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. 2024 Mar 27;132(3):037007. doi: 10.1289/EHP12548

Figure 2.

Figure 2 is a flowchart titled Trial profile and analysis population for primary outcomes with four steps: Enrollment, Allocation, Follow-up, and Analysis. Step 1: Enrollment: 440 households were assessed for eligibility. Of 440 households, 383 were excluded, which includes 326 households that did not meeting inclusion criteria (e.g., arsenic below EPA MCL of 10 μg/L), 2 households that declined to participate, and 62 households that were not enrolled due to COVID lockdowns. There were 50 households that were randomized. Step 2: Allocation: There were 27 households and 51 participants that were allocated to the mobile Health and Filter arm and received allocated intervention. There were 23 households and 33 participants that were allocated to the Intensive arm and received intervention. Step 3: Follow-up: 4 participants from 4 households were lost to follow-up (mHealth & Filter arm), which includes 3 participants who moved households and 1 participant who was deceased. Four participants from 4 households were lost to follow-up (intensive arm), which includes 1 participant who had issues with well, 1 participant who moved households, 1 participant who had COVID-19, and 1 participant whom could not be contacted. Step 4: Analysis: There were 26 households with 46 participants that were analyzed, excluding 1 participant who did not provide a urine sample for health reasons. There were 19 households with 28 participants, excluding 0 households with 0 participants.

The Strong Heart Water Study randomized controlled trial profile and analysis population for primary outcomes, June 2016–May 2021. Household assessment for eligibility began in June 2016, and the trial completed in May 2021. Note: mHealth, mobile Health.