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

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

Study Overview

• Status: Active, not recruiting
• Conditions: Sedentary Behavior; Physical Inactivity; Lack of Physical Activity
• Intervention / Treatment: Behavioral: LADIES online intervention (R33 phase); Behavioral: LADIES online control (R33 phase)

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 Type: Interventional
• Enrollment (Estimated): 60
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Melicia Whitt-Glover, PhD; Phone Number: 110 3362938540; Email: mwhittglover@gramercyresearch.com
• Study Contact Backup: Name: Tiffany Williams, MPH; Phone Number: 111 336293850; Email: twilliams@gramercyresearch.com

Study Locations

• United States
  • North Carolina
    • Knightdale, North Carolina, United States, 27545
      • Gramercy Research Group

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: LADIES online intervention (R33 phase); 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); 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.; Other Names: LADIES online
Placebo Comparator: LADIES online control (R33 phase); 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); 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Sedentary behavior	Daily bouts over 14 consecutive days using a wrist-worn accelerometer	Baseline and immediately post intervention
Self-reported physical activity	Participant reported using the 7-item self-administered modifided International Physical Activity Questionnaire	Baseline and immediately post intervention
Clinical measures	Height, weight, seated blood pressure, waist circumference	Baseline and immediately post intervention

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (Actual): May 22, 2022
• Primary Completion (Estimated): November 30, 2025
• Study Completion (Estimated): November 30, 2025

Study Registration Dates

• First Submitted: July 18, 2022
• First Submitted That Met QC Criteria: July 22, 2022
• First Posted (Actual): July 25, 2022

Study Record Updates

• Last Update Posted (Actual): April 19, 2024
• Last Update Submitted That Met QC Criteria: April 18, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Neurologic Manifestations; Dyskinesias; Hypokinesia
• Other Study ID Numbers: R21AG070657 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No