Family-Based Obesity Intervention for Mexican Americans

Overseen By Becky Marquez, PhD

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: Becky Marquez

Disqualifiers: Pregnancy, Physical limitations, Weight loss surgery, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 24

236 Participants Needed

Trial Summary

Do I need to stop my current medications to join the trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What data supports the effectiveness of the treatment for obesity in Mexican Americans?

Research shows that culturally adapted behavioral weight-loss programs for Mexican American women can lead to significant weight loss and improved family relationships, which are linked to better weight management outcomes. A study found that adding relationship skills training to standard behavioral treatment resulted in greater weight loss and improved family dynamics. ^{1 2 3 4 5}

Is the Family-Based Obesity Intervention for Mexican Americans safe for participants?

The studies reviewed suggest that behavioral weight management interventions, including those with relationship skills training, are generally safe for participants. No specific safety concerns were reported in the studies involving Mexican American populations. ^{3 4 5 6 7}

How does the Family-Based Obesity Intervention for Mexican Americans differ from other treatments for obesity?

This treatment is unique because it combines standard behavioral weight management with relationship skills training, emphasizing family involvement and cultural sensitivity, which has shown to be more effective for weight loss in Mexican Americans compared to individual-focused approaches. ^{3 4 6 8 9}

What is the purpose of this trial?

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.

Eligibility Criteria

This trial is for Mexican or Mexican American mothers and adult daughters living in San Diego County, aged 18-65 with a BMI of 25-45. They must be able to read and write in English or Spanish. Those pregnant, planning pregnancy, with physical limitations for exercise, currently in weight loss programs, post-weight loss surgery, or with serious health conditions cannot join.

Inclusion Criteria

Mexican or Mexican American

Reside in San Diego County

I am female.

Exclusion Criteria

I find it hard to walk or do similar exercises due to a physical limitation.

I have a serious health or mental condition.

Currently participating in a weight loss program

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intervention

Participants receive standard behavioral treatment or standard behavioral treatment plus relationship skills training

6 months

24 weekly sessions

Maintenance

Participants continue with maintenance phase to support long-term weight management

6 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

12 months

Treatment Details

Interventions

• Standard behavioral treatment
• Standard behavioral treatment plus relationship skills training

Trial Overview The study compares two obesity treatments: one combines standard behavioral treatment with relationship skills training; the other uses only the standard treatment. The aim is to see if improving family interactions helps better manage weight by supporting healthy eating and activity.

Participant Groups

Group I: Standard behavioral treatment plus relationship skills training Experimental Treatment 1 Intervention

Nutrition and physical activity education along with behavior modification techniques plus brief and structured counseling on family functioning

Group II: Standard behavioral treatment Active Control 1 Intervention

Nutrition and physical activity education along with behavior modification techniques

Standard behavioral treatment is already approved in United States for the following indications:

Approved in United States as Standard Behavioral Treatment for:

• Obesity
• Type 2 Diabetes

Who Is Running the Clinical Trial?

Becky Marquez

Lead Sponsor

Trials

1

Recruited

240+

Findings from Research

The study applied the Transtheoretical Model of Behavior Change to a sample of Mexican American women in a weight-loss program, identifying five distinct profiles of change that align with previous research in other behavioral contexts.

Although the sample size was small, the findings support the effectiveness of the Transtheoretical Model for understanding weight-loss behaviors in Hispanic populations, highlighting the need for more inclusive future research.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Application of the transtheoretical model of behavior change for obesity in Mexican American women. Surís, AM., Trapp, MC., DiClemente, CC., et al.[2019]

A core outcome set for behavioral weight management programs (BWMPs) is being developed to standardize how outcomes are reported, allowing for better comparison of different interventions for adults with overweight and obesity.

The study will utilize a Delphi process involving 40 experts to reach consensus on which outcomes to measure and the definitions or instruments to use, ensuring that the findings are relevant and applicable in real-world settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Development of a core outcome set for behavioural weight management programmes for adults with overweight and obesity: protocol for obtaining expert consensus using Delphi methodology. Mackenzie, RM., Ells, LJ., Simpson, SA., et al.[2023]

A culturally-adapted weight-loss program for obese Spanish-speaking Mexican women was successfully implemented, with 47 participants and a focus on group activities and Mexican traditions over 12 months.

Participants achieved a mean weight loss of 7.2 kg and a BMI reduction of 5.5 kg/m² by the end of the study, demonstrating the efficacy of the intervention in promoting weight loss in this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A weight-loss intervention program designed for Mexican-American women: cultural adaptations and results. Lindberg, NM., Stevens, VJ., Vega-López, S., et al.[2022]

A culturally-sensitive nutrition and dietary counseling intervention targeting Mexican Americans in New York City showed promising preliminary results in improving participant satisfaction and self-reported changes in eating and exercise habits.

The program, developed through a partnership between community and academic organizations, utilized Motivational Interviewing techniques and adaptations based on the Behavioral Model for Vulnerable Populations to enhance its sustainability and scalability.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Case Study in Academic-Community Partnerships: A Community-Based Nutrition Education Program for Mexican Immigrants. Leng, J., Costas-Muniz, R., Pelto, D., et al.[2022]

A 16-week weight management program that included relationship skills training (SRT) for Mexican American mothers and their adult daughters led to greater improvements in relational functioning and weight loss compared to a standard behavioral (SB) program, with the SRT group achieving an average weight loss of -5.6% versus -3.9% in the SB group.

Participants in the SRT group were more successful in achieving at least 3% weight loss (75% vs. 40% in the SB group), suggesting that enhancing family relationships can positively impact weight management outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Improving Relational Functioning in Mother-Daughter Dyads With Obesity. Marquez, B., Lebensohn-Chialvo, F., Huang, X., et al.[2023]

The introduction of a Bilingual Case Manager in a pediatric weight management clinic significantly increased enrollment of Hispanic families, boosting participation over ten-fold.

Outcomes for Hispanic families in the program were equal to or better than those of other racial/ethnic groups, highlighting the effectiveness of a family-centered and culturally sensitive approach in obesity treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adapting a tertiary-care pediatric weight management clinic to better reach Spanish-speaking families. Guzman, A., Irby, MB., Pulgar, C., et al.[2021]

Behavioral conduct therapies (BCT) can lead to modest weight loss of 3% to 9% over long-term follow-ups of at least 12 months, but adherence to these treatments tends to decline significantly, with retention rates dropping from 92% at three months to 55% at 24 months.

There is a lack of research on the effectiveness of BCT in Latino or Hispanic populations, highlighting the need for more culturally inclusive studies to better understand and address obesity in diverse groups.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Review of controled clinical trials of behavioral treatment for obesity]. Márquez-Ibáñez, B., Armendáriz-Anguiano, AL., Bacardí-Gascón, M., et al.[2013]

A study involving 168 obese Mexican American women found that a family-based intervention led to the greatest weight loss compared to individual and comparison groups, highlighting the effectiveness of involving family in weight loss efforts.

Both the family and individual intervention groups achieved significant weight loss compared to the comparison group, suggesting that culturally tailored programs can effectively support weight reduction in Mexican Americans.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Family versus individually oriented intervention for weight loss in Mexican American women. Cousins, JH., Rubovits, DS., Dunn, JK., et al.[2018]

In a study of 100 overweight or obese Mexican-American women, a strong commitment to attitudinal familism was linked to lower adherence to a behavioral weight management program, indicating that prioritizing family needs may hinder personal health goals.

The findings suggest that incorporating an understanding of familism into weight management interventions could improve adherence and effectiveness for Mexican-American women.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Attitudinal familism predicts weight management adherence in Mexican-American women. Austin, JL., Smith, JE., Gianini, L., et al.[2021]

References

1. England pubmed.ncbi.nlm.nih.gov

Application of the transtheoretical model of behavior change for obesity in Mexican American women. [2019]

2. England pubmed.ncbi.nlm.nih.gov

Development of a core outcome set for behavioural weight management programmes for adults with overweight and obesity: protocol for obtaining expert consensus using Delphi methodology. [2023]

3. United States pubmed.ncbi.nlm.nih.gov

A weight-loss intervention program designed for Mexican-American women: cultural adaptations and results. [2022]

4. Netherlands pubmed.ncbi.nlm.nih.gov

A Case Study in Academic-Community Partnerships: A Community-Based Nutrition Education Program for Mexican Immigrants. [2022]

5. United States pubmed.ncbi.nlm.nih.gov

Improving Relational Functioning in Mother-Daughter Dyads With Obesity. [2023]

6. United States pubmed.ncbi.nlm.nih.gov

Adapting a tertiary-care pediatric weight management clinic to better reach Spanish-speaking families. [2021]

7. Spain pubmed.ncbi.nlm.nih.gov

[Review of controled clinical trials of behavioral treatment for obesity]. [2013]

8. United States pubmed.ncbi.nlm.nih.gov

Family versus individually oriented intervention for weight loss in Mexican American women. [2018]

9. United States pubmed.ncbi.nlm.nih.gov

Attitudinal familism predicts weight management adherence in Mexican-American women. [2021]