- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05120804
Family Functioning in Obesity Treatment for Mexican Americans
February 10, 2026 updated by: Becky Marquez
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.
Study Overview
Status
Active, not recruiting
Conditions
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 Type
Interventional
Enrollment (Estimated)
236
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
California
-
La Jolla, California, United States, 92037
- University of California San Diego
-
La Jolla, California, United States, 93093
- University of California San Diego
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 65 years (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Description
Inclusion Criteria:
- Female
- 18-65 years of age
- Mexican or Mexican American
- Reside in San Diego County
- Body mass index of 25-45 kg/m2
Exclusion Criteria:
- 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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: Standard behavioral treatment
Nutrition and physical activity education along with behavior modification techniques
|
Nutrition and physical activity education along with behavior modification techniques
Other Names:
|
|
Experimental: Standard behavioral treatment plus relationship skills training
Nutrition and physical activity education along with behavior modification techniques plus brief and structured counseling on family functioning
|
Nutrition and physical activity education along with behavior modification techniques plus relationship skills training
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Weight change
Time Frame: baseline to 6 month post-intervention
|
Weight loss
|
baseline to 6 month post-intervention
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Weight change
Time Frame: 6 month post-intervention to 12 month follow-up
|
Weight loss maintenance
|
6 month post-intervention to 12 month follow-up
|
|
Anthropometric measurement
Time Frame: baseline to 6 month post-intervention and 12 month follow-up
|
Percent body fat
|
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
|
Percent A1C
|
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
|
Observational coding of family communication
|
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
|
Food frequency questionnaire
|
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
|
Accelerometer
|
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
|
PHQ9
|
baseline to 6 month post-intervention and 12 month follow-up
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
February 22, 2022
Primary Completion (Estimated)
August 31, 2026
Study Completion (Estimated)
August 31, 2026
Study Registration Dates
First Submitted
October 11, 2021
First Submitted That Met QC Criteria
November 3, 2021
First Posted (Actual)
November 15, 2021
Study Record Updates
Last Update Posted (Actual)
February 11, 2026
Last Update Submitted That Met QC Criteria
February 10, 2026
Last Verified
February 1, 2026
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 210620
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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