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

Gramercy Research Group

Status: Active, not recruiting

Conditions: Physical Inactivity; Lack of Physical Activity; Sedentary Behavior

Treatments: Behavioral: LADIES online intervention (R33 phase); Behavioral: LADIES online control (R33 phase)

Study type: Interventional

Funder types: Other

Identifiers

NCT05472402

R21AG070657

Details and patient eligibility

About

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

Full 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

Enrollment: 60 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion 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.

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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60 participants in 2 patient groups, including a placebo group

LADIES online intervention (R33 phase)

Experimental group

Description:

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.

Treatment:

Behavioral: LADIES online intervention (R33 phase)

LADIES online control (R33 phase)

Placebo Comparator group

Description:

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.

Treatment:

Behavioral: LADIES online control (R33 phase)