NCT04832243

Brief Summary

List experiment to measure food and water insecurity

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
1,553

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Feb 2021

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 19, 2021

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

April 1, 2021

Completed
4 days until next milestone

First Posted

Study publicly available on registry

April 5, 2021

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2021

Completed
Last Updated

April 5, 2021

Status Verified

April 1, 2021

Enrollment Period

11 months

First QC Date

April 1, 2021

Last Update Submit

April 2, 2021

Conditions

Keywords

Food InsecurityWater Insecurity

Outcome Measures

Primary Outcomes (6)

  • 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)

  • 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)

  • 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)

  • 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)

  • 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)

  • 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)

Study Arms (2)

Experimental: V1: List No. 1

EXPERIMENTAL

As this is a survey experiment, the "intervention" involves random assignment to a survey questionnaire with specific wording. The first version of the questionnaire includes 6 sets of 3 true-false statements that are innocuous and contextually applicable (e.g., weather, cultural norms) such that there is a low likelihood that the participant will answer untruthfully. The statements on food and water insecurity that are included in the experimental version are omitted.

Other: Survey questionnaire

Experimental: V2: List No. 2

EXPERIMENTAL

As this is a survey experiment, the "intervention" involves random assignment to a survey questionnaire with specific wording. The second version of the questionnaire includes 6 sets of 4 true-false statements that are innocuous and contextually applicable (e.g., weather, cultural norms) such that there is a low likelihood that the participant will answer untruthfully for 3 of the true-false statements. One statement in each set relates to food and water insecurity and is designed to determine the extent to which social desirability bias may influence responses to food and water insecurity questions.

Other: Survey questionnaire

Interventions

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

Experimental: V1: List No. 1Experimental: V2: List No. 2

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • All adults who consider Nyakabare their primary place of residence and who are capable of providing consent

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mbarara University of Science and Technology

Mbarara, Uganda

RECRUITING

MeSH Terms

Interventions

Surveys and Questionnaires

Intervention Hierarchy (Ancestors)

Data CollectionEpidemiologic MethodsInvestigative TechniquesHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationPublic HealthEnvironment and Public Health

Study Officials

  • Alexander C Tsai, MD

    Massachusetts General Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Alexander C Tsai, MD

CONTACT

Emily Satinsky, MSc

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Masking Details
Study participants are asked to identify the number of true statements in a list, where the number of true statements is randomly assigned. Neither study participants nor outcomes assessors are provided with information about "treatment" assignment.
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor of Psychiatry

Study Record Dates

First Submitted

April 1, 2021

First Posted

April 5, 2021

Study Start

February 19, 2021

Primary Completion

December 31, 2021

Study Completion

December 31, 2021

Last Updated

April 5, 2021

Record last verified: 2021-04

Data Sharing

IPD Sharing
Will not share

Locations