跳至主要内容
临床试验/NCT05120804
NCT05120804进行中(未招募)不适用

Improving Family Functioning in Obesity Treatment for Mexican American Women

Becky Marquez2 个研究点 分布在 1 个国家目标入组 236 人开始时间: 2022年2月22日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
进行中(未招募)
发起方
入组人数
236
试验地点
2
主要终点
Weight change

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • 18-65 years of age
  • Mexican or Mexican American
  • Reside in San Diego County
  • Body mass index of 25-45 kg/m2

排除标准

  • 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

研究组 & 干预措施

Standard behavioral treatment

Active Comparator

Nutrition and physical activity education along with behavior modification techniques

干预措施: Standard behavioral treatment (Behavioral)

Standard behavioral treatment plus relationship skills training

Experimental

Nutrition and physical activity education along with behavior modification techniques plus brief and structured counseling on family functioning

干预措施: Standard behavioral treatment plus relationship skills training (Behavioral)

结局指标

主要结局

Weight change

时间窗: baseline to 6 month post-intervention

Weight loss

次要结局

  • Anthropometric measurement(baseline to 6 month post-intervention and 12 month follow-up)
  • Psychosocial factors(baseline to 6 month post-intervention and 12 month follow-up)
  • Family functioning(baseline to 6 month post-intervention and 12 month follow-up)
  • Physical activity(baseline to 6 month post-intervention and 12 month follow-up)
  • Weight change(6 month post-intervention to 12 month follow-up)
  • Hemoglobin A1C(baseline to 6 month post-intervention and 12 month follow-up)
  • Eating behavior(baseline to 6 month post-intervention and 12 month follow-up)

研究者

发起方
Becky Marquez
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Becky Marquez

Assistant Professor

University of California, San Diego

研究点 (2)

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