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Completed

NCT Number: NCT03492619

Intervention for Women in Costa Rica

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.

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Key information

Age range

18 year–60 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Municipality of Alajuela

Alajuela, Costa Rica

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Intensive Intervention

Behavioral

an intervention focused on alleviating discouragement, food insecurity, and excess weight in women and targeted at the individual, family, and community levels

Non-Intensive Intervention

Behavioral

Group sessions for healthy lifestyle

Primary outcomes

  1. Change from baseline to 6 months in body mass index

    Time frame: 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.

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

    Time frame: Baseline and 6 months

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

  3. Change from baseline to 6 months in waist circumference

    Time frame: Baseline and 6 months

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

Secondary outcomes

  1. 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.

    Time frame: Baseline and 6 months

    The scale consists of 4 sub-scales

  2. Change from baseline to 6 months in proportion of women that contribute to household support and find a job

    Time frame: Baseline and 6 months

    Women that began to contribute to their household support or/and found a job

  3. Change from baseline to 6 months in psychological empowerment as assessed by the Scale of Personal Agency and Empowerment.

    Time frame: Baseline and 6 months

    We will use the subscale for agency of the Scale of Personal Agency and Empowerment.

  4. Change from baseline to 6 months in the consumption of sugar drinks and fried foods as assessed by a food-frequency questionnaire

    Time frame: Baseline and 6 months

    We will use a food frequency with the categories: times per day, per week or per month

  5. Change from baseline to 6 months in metabolic equivalents per week of physical activity

    Time frame: Baseline and 6 months

    We ask about type of activity, how many times a week and how many minutes in each session of physical activity and we will convert to metabolic equivalents per week

  6. Change from baseline to 6 months in discouragement feelings as assessed by the Spanish version of the Hospital Anxiety and Depression Scale

    Time frame: Baseline and 6 months

    We will use the 7 items of the depression's subscale

  7. Change from baseline to 6 months in anxiety symptoms as assessed by the Spanish version of the Hospital Anxiety and Depression Scale

    Time frame: Baseline and 6 months

    We will use the 7 items of the anxiety's subscale

Sponsors and collaborators

Lead sponsor

University of South Carolina

Other

Collaborators

  • Agenda de Mujeres
  • Municipality of Alajuela
  • Universidad de Costa Rica

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2017
Study completion
2017
First posted
Apr 10, 2018
Registry last updated
Apr 10, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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