NCT04375423

Mobile Behavioral Ecological Momentary Assessment and Intervention in Rakai, Uganda

Completed NA Last updated 22 July 2020

What this trial tests

NA trial testing Ecological momentary assessment and intervention: Behaviorally-dependent messaging in Ecological Momentary Assessment and Intervention in 58 participants. Completed in 31 May 2017.

Timeline

15 February 2016

Primary endpoint
31 May 2017

31 May 2017

Quick facts

Lead sponsor	Johns Hopkins University
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	other
Enrollment	58
Start date	15 February 2016
Primary completion	31 May 2017
Estimated completion	31 May 2017

Drugs / interventions tested

• Ecological momentary assessment and intervention: Behaviorally-dependent messaging
• Ecological momentary assessment only

Conditions studied

• Ecological Momentary Assessment and Intervention — all drugs for Ecological Momentary Assessment and Intervention →

Sponsor

Johns Hopkins University

Who can join

18 and older, any sex, with Ecological Momentary Assessment and Intervention. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Ecological Momentary Assessment and Intervention (EMAI) is an emerging technique for gathering richer and more relevant data through repeated, longitudinal sampling of participants in their natural setting in order to deliver real-time interventions. The main study objective is to conduct a pilot EMAI study in Rakai, Uganda. Secondary objectives are to assess processes, facilitators, and barriers to EMAI. The study will compare behaviors between participants randomized to receive intervention messages and those not receiving messages. To assess EMAI validity and relevance, EMAI-collected behavioral data will be compared with traditional questionnaire-collected data.

After recruitment, participants will be given a smartphone with an application that will collect geospatial coordinates and ask behavioral assessment questions on topics including diet/alcohol, smoking, and sexual behaviors. Participants will have training on the phone and application, demonstrating proficiency with the EMAI interface prior to study start.

Days 1-30, Baseline Behaviors: Participants will complete assessment questions to establish baseline behaviors. This will include twice-daily and weekly behavioral report prompts and participant-initiated event-contingent behavioral reports. After the initial 30 day period, participants will return to the study office to complete a short questionnaire and to be randomized to the second phase of follow-up.

Days 31-90, Randomized Evaluation: Participants will be randomized in a 1:1 ratio to either continue assessment questions only (control arm) or to also begin receiving intervention messages (intervention arm) in response to reported behaviors. Messages will encourage positive behaviors and suggest alternatives to negative behaviors (e.g. "Eating a mixed diet (meats and vegetables) is a healthy way to go."). At 90 days of follow-up, participants will return to the study office to complete a brief questionnaire on behaviors and smartphone experiences.

Study hypotheses are as follows: EMAI can be successfully implemented in Uganda, and participants receiving intervention messaging will have improved self-reported health behaviors compared to controls; EMAI will be feasible and acceptable by this population; and, EMAI-collected data will correlate with traditional questionnaire-collected data.

Outcomes will be assessed using descriptive statistics, multivariate regression and analysis of themes in patient EMAI experience and acceptability.

Publications & conference data

3 peer-reviewed publications reference this trial (live from Europe PMC):

1. Acceptability and feasibility of mobile phone-based ecological momentary assessment and intervention in Uganda: A pilot randomized controlled trial.
   Beres LK, Mbabali I, Anok A, Katabalwa C, et al · · 2022 · cited 7× · PMID 36018846 · DOI 10.1371/journal.pone.0273228
2. Mobile Ecological Momentary Assessment and Intervention and Health Behavior Change Among Adults in Rakai, Uganda: Pilot Randomized Controlled Trial.
   Beres LK, Mbabali I, Anok A, Katabalwa C, et al · · 2021 · cited 7× · PMID 34283027 · DOI 10.2196/22693
3. Leveraging Ecological Momentary Assessment Data to Characterize Individual Mobility: Exploratory Pilot Study in Rural Uganda.
   Khalifa A, Beres LK, Anok A, Mbabali I, et al · · 2024 · cited 1× · PMID 38857493 · DOI 10.2196/54207