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

Aktiv, nicht rekrutierend
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Die klinische Studie NCT05472402 (LADIES Online) ist eine interventionsstudie zur Untersuchung von Sitzendes Verhalten, Lack of Physical Activity, Körperliche Inaktivität und hat den Status aktiv, nicht rekrutierend. Die Studie startete am 22. Mai 2022 und soll 60 Teilnehmer aufnehmen. Durchgeführt von Gramercy Research Group ist der Abschluss für 30. November 2025 geplant. Die Daten von ClinicalTrials.gov wurden zuletzt am 19. April 2024 aktualisiert.
Kurzbeschreibung
This study will identify strategies for modifying a physical activity intervention, previously delivered in a face-to-face format, for online implementation.
Ausführliche Beschreibung
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
Offizieller Titel

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

Erkrankungen
Sitzendes VerhaltenLack of Physical ActivityKörperliche Inaktivität
Weitere Studien-IDs
NCT-Nummer
Studienbeginn (tatsächlich)
2022-05-22
Zuletzt aktualisiert
2024-04-19
Studienende (vorauss.)
2025-11-30
Geplante Rekrutierung
60
Studientyp
Interventionsstudie
PHASE
Nicht zutreffend
Status
Aktiv, nicht rekrutierend
Primäres Ziel
Andere
Zuteilungsmethode
Randomisiert
Interventionsmodell
Parallel
Verblindung
Keine (offene Studie)
Studienarme/Interventionen
Teilnehmergruppe/StudienarmIntervention/Behandlung
ExperimentellLADIES 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.
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.
Placebo-VergleichspräparatLADIES 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.
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.
Hauptergebnismessungen
ErgebnismessungBeschreibung der MessungZeitrahmen
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
Nebenergebnismessungen
ErgebnismessungBeschreibung der MessungZeitrahmen
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
Eignungskriterien

  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.
Gramercy Research Group logoGramercy Research Group
Verantwortliche Partei
Melicia Whitt-Glover, Hauptprüfer, President & CEO, Gramercy Research Group
Keine Kontaktdaten vorhanden
1 Studienstandorte in 1 Ländern

North Carolina

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