Intervention for Women in Costa Rica

NCT03492619 | Completed

• 1 other identifier: Pro00061663
• Study Type: interventional
• Target: 171
• Locations: 1 country
• Sites: 1

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.

Conditions

Obesity; Food Habits; Mental Depression

Keywords

obesity; food insecurity; depressive symptoms; empowerment

Outcome Measures

Primary Outcomes (3)

• 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.

  Baseline and 6 months

• 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."

  Baseline and 6 months

• Change from baseline to 6 months in waist circumference

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

  Baseline and 6 months

Secondary Outcomes (7)

• 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

Study Arms (2)

Non-Intensive Intervention

ACTIVE COMPARATOR

Three short group sessions that promote healthy lifestyles

Behavioral: Non-Intensive Intervention

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.

Behavioral: Intensive Intervention

Interventions

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

Intensive Intervention

Non-Intensive Intervention BEHAVIORAL

Group sessions for healthy lifestyle

Non-Intensive Intervention

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• University of South Carolina: lead
• Universidad de Costa Rica: collaborator
• Municipality of Alajuela: collaborator
• Agenda de Mujeres: collaborator

Study Sites (1)

Municipality of Alajuela

Alajuela, Costa Rica

Location

Related Publications (13)

• 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

  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/

  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/

  PMID: 24983070 BACKGROUND

• 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

  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

  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.

  PMID: 23459802 BACKGROUND

• 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.

  PMID: 12672921 BACKGROUND

• 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.

  PMID: 11385061 BACKGROUND

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

  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.

  PMID: 20385345 BACKGROUND

• 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;

  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.

  PMID: 18287371 BACKGROUND

• 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.

  PMID: 32037021 DERIVED

MeSH Terms

Conditions

Obesity; Feeding Behavior; Depression; Empowerment

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Behavior, Animal; Behavior; Behavioral Symptoms; Social Behavior

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: March 23, 2018
• First Posted: April 10, 2018
• Study Start: February 1, 2017
• Primary Completion: November 30, 2017
• Study Completion: December 15, 2017
• Last Updated: April 10, 2018

Record last verified: 2018-04

Locations

CO (1)