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

• Sponsor: Gramercy Research Group (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT05472402
• Collaborator: (none)
• Enrollment: 60
• Location: 1
• Arm: 1
• Anticipated Duration (Months): 15.3
• Patients Per Site Per Month: 3.9

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Sedentary Behavior; Lack of Physical Activity; Physical Inactivity	Other: Focus group	N/A

Detailed 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

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 60 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Intervention Model Description: The R21 phase will use 4 focus groups with 48 black women, and feedback from 12 expert advisors to modify content from our existing evidence-based PA curriculum for online implementation. The R33 phase will use a randomized controlled trial design to implement a pilot study to evaluate the feasibility, acceptability, and impact on PA of the online PA curriculum.The R21 phase will use 4 focus groups with 48 black women, and feedback from 12 expert advisors to modify content from our existing evidence-based PA curriculum for online implementation. The R33 phase will use a randomized controlled trial design to implement a pilot study to evaluate the feasibility, acceptability, and impact on PA of the online PA curriculum.
• Masking: None (Open Label)
• Primary Purpose: Other
• Official Title: Feasibility and Acceptability of an Online Program to Promote Physical Activity Among Black Women
• Actual Study Start Date: May 22, 2022
• Anticipated Primary Completion Date: Jun 30, 2023
• Anticipated Study Completion Date: Aug 31, 2023

Arms and Interventions

Arm

Intervention/Treatment

Other: LADIES online planning focus groups Participants will including up to 40 women who will participate in a single focus group to answer questions related to planning for modification of an existing in-person intervention for online delivery. Data from the focus groups will be used to modify the curriculum. Separately, a 12-person advisory board will be identified to provide input on the revised curriculum to assist with planning a future pilot study.

Other: Focus group; Participants will participate in a single focus group lasting up to 90 minutes.

Outcome Measures

Primary Outcome Measures

1. Factors needed to adapt a group-based in-person intervention for online implementation [Month 9]

   Number of factors identified to adapt recruitment, screening, enrollment, randomization, and data collection process for online implementation

2. Feasibility and acceptability of the online curricula from advisory team members [Month 20]

   Length of time required for each phase of recruitment, screening, and enrollment process Noted challenges and concerns with planned recruitment, screening, and enrollment process Length of time for randomization and data collection process Acceptability and satisfaction of recruitment, screening, enrollment, randomization, and data collection process (based on 5-point Likert scale)

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: Yes

Focus group participant 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.

Advisory team member eligibility:

1. female

2. black/African American

3. 18 years of age

4. able to speak and read English fluently

5. potentially interested in participating in an online health intervention

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Gramercy Research Group	Winston-Salem	North Carolina	United States	27106

Sponsors and Collaborators

• Gramercy Research Group

Investigators

• Principal Investigator: Melicia Whitt-Glover, PhD, Gramercy Research Group
• Principal Investigator: Robert Newton, PhD, Pennington Biomedical Research Center

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Melicia Whitt-Glover, President & CEO, Gramercy Research Group
• ClinicalTrials.gov Identifier: NCT05472402
• Other Study ID Numbers: R21AG070657
• First Posted: Jul 25, 2022
• Last Update Posted: Jul 25, 2022
• Last Verified: Jul 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Hypokinesia

Study Results

No Results Posted as of Jul 25, 2022