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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04832243
Other study ID # 2013P000395_2
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date February 19, 2021
Est. completion date December 31, 2021

Study information

Verified date April 2021
Source Massachusetts General Hospital
Contact Alexander C Tsai, MD
Phone 617-724-1120
Email actsai@partners.org
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

List experiment to measure food and water insecurity


Description:

Food and water insecurity are complex, multi-domain constructs. Given their known association with important health and mental health outcomes, accurate assessment of food and water insecurity in resource-limited settings is paramount. The purpose of this study is to use a list experiment methodology to assess the extent to which there is bias in conventional survey-based means of direct elicitation of food and water insecurity. The list experiment provides an indirect means to measure a particular construct of interest. It is hypothesized that social desirability may cause upward bias in conventional survey-based means of direct elicitation of food and water insecurity.


Recruitment information / eligibility

Status Recruiting
Enrollment 1553
Est. completion date December 31, 2021
Est. primary completion date December 31, 2021
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - All adults who consider Nyakabare their primary place of residence and who are capable of providing consent Exclusion Criteria: - Minors younger than 18 years of age, with the exception of emancipated minors - Persons who do not consider Nyakabare Parish their primary place of residence, e.g., persons who happen to be visiting Nyakabare at the time of the survey or who own a home in Nyakabare but spend most of their time outside the parish - Persons with psychosis, neurological damage, acute intoxication, or other cognitive impairment (all of which are determined informally in the field by non-clinical research staff in consultation with a supervisor)

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Survey questionnaire
Each version of the questionnaire includes a different number of true-false statements that study participants are asked to identify.

Locations

Country Name City State
Uganda Mbarara University of Science and Technology Mbarara

Sponsors (2)

Lead Sponsor Collaborator
Massachusetts General Hospital Mbarara University of Science and Technology

Country where clinical trial is conducted

Uganda, 

Outcome

Type Measure Description Time frame Safety issue
Primary No Food Due to Lack of Money "In the last month, was there ever no food to eat in the house because the participant lacked money to buy more?" (single item, culturally adapted from the 3-item Household Hunger Scale of USAID's Household Food Insecurity Access Scale [HFIAS]; response options yes/no) Baseline (The experimental manipulation in this study has to do with which version of the survey the study participant receives, so the time frame for assessment is immediate even though participants are asked about the past month)
Primary No Water Due to Difficulty Collecting "In the last month, was there ever no water in the participant's house because it was too difficult to collect more?" (single item, culturally adapted to indicate water insecurity, paralleling the 3-item Household Hunger Scale of USAID's Household Food Insecurity Access Scale [HFIAS]; response options yes/no) Baseline (The experimental manipulation in this study has to do with which version of the survey the study participant receives, so the time frame for assessment is immediate even though participants are asked about the past month)
Primary Going to Sleep Hungry "In the last month, did the participant or one of their household members ever go to sleep hungry because there was not enough food?" (single item, culturally adapted from the 3-item Household Hunger Scale of USAID's Household Food Insecurity Access Scale [HFIAS]; response options yes/no) Baseline (The experimental manipulation in this study has to do with which version of the survey the study participant receives, so the time frame for assessment is immediate even though participants are asked about the past month)
Primary Going to Sleep Thirsty "In the last month, did the participant or one of their household members ever go to sleep thirsty because there was not enough water?" (single item, culturally adapted to indicate water insecurity, paralleling the 3-item Household Hunger Scale of USAID's Household Food Insecurity Access Scale [HFIAS]; response options yes/no) Baseline (The experimental manipulation in this study has to do with which version of the survey the study participant receives, so the time frame for assessment is immediate even though participants are asked about the past month)
Primary No Food for Entire Day "In the last month, did the participant or one of their household members ever go an entire day and night without eating anything because there was not enough food?" (single item, culturally adapted from the 3-item Household Hunger Scale of USAID's Household Food Insecurity Access Scale [HFIAS]; response options yes/no) Baseline (The experimental manipulation in this study has to do with which version of the survey the study participant receives, so the time frame for assessment is immediate even though participants are asked about the past month)
Primary Drink Unsafe Water "In the last month, did the participant or one of their household members ever drink water that they thought might not be safe for their health?" (single item, culturally adapted to indicate water insecurity, developed specifically for this study; response options yes/no) Baseline (The experimental manipulation in this study has to do with which version of the survey the study participant receives, so the time frame for assessment is immediate even though participants are asked about the past month)
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