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- Ensayo clínico NCT05120804
Funcionamiento familiar en el tratamiento de la obesidad para mexicoamericanos
Mejorando el funcionamiento familiar en el tratamiento de la obesidad para mujeres mexicoamericanas
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.
Descripción general del estudio
Estado
Condiciones
Descripción detallada
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.
Tipo de estudio
Inscripción (Estimado)
Fase
- No aplica
Contactos y Ubicaciones
Ubicaciones de estudio
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California
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La Jolla, California, Estados Unidos, 92037
- University of California San Diego
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La Jolla, California, Estados Unidos, 93093
- University of California San Diego
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
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
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
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Comparador activo: Standard behavioral treatment
Nutrition and physical activity education along with behavior modification techniques |
Nutrition and physical activity education along with behavior modification techniques
Otros nombres:
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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 |
Nutrition and physical activity education along with behavior modification techniques plus relationship skills training
Otros nombres:
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Weight change
Periodo de tiempo: baseline to 6 month post-intervention
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Weight loss |
baseline to 6 month post-intervention
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Weight change
Periodo de tiempo: 6 month post-intervention to 12 month follow-up
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Weight loss maintenance |
6 month post-intervention to 12 month follow-up
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|
Anthropometric measurement
Periodo de tiempo: baseline to 6 month post-intervention and 12 month follow-up
|
Percent body fat |
baseline to 6 month post-intervention and 12 month follow-up
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|
Hemoglobin A1C
Periodo de tiempo: baseline to 6 month post-intervention and 12 month follow-up
|
Percent A1C |
baseline to 6 month post-intervention and 12 month follow-up
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|
Family functioning
Periodo de tiempo: baseline to 6 month post-intervention and 12 month follow-up
|
Observational coding of family communication |
baseline to 6 month post-intervention and 12 month follow-up
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Eating behavior
Periodo de tiempo: baseline to 6 month post-intervention and 12 month follow-up
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Food frequency questionnaire |
baseline to 6 month post-intervention and 12 month follow-up
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Physical activity
Periodo de tiempo: baseline to 6 month post-intervention and 12 month follow-up
|
Accelerometer |
baseline to 6 month post-intervention and 12 month follow-up
|
|
Psychosocial factors
Periodo de tiempo: baseline to 6 month post-intervention and 12 month follow-up
|
PHQ9 |
baseline to 6 month post-intervention and 12 month follow-up
|
Colaboradores e Investigadores
Patrocinador
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Estimado)
Finalización del estudio (Estimado)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- 210620
Plan de datos de participantes individuales (IPD)
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Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
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