NCT07114822

Brief Summary

We will test the HOPE intervention on changing behavior of people to exercise more (take more steps each day).

Trial Health

57
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
120

participants targeted

Target at P50-P75 for not_applicable diabetes-mellitus-type-2

Timeline
Completed

Started Oct 2025

Shorter than P25 for not_applicable diabetes-mellitus-type-2

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 17, 2025

Completed
4 months until next milestone

First Posted

Study publicly available on registry

August 11, 2025

Completed
2 months until next milestone

Study Start

First participant enrolled

October 21, 2025

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2025

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2026

Completed
Last Updated

August 11, 2025

Status Verified

August 1, 2025

Enrollment Period

1 month

First QC Date

April 17, 2025

Last Update Submit

August 6, 2025

Conditions

Diabetes Mellitus Type 2

Outcome Measures

Primary Outcomes (1)

  • Step Count

    Participants will take a screenshot of their monthly steps at baseline and after the 4-week intervention

    1 month

Secondary Outcomes (3)

  • Average fasting glucose

    1 week

  • HbA1c

    Baseline

  • Change in weight and Body Mass Index (BMI)

    1 month

Study Arms (2)

HOPE Group

EXPERIMENTAL

Group with Peer leaders

Behavioral: Harnessing Online Peer Education

Control

NO INTERVENTION

Group without Peer Leaders

Interventions

Harnessing Online Peer EducationBEHAVIORAL

This group will have peer leaders that will engage participants in the groups. These peer leaders are those with type II diabetes that have over the recommended amount of exercise each week.

HOPE Group

Eligibility Criteria

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

You may qualify if:

  • years or older
  • Living in the US
  • Self-report diagnosis of type II diabetes
  • Has an app to track step count

You may not qualify if:

  • On insulin or an injectable weight loss drug

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UC Irvine

Irvine, California, 92617, United States

RECRUITING

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Central Study Contacts

Staff Research Associate

CONTACT

(949) 522-9165hopestudy@hs.uci.edu

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

April 17, 2025

First Posted

August 11, 2025

Study Start

October 21, 2025

Primary Completion

December 1, 2025

Study Completion

May 1, 2026

Last Updated

August 11, 2025

Record last verified: 2025-08

Data Sharing

IPD Sharing
Will not share

Locations

US(1)