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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to help Mexican American families tackle obesity by improving communication and collaboration. It tests two approaches: one focuses on nutrition and exercise education (standard behavioral treatment), while the other adds family relationship skills to this training (standard behavioral treatment plus relationship skills training). The goal is to enhance weight management by strengthening family bonds. Ideal candidates are Mexican or Mexican American women living in San Diego who struggle with obesity and seek to improve family dynamics. As an unphased trial, this study offers a unique opportunity to enhance family dynamics while addressing obesity.

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 prior data suggests that this intervention is safe for families?

Research has shown that behavioral treatments for obesity are generally safe and well-tolerated. In studies, these treatments often help individuals lose about 9% of their starting weight over 20 weeks. These methods focus on changing eating and exercise habits and typically do not cause serious side effects.

The treatment in this trial includes a standard behavioral approach plus training in relationship skills to improve family interactions. Previous studies combining behavior change with family support have shown positive results. Reports suggest that adding family-focused counseling does not increase risks and may enhance the treatment's effectiveness.

Participants usually experience only minor side effects. Most issues, such as feeling hungrier or being more aware of eating habits, are mild and temporary. Overall, this type of program is considered safe and helpful for managing obesity. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about these treatments for obesity among Mexican Americans because they integrate family dynamics into the intervention. The "Standard behavioral treatment plus relationship skills training" stands out by combining nutrition and physical activity education with counseling on family functioning. This approach acknowledges the crucial role of family support in behavior change, which is often overlooked in traditional obesity treatments that mainly focus on individual behavior modification. By addressing family interactions, this method aims to improve long-term success in maintaining healthy lifestyle changes.

What evidence suggests that this trial's treatments could be effective for obesity?

Research has shown that adding relationship skills training to regular weight loss programs helps Mexican American families lose more weight and improve family relationships. In this trial, participants in one arm will receive standard behavioral treatment plus relationship skills training, which includes nutrition and physical activity education, behavior modification techniques, and structured counseling on family functioning. Studies have found that when family members, such as mothers and daughters, work on their relationship skills, they communicate better and support each other in making healthier eating and exercise choices. This approach addresses obesity by focusing on both health and family bonds. Family-based treatments have succeeded in helping people lose weight and maintain it over time. By improving how family members interact, this method strengthens their ability to manage weight in the long run. ^{6 7 8 9 10}

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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]

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 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]

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]

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]

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]

Citations

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Improving Family Functioning in Obesity Treatment for Mexican ... ... treatment outcomes, this study tests a behavioral weight management intervention that provides relationship skills counseling to mothers and adult daughters.

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Family Functioning in Obesity Treatment for Mexican ... ... treatment outcomes, this study tests a behavioral weight management intervention that provides relationship skills counseling to mothers and adult daughters.

3. withpower.com withpower.com/trial/phase-obesity-2022-fabee

Family-Based Obesity Intervention for Mexican Americans A study found that adding relationship skills training to standard behavioral treatment resulted in greater weight loss and improved family dynamics.

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Behavioral Weight Management Interventions for Hispanic ... This systematic review aims to provide an overview of behavioral weight management interventions adapted for Hispanic men and describe their tailoring ...

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Family-Based Behavioral Treatment for Childhood Obesity ... The intervention led to improved weight outcomes over 24 months for children. In addition, family-based treatment had similar benefits for ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC3233993/

Behavioral Treatment of Obesity - PMC This paper provides an overview of the structure and principles of behavioral weight loss treatment. The short- and long-term effectiveness of this approach is ...

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BEHAVIORAL TREATMENT OF OBESITY The data indicate that patients currently treated by a comprehensive group, behavioral approach lose approximately 8.5 kg (about 9% of initial weight) in 20 ...

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Parenting Training Plus Behavioral Treatment for Children ... This randomized clinical trial compares the effectiveness of behavior change strategies using family-based behavioral treatment (FBT) plus ...

9. clinicaltrials.gov clinicaltrials.gov/study/NCT00746265

NCT00746265 | Behavioral Treatment for Weight Loss This project compares gold standard cognitive-behavioral therapy (based on LEARN, Diabetes Prevention Program, LOOK Ahead) used in both research and clinical ...

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Behavior‐change lifestyle interventions for the treatment of ... This scoping review discusses optimal behavior-change lifestyle interventions in the treatment of overweight and obesity in children and adolescents.