Clinical trial NCT05472402: 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
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Sedentary Behavior
Lack of Physical Activity
Physical Inactivity
Lead sponsor: Gramercy Research Group
Sponsor class: OTHER
First posted: 2022-07-25
Enrollment: 60
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
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. - 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.
Primary purpose: OTHER

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

Eligibility criteria: 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.

Primary outcomes:
measure: Daily step counts
timeFrame: Baseline and immediately post intervention
measure: Bouts of moderate-to-vigorous physical activity
timeFrame: Baseline and immediately post intervention
Secondary outcomes:
measure: Sedentary behavior
timeFrame: Baseline and immediately post intervention
measure: Self-reported physical activity
timeFrame: Baseline and immediately post intervention
measure: Clinical measures
timeFrame: Baseline and immediately post intervention
Other outcomes:
Locations:
city: Knightdale
country: United States
facility: Gramercy Research Group
state: North Carolina
Study officials:
affiliation: Gramercy Research Group
name: Melicia Whitt-Glover, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Pennington Biomedical Research Center
name: Robert Newton, PhD
role: PRINCIPAL_INVESTIGATOR
References: