Family Functioning in Obesity Treatment for Mexican Americans
Primary Purpose
Obesity
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Standard behavioral treatment
Standard behavioral treatment plus relationship skills training
Sponsored by
About this trial
This is an interventional treatment trial for Obesity
Eligibility 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
Sites / Locations
- University of California San DiegoRecruiting
- University of California San DiegoRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Standard behavioral treatment
Standard behavioral treatment plus relationship skills training
Arm Description
Nutrition and physical activity education along with behavior modification techniques
Nutrition and physical activity education along with behavior modification techniques plus brief and structured counseling on family functioning
Outcomes
Primary Outcome Measures
Weight change
Weight loss
Secondary Outcome Measures
Weight change
Weight loss maintenance
Anthropometric measurement
Percent body fat
Hemoglobin A1C
Percent A1C
Family functioning
Observational coding of family communication
Eating behavior
Food frequency questionnaire
Physical activity
Accelerometer
Psychosocial factors
PHQ9
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05120804
Brief Title
Family Functioning in Obesity Treatment for Mexican Americans
Official Title
Improving Family Functioning in Obesity Treatment for Mexican American Women
Study Type
Interventional
2. Study Status
Record Verification Date
June 2023
Overall Recruitment Status
Recruiting
Study Start Date
February 22, 2022 (Actual)
Primary Completion Date
July 31, 2026 (Anticipated)
Study Completion Date
July 31, 2026 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Becky Marquez
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
236 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Standard behavioral treatment
Arm Type
Active Comparator
Arm Description
Nutrition and physical activity education along with behavior modification techniques
Arm Title
Standard behavioral treatment plus relationship skills training
Arm Type
Experimental
Arm Description
Nutrition and physical activity education along with behavior modification techniques plus brief and structured counseling on family functioning
Intervention Type
Behavioral
Intervention Name(s)
Standard behavioral treatment
Other Intervention Name(s)
SBT
Intervention Description
Nutrition and physical activity education along with behavior modification techniques
Intervention Type
Behavioral
Intervention Name(s)
Standard behavioral treatment plus relationship skills training
Other Intervention Name(s)
SBTR
Intervention Description
Nutrition and physical activity education along with behavior modification techniques plus relationship skills training
Primary Outcome Measure Information:
Title
Weight change
Description
Weight loss
Time Frame
baseline to 6 month post-intervention
Secondary Outcome Measure Information:
Title
Weight change
Description
Weight loss maintenance
Time Frame
6 month post-intervention to 12 month follow-up
Title
Anthropometric measurement
Description
Percent body fat
Time Frame
baseline to 6 month post-intervention and 12 month follow-up
Title
Hemoglobin A1C
Description
Percent A1C
Time Frame
baseline to 6 month post-intervention and 12 month follow-up
Title
Family functioning
Description
Observational coding of family communication
Time Frame
baseline to 6 month post-intervention and 12 month follow-up
Title
Eating behavior
Description
Food frequency questionnaire
Time Frame
baseline to 6 month post-intervention and 12 month follow-up
Title
Physical activity
Description
Accelerometer
Time Frame
baseline to 6 month post-intervention and 12 month follow-up
Title
Psychosocial factors
Description
PHQ9
Time Frame
baseline to 6 month post-intervention and 12 month follow-up
10. Eligibility
Sex
Female
Gender Based
Yes
Gender Eligibility Description
Self-identify as female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Becky Marquez, PhD
Phone
858 246-2476
Email
bemarquez@ucsd.edu
Facility Information:
Facility Name
University of California San Diego
City
La Jolla
State/Province
California
ZIP/Postal Code
92037
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Becky Marquez, PhD MPH
Facility Name
University of California San Diego
City
La Jolla
State/Province
California
ZIP/Postal Code
93093
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Becky Marquez, PhD
12. IPD Sharing Statement
Plan to Share IPD
No
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Family Functioning in Obesity Treatment for Mexican Americans
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