NCT06141850

Brief Summary

PEACH2 is a community-based study, targeting individuals affected by diabetes. Study participants will be randomized into the PEACH2 Intervention Arm or the Control Arm. The intervention lasts for 16 weeks and participants will be followed for 12 months in total.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
290

participants targeted

Target at P50-P75 for not_applicable covid19

Timeline
Completed

Started Dec 2023

Typical duration for not_applicable covid19

Geographic Reach
1 country

1 active site

Status
completed

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

First Submitted

Initial submission to the registry

November 17, 2023

Completed
4 days until next milestone

First Posted

Study publicly available on registry

November 21, 2023

Completed
15 days until next milestone

Study Start

First participant enrolled

December 6, 2023

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 8, 2025

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 25, 2025

Completed
11 months until next milestone

Results Posted

Study results publicly available

February 23, 2026

Completed
Last Updated

February 23, 2026

Status Verified

February 1, 2026

Enrollment Period

1.1 years

First QC Date

November 17, 2023

Results QC Date

January 7, 2026

Last Update Submit

February 16, 2026

Conditions

Outcome Measures

Primary Outcomes (1)

  • Number of Participants With Symptoms Who Use a COVID-19 Test

    The number of individuals who reported (1) having COVID or COVID-like symptoms and (2) taking a COVID-19 test in the past month as reported using survey data (baseline only) or the text-based COVID-19 reporting tool created for this study (weeks 4, 8, and 12).

    Baseline, Weeks 4, 8, and 12

Secondary Outcomes (2)

  • Percent of Participants Receiving COVID-19 Vaccination

    Baseline, Week 16 (completion of intervention), and Month 12

  • Number of Participants Adhering to COVID-19 Prevention Behaviors

    Baseline, Week 16 (completion of intervention), and Month 12

Study Arms (2)

Project PEACH2 Intervention

EXPERIMENTAL

In addition to a text-based reporting tool for reporting COVID-19 testing, participants randomized to the Project PEACH2 intervention will be sent weekly behavioral nudges via mobile phone text message to encourage adherence to COVID-19 testing and preventive behaviors.

Behavioral: COVID-19 Test ReportingBehavioral: Personalized Nudges via Text Messaging

Control Group

ACTIVE COMPARATOR

Participants randomized to the control group will receive access to the text-based COVID-19 reporting tool and receive weekly texts on diabetes prevention, management or care.

Behavioral: COVID-19 Test ReportingBehavioral: Non-personalized Nudges via Text Messaging

Interventions

Participants will use a simple text-based data reporting tool which they will be asked to use to report any COVID-19 testing during the 12-month long study.

Control GroupProject PEACH2 Intervention

Weekly behavioral nudges via mobile phone text messages, personalized to participants' diabetes status, race/ethnicity, age group, sex, and/or vaccine/testing history, will be sent in weeks 1-16 of the intervention to encourage adherence to COVID-19 testing and preventive behaviors as well as other behaviors important for diabetes management, prevention, or care.

Project PEACH2 Intervention

Weekly behavioral nudges via mobile phone text messages will be sent in weeks 1-16 of the intervention sharing tips lifestyle behaviors important for diabetes management and prevention (e.g., exercise, eating a healthy diet, etc.).

Control Group

Eligibility Criteria

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

You may qualify if:

  • English speaking
  • Living in Georgia, USA
  • Have access to a cellphone
  • Not currently pregnant
  • At-risk for diabetes, have diabetes, or are a family caregiver of someone living with diabetes
  • Agree to receive text messages and be randomized to the intervention or control arm of the study

You may not qualify if:

  • none

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Emory University

Atlanta, Georgia, 30322, United States

Location

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract Diseases

Results Point of Contact

Title
Mary Beth Weber, PhD, MPH
Organization
Emory University

Study Officials

  • Mary Beth Weber, PhD, MPH

    Emory University

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

November 17, 2023

First Posted

November 21, 2023

Study Start

December 6, 2023

Primary Completion

January 8, 2025

Study Completion

March 25, 2025

Last Updated

February 23, 2026

Results First Posted

February 23, 2026

Record last verified: 2026-02

Data Sharing

IPD Sharing
Will share

All deidentified data will be made publicly available.

Shared Documents
STUDY PROTOCOL, SAP, ICF, ANALYTIC CODE
Time Frame
Data will be made available upon trial completion, with no end date.
Access Criteria
Data will be available to anyone who wishes to access the data, for any purpose. Data will be available by emailing the study PI at mbweber@emory.edu or though the data repositories for the RADx-UP network.

Locations