Evaluation of Marketing Interventions in Colombia

August 21, 2017 updated by: Kathryn Yount, Emory University

Evaluation Of The Effect Of Marketing Interventions For Women On Economic Empowerment And Risk Of Intimate Partner Violence In Colombia

The proposed project seeks to implement a cluster-randomized controlled trial (RCT) to measure the impact of increasing women´s incomes and providing gender equality trainings on women´s empowerment and risk of intimate partner violence (IPV) in Colombia. This project will be the first in Latin America to evaluate rigorously the impact of a marketing intervention, alone and combined with IPV prevention training. The knowledge generated from this evaluation has the potential to identify the most effective solutions to empower women, as well as to drive transformative change in current approaches to reduce IPV and promote gender equality in highly vulnerable populations in Colombia, and worldwide.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

The proposed project seeks to implement a cluster-randomized controlled trial (RCT) to measure the impact of increasing women´s incomes and providing gender equality trainings on women´s empowerment and risk of intimate partner violence (IPV) in Colombia. This project will be the first in Latin America to evaluate rigorously the impact of a marketing intervention, alone and combined with IPV prevention training. The knowledge generated from this evaluation has the potential to identify the most effective solutions to empower women, as well as to drive transformative change in current approaches to reduce IPV and promote gender equality in highly vulnerable populations in Colombia, and worldwide.

The goal of the project is to estimate the impact of generating livelihood opportunities and providing gender-based violence (GBV) training to reduce IPV among women in Colombia. This will generate much needed evidence on the most effective approach to empower women smallholder farmers and reduce their exposure to IPV. Investigators will conduct a cluster randomized controlled trial targeting approximately 100 smallholder farmers' associations and approximately 2700 women. Results will inform and strengthen future programming of humanitarian assistance and can be replicated in humanitarian interventions in other parts of the world.

The experimental operational research will compare two programmatic modalities and their impact on women's risk of exposure to IPV, against a comparison group where no intervention takes place. The modalities will include: (1) providing a stable income for women, and (2) providing a stable income and IPV trainings to women. The evaluation will take place in five departments: Cauca, Valle de Cauca, Meta, Caquetá, and Nariño.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
1882

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Colombia
    • Bogotá
      • Aurora, Bogotá, Colombia
        • World Food Programme Colombia

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 60 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Women currently married or living together with a man as if married
  • Males or females who are active within the farmer's association are eligible to participate

Exclusion Criteria:

  • Women who have a husband/partner who is living elsewhere permanently

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Treatment Group 1
Farmers associations, including men and women, will be randomized to receive the smallholder marketing intervention.
Other: Smallholder Marketing
The smallholder marketing intervention involves product purchasing (e.g., bananas, beans, goats, eggs) from smallholder farmers' associations through WFP's large procurement procedures. WFP is will also provide technical training on topics such as sustainable farming practices, quality control, and business practices.
Experimental: Treatment Group 2
Farmers associations, including men and women, will be randomized to receive the smallholder marketing intervention combined with the intimate partner violence (IPV) prevention training.
Other: Smallholder Marketing
The smallholder marketing intervention involves product purchasing (e.g., bananas, beans, goats, eggs) from smallholder farmers' associations through WFP's large procurement procedures. WFP is will also provide technical training on topics such as sustainable farming practices, quality control, and business practices.
Other: Intimate Partner Violence (IPV) Prevention Training
IPV prevention training involves 24 hours of gender training (gender equality and rights, economic empowerment, gender-based violence prevention), and 8 hours of nutrition and food security training (with a focus on gender).
No Intervention: Comparison Group 3
Women involved with farmers's associations that work independently of World Food Programmes (WFP's) assistance.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Incidence Physical and/or Sexual IPV
Time Frame: Post-Baseline (12 Months)
The number of new physical and/or sexual IPV encounters as reported in the study survey.
Post-Baseline (12 Months)
Change in Prevalence of Physical and/or Sexual IPV
Time Frame: Baseline, End-Line (12 Months Post Intervention)
The difference in the number of physical or sexual IPV encounters between baseline and post intervention as reported in the study survey.
Baseline, End-Line (12 Months Post Intervention)

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Incidence Physical IPV
Time Frame: Post-Baseline (12 Months)
The number of new physical IPV encounters reported.
Post-Baseline (12 Months)
Incidence Sexual IPV
Time Frame: Post-Baseline (12 Months)
The number of new sexual IPV encounters as reported in the study survey.
Post-Baseline (12 Months)
Incidence Psychological IPV
Time Frame: Post-Baseline (12 Months)
The number of new physiological IPV encounters as reported in the study survey.
Post-Baseline (12 Months)
Incidence Economic Coercion
Time Frame: Post-Baseline (12 Months)
The number of new encounters of economic coercion as reported in the study survey.
Post-Baseline (12 Months)
Change in Prevalence of Physical IPV
Time Frame: Baseline, End-Line (12 Months Post Intervention)
The difference in the number of physical IPV encounters between baseline and post intervention as reported in the study survey.
Baseline, End-Line (12 Months Post Intervention)
Change in Prevalence of Sexual IPV
Time Frame: Baseline, End-Line (12 Months Post Intervention)
The difference in the number of sexual IPV encounters between baseline and post intervention as reported in the study survey.
Baseline, End-Line (12 Months Post Intervention)
Change in Prevalence of Psychological IPV
Time Frame: Baseline, End-Line (12 Months Post Intervention)
The difference in the number of psychological IPV encounters between baseline and post intervention as reported in the study survey.
Baseline, End-Line (12 Months Post Intervention)
Change in Prevalence of Economic Coercion
Time Frame: Baseline, End-Line (12 Months Post Intervention)
The difference in the number of economic coercion encounters between baseline and post intervention as reported in the study survey.
Baseline, End-Line (12 Months Post Intervention)

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Women's Attitudes Towards Gender
Time Frame: End-Line (12 Months Post Intervention)
General attitudes towards gender will be qualitatively collected via interview from women post intervention.
End-Line (12 Months Post Intervention)
Change in Women's Economic Empowerment
Time Frame: Baseline, End-Line (12 Months Post Intervention)
Changes in women's thoughts on economic empowerment will be qualitatively collected via interview.
Baseline, End-Line (12 Months Post Intervention)
Change in Women's Attitudes Towards Gender
Time Frame: Baseline, End-Line (12 Months Post Intervention)
Differences in general attitudes towards gender will be qualitatively collected via interview from women from baseline to post intervention.
Baseline, End-Line (12 Months Post Intervention)
Household Food Insecurity
Time Frame: End-Line (12 Months Post Intervention)
Access to adequate amounts of food for the household will be assessed via interview.
End-Line (12 Months Post Intervention)
Change in Household Food Insecurity
Time Frame: Baseline, End-Line (12 Months Post Intervention)
Change in access to adequate amounts of food for the household from baseline to end-line will be assessed via interview.
Baseline, End-Line (12 Months Post Intervention)
Total Personal and Household Income
Time Frame: End-Line (12 Months Post Intervention)
The total income generated for a household will be collected via interview.
End-Line (12 Months Post Intervention)
Change in Total Personal and Household Income
Time Frame: Baseline, End-Line (12 Months Post Intervention)
The difference in the total income generated for a household from baseline to end-line.
Baseline, End-Line (12 Months Post Intervention)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Emory University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 2, 2016

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 31, 2017

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 31, 2017

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 5, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 5, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 7, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 22, 2017

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 21, 2017

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2017

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • IRB00083606

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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