Clinical Trial Details
— Status: Recruiting
Administrative data
NCT number |
NCT05120804 |
Other study ID # |
210620 |
Secondary ID |
|
Status |
Recruiting |
Phase |
N/A
|
First received |
|
Last updated |
|
Start date |
February 22, 2022 |
Est. completion date |
July 31, 2026 |
Study information
Verified date |
June 2023 |
Source |
University of California, San Diego |
Contact |
Becky Marquez, PhD |
Phone |
858 246-2476 |
Email |
bemarquez[@]ucsd.edu |
Is FDA regulated |
No |
Health authority |
|
Study type |
Interventional
|
Clinical Trial 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.
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.