Feasibility and Acceptability of an Online Program to Promote Physical Activity Among Black Women

Physical Inactivity Clinical Trial

— LADIES Online  

Official title:

Feasibility and Acceptability of an Online Program to Promote Physical Activity Among Black Women

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05472402
• Other study ID #: R21AG070657
• Status: Active, not recruiting
• Phase: N/A
• 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
• 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.

Related Conditions & MeSH terms

• Hypokinesia
• Lack of Physical Activity
• Physical Inactivity
• Sedentary Behavior

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