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Family Functioning in Obesity Treatment for Mexican Americans

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ClinicalTrials.gov Identifier: NCT05120804
Recruitment Status : Recruiting
First Posted : November 15, 2021
Last Update Posted : May 17, 2022
Sponsor:
Information provided by (Responsible Party):
Becky Marquez, University of California, San Diego

Study Description
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Brief 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 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.

Condition or disease Intervention/treatment Phase
Obesity Behavioral: Standard behavioral treatment Behavioral: Standard behavioral treatment plus relationship skills training Not Applicable

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
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 236 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Improving Family Functioning in Obesity Treatment for Mexican American Women
Actual Study Start Date : February 22, 2022
Estimated Primary Completion Date : July 31, 2026
Estimated Study Completion Date : July 31, 2026

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Active Comparator: Standard behavioral treatment
Nutrition and physical activity education along with behavior modification techniques
 Behavioral: Standard behavioral treatment
Nutrition and physical activity education along with behavior modification techniques
Other Name: SBT
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
 Behavioral: Standard behavioral treatment plus relationship skills training
Nutrition and physical activity education along with behavior modification techniques plus relationship skills training
Other Name: SBTR


Outcome Measures
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Primary Outcome Measures :
  1. Weight change [ Time Frame: baseline to 6 month post-intervention ]
    Weight loss


Secondary Outcome Measures :
  1. Weight change [ Time Frame: 6 month post-intervention to 12 month follow-up ]
    Weight loss maintenance

  2. Anthropometric measurement [ Time Frame: baseline to 6 month post-intervention and 12 month follow-up ]
    Percent body fat

  3. Hemoglobin A1C [ Time Frame: baseline to 6 month post-intervention and 12 month follow-up ]
    Percent A1C

  4. Family functioning [ Time Frame: baseline to 6 month post-intervention and 12 month follow-up ]
    Observational coding of family communication

  5. Eating behavior [ Time Frame: baseline to 6 month post-intervention and 12 month follow-up ]
    Food frequency questionnaire

  6. Physical activity [ Time Frame: baseline to 6 month post-intervention and 12 month follow-up ]
    Accelerometer

  7. Psychosocial factors [ Time Frame: baseline to 6 month post-intervention and 12 month follow-up ]
    PHQ9


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Self-identify as female
Accepts Healthy Volunteers:   Yes
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05120804


Contacts
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Contact: Becky Marquez, PhD 858 246-2476 bemarquez@ucsd.edu

Locations
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United States, California
University of California San Diego Recruiting
La Jolla, California, United States, 92037
Contact: Becky Marquez, PhD MPH         
University of California San Diego Recruiting
La Jolla, California, United States, 93093
Contact: Becky Marquez, PhD         
Sponsors and Collaborators
Becky Marquez
More Information
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Responsible Party: Becky Marquez, Assistant Professor, University of California, San Diego
ClinicalTrials.gov Identifier: NCT05120804    
Other Study ID Numbers: 210620
First Posted: November 15, 2021    Key Record Dates
Last Update Posted: May 17, 2022
Last Verified: May 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Obesity
Overnutrition
Nutrition Disorders
Overweight
Body Weight