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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.

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

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
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

Other trials in United States

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 groups in NCT05120804
Study groupRoleWhat they receive
Standard behavioral treatmentActive comparatorNutrition and physical activity education along with behavior modification techniques
Receives: Behavioral: Standard behavioral treatment
Standard behavioral treatment plus relationship skills trainingExperimentalNutrition 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.

  1. Weight change

    Weight loss

    Measured: baseline to 6 month post-intervention

Secondary outcomes (7)
  1. Weight change

    Weight loss maintenance

    Measured: 6 month post-intervention to 12 month follow-up

  2. Anthropometric measurement

    Percent body fat

    Measured: baseline to 6 month post-intervention and 12 month follow-up

  3. Hemoglobin A1C

    Percent A1C

    Measured: baseline to 6 month post-intervention and 12 month follow-up

  4. Family functioning

    Observational coding of family communication

    Measured: baseline to 6 month post-intervention and 12 month follow-up

  5. Eating behavior

    Food frequency questionnaire

    Measured: baseline to 6 month post-intervention and 12 month follow-up

  6. Physical activity

    Accelerometer

    Measured: baseline to 6 month post-intervention and 12 month follow-up

  7. 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.

  1. First posted15 Nov 2021
  2. Study start22 Feb 2022
  3. Primary completion28 Feb 2027 (estimated)
  4. Study completion28 Feb 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
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
236 participants (estimated)
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

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.

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