NCT06567184

Brief Summary

The aim of this study is to assess the feasibility and preliminary effectiveness of the adapted Strong Hearts (SH) intervention to improve weight status, American Heart Association's Life's Essential 8 (AHA Essential 8), and health behaviors among Black/African American and/or Hispanic/Latinx urban residents with overweight or obesity.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
51

participants targeted

Target at P25-P50 for not_applicable cardiovascular-diseases

Timeline
Completed

Started Jan 2023

Shorter than P25 for not_applicable cardiovascular-diseases

Geographic Reach
1 country

2 active sites

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

Study Start

First participant enrolled

January 5, 2023

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 29, 2023

Completed
11 days until next milestone

Study Completion

Last participant's last visit for all outcomes

August 9, 2023

Completed
1 year until next milestone

First Submitted

Initial submission to the registry

August 14, 2024

Completed
8 days until next milestone

First Posted

Study publicly available on registry

August 22, 2024

Completed
Last Updated

August 22, 2024

Status Verified

August 1, 2024

Enrollment Period

7 months

First QC Date

August 14, 2024

Last Update Submit

August 19, 2024

Conditions

Cardiovascular Diseases

Outcome Measures

Primary Outcomes (1)

  • Body Weight

    Change in body weight

    12 weeks

Secondary Outcomes (6)

  • Fruit and Vegetable Consumption

    12 weeks

  • Self-reported healthy eating behaviors

    12 weeks

  • Physical activity - Active Minutes

    12 weeks

  • Physical activity - Steps

    12 weeks

  • Participant Acceptability

    12 weeks

  • +1 more secondary outcomes

Study Arms (1)

Strong Hearts Urban

EXPERIMENTAL

A 12-week multi-level intervention targeting behavior modification, nutrition education, strength training, aerobic exercise, and stress reduction activities

Behavioral: Strong Hearts Urban

Interventions

Strong Hearts UrbanBEHAVIORAL

A 12-week multi-level intervention targeting behavior modification, nutrition education, strength training, aerobic exercise, and stress reduction activities

Strong Hearts Urban

Eligibility Criteria

Age18 Years+
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsWhat is your gender?
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Women aged 18 or older
  • Overweight or obese (BMI≥25)
  • Less than 150 minutes of moderate physical activity per week
  • Black/African American race and/or Hispanic/Latinx ethnicity

You may not qualify if:

  • Pregnancy, or intent to become pregnant during the study duration
  • Unable to read and communicate in English
  • Planning to participate in another health behavior change program in the next three months
  • Unable/unwilling to provide informed consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

West Dallas Multipurpose Center

Dallas, Texas, 75212, United States

Location

Texas A&M AgriLife Research and Extension Center at Dallas

Dallas, Texas, 75252, United States

Location

MeSH Terms

Conditions

Cardiovascular Diseases

Study Officials

  • Chad D Rethorst, Ph.D.

    Texas A&M AgriLife Research

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 14, 2024

First Posted

August 22, 2024

Study Start

January 5, 2023

Primary Completion

July 29, 2023

Study Completion

August 9, 2023

Last Updated

August 22, 2024

Record last verified: 2024-08

Data Sharing

IPD Sharing
Will not share

Locations

US(2)