Clinical trial NCT03492619: Intervention for Women in Costa Rica
Official title: Intervention for Women in Costa Rica Who Are Discouraged and Have Food Insecurity and Excess Body Weight
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity
Food Habits
Mental Depression
Keywords: obesity
food insecurity
depressive symptoms
empowerment
Lead sponsor: University of South Carolina
Sponsor class: OTHER
Collaborators: name: Universidad de Costa Rica
name: Municipality of Alajuela
name: Agenda de Mujeres
First posted: 2018-04-10
Enrollment: 171
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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:

Specific Aim 1: To determine the impact of an intervention to alleviate discouragement feelings among food-insecure, excess-weight women. Hypothesis 1: After the intervention, the participants in the intervention group, as compared with the control group, will reduce their household food security status, increase their psychological and economic empowerment level, decrease their depression and anxiety levels, increase perceived social support, and decrease their body mass index and waist circumference. Qualitative methods, specifically group interviews and semi-structured in-depth interviews, also are used to assess the intervention Specific Aim 2: To qualitatively examine the impact of the intervention on gender norms, including co-responsibility in the household (i.e., joint decision-making, sharing responsibilities in the household, including taking care of children and the disabled and contributing to household support), and self-care, including healthy nutrition.

To address these aims, we designed a cluster-randomized controlled trial design at the health-center level, the first level of care in Costa Rica. Investigators randomize 15 matched pairs of health centers in a 1:1 ratio to intervention and control arms, and enroll 7 participants per health center (total n=210).

For specific aim #2 the investigators will use qualitative methods, such as group interviews, semi-structured in-depth interviews, and non-participant observation This study is significant because there are no interventions in Costa Rica or other countries that aim to improve both food security and health, including mental health and excess body weight, in food-insecure women with excess body weight. Therefore, studies are needed to develop, implement, and evaluate the efficacy and effectiveness of interventions targeting these women.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

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

Primary outcomes:
measure: Change from baseline to 6 months in body mass index
timeFrame: Baseline and 6 months
measure: Change from baseline to 6 months in household food insecurity as assessed by the food insecurity scale for Costa Rica
timeFrame: Baseline and 6 months
measure: Change from baseline to 6 months in waist circumference
timeFrame: Baseline and 6 months
Secondary outcomes:
measure: 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.
timeFrame: Baseline and 6 months
measure: Change from baseline to 6 months in proportion of women that contribute to household support and find a job
timeFrame: Baseline and 6 months
measure: Change from baseline to 6 months in psychological empowerment as assessed by the Scale of Personal Agency and Empowerment.
timeFrame: Baseline and 6 months
measure: Change from baseline to 6 months in the consumption of sugar drinks and fried foods as assessed by a food-frequency questionnaire
timeFrame: Baseline and 6 months
measure: Change from baseline to 6 months in metabolic equivalents per week of physical activity
timeFrame: Baseline and 6 months
measure: Change from baseline to 6 months in discouragement feelings as assessed by the Spanish version of the Hospital Anxiety and Depression Scale
timeFrame: Baseline and 6 months
measure: Change from baseline to 6 months in anxiety symptoms as assessed by the Spanish version of the Hospital Anxiety and Depression Scale
timeFrame: Baseline and 6 months
Other outcomes:
Locations:
city: Alajuela
country: Costa Rica
facility: Municipality of Alajuela
Study officials:
References:
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citation: Martinez-Jaikel T, Frongillo EA, Blake CE, Fram MS, Esquivel-Solis V. Reducing Both Food Insecurity and Excess Body Weight in Costa Rican Women: A Cluster Randomized Trial. Am J Prev Med. 2020 May;58(5):736-747. doi: 10.1016/j.amepre.2019.11.021. Epub 2020 Feb 6.