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Intervention for Women in Costa Rica

Primary Purpose

Obesity, Food Habits, Mental Depression

Status
Completed
Phase
Not Applicable
Locations
Costa Rica
Study Type
Interventional
Intervention
Intensive Intervention
Non-Intensive Intervention
Sponsored by
University of South Carolina
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Obesity focused on measuring obesity, food insecurity, depressive symptoms, empowerment

Eligibility Criteria

18 Years - 60 Years (Adult)FemaleAccepts Healthy Volunteers

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

Sites / Locations

  • Municipality of Alajuela

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Non-Intensive Intervention

Intensive Intervention

Arm Description

Three short group sessions that promote healthy lifestyles

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.

Outcomes

Primary Outcome Measures

Change from baseline to 6 months in body mass index
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
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
Waist circumference is a measure of health risk associated with excess fat around the waist.

Secondary Outcome Measures

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.
The scale consists of 4 sub-scales
Change from baseline to 6 months in proportion of women that contribute to household support and find a job
Women that began to contribute to their household support or/and found a job
Change from baseline to 6 months in psychological empowerment as assessed by the Scale of Personal Agency and Empowerment.
We will use the subscale for agency of the Scale of Personal Agency and Empowerment.
Change from baseline to 6 months in the consumption of sugar drinks and fried foods as assessed by a food-frequency questionnaire
We will use a food frequency with the categories: times per day, per week or per month
Change from baseline to 6 months in metabolic equivalents per week of physical activity
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
Change from baseline to 6 months in discouragement feelings as assessed by the Spanish version of the Hospital Anxiety and Depression Scale
We will use the 7 items of the depression's subscale
Change from baseline to 6 months in anxiety symptoms as assessed by the Spanish version of the Hospital Anxiety and Depression Scale
We will use the 7 items of the anxiety's subscale

Full Information

First Posted
March 23, 2018
Last Updated
April 7, 2018
Sponsor
University of South Carolina
Collaborators
Universidad de Costa Rica, Municipality of Alajuela, Agenda de Mujeres
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1. Study Identification

Unique Protocol Identification Number
NCT03492619
Brief Title
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

2. Study Status

Record Verification Date
April 2018
Overall Recruitment Status
Completed
Study Start Date
February 1, 2017 (Actual)
Primary Completion Date
November 30, 2017 (Actual)
Study Completion Date
December 15, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of South Carolina
Collaborators
Universidad de Costa Rica, Municipality of Alajuela, Agenda de Mujeres

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity, Food Habits, Mental Depression
Keywords
obesity, food insecurity, depressive symptoms, empowerment

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
171 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Non-Intensive Intervention
Arm Type
Active Comparator
Arm Description
Three short group sessions that promote healthy lifestyles
Arm Title
Intensive Intervention
Arm Type
Experimental
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Intensive Intervention
Intervention Description
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
Intervention Name(s)
Non-Intensive Intervention
Intervention Description
Group sessions for healthy lifestyle
Primary Outcome Measure Information:
Title
Change from baseline to 6 months in body mass index
Description
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.
Time Frame
Baseline and 6 months
Title
Change from baseline to 6 months in household food insecurity as assessed by the food insecurity scale for Costa Rica
Description
This scale is comprised of 14 items. The response categories include ''never,'', ''sometimes'' and ''many times."
Time Frame
Baseline and 6 months
Title
Change from baseline to 6 months in waist circumference
Description
Waist circumference is a measure of health risk associated with excess fat around the waist.
Time Frame
Baseline and 6 months
Secondary Outcome Measure Information:
Title
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.
Description
The scale consists of 4 sub-scales
Time Frame
Baseline and 6 months
Title
Change from baseline to 6 months in proportion of women that contribute to household support and find a job
Description
Women that began to contribute to their household support or/and found a job
Time Frame
Baseline and 6 months
Title
Change from baseline to 6 months in psychological empowerment as assessed by the Scale of Personal Agency and Empowerment.
Description
We will use the subscale for agency of the Scale of Personal Agency and Empowerment.
Time Frame
Baseline and 6 months
Title
Change from baseline to 6 months in the consumption of sugar drinks and fried foods as assessed by a food-frequency questionnaire
Description
We will use a food frequency with the categories: times per day, per week or per month
Time Frame
Baseline and 6 months
Title
Change from baseline to 6 months in metabolic equivalents per week of physical activity
Description
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
Time Frame
Baseline and 6 months
Title
Change from baseline to 6 months in discouragement feelings as assessed by the Spanish version of the Hospital Anxiety and Depression Scale
Description
We will use the 7 items of the depression's subscale
Time Frame
Baseline and 6 months
Title
Change from baseline to 6 months in anxiety symptoms as assessed by the Spanish version of the Hospital Anxiety and Depression Scale
Description
We will use the 7 items of the anxiety's subscale
Time Frame
Baseline and 6 months

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Facility Information:
Facility Name
Municipality of Alajuela
City
Alajuela
Country
Costa Rica

12. IPD Sharing Statement

Citations:
Citation
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
Results Reference
background
Citation
2. Food Research & Action Center. Fighting Obesity and Hunger [Internet]. 2015 [cited 2015 Oct 29]. Available from: http://frac.org/initiatives/hunger-and-obesity/
Results Reference
background
PubMed Identifier
24983070
Citation
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/
Results Reference
background
Citation
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
Results Reference
background
Citation
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
Results Reference
background
PubMed Identifier
23459802
Citation
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.
Results Reference
background
PubMed Identifier
12672921
Citation
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.
Results Reference
background
PubMed Identifier
11385061
Citation
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.
Results Reference
background
Citation
9. Ministerio de Salud. Encuesta Nacional de Nutrición: Fascículo Antropometría. [Internet]. 1996. Available from: http://www.binasss.sa.cr/Micro96.pdf
Results Reference
background
PubMed Identifier
20385345
Citation
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.
Results Reference
background
Citation
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;
Results Reference
background
PubMed Identifier
18287371
Citation
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.
Results Reference
background
PubMed Identifier
32037021
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.
Results Reference
derived

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Intervention for Women in Costa Rica

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