An interventional study of LADIES online intervention (R33 phase) and LADIES online control (R33 phase) in Sedentary Behavior, Lack of Physical Activity and Physical Inactivity, sponsored by Gramercy Research Group. Active, not recruiting at 1 site in United States. Open to female participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-04-19.
Sponsored by Gramercy Research Group · Not applicable, Interventional, and Other
This study will identify strategies for modifying a physical activity intervention, previously delivered in a face-to-face format, for online implementation.
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
84 studies on the registry are indexed under Hypokinesia; 10 are open to participants now.
This study's planned enrollment of 60 is close to the median of 60 across 65 interventional studies indexed under Hypokinesia.
Browse Hypokinesia studies →Gramercy Research Group is the lead sponsor of 2 studies on the registry; none are open to participants now.
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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 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 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
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.
Daily step counts
Daily walking over 14 consecutive days
Time frame: Baseline and immediately post intervention
Bouts of moderate-to-vigorous physical activity
Daily bouts over 14 consecutive days using a wrist-worn accelerometer
Time frame: Baseline and immediately post intervention
Sedentary behavior
Daily bouts over 14 consecutive days using a wrist-worn accelerometer
Time frame: Baseline and immediately post intervention
Self-reported physical activity
Participant reported using the 7-item self-administered modifided International Physical Activity Questionnaire
Time frame: Baseline and immediately post intervention
Clinical measures
Height, weight, seated blood pressure, waist circumference
Time frame: Baseline and immediately post intervention
Plan to share: No
No publications or documents are linked to this record.
This study is active, not recruiting, as verified in Apr 2024. You cannot join it, but the record below documents what was studied.
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Gramercy Research Group