Mobile Behavioral Ecological Momentary Assessment and Intervention in Rakai, Uganda

NCT ID: NCT04375423

Last Updated: 2020-07-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 58 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-02-15
• Study Completion Date: 2017-05-31

Brief Summary

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.

Conditions

Ecological Momentary Assessment and Intervention

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Intervention

On smartphones, participants in this arm will receive twice daily and weekly prompts to report on behaviors under study and be able to send self-initiated event-contingent reports on behaviors under study. In response to the behaviors they report, they receive messages on their smartphones supporting ongoing healthy behaviors or suggesting alternative behaviors to limit risks. They will complete in-person assessments at enrollment, 30-days and study exit at 90-days.

Group Type: EXPERIMENTAL

Ecological momentary assessment and intervention: Behaviorally-dependent messaging

Intervention Type: BEHAVIORAL

In response to behavioral data submitted intervention arm participants receive messages on their phones reinforcing healthy behaviors or encouraging alternative behaviors to limit risks

Ecological momentary assessment only

Intervention Type: BEHAVIORAL

Participants will receive twice daily and weekly prompts to submit behavioral report data and self-initiate event-contingent behavioral report data submissions

Control

On smartphones, participants in this arm will receive twice daily and weekly prompts to report on behaviors under study and be able to send self-initiated event-contingent reports on behaviors under study. They will complete in-person assessments at enrollment, 30-days and study exit at 90-days.

Group Type: ACTIVE_COMPARATOR

Ecological momentary assessment only

Intervention Type: BEHAVIORAL

Participants will receive twice daily and weekly prompts to submit behavioral report data and self-initiate event-contingent behavioral report data submissions

Interventions

Ecological momentary assessment and intervention: Behaviorally-dependent messaging

In response to behavioral data submitted intervention arm participants receive messages on their phones reinforcing healthy behaviors or encouraging alternative behaviors to limit risks

Intervention Type: BEHAVIORAL

Ecological momentary assessment only

Participants will receive twice daily and weekly prompts to submit behavioral report data and self-initiate event-contingent behavioral report data submissions

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• 18 years or older
• literate
• current Rakai Community Cohort Study participant

We will purposely recruit a sample that has a broad range of participant characteristics in our study to optimize diversity of responses and increase study generalizability. Specific variables for which we will target sampling include: gender (~50% female), age (at least 20% among age groups 18-25, 26-35, >50), and occupation (at least 20% traders and farmers).

Exclusion Criteria

• Participants without a listed phone number in the Rakai Community Cohort Study

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Rakai Health Sciences Program

OTHER

Sponsor Role: collaborator

Johns Hopkins University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Larry Chang, MD

Role: PRINCIPAL_INVESTIGATOR

Johns Hopkins University

References

Beres LK, Mbabali I, Anok A, Katabalwa C, Mulamba J, Thomas AG, Bugos E, Nakigozi G, Grabowski MK, Chang LW. Mobile Ecological Momentary Assessment and Intervention and Health Behavior Change Among Adults in Rakai, Uganda: Pilot Randomized Controlled Trial. JMIR Form Res. 2021 Jul 20;5(7):e22693. doi: 10.2196/22693.

Reference Type: DERIVED

PMID: 34283027 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

IRB00065934

Identifier Type: -

Identifier Source: org_study_id