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临床试验/NCT03492619
NCT03492619已完成不适用

Intervention for Women in Costa Rica Who Are Discouraged and Have Food Insecurity and Excess Body Weight

University of South Carolina1 个研究点 分布在 1 个国家目标入组 171 人开始时间: 2017年2月1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
入组人数
171
试验地点
1
主要终点
Change from baseline to 6 months in body mass index

研究概览

简要总结

The study develops, implements, and evaluates an intervention focused on alleviating discouragement, food insecurity, and excess weight in women,targeted at the individual, family, and community levels in the Canton Central of the province of Alajuela, Costa Rica.

详细描述

Food insecurity is defined as "limited or uncertain availability of nutritionally adequate and safe foods or limited or uncertain ability to acquire acceptable foods in socially acceptable ways." The coexistence of excess body weight and food insecurity is recognized by researchers and increasingly by the broader public. Poverty and household food insecurity are priority topics for the global community because of their negative impacts in physical and mental health. In Costa Rica, there are no specific data about how many households are affected by food insecurity, but it is well-known that the poverty level has stood at about 20% for the past five years and that food insecurity has an economic component through material deprivation. Thus, even though food insecurity is not the same as poverty, the conditions often coexist.

Multiple studies have concluded that poverty and household food insecurity are often associated with excess body weight in women, but not men. Excess body weight, as defined as Body Mass Index ≥25, is a global health problem and the major public health problem in Costa Rican women. In 2008-2009, 59.7% of women between 20 and 44 years of age have excess body weight, reaching 77.3% in women who are 45 to 64 years of age. Excess body weight also has multiple consequences for physical and mental health. Thus, women with excess body weight and food insecurity have compromised their physical and mental health in multiple ways.

This project builds on a productive partnership between the School of Nutrition of the University of Costa Rica, the association Agenda de Mujeres, the Hospital of Alajuela, and the Women´s Office of the Municipality of Alajuela. For the last eight years, these organizations have been working together to implement health promotion interventions in low-income women with excess weight. For this project, we have the support of the University of South Carolina.

The conceptual framework that guides the intervention is based on the investigators' previous work in Costa Rica that found that discouragement - or in other words, "feeling depressed" - is the primary link in the coexistence of food insecurity and excess body weight among Costa Rican women.

The study is a 6-month intervention targeted at the individual, family, and community levels in the Canton Central of the province of Alajuela, Costa Rica. The specific aims are:

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 60 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • Being excess weight BMI ≥ 25, according to the World Health Organization classification
  • Being between 18 and 60 years old
  • Being food insecure ( low, moderate, or severe) according to have a score ≥ 17 in the Food Insecurity Scale of Costa Rica
  • Living in the selected community
  • Being willing to participate fully in the study
  • Having at least one other adult household member( ideally) or family member willing to participate

排除标准

  • Having a diagnosis of diabetes mellitus
  • Don't Know how to read and write
  • Not being pregnant at the time of recruitment

研究组 & 干预措施

Non-Intensive Intervention

Active Comparator

Three short group sessions that promote healthy lifestyles

干预措施: Non-Intensive Intervention (Behavioral)

Intensive Intervention

Experimental

a) Individual level: a six-month intervention comprised of 12 two-hour sessions, three follow-up monthly sessions, two workshops with the participants' household members and community members and one final session that will be graduation day; b) Household level: 2 workshops about co-responsibility in the household, and self-care and nutrition, including a theater performance. Six assignments with household members' participation; c) Community level: Distribution of 2 different educational materials (one about co-responsibility and another about self-care, including healthy nutrition) and carry out the 2 workshops mentioned above, both with household and community members.

干预措施: Intensive Intervention (Behavioral)

结局指标

主要结局

Change from baseline to 6 months in body mass index

时间窗: Baseline and 6 months

Body mass index is defined as the body mass divided by the square of the body height, and is expressed in units of kg/m2.

Change from baseline to 6 months in household food insecurity as assessed by the food insecurity scale for Costa Rica

时间窗: Baseline and 6 months

This scale is comprised of 14 items. The response categories include ''never,'', ''sometimes'' and ''many times."

Change from baseline to 6 months in waist circumference

时间窗: Baseline and 6 months

Waist circumference is a measure of health risk associated with excess fat around the waist.

次要结局

  • Change from baseline to 6 months in social support from family and friends for healthy eating as assessed by the social Support and Eating Habits Survey.(Baseline and 6 months)
  • Change from baseline to 6 months in proportion of women that contribute to household support and find a job(Baseline and 6 months)
  • Change from baseline to 6 months in psychological empowerment as assessed by the Scale of Personal Agency and Empowerment.(Baseline and 6 months)
  • Change from baseline to 6 months in the consumption of sugar drinks and fried foods as assessed by a food-frequency questionnaire(Baseline and 6 months)
  • Change from baseline to 6 months in metabolic equivalents per week of physical activity(Baseline and 6 months)
  • Change from baseline to 6 months in discouragement feelings as assessed by the Spanish version of the Hospital Anxiety and Depression Scale(Baseline and 6 months)
  • Change from baseline to 6 months in anxiety symptoms as assessed by the Spanish version of the Hospital Anxiety and Depression Scale(Baseline and 6 months)

研究者

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

Edward Frongillo, Jr.

Professor

University of South Carolina

研究点 (1)

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