Intervention for Women in Costa Rica

NCT ID: NCT03492619

Last Updated: 2018-04-10

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 171 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-02-01
• Study Completion Date: 2017-12-15

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.

Conditions

Obesity; Food Habits; Mental Depression

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Non-Intensive Intervention

Three short group sessions that promote healthy lifestyles

Group Type: ACTIVE_COMPARATOR

Non-Intensive Intervention

Intervention Type: BEHAVIORAL

Group sessions for healthy lifestyle

Intensive Intervention

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.

Group Type: EXPERIMENTAL

Intensive Intervention

Intervention Type: BEHAVIORAL

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

Interventions

Intensive Intervention

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

Intervention Type: BEHAVIORAL

Non-Intensive Intervention

Group sessions for healthy lifestyle

Intervention Type: BEHAVIORAL

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Universidad de Costa Rica

OTHER

Sponsor Role: collaborator

Municipality of Alajuela

UNKNOWN

Sponsor Role: collaborator

Agenda de Mujeres

UNKNOWN

Sponsor Role: collaborator

University of South Carolina

OTHER

Sponsor Role: lead

Responsible Party

Edward Frongillo, Jr.

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Municipality of Alajuela

Alajuela, , Costa Rica

Countries

Costa Rica

References

1. United States Department of Agriculture. Guide to Measuring Household Food Security (Revised 2000) [Internet]. [cited 2014 Oct 5]. Available from: http://www.fns.usda.gov/guide-measuring-household-food-security-revised-2000

Reference Type: BACKGROUND

2. Food Research & Action Center. Fighting Obesity and Hunger [Internet]. 2015 [cited 2015 Oct 29]. Available from: http://frac.org/initiatives/hunger-and-obesity/

Reference Type: BACKGROUND

Institute of Medicine (US). Hunger and Obesity: Understanding a Food Insecurity Paradigm: Workshop Summary. Washington (DC): National Academies Press (US); 2011. Available from http://www.ncbi.nlm.nih.gov/books/NBK209372/

Reference Type: BACKGROUND

PMID: 24983070 (View on PubMed)

4. Frongillo E, Olson C, Rauschenbach B, Kendall A. Nutritional Consequences of Food Insecurity in a Rural New York State County [Internet]. 1997 [cited 2015 Jan 6]. Available from: http://www.irp.wisc.edu/publications/dps/pdfs/dp112097.pdf

Reference Type: BACKGROUND

5. Instituto Nacional de Estadisticas y Censos. Poverty in Costa Rica [Internet]. 2014 [cited 2015 Apr 12]. Available from: http://www.inec.go.cr/Web/Home/pagPrincipal.aspx

Reference Type: BACKGROUND

Schlussel MM, Silva AA, Perez-Escamilla R, Kac G. Household food insecurity and excess weight/obesity among Brazilian women and children: a life-course approach. Cad Saude Publica. 2013 Feb;29(2):219-26. doi: 10.1590/s0102-311x2013000200003.

Reference Type: BACKGROUND

PMID: 23459802 (View on PubMed)

Adams EJ, Grummer-Strawn L, Chavez G. Food insecurity is associated with increased risk of obesity in California women. J Nutr. 2003 Apr;133(4):1070-4. doi: 10.1093/jn/133.4.1070.

Reference Type: BACKGROUND

PMID: 12672921 (View on PubMed)

Townsend MS, Peerson J, Love B, Achterberg C, Murphy SP. Food insecurity is positively related to overweight in women. J Nutr. 2001 Jun;131(6):1738-45. doi: 10.1093/jn/131.6.1738.

Reference Type: BACKGROUND

PMID: 11385061 (View on PubMed)

9. Ministerio de Salud. Encuesta Nacional de Nutrición: Fascículo Antropometría. [Internet]. 1996. Available from: http://www.binasss.sa.cr/Micro96.pdf

Reference Type: BACKGROUND

Azarbad L, Gonder-Frederick L. Obesity in women. Psychiatr Clin North Am. 2010 Jun;33(2):423-40. doi: 10.1016/j.psc.2010.01.003.

Reference Type: BACKGROUND

PMID: 20385345 (View on PubMed)

11.Martinez-Jaikel T, Frongillo E. Primary role of discouragement in co-existence of food insecurity and excess weight in Costa Rican women. J Hunger Environ Nutr. 2016;

Reference Type: BACKGROUND

Gonzalez W, Jimenez A, Madrigal G, Munoz LM, Frongillo EA. Development and validation of measure of household food insecurity in urban Costa Rica confirms proposed generic questionnaire. J Nutr. 2008 Mar;138(3):587-92. doi: 10.1093/jn/138.3.587.

Reference Type: BACKGROUND

PMID: 18287371 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 32037021 (View on PubMed)

Other Identifiers

Pro00061663

Identifier Type: -

Identifier Source: org_study_id