ObesityNCT03492619
Intervention for Women in Costa Rica
A study testing Intensive Intervention and Non-Intensive Intervention in people with Obesity and Food Habits, run by University of South Carolina at 1 site in Costa Rica.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 60 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Obesity, Food Habits, Mental Depression
- What is being tested?
- Intensive Intervention and Non-Intensive Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 171 participants
- Where
- 1 siteCosta Rica
- Study dates
- 1 Feb 2017to 15 Dec 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- Having a diagnosis of diabetes mellitus
- Don't Know how to read and write
- Not being pregnant at the time of recruitment
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Intervention for Women in Costa Rica Who Are Discouraged and Have Food Insecurity and Excess Body Weight
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.
Read the 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
- Being tested
- Intensive Intervention, Non-Intensive Intervention
- Keywords
- obesity, food insecurity, depressive symptoms, empowerment
- Medical subject headings
- Obesity, Feeding Behavior, Depression, Empowerment
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intensive InterventionBehavioural
an intervention focused on alleviating discouragement, food insecurity, and excess weight in women and targeted at the individual, family, and community levels
Non-Intensive InterventionBehavioural
Group sessions for healthy lifestyle
| Study group | Role | What they receive |
|---|---|---|
| Non-Intensive Intervention | Active comparator | Three short group sessions that promote healthy lifestyles Receives: 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. Receives: Behavioral: Intensive Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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."
Measured: 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.
Measured: 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.
The scale consists of 4 sub-scales
Measured: Baseline and 6 months
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
Measured: Baseline and 6 months
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.
Measured: 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
We will use a food frequency with the categories: times per day, per week or per month
Measured: Baseline and 6 months
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
Measured: Baseline and 6 months
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
Measured: Baseline and 6 months
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
Measured: Baseline and 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Apr 2018
- Study start1 Feb 2017
- Primary completion30 Nov 2017
- Study completion15 Dec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (13)Papers the sponsor has linked to this study.
- Other trials for ObesityStudies of the same condition, open and under way.
- More trials run by University of South CarolinaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 171 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of South Carolina
- Sponsor type
- University, hospital or other
- Collaborators
- Universidad de Costa Rica, Municipality of Alajuela, Agenda de Mujeres
- Responsible party
- Principal investigator, Edward Frongillo, Jr., University of South Carolina
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03492619
- Sponsor's protocol ID
- Pro00061663
- Status last verified
- Apr 2018
- First submitted
- 23 Mar 2018
- Last updated
- 10 Apr 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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
2. Food Research & Action Center. Fighting Obesity and Hunger [Internet]. 2015 [cited 2015 Oct 29]. Available from: http://frac.org/initiatives/hunger-and-obesity/
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/
PubMed 249830704. 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
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
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.
PubMed 23459802Adams 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.
PubMed 12672921Townsend 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.
PubMed 113850619. Ministerio de Salud. Encuesta Nacional de Nutrición: Fascículo Antropometría. [Internet]. 1996. Available from: http://www.binasss.sa.cr/Micro96.pdf
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.
PubMed 2038534511.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;
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.
PubMed 18287371Martinez-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.
PubMed 32037021
Study at a glance
From the registry record, last updated by the sponsor on 10 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intervention for Women in Costa Rica Who Are Discouraged and Have Food Insecurity and Excess Body Weight
- ClinicalTrials.gov ID
- NCT03492619
- Acronym / sponsor ID
- Pro00061663
- Conditions
- Obesity, Food Habits, Mental Depression
- Keywords
- obesity, food insecurity, depressive symptoms, empowerment
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 171 participants (actual)
- Lead sponsor
- University of South CarolinaUniversity, hospital or other
- Collaborators
- Universidad de Costa Rica, Municipality of Alajuela, Agenda de Mujeres
- Study start
- 1 Feb 2017 (actual)
- Primary completion
- 30 Nov 2017 (actual)
- Study completion
- 15 Dec 2017 (actual)
- First posted
- 10 Apr 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Non-Intensive Intervention | Active comparator | Behavioral: Non-Intensive InterventionThree short group sessions that promote healthy lifestyles |
| Intensive Intervention | Experimental | Behavioral: Intensive Interventiona) 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. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (3 listed)
- Having a diagnosis of diabetes mellitus
- Don't Know how to read and write
- Not being pregnant at the time of recruitment
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Intensive Interventionan intervention focused on alleviating discouragement, food insecurity, and excess weight in women and targeted at the individual, family, and community levels | Behavioural | Intensive Intervention |
| Non-Intensive InterventionGroup sessions for healthy lifestyle | Behavioural | Non-Intensive Intervention |
Primary outcome
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.
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."
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.
7 secondary outcomes
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
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
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
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
Change from baseline to 6 months in metabolic equivalents per week of physical activity
Time frame: Baseline and 6 months
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
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Apr 2018.
- Background1. 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
- Background2. Food Research & Action Center. Fighting Obesity and Hunger [Internet]. 2015 [cited 2015 Oct 29]. Available from: http://frac.org/initiatives/hunger-and-obesity/
- Background: PubMed 24983070Institute 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/
- Background4. 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
- Background5. 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: PubMed 23459802Schlussel 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.
- Background: PubMed 12672921Adams 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.
- Background: PubMed 11385061Townsend 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.
- Background9. Ministerio de Salud. Encuesta Nacional de Nutrición: Fascículo Antropometría. [Internet]. 1996. Available from: http://www.binasss.sa.cr/Micro96.pdf
- Background: PubMed 20385345Azarbad 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.
- Background11.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: PubMed 18287371Gonzalez 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intensive Intervention and Non-Intensive Intervention in people with Obesity and Food Habits, run by University of South Carolina at 1 site in Costa Rica.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Apr 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Costa Rica. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline to 6 months in body mass index (time frame: Baseline and 6 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03492619, which also lists 13 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Apr 2018.