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

NCT05472402 | Active Not Recruiting

• 1 other identifier: R21AG070657
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Sedentary Behavior; Lack of Physical Activity; Physical Inactivity

Outcome Measures

Primary Outcomes (2)

• Daily step counts

  Daily walking over 14 consecutive days

  Baseline and immediately post intervention

• Bouts of moderate-to-vigorous physical activity

  Daily bouts over 14 consecutive days using a wrist-worn accelerometer

  Baseline and immediately post intervention

Secondary Outcomes (3)

• Sedentary behavior

  Baseline and immediately post intervention

• Self-reported physical activity

  Baseline and immediately post intervention

• Clinical measures

  Baseline and immediately post intervention

Study Arms (2)

LADIES online intervention (R33 phase)

EXPERIMENTAL

Participants will include 30 women who will be randomized to receive six (6) months of online group-based intervention sessions that teach participants how to increase physical activity levels.

Behavioral: LADIES online intervention (R33 phase)

LADIES online control (R33 phase)

PLACEBO COMPARATOR

Participants will include 30 women who will be randomized to receive self-guided materials that teach participants how to increase physical activity levels. Placebo comparator participants will receive their materials via the online platform.

Behavioral: LADIES online control (R33 phase)

Interventions

LADIES online intervention (R33 phase) BEHAVIORAL

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.

Also known as: LADIES online

LADIES online intervention (R33 phase)

LADIES online control (R33 phase) BEHAVIORAL

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.

LADIES online control (R33 phase)

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Self-reported female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

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.

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Gramercy Research Group: lead

Study Sites (1)

Gramercy Research Group

Knightdale, North Carolina, 27545, United States

Location

MeSH Terms

Conditions

Sedentary Behavior

Condition Hierarchy (Ancestors)

Behavior

Study Officials

• Melicia Whitt-Glover, PhD

  Gramercy Research Group

  PRINCIPAL INVESTIGATOR

• Robert Newton, PhD

  Pennington Biomedical Research Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: President & CEO

Model Details: 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. - This phase has been completed. 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.

Study Record Dates

• First Submitted: July 18, 2022
• First Posted: July 25, 2022
• Study Start: May 22, 2022
• Primary Completion: November 30, 2025
• Study Completion: November 30, 2025
• Last Updated: April 19, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)