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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT05472402
Other study ID # R21AG070657
Secondary ID
Status Active, not recruiting
Phase N/A
First received
Last updated
Start date May 22, 2022
Est. completion date November 30, 2025

Study information

Verified date April 2024
Source Gramercy Research Group
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This study will identify strategies for modifying a physical activity intervention, previously delivered in a face-to-face format, for online implementation.


Description:

Research demonstrates the health-related benefits of participation in daily physical activity (PA), including prevention and treatment of chronic diseases. Despite this knowledge, the majority of US adults, particularly black women, do not achieve recommended levels of PA and, consequently, have higher rates of related chronic disease. An efficacy study led by the proposed Principal Investigator developed and tested an in person, 10-month group-based faith-integrated (FI) or secular (SEC) PA intervention, compared with a self-guided control (SG) for black women. Both FI and SEC were superior to SG for increasing daily steps after 10 months, and FI was superior to SG for increasing daily steps 12 months post intervention. Barriers to program participation noted by participants included childcare and work responsibilities and proximity to the group meeting location. The 2018 PA Guidelines Advisory Committee Scientific Report highlighted the need for effective strategies to promote PA, including internet-delivered interventions which have demonstrated strong evidence for effectiveness at increasing PA levels. Limited data exist regarding the efficacy of internet-delivered interventions in racial/ethnic minority groups. Online delivery of our evidence-based program may increase reach and address known barriers to PA program participation in black women. This project will explore strategies for adapting the program for web-based delivery of the existing curriculum. R21 phase aims are: Aim 1: Solicit input from individuals representative of the population of focus to inform the translation of the FI curriculum for online use; Aim 2: Use the knowledge gathered in Aim 1 to adapt existing FI and SG curricula for online use; Aim 3: Assess acceptability of the online curricula in an advisory group similar to the target population. Investigators will conduct focus groups with black women to understand factors that would influence online delivery of the curriculum. A 12-member advisory group will be convened to assist with developing materials/strategies to adapt the curriculum for online delivery. In an iterative approach where material is tested, refined, and retested until complete, investigators will engage the advisory group in feasibility testing of the online curriculum


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 60
Est. completion date November 30, 2025
Est. primary completion date November 30, 2025
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 18 Years and older
Eligibility 1. self-identified female 2. black/African American 3. > 18 years of age 4. self-reported low active (i.e., achieving < 150 minutes per week of moderate-to-vigorous physical activity) 5. no physical limitations or medical conditions that would be impacted by physical activity 6. own a smartphone or computer with reliable high speed internet access 7. able to speak and read English fluently; 8) potentially interested in participating in an online health intervention.

Study Design


Intervention

Behavioral:
LADIES online intervention (R33 phase)
Participants will participate weekly online group sessions over 6 months. Participants will also receive access to written intervention materials, access to an online walking program, and access to weekly podcasts that are aligned with the intervention sessions and that support physical activity lessons with biblical scriptures.
LADIES online control (R33 phase)
Participants will receive online access to a written self-guided curriculum that is self-paced and teaches participants how to increase physical activity. Participants will be encouraged to complete the self-guided curriculum within 6 months.

Locations

Country Name City State
United States Gramercy Research Group Knightdale North Carolina

Sponsors (1)

Lead Sponsor Collaborator
Gramercy Research Group

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Daily step counts Daily walking over 14 consecutive days Baseline and immediately post intervention
Primary Bouts of moderate-to-vigorous physical activity Daily bouts over 14 consecutive days using a wrist-worn accelerometer Baseline and immediately post intervention
Secondary Sedentary behavior Daily bouts over 14 consecutive days using a wrist-worn accelerometer Baseline and immediately post intervention
Secondary Self-reported physical activity Participant reported using the 7-item self-administered modifided International Physical Activity Questionnaire Baseline and immediately post intervention
Secondary Clinical measures Height, weight, seated blood pressure, waist circumference Baseline and immediately post intervention
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