Community Health Adaptation & Resilience Mobilization (CHARM) HeatWise

NCT07500545 | Recruiting

• 2 other identifiers: IRB #I25-022OT2HL158287
• Study Type: interventional
• Target: 580
• Locations: 1 country
• Sites: 1

Brief Summary

Extreme heat events pose serious health risks, especially for communities with limited access to cooling, transportation, or social support. This study pilots and tests HEATwise, a heat preparedness program delivered at trusted community centers in Lake County, California, serving older adults, Tribal members, and people experiencing housing or economic hardship. HEATwise is a 12-week program which includes a group workshop on heat risks and preparedness, one-on-one resource navigation, a community celebration event, and a cooling and emergency supply kit. The pilot phase (2026) will assess feasibility and acceptability at three sites with approximately 60 participants. The full trial (2027-2028) will randomly assign eight sites to receive HEATwise immediately or after a delay, measuring whether the program increases protective behaviors, reduces heat-related symptoms, and strengthens resilience over 12 months.

Conditions

Heat Illness

Keywords

Extreme Heat; Rural Preparedness; Community Engaged Research; Community-Based Participatory Research

Outcome Measures

Primary Outcomes (1)

• Change in Symptoms

  Change in self-reported heat-illness symptoms: "Self-reported heat stress measure". Range 0-8, with higher scores indicating higher heat stress

  3-months post-intervention

Secondary Outcomes (1)

• Change in individual and community resilience scores: "Communities Advancing Resilience Toolkit"

  Baseline to 15-months post-enrollment (12-month follow-up period)

Study Arms (2)

Immediate HEATWise

EXPERIMENTAL

Intervention shortly after enrollment

Behavioral: CHARM HeatWise

Delayed HEATWise)

OTHER

Treatment as usual. These sites will offer the HEATwise program the following year, after the intervention is complete, and all waitlist control participants will be invited to participate.

Behavioral: CHARM HeatWise

Interventions

CHARM HeatWise BEHAVIORAL

HEATWise consists of structured, facilitator-led training sessions on extreme heat preparedness and response, distribution of heat resilience kits, and community engagement activities designed to promote protective behaviors. The intervention is delivered at the cluster (site) level in community-based settings and focuses on reducing risk of heat-related illness and improving individual and community resilience.

Delayed HEATWise); Immediate HEATWise

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Eligible participants are adults (≥18 years) who have resided in Lake County for at least 6 months, are able to access a phone for study communications, and are willing to provide a valid secondary contact for the duration of the study.

You may not qualify if:

• Participants must also be a recognized member or affiliate of a articipating site, referred by the site, or reside within 5 miles of the site. Individuals are excluded if another household member is already enrolled in the study, if they cannot provide a secondary or emergency contact, are unable to independently complete study activities, or plan to be away for 15 or more consecutive days during the intervention period.

Sponsors & Collaborators

• Public Health Institute, California: lead
• National Heart, Lung, and Blood Institute (NHLBI): collaborator

Study Sites (1)

Big Valley Rancheria

Lakeport, California, 95453, United States

RECRUITING

MeSH Terms

Conditions

Heat Stress Disorders

Condition Hierarchy (Ancestors)

Wounds and Injuries

Study Officials

• Michelle Wong

  Public Health Institute

  PRINCIPAL INVESTIGATOR

• Susan Paulukonis

  Public Health Institute

  PRINCIPAL INVESTIGATOR

• Sarah Ryan

  Big Valley Band of Pomo Indians

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Scarlet Sands-Bliss, MS

CONTACT

510-285-5500; info@trackingcalifornia.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This study uses a cluster randomized, parallel assignment, waitlist-controlled design. Community-based sites serving rural, underserved populations are randomized to either immediate implementation of the Helping Everyone Adapt Together-Wise (HEATWise) or to a waitlist control condition. Participants at control sites complete baseline and follow-up assessments during the six-month evaluation period and receive the intervention after primary outcome data collection is completed. Randomization occurs at the site level to reduce contamination, and analyses account for clustering.

Study Record Dates

• First Submitted: March 23, 2026
• First Posted: March 30, 2026
• Study Start: April 15, 2026
• Primary Completion (Estimated): June 2, 2028
• Study Completion (Estimated): June 2, 2028
• Last Updated: April 17, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: Following publication of the primary results or upon study completion, consistent with the approved Data Management and Sharing Plan.
• Access Criteria: Data will be available to qualified researchers through ICPSR under applicable data use agreements.

Locations

US (1)