Standard Behavioral Treatment
BehavioralNutrition and physical activity education along with behavior modification techniques
Other names: SBT
NCT Number: NCT05120804
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.
This study is active but is not currently recruiting participants.
Notify Me18 year–65 year
Female
Interventional
Not applicable
University of California San Diego, La Jolla, California, United States
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Nutrition and physical activity education along with behavior modification techniques
Other names: SBT
Nutrition and physical activity education along with behavior modification techniques plus relationship skills training
Other names: SBTR
Time frame: baseline to 6 month post-intervention
Weight loss
Time frame: 6 month post-intervention to 12 month follow-up
Weight loss maintenance
Time frame: baseline to 6 month post-intervention and 12 month follow-up
Percent body fat
Time frame: baseline to 6 month post-intervention and 12 month follow-up
Percent A1C
Time frame: baseline to 6 month post-intervention and 12 month follow-up
Observational coding of family communication
Time frame: baseline to 6 month post-intervention and 12 month follow-up
Food frequency questionnaire
Time frame: baseline to 6 month post-intervention and 12 month follow-up
Accelerometer
Time frame: baseline to 6 month post-intervention and 12 month follow-up
PHQ9
Becky Marquez
Other
Improving Family Functioning in Obesity Treatment for Mexican American Women
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT06993792
Body Weight, Diabetes Mellitus
Sun City West, Arizona, United States
View Trial DetailsNCT04335799
Body Weight, Nutrition Disorders
Tampa, Florida, United States
View Trial DetailsNCT05198765
Body Weight, Diabetes Mellitus
Minneapolis, Minnesota, United States
View Trial DetailsNCT00739362
Body Weight, Body Weight Changes
Phoenix, Arizona, United States
View Trial Details