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临床试验/NCT05589740
NCT05589740已完成不适用

Wellness With Culturally Optimized Messages for Ethnic-diverse Latinos

Harvard School of Public Health (HSPH)1 个研究点 分布在 1 个国家目标入组 76 人开始时间: 2022年7月13日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
76
试验地点
1
主要终点
Change in levels of blood pressure risk factor

研究概览

简要总结

This project aims to redesign and optimize a deep-structure culturally-tailored healthy eating program and test its effectiveness in improving dietary outcomes, anthropometric, and blood pressure among 75 diverse Latinos, compared to surface-level messages.

详细描述

This project aims to redesign and optimize a deep-structure culturally-tailored healthy eating program and test its effectiveness in improving dietary outcomes, anthropometric, and blood pressure among 75 diverse Latinos, compared to surface-level messages. The WELCOME study will be based on the RE-AIM framework with improved reach, adoption, implementation, and maintenance strategies. The intervention arm is a deep-structure cultural tailored text messages for distinct Latino heritages (e.g., Caribbean and non-Caribbean) informed by mixed-methods formative research, compared to surface-level healthy eating messages based on the USDA My Plate Spanish version. The program runs for 6 months: 2-months delivery phase + 2-months reinforcement phase + 2-months maintenance phase.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Triple (Participant, Investigator, Outcomes Assessor)

入排标准

年龄范围
25 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者
是

入选标准

  • •age 25-65 y/o
  • •self-reported Hispanic/Latino heritage
  • •able to understand and answer questions in Spanish or English
  • •living in Massachusetts for the past year and not planning to move in the next year
  • •having a cellphone with the capacity of receiving and sending text messages and giving consent for the Study to text this number as part of the intervention

排除标准

  • •self-reported diagnosis of cancer, diabetes or major stomach or heart condition (e.g.: gastrointestinal cancers, coronary heart disease, previous stroke or heart attack, severe dietary allergies or restrictions)
  • •planning to move Massachusetts in the next year
  • •currently pregnant
  • •institutionalized (i.e.: hospital, prison, etc.).

研究组 & 干预措施

Intervention

Experimental

Intervention group consisting of culturally-tailored healthy eating advice through daily text messages for 2 months (delivery phase); a subsequent reinforcement phase of 2-months to repeat the text messages; and a subsequent maintenance phase of 2-months with no text messages.

干预措施: Culturally tailored healthy eating advice (Behavioral)

Control

Active Comparator

Control group consisting of general healthy eating advice through daily text messages for 2 months (delivery phase); a subsequent reinforcement phase of 2-months to repeat the text messages; and a subsequent maintenance phase of 2-months with no text messages.

干预措施: Standard healthy eating advice (Behavioral)

结局指标

主要结局

Change in levels of blood pressure risk factor

时间窗: Month 4

Estimate the change in the value of systolic and diastolic blood pressure (mmHg)

Change in dietary habits

时间窗: Month 4

Determine the change in the score of dietary behaviors (range 1-5)

Changes in diet quality score

时间窗: Month 4

Determine the change in score of short diet quality screener (range 18-54; from lowest to highest quality)

Change in levels of adipose risk factor

时间窗: Month 4

Estimate the change in the value of waist circumference (cm)

次要结局

  • Changes in diet satisfaction: diet satisfaction scale(Month 4)

研究者

发起方
Harvard School of Public Health (HSPH)
申办方类型
Other
责任方
Principal Investigator
主要研究者

Josiemer Mattei

Donald and Sue Pritzker Associate Professor of Nutrition

Harvard School of Public Health (HSPH)

研究点 (1)

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