Feasibility and Acceptability of an Online Program to Promote Physical Activity Among Black Women
Primary Purpose
Sedentary Behavior, Lack of Physical Activity, Physical Inactivity
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Focus group
Sponsored by
About this trial
This is an interventional other trial for Sedentary Behavior
Eligibility Criteria
Focus group participant eligibility:
- self-identified female
- black/African American
- > 18 years of age
- self-reported low active (i.e., achieving < 150 minutes per week of moderate-to-vigorous physical activity)
- no physical limitations or medical conditions that would be impacted by physical activity
- own a smartphone or computer with reliable high speed internet access
- able to speak and read English fluently; 8) potentially interested in participating in an online health intervention.
Advisory team member eligibility:
- female
- black/African American
- > 18 years of age
- able to speak and read English fluently
- potentially interested in participating in an online health intervention
Sites / Locations
- Gramercy Research GroupRecruiting
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
LADIES online planning focus groups
Arm Description
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.
Outcomes
Primary Outcome Measures
Factors needed to adapt a group-based in-person intervention for online implementation
Number of factors identified to adapt recruitment, screening, enrollment, randomization, and data collection process for online implementation
Feasibility and acceptability of the online curricula from advisory team members
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)
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05472402
Brief Title
Feasibility and Acceptability of an Online Program to Promote Physical Activity Among Black Women
Official Title
Feasibility and Acceptability of an Online Program to Promote Physical Activity Among Black Women
Study Type
Interventional
2. Study Status
Record Verification Date
July 2022
Overall Recruitment Status
Recruiting
Study Start Date
May 22, 2022 (Actual)
Primary Completion Date
June 30, 2023 (Anticipated)
Study Completion Date
August 31, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Gramercy Research Group
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. 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.
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sedentary Behavior, Lack of Physical Activity, Physical Inactivity
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
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.
Masking
None (Open Label)
Allocation
N/A
Enrollment
60 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
LADIES online planning focus groups
Arm Type
Other
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Focus group
Intervention Description
Participants will participate in a single focus group lasting up to 90 minutes.
Primary Outcome Measure Information:
Title
Factors needed to adapt a group-based in-person intervention for online implementation
Description
Number of factors identified to adapt recruitment, screening, enrollment, randomization, and data collection process for online implementation
Time Frame
Month 9
Title
Feasibility and acceptability of the online curricula from advisory team members
Description
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)
Time Frame
Month 20
10. Eligibility
Sex
Female
Gender Based
Yes
Gender Eligibility Description
Self-reported female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Focus group participant eligibility:
self-identified female
black/African American
> 18 years of age
self-reported low active (i.e., achieving < 150 minutes per week of moderate-to-vigorous physical activity)
no physical limitations or medical conditions that would be impacted by physical activity
own a smartphone or computer with reliable high speed internet access
able to speak and read English fluently; 8) potentially interested in participating in an online health intervention.
Advisory team member eligibility:
female
black/African American
> 18 years of age
able to speak and read English fluently
potentially interested in participating in an online health intervention
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Melicia Whitt-Glover, PhD
Phone
3362938540
Ext
110
Email
mwhittglover@gramercyresearch.com
First Name & Middle Initial & Last Name or Official Title & Degree
Tiffany Williams, MPH
Phone
336293850
Ext
111
Email
twilliams@gramercyresearch.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Melicia Whitt-Glover, PhD
Organizational Affiliation
Gramercy Research Group
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Robert Newton, PhD
Organizational Affiliation
Pennington Biomedical Research Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Gramercy Research Group
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27106
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Melicia Whitt-Glover, PhD
Phone
336-293-8540
Email
mwhittglover@gramercyresearch.com
First Name & Middle Initial & Last Name & Degree
Tiffany Williams, MPH
Phone
3362938540
Email
twilliams@gramercyresearch.com
12. IPD Sharing Statement
Plan to Share IPD
No
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Feasibility and Acceptability of an Online Program to Promote Physical Activity Among Black Women
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