 valid days, with at least 600 minutes of wear time per day, was required for inclusion in the analysis. Unit of measure: minutes/day.
Measured: Baseline, 9, and 12 months
Secondary outcomes (15)
BMI-for-age z-score
Body mass index (BMI)-for-age z-score calculated in children from measured body weight and height using WHO reference standards. BMI was calculated as weight in kilograms divided by height in meters squared, and age- and sex-specific z-scores were derived using WHO AnthroPlus. Unit of measure: z-score.
Measured: Baseline, 4.5, 9, and 12 months
Body Mass Index (BMI) (kg/m²)
BMI calculated in adults from measured body weight and height as weight in kilograms divided by height in meters squared. Unit of measure: kg/m².
Measured: Baseline, 4.5, 9, and 12 months
Waist-to-height ratio
Waist-to-height ratio calculated in children as waist circumference divided by height, both in centimeters. Waist circumference and height were measured using standardized anthropometric procedures. Unit of measure: ratio.
Measured: Baseline, 4.5, 9, and 12 months
Waist-to-hip ratio
Waist-to-hip ratio calculated in adults as waist circumference divided by hip circumference. Waist and hip circumferences were measured in centimeters using a Gullick II measuring tape. Unit of measure: ratio
Measured: Baseline, 4.5, 9, and 12 months
Systolic and diastolic blood pressure (mmHg)
Systolic and diastolic blood pressure measured on the right arm using an OMRON HEM-907XL monitor after 5 minutes of rest. Two measurements were taken 2 minutes apart in adults and children. Unit of measure: mmHg
Measured: Baseline, 4.5, 9, and 12 months
Total cholesterol concentration (mg/dL)
Total cholesterol concentration measured in adults and children from venous blood samples by an external clinical laboratory using automated spectrophotometry. Unit of measure: mg/dL
Measured: Baseline and 9 months
Fasting glucose concentration (mg/dL)
Fasting blood glucose concentration measured in adults and children from venous blood samples by an external clinical laboratory using automated spectrophotometry. Unit of measure: mg/dL
Measured: Baseline and 9 months
HDL cholesterol concentration (mg/dL)
HDL cholesterol concentration measured in adults and children from venous blood samples by an external clinical laboratory using automated spectrophotometry. Unit of measure: mg/dL
Measured: Baseline and 9 months
LDL cholesterol concentration (mg/dL)
LDL cholesterol concentration measured in adults and children from venous blood samples by an external clinical laboratory using automated spectrophotometry. Unit of measure: mg/dL
Measured: Baseline and 9 months
HOMA-IR
Homeostatic Model Assessment of Insulin Resistance (HOMA-IR) calculated from fasting glucose and fasting insulin concentrations in adults and children.
Measured: Baseline and 9 months
Daily energy intake (kcal/day)
Daily energy intake in adults and children assessed using the USDA multiple-pass 24-hour dietary recall method, with food models and portion utensils to assist portion-size estimation. Dietary intake data were analyzed using a specialized "Food Dictionary" database combining ESHA Food Processor II and regional CIAD A.C. data. Unit of Measure: g/day.
Measured: Baseline, 4.5, 9, and 12 months
Daily carbohydrate intake (g/day)
Daily carbohydrate intake in adults and children assessed using the USDA multiple-pass 24-hour dietary recall method, with food models and portion utensils to assist portion-size estimation. Dietary intake data were analyzed using a specialized "Food Dictionary" database combining ESHA Food Processor II and regional CIAD A.C. data. Unit of Measure: g/day.
Measured: Baseline, 4.5, 9, and 12 months
Daily protein intake (g/day)
Daily protein intake in adults and children assessed using the USDA multiple-pass 24-hour dietary recall method, with food models and portion utensils to assist portion-size estimation. Dietary intake data were analyzed using a specialized "Food Dictionary" database combining ESHA Food Processor II and regional CIAD A.C. data. Unit of measure: g/day.
Measured: Baseline, 4.5, 9, and 12 months
Daily fat intake (g/day)
Daily fat intake in adults and children assessed using the USDA multiple-pass 24-hour dietary recall method, with food models and portion utensils to assist portion-size estimation. Dietary intake data were analyzed using a specialized "Food Dictionary" database combining ESHA Food Processor II and regional CIAD A.C. data. Unit of Measure: g/day.
Measured: Baseline, 4.5, 9, and 12 months
Sustainability determinants (barriers and facilitators)
Parents and children participated in two focus groups, conducted after 20 sessions (2.5 months) and after 44 sessions (9 months), to assess program acceptability and explore determinants of feasibility and sustainability. Qualitative data addressed participants' experiences, areas for improvement, and preferences for future activities and content. Interviews were also conducted with key community center staff and administrators to assess organizational and multilevel factors influencing AFL implementation and its perceived community benefits. Focus group and interview guides were informed by the Consolidated Framework for Implementation Research, and data were analyzed thematically.
Measured: At 2.5 months and 9 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Sep 2026
- Study start23 May 2024
- Primary completion29 Sep 2025
- Study completion3 Oct 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Obesity PreventionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- The study employed a quasi-experimental two-group design incorporating both quantitative and qualitative methods to assess the feasibility of the AFL program and explore factors related to effective long-term implementation (e.g., acceptability, barriers, and facilitators). The program was implemented and evaluated over a 12-month period, divided into four phases. The control group received only monthly health-promotion sessions.
- Masking
- None (open label)
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidad Autonoma de Baja California
- Sponsor type
- University, hospital or other
- Collaborators
- San Diego State University
- Responsible party
- Principal investigator, Alva Nidia Laprada Villegas, Universidad Autonoma de Baja California
- Investigators
- Alva Nidia Laprada Villegas, MS, Principal investigator, Universidad Autonoma de Baja CaliforniaDaniela Guadalupe Gonzalez Valencia, PhD, Study director, Universidad Autonoma de Baja CaliforniaNoe C Crespo, MS, MPH, PhD, Study director, San Diego State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07847645
- Sponsor's protocol ID
- FMM/CEI-FMM/016/2023-2
- Status last verified
- Sep 2026
- First submitted
- 17 Sep 2026
- Last updated
- 29 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: IPD will not be shared outside the research team to protect participant confidentiality, as specified in the informed consent.
Study at a glance
From the registry record, last updated by the sponsor on 29 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of a Binational Healthy Lifestyle Program in Underserved Communities in Mexicali, Baja California: The Athletes for Life Program (AFL-Mexicali)
- ClinicalTrials.gov ID
- NCT07847645
- Acronym / sponsor ID
- FMM/CEI-FMM/016/2023-2
- Conditions
- Obesity Prevention, Healthy Lifestyle Behaviors
- Keywords
- Fitness, Physical Activity, Feasibility pilot study, Nutrition, Schoolchildren, Family, Healthy Lifestyle Program
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- Universidad Autonoma de Baja CaliforniaUniversity, hospital or other
- Collaborators
- San Diego State University
- Study start
- 23 May 2024 (actual)
- Primary completion
- 29 Sep 2025 (actual)
- Study completion
- 3 Oct 2025 (actual)
- First posted
- 29 Sep 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Childhood obesity affects 36.6% of children in Mexico and nearly 50% in Baja California. Traditional weight-centered interventions yield modest and unsustainable results. In contrast, improving cardiorespiratory fitness provides broad health benefits independently of weight loss. This quasi-experimental study assesses the feasibility and viability of Athletes for Life (AFL)-a community- and family-based behavioral program for parent-child dyads in Mexicali-comparing its overall impact against a control group.
Detailed description
The literature indicates that interventions addressing childhood overweight and obesity commonly integrate physical activity, nutrition, and behavioral change strategies; however, most evaluate their impact primarily through changes in body weight, yielding modest and poorly sustainable results. In contrast, improvements in cardiorespiratory fitness are associated with benefits in cardiometabolic health, prevention of premature cardiovascular disease, academic performance, and mental health in children and adolescents, even independently of weight loss. Furthermore, evidence highlights the role of parents and children as active agents in the adoption of healthy lifestyles and recognizes community centers as promising settings for implementing family-based programs. Athletes for Life (AFL), a multilevel, family-based behavioral healthy lifestyle program, emerges as a more viable alternative to weight-centered approaches, having demonstrated favorable outcomes in cardiovascular health, body fat reduction, and the home food environment across several pilot studies. To evaluate the feasibility of the Athletes for Life program on cardiorespiratory fitness, physical activity level, diet quality, and metabolic risk indicators among participating families from a community center in Mexicali, as well as its viability for long-term implementation. The study employed a two-group quasi-experimental design that incorporated both quantitative and qualitative methodologies. It was implemented and evaluated over a 12-month period divided into four phases: beginner, intermediate, advanced, and a final sustainability phase, in which nutrition and physical activity content and skills progressively increased. Two government-operated community centers participated in the study. One center received the intervention program, while the control center received monthly healthy lifestyle promotion sessions. A total of 14 parent-child dyads participated, and convenience non-probabilistic sampling was used. The project was structured into three major stages: 1) assessment of the contextual needs of the community centers and their members (administrators, staff, instructors, and users); 2) program implementation and impact evaluation through the assessment of physical fitness (YMCA 3-Minute Step Test and 1-mile run), physical activity level (accelerometry), anthropometry, cardiometabolic indicators, and diet quality; and 3) exploration of acceptability and the multilevel and organizational factors associated with effective program implementation. Outcome measurements were collected at baseline and at 4.5, 9, and 12 months. Data were analyzed using qualitative or quantitative methodologies according to data type, with Excel, QSR NVivo 14, SPSS v.24, and Prism software.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- The study employed a quasi-experimental two-group design incorporating both quantitative and qualitative methods to assess the feasibility of the AFL program and explore factors related to effective long-term implementation (e.g., acceptability, barriers, and facilitators). The program was implemented and evaluated over a 12-month period, divided into four phases. The control group received only monthly health-promotion sessions.
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Behavioral: Healthy lifestyle programThe Athletes for Life (AFL) program in Mexicali is adapted from the original AFL methodology (Crespo et al., 2015) using national and international nutrition and physical activity guidelines. Program Structure * Phases: The program is divided into four progressive stages: beginner, intermediate, advanced, and a final sustainability phase. * Duration: The active phase lasts 9 months, featuring biweekly 1.5-hour sessions structured in both separate (parents/children) and joint family formats. * Sustainability: A 3-month non-intensive follow-up period promotes family autonomy through weekly phone calls or messages. * Theoretical Framework \& Strategies The curriculum integrates operant conditioning and the socioecological model to encourage healthy behavior changes across individual, interpersonal, and social levels. Key strategies include: positive reinforcement, a point/reward system, goal setting, self-monitoring, behavior modeling and social support. |
| Control group | Other | Other: Control groupThe control group did not receive any AFL program content throughout the study period. Instead, participating families received monthly 90-minute health-promotion sessions consisting of educational presentations and simple activities aimed at promoting healthy lifestyle behaviors, with a focus on physical activity and nutrition. |
Who may qualify
- Ages
- 6 to 12 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Parent or caregiver aged 18 years or older
- Child aged 6 to 12 years
- Residence within 4 km of one of the targeted community centers
Key exclusion criteria (2 listed)
- Presence of a mental or physical condition that contraindicated participation in sports/exercise
- Participation in formal sports activities (e.g., baseball, karate, or soccer)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Healthy lifestyle programThe AFL program in Mexicali is a family-based healthy lifestyle behavioral program aimed at improving physical fitness, physical activity level, diet quality, and metabolic risk indicators. Structure \& Phases: Features a 9-month active phase (biweekly 1.5-hour sessions progressing through beginner, intermediate, and advanced stages) followed by a 3-month sustainability phase with weekly remote check-ins. * Behavioral Framework: Built on operant conditioning and socioecological models using goal setting, point/reward systems, positive reinforcement, and healthy food environments. * Core Components: Nutrition Education: Teaches portion sizes, food groups, and beverage choices (45 minutes for adults, 10 minutes for children). Physical Exercise: Focuses on physical conditioning, motor skills, and sports like soccer, volleyball, and baseball (45 minutes for adults, 80 minutes for children). Olympic Events: Celebratory family physical activity events held at the end of each stage. | Behavioural | Intervention group |
| Control groupThe control group did not receive any AFL program content throughout the study period. Instead, participating families received monthly 90-minute health-promotion sessions consisting of educational presentations and simple activities aimed at promoting healthy lifestyle behaviors, with a focus on physical activity and nutrition. | Other | Control group |
Primary outcome
1-Mile Run/Walk Test completition time (seconds)
Time frame: Baseline, 4.5, 9 and 12 months
Time required to complete a 1,605-meter (1-mile) run/walk test, recorded in minutes and seconds. The test was used as an indirect measure of cardiorespiratory fitness in adults and children. Unit of measure: seconds.
Estimated VO₂max (mL/kg/min)
Time frame: Baseline, 4.5, 9, and 12 months
Maximum oxygen consumption (VO₂max) estimated using the Three-Minute Step Test (TMST). Adults and children stepped onto an 11-inch platform at a constant cadence of 96 beats per minute (BPM) for 3 minutes. Heart rate was monitored using a Polar FT1 device. Unit of measure: mL/kg/min
Moderate-to-vigorous physical activity (MVPA) (minutes/day)
Time frame: Baseline, 9 and 12 months
Daily time spent in moderate-to-vigorous physical activity, objectively assessed in adults and children using a waist-worn ActiGraph wGT3X-BT accelerometer during 7-day assessment periods. A minimum of 4 valid days, with at least 600 minutes of wear time per day, was required for inclusion in the analysis. Unit of measure: minutes/day.
Sedentary time (minutes/day)
Time frame: Baseline, 9, and 12 months
Daily time spent in sedentary behavior, objectively assessed in adults and children using a waist-worn ActiGraph wGT3X-BT accelerometer during 7-day assessment periods. A minimum of 4 valid days, with at least 600 minutes of wear time per day, was required for inclusion in the analysis. Unit of measure: minutes/day.
15 secondary outcomes
BMI-for-age z-score
Time frame: Baseline, 4.5, 9, and 12 months
Body Mass Index (BMI) (kg/m²)
Time frame: Baseline, 4.5, 9, and 12 months
Waist-to-height ratio
Time frame: Baseline, 4.5, 9, and 12 months
Waist-to-hip ratio
Time frame: Baseline, 4.5, 9, and 12 months
Systolic and diastolic blood pressure (mmHg)
Time frame: Baseline, 4.5, 9, and 12 months
Total cholesterol concentration (mg/dL)
Time frame: Baseline and 9 months
Fasting glucose concentration (mg/dL)
Time frame: Baseline and 9 months
HDL cholesterol concentration (mg/dL)
Time frame: Baseline and 9 months
LDL cholesterol concentration (mg/dL)
Time frame: Baseline and 9 months
HOMA-IR
Time frame: Baseline and 9 months
Daily energy intake (kcal/day)
Time frame: Baseline, 4.5, 9, and 12 months
Daily carbohydrate intake (g/day)
Time frame: Baseline, 4.5, 9, and 12 months
Daily protein intake (g/day)
Time frame: Baseline, 4.5, 9, and 12 months
Daily fat intake (g/day)
Time frame: Baseline, 4.5, 9, and 12 months
Sustainability determinants (barriers and facilitators)
Time frame: At 2.5 months and 9 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Sep 2026.
- Individual participant dataSharing planned: No. IPD will not be shared outside the research team to protect participant confidentiality, as specified in the informed consent.
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Healthy Volunteers
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Alva Nidia Laprada Villegas, MS principal investigator
Universidad Autonoma de Baja California
Daniela Guadalupe Gonzalez Valencia, PhD study director
Universidad Autonoma de Baja California
Noe C Crespo, MS, MPH, PhD study director
San Diego State University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Healthy lifestyle program in people with Obesity Prevention and Healthy Lifestyle Behaviors, 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 3 inclusion and 2 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: finished, as of the sponsor's last update on 29 Sep 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
1-Mile Run/Walk Test completition time (seconds) (time frame: Baseline, 4.5, 9 and 12 months). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 29 Sep 2026.