ObesityNCT05120804
Family Functioning in Obesity Treatment for Mexican Americans
A study testing Standard behavioral treatment and Standard behavioral treatment plus relationship skills training in people with Obesity, run by Becky Marquez at 2 sites in United States.
Trial summary
Mexican American families share similar elevated risks for obesity and obesity-related conditions, such as type 2 diabetes. Because negative family interactions and relationships (e.g., poor communication, high conflict, low emotional closeness) are associated with obesity treatment outcomes, this study tests a… Read more about this study
- Who is it for?
- Ages 18 to 65 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Obesity
- What is being tested?
- Standard behavioral treatment and Standard behavioral treatment plus relationship skills training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 236 participants
- Where
- 2 sitesUnited States
- Study dates
- 22 Feb 2022to 28 Feb 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 to 65 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Female
- 18-65 years of age
- Mexican or Mexican American
- Reside in San Diego County
- Body mass index of 25-45 kg/m2
Who cannot join
- Unable to read and write in English or Spanish
- Pregnant or plan to become pregnant in the next year
- Have a physical limitation that makes exercise like walking difficult
- Currently participating in a weight loss program
- Underwent weight loss surgery
- Report a serious medical or psychological condition
Trial locations and contacts
2 sites in 1 country.
United States2 sites
University of California San Diego
La Jolla, California, 92037
University of California San Diego
La Jolla, California, 93093
About this study
Official title: Improving Family Functioning in Obesity Treatment for Mexican American Women
Mexican American families share similar elevated risks for obesity and obesity-related conditions, such as type 2 diabetes. Because negative family interactions and relationships (e.g., poor communication, high conflict, low emotional closeness) are associated with obesity treatment outcomes, this study tests a behavioral weight management intervention that provides relationship skills counseling to mothers and adult daughters. The goal is to improve family interaction patterns to buffer challenges and strengthen collaboration for eating and physical activity behaviors that support long-term weight management and thus provide an effective obesity treatment approach to address a major public health concern.
Read the detailed description
Mexican American women are disproportionately affected by obesity and obesity-related conditions, such as type 2 diabetes. Obesity and diabetes are highly concordant in Mexican American families. Given the younger age of onset of diabetes in women with familial history, targeting mothers and their adult daughters for obesity treatment is warranted. From a family systems perspective, family-level approaches to obesity treatment can improve the adoption and maintenance of weight management behaviors. Including family members in treatment may also serve as a culturally salient intervention strategy as Mexican Americans endorse high level of familism. In contrast to traditional individual-level approaches to obesity treatment, a family-level approach grounded in familism would promote shared goals, collaborative problem solving, and communal coping when treating family members alongside each other. An important construct to consider when working with intergenerational Mexican American families is differences in acculturation, which may translate into differences in attitudes and behaviors. A wider gap in acculturation between parent and child has previously been associated with lower family functioning (e.g., poor communication, high conflict, low cohesion). However, interventions that promote bicultural competence by changing interactional patterns have been effective at improving family functioning. Hence, this study will conduct a randomized control trial testing the efficacy of a behavioral weight management intervention with brief and structured counseling on family functioning. Mexican American mothers and adult daughters (n=118 dyads) will be randomly assigned to receive standard behavioral treatment (SBT) or standard behavioral treatment plus relationship skills training (SBTR). Dyads participating in SBT or SBTR will attend 24 weekly sessions focused on nutrition and physical activity education along with behavior modification techniques. Dyads participating in SBTR will also receive experiential-based relationship skills training that draws from both general family systems concepts and behavioral family/couples therapy approaches to support familism, biculturalism, and communication competencies. The 12-month trial will consist of an intervention phase (1-6 months) and a maintenance phase (7-12 months). Assessments will be conducted at baseline and at the end of the intervention and maintenance phases. The primary outcome is weight loss. Secondary outcomes include treatment adherence (session attendance and self-monitoring records), physiological indicators of diabetes risk (hemoglobin A1c, waist circumference, and body fat percentage), health behaviors (eating and physical activity), psychological well-being (depression and perceived stress), and family functioning (subjective self-report and objective behavioral coding). Dyads in the SBTR group are expected to achieve greater improvements in primary and secondary outcomes than the STB group. Additionally, mediation by family functioning of intervention effects on primary and secondary outcomes will be examined.
- Conditions
- Obesity
- Being tested
- Standard behavioral treatment, Standard behavioral treatment plus relationship skills training
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standard behavioral treatmentBehavioural
Also called SBT
Nutrition and physical activity education along with behavior modification techniques
Standard behavioral treatment plus relationship skills trainingBehavioural
Also called SBTR
Nutrition and physical activity education along with behavior modification techniques plus relationship skills training
| Study group | Role | What they receive |
|---|---|---|
| Standard behavioral treatment | Active comparator | Nutrition and physical activity education along with behavior modification techniques Receives: Behavioral: Standard behavioral treatment |
| Standard behavioral treatment plus relationship skills training | Experimental | Nutrition and physical activity education along with behavior modification techniques plus brief and structured counseling on family functioning Receives: Behavioral: Standard behavioral treatment plus relationship skills training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Weight change
Weight loss
Measured: baseline to 6 month post-intervention
Secondary outcomes (7)
Weight change
Weight loss maintenance
Measured: 6 month post-intervention to 12 month follow-up
Anthropometric measurement
Percent body fat
Measured: baseline to 6 month post-intervention and 12 month follow-up
Hemoglobin A1C
Percent A1C
Measured: baseline to 6 month post-intervention and 12 month follow-up
Family functioning
Observational coding of family communication
Measured: baseline to 6 month post-intervention and 12 month follow-up
Eating behavior
Food frequency questionnaire
Measured: baseline to 6 month post-intervention and 12 month follow-up
Physical activity
Accelerometer
Measured: baseline to 6 month post-intervention and 12 month follow-up
Psychosocial factors
PHQ9
Measured: baseline to 6 month post-intervention and 12 month follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Nov 2021
- Study start22 Feb 2022
- Primary completion28 Feb 2027 (estimated)
- Study completion28 Feb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 236 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Becky Marquez
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Becky Marquez, University of California, San Diego
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05120804
- Sponsor's protocol ID
- 210620
- Status last verified
- Feb 2026
- First submitted
- 11 Oct 2021
- Last updated
- 6 Nov 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improving Family Functioning in Obesity Treatment for Mexican American Women
- ClinicalTrials.gov ID
- NCT05120804
- Acronym / sponsor ID
- 210620
- Conditions
- Obesity
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 236 participants (estimated)
- Lead sponsor
- Becky MarquezUniversity, hospital or other
- Study start
- 22 Feb 2022 (actual)
- Primary completion
- 28 Feb 2027 (estimated)
- Study completion
- 28 Feb 2027 (estimated)
- First posted
- 15 Nov 2021 (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.
Mexican American families share similar elevated risks for obesity and obesity-related conditions, such as type 2 diabetes. Because negative family interactions and relationships (e.g., poor communication, high conflict, low emotional closeness) are associated with obesity treatment outcomes, this study tests a behavioral weight management intervention that provides relationship skills counseling to mothers and adult daughters. The goal is to improve family interaction patterns to buffer challenges and strengthen collaboration for eating and physical activity behaviors that support long-term weight management and thus provide an effective obesity treatment approach to address a major public health concern.
Detailed description
Mexican American women are disproportionately affected by obesity and obesity-related conditions, such as type 2 diabetes. Obesity and diabetes are highly concordant in Mexican American families. Given the younger age of onset of diabetes in women with familial history, targeting mothers and their adult daughters for obesity treatment is warranted. From a family systems perspective, family-level approaches to obesity treatment can improve the adoption and maintenance of weight management behaviors. Including family members in treatment may also serve as a culturally salient intervention strategy as Mexican Americans endorse high level of familism. In contrast to traditional individual-level approaches to obesity treatment, a family-level approach grounded in familism would promote shared goals, collaborative problem solving, and communal coping when treating family members alongside each other. An important construct to consider when working with intergenerational Mexican American families is differences in acculturation, which may translate into differences in attitudes and behaviors. A wider gap in acculturation between parent and child has previously been associated with lower family functioning (e.g., poor communication, high conflict, low cohesion). However, interventions that promote bicultural competence by changing interactional patterns have been effective at improving family functioning. Hence, this study will conduct a randomized control trial testing the efficacy of a behavioral weight management intervention with brief and structured counseling on family functioning. Mexican American mothers and adult daughters (n=118 dyads) will be randomly assigned to receive standard behavioral treatment (SBT) or standard behavioral treatment plus relationship skills training (SBTR). Dyads participating in SBT or SBTR will attend 24 weekly sessions focused on nutrition and physical activity education along with behavior modification techniques. Dyads participating in SBTR will also receive experiential-based relationship skills training that draws from both general family systems concepts and behavioral family/couples therapy approaches to support familism, biculturalism, and communication competencies. The 12-month trial will consist of an intervention phase (1-6 months) and a maintenance phase (7-12 months). Assessments will be conducted at baseline and at the end of the intervention and maintenance phases. The primary outcome is weight loss. Secondary outcomes include treatment adherence (session attendance and self-monitoring records), physiological indicators of diabetes risk (hemoglobin A1c, waist circumference, and body fat percentage), health behaviors (eating and physical activity), psychological well-being (depression and perceived stress), and family functioning (subjective self-report and objective behavioral coding). Dyads in the SBTR group are expected to achieve greater improvements in primary and secondary outcomes than the STB group. Additionally, mediation by family functioning of intervention effects on primary and secondary outcomes will be examined.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard behavioral treatment | Active comparator | Behavioral: Standard behavioral treatmentNutrition and physical activity education along with behavior modification techniques |
| Standard behavioral treatment plus relationship skills training | Experimental | Behavioral: Standard behavioral treatment plus relationship skills trainingNutrition and physical activity education along with behavior modification techniques plus brief and structured counseling on family functioning |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Female
- 18-65 years of age
- Mexican or Mexican American
- Reside in San Diego County
- Body mass index of 25-45 kg/m2
Key exclusion criteria (6 listed)
- Unable to read and write in English or Spanish
- Pregnant or plan to become pregnant in the next year
- Have a physical limitation that makes exercise like walking difficult
- Currently participating in a weight loss program
- Underwent weight loss surgery
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 |
|---|---|---|
| Standard behavioral treatmentAlso: SBTNutrition and physical activity education along with behavior modification techniques | Behavioural | Standard behavioral treatment |
| Standard behavioral treatment plus relationship skills trainingAlso: SBTRNutrition and physical activity education along with behavior modification techniques plus relationship skills training | Behavioural | Standard behavioral treatment plus relationship skills training |
Primary outcome
Weight change
Time frame: baseline to 6 month post-intervention
Weight loss
7 secondary outcomes
Weight change
Time frame: 6 month post-intervention to 12 month follow-up
Anthropometric measurement
Time frame: baseline to 6 month post-intervention and 12 month follow-up
Hemoglobin A1C
Time frame: baseline to 6 month post-intervention and 12 month follow-up
Family functioning
Time frame: baseline to 6 month post-intervention and 12 month follow-up
Eating behavior
Time frame: baseline to 6 month post-intervention and 12 month follow-up
Physical activity
Time frame: baseline to 6 month post-intervention and 12 month follow-up
Psychosocial factors
Time frame: baseline to 6 month post-intervention and 12 month follow-up
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Nov 2026.
- Individual participant dataSharing planned: No
Related trials for Obesity
RecruitingObservational study
Endoscopic Sleeve Gastroplasty (ESG) Prospective Trial for Obesity (EGO-Trial)
Obesity
Active, not recruitingPhase 4
Effects of Sequential Therapy With Mexidol® (Intravenous) and Mexidol® FORTE 250 (Oral) on Functional Brain Activity Assessed by Functional Magnetic Resonance Imaging and Biochemical Parameters in Patients With Chronic Cerebral Ischemia: A Comparison of Patients With and Without Metabolic Disorders
Metabolic Abnormalities, Obesity & Overweight
Recruiting
Exercise Training and Vitamin D Metabolism
Obesity & Overweight, Vitamin D
Recruiting
Metabolic Health, Bones and Nuts During Weight Loss in Adults
Weight Loss, Bone Density
Active, not recruiting
Effect of Probiotics on Insulin Sensitivity in Overweight and Obese Pregnancy
Obesity & Overweight, Gestational Diabetes Mellitus (GDM)
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.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Standard behavioral treatment and Standard behavioral treatment plus relationship skills training in people with Obesity, run by Becky Marquez at 2 sites in United States.
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 5 inclusion and 6 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 6 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. 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?
Weight change (time frame: baseline to 6 month post-intervention). 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 6 Nov 2026.