Ecological Momentary Assessment and InterventionNCT04375423
Mobile Behavioral Ecological Momentary Assessment and Intervention in Rakai, Uganda
A study testing Ecological momentary assessment and intervention: Behaviorally-dependent messaging and Ecological momentary assessment only in people with Ecological Momentary Assessment and Intervention, run by Johns Hopkins University.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Ecological Momentary Assessment and Intervention
- What is being tested?
- Ecological momentary assessment and intervention: Behaviorally-dependent messaging and Ecological momentary assessment only
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 58 participants
- Where
- No sites listed yet
- Study dates
- 15 Feb 2016to 31 May 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- Participants without a listed phone number in the Rakai Community Cohort Study
About this study
Official title: Mobile Behavioral Ecological Momentary Assessment and Intervention in Rakai, Uganda: A Pilot Study
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.
Read more
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.
- Being tested
- Ecological momentary assessment and intervention: Behaviorally-dependent messaging, Ecological momentary assessment only
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ecological momentary assessment and intervention: Behaviorally-dependent messagingBehavioural
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 onlyBehavioural
Participants will receive twice daily and weekly prompts to submit behavioral report data and self-initiate event-contingent behavioral report data submissions
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | 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. Receives: Behavioral: Ecological momentary assessment and intervention: Behaviorally-dependent messaging; Behavioral: Ecological momentary assessment only |
| Control | Active comparator | 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. Receives: Behavioral: Ecological momentary assessment only |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in health behavior according to EMAI self-report
change in the proportion of days when participant reports 'yes' to behavior over total days behavior measured, comparing baseline to follow-up in self-reported: alcohol consumption, fruit and vegetable consumption; cigarette smoking, and sex with a non-longterm or non-marital partner
Measured: Daily, comparing baseline (days 1-30) to follow up (days 31-90), up to a total 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 May 2020
- Study start15 Feb 2016
- Primary completion31 May 2017
- Study completion31 May 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Ecological Momentary Assessment and InterventionStudies of the same condition, open and under way.
- More trials run by Johns Hopkins UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 58 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johns Hopkins University
- Sponsor type
- University, hospital or other
- Collaborators
- Rakai Health Sciences Program
- Responsible party
- Sponsor
- Investigators
- Larry Chang, MD, Principal investigator, Johns Hopkins University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04375423
- Sponsor's protocol ID
- IRB00065934
- Status last verified
- Jul 2020
- First submitted
- 1 May 2020
- Last updated
- 22 Jul 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 34283027
Study at a glance
From the registry record, last updated by the sponsor on 22 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mobile Behavioral Ecological Momentary Assessment and Intervention in Rakai, Uganda: A Pilot Study
- ClinicalTrials.gov ID
- NCT04375423
- Acronym / sponsor ID
- IRB00065934
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 58 participants (actual)
- Lead sponsor
- Johns Hopkins UniversityUniversity, hospital or other
- Collaborators
- Rakai Health Sciences Program
- Study start
- 15 Feb 2016 (actual)
- Primary completion
- 31 May 2017 (actual)
- Study completion
- 31 May 2017 (actual)
- First posted
- 5 May 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Behavioral: Ecological momentary assessment and intervention: Behaviorally-dependent messaging, Behavioral: Ecological momentary assessment onlyOn 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. |
| Control | Active comparator | Behavioral: Ecological momentary assessment onlyOn 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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).
Key exclusion criteria (1 listed)
- Participants without a listed phone number in the Rakai Community Cohort Study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ecological momentary assessment and intervention: Behaviorally-dependent messagingIn response to behavioral data submitted intervention arm participants receive messages on their phones reinforcing healthy behaviors or encouraging alternative behaviors to limit risks | Behavioural | Intervention |
| Ecological momentary assessment onlyParticipants will receive twice daily and weekly prompts to submit behavioral report data and self-initiate event-contingent behavioral report data submissions | Behavioural | Control, Intervention |
Primary outcome
Change in health behavior according to EMAI self-report
Time frame: Daily, comparing baseline (days 1-30) to follow up (days 31-90), up to a total 90 days
change in the proportion of days when participant reports 'yes' to behavior over total days behavior measured, comparing baseline to follow-up in self-reported: alcohol consumption, fruit and vegetable consumption; cigarette smoking, and sex with a non-longterm or non-marital partner
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jul 2020.
- Derived from this study: PubMed 34283027Beres 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Larry Chang, MD principal investigator
Johns Hopkins University
Questions about this trial
What is this clinical trial studying?
A study testing Ecological momentary assessment and intervention: Behaviorally-dependent messaging and Ecological momentary assessment only in people with Ecological Momentary Assessment and Intervention, run by Johns Hopkins University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in health behavior according to EMAI self-report (time frame: Daily, comparing baseline (days 1-30) to follow up (days 31-90), up to a total 90 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04375423, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jul 2020.