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临床试验/NCT03978416
NCT03978416终止不适用

Development of Novel Behavioral Intervention for Sustainable Weight Loss in Hispanic Adults With Obesity

Tufts University2 个研究点 分布在 1 个国家目标入组 23 人开始时间: 2019年8月23日最近更新:
适应症

试验速览

阶段
不适用
状态
终止
入组人数
23
试验地点
2
主要终点
Weight change

研究概览

简要总结

There are great disparities in the prevalence of obesity and chronic disease in different sociodemographic groups. US Hispanic adults, in particular, have a higher prevalence of obesity and chronic diseases than non-Hispanic whites. Population aging is also a major contributing factor to the high prevalence of chronic disease, and Hispanics already make up approximately 10% of the older population. Therefore, preventive measures are needed to reduce the burden of chronic disease risks for Hispanics. Current lifestyle interventions for weight management have been particularly ineffective in this population.

The purpose of this pilot project is to develop a novel tailored lifestyle intervention for use by Hispanic older adults with obesity. The Healthy Weight for Living intervention has been validated among adults with mixed racial/ethnic backgrounds and has achieved clinically impactful weight-loss. Its design features make it particularly suitable for use in populations with low adherence to traditional interventions, including no requirement for daily food logging and no increase in physical activity.

The final product of this project will be a culturally adapted prototype intervention in Hispanic older adults that accounts for cultural heterogeneity. This work has direct relevance to reducing health disparities and the burden of obesity-associated chronic disease in a particularly at-risk population.

详细描述

The scientific premise of this project is that appropriately tailored lifestyle interventions for weight loss can achieve clinically impactful weight loss in Hispanic adults with obesity. Older adults will be the focus, recognizing that requirements for tailoring may vary according to age group. Given that older adults have a higher risk of chronic diseases caused by obesity, there is a great need to focus on factors that disproportionately affect older Hispanic adults. The objective of this project is to tailor a validated lifestyle intervention developed and used by our team in ethnically mixed populations to older Hispanic adults with obesity. This novel intervention does not require food logging or a large increase in physical activity to achieve weight loss, making it more acceptable to population groups with low adherence to traditional interventions. The long-term goal of this work is to create an effective, culturally acceptable, sustainable, and scalable lifestyle weight management program for routine use in Hispanic adults with obesity. Findings from this work will be directly applicable to future community interventions and will be relevant for public health measures in this at-risk population.

The specific aims are:

Aim 1: To conduct focus groups in Hispanic older adults with obesity to identify factors that can be addressed in the tailored intervention. Information will be collected on practical and cultural barriers and promoters of successful weight management, including food access, dietary patterns, physical activity, time and financial constraints, and additional psychosocial and cultural factors.

Hypothesis 1: Malleable dietary and psychosocial targets for weight loss and weight loss maintenance can be identified, including factors such as food cravings, hunger and disinhibited eating that have been shown to be effective targets in other population groups.

Aim 2: To conduct a pilot behavioral intervention of an initially adapted program in Hispanic older adults with obesity. A prototype bilingual English-Spanish lifestyle intervention for weight reduction will be created. The prototype will then be iteratively refined during a series of short-term tests (two tests lasting 4 weeks, followed by a final test lasting 12 weeks) of intervention delivery. In these interventions, % weight loss, % drop-out, and safety benchmarks will be monitored. Participant-reported barriers to adherence identified during group meetings and exit interviews will be targets for improvement in successive iterations.

研究设计

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

盲法说明

The purpose of this project is to develop a lifestyle intervention for weight loss by conducting three pilot studies where small groups of participants undergo progressively developed versions of the intervention. There will not be masking as both subjects and investigators will be aware of the intervention.

入排标准

年龄范围
50 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 未提供

排除标准

  • 未提供

结局指标

主要结局

Weight change

时间窗: Pilot 1 and 2: 4 weeks. Pilot 3: 12 weeks

Change in weight from baseline to the end of the intervention period

Attendance to weekly group meetings

时间窗: Pilot 1 and 2: 4 weeks. Pilot 3: 12 weeks

Adherence will be measured as meeting attendance

次要结局

  • Change in blood pressure (systolic and diastolic)(Depending on pilot phase the time frame will be 4 weeks or 12 weeks)
  • Change in waist circumference(Depending on pilot phase the time frame will be 4 weeks or 12 weeks)
  • Change in hip circumference(Depending on pilot phase the time frame will be 4 weeks or 12 weeks)
  • Themes generated from qualitative data(Baseline, 4 weeks for pilot cycles 1 and 2, and 12 weeks for pilot cycle 3)
  • Financial well-being(Baseline)
  • Dietary intake(Baseline)
  • Dietary behavior(Baseline)
  • Perceived stress(Baseline)
  • Eating behavior (hunger, satiety, cognitive restraint)(Baseline)
  • Acculturation(Baseline)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Maria Carlota Dao

Scientist

Tufts University

研究点 (2)

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