Sedentary BehaviorLADIES OnlineNCT05472402
Feasibility and Acceptability of an Online Program to Promote Physical Activity Among Black Women
A study testing LADIES online intervention (R33 phase) in people with Sedentary Behavior and Lack of Physical Activity, run by Gramercy Research Group at 1 site in United States.
Trial summary
This study will identify strategies for modifying a physical activity intervention, previously delivered in a face-to-face format, for online implementation. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Sedentary Behavior, Lack of Physical Activity, Physical Inactivity
- What is being tested?
- LADIES online intervention (R33 phase)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- 22 May 2022to 30 Nov 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
- self-identified female
- black/African American
- > 18 years of age
- self-reported low active (i.e., achieving < 150 minutes per week of moderate-to-vigorous physical activity)
- no physical limitations or medical conditions that would be impacted by physical activity
- own a smartphone or computer with reliable high speed internet access
- able to speak and read English fluently; 8) potentially interested in participating in an online health intervention.
Trial locations and contacts
1 site in 1 country.
United States1 site
Gramercy Research Group
Knightdale, North Carolina, 27545
About this study
This study will identify strategies for modifying a physical activity intervention, previously delivered in a face-to-face format, for online implementation.
Read the 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
- Being tested
- LADIES online intervention (R33 phase), LADIES online control (R33 phase)
- Medical subject headings
- Sedentary Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LADIES online intervention (R33 phase)Behavioural
Also called LADIES online
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.
LADIES online control (R33 phase)Behavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| LADIES online intervention (R33 phase) | Experimental | 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. Receives: Behavioral: LADIES online intervention (R33 phase) |
| LADIES online control (R33 phase) | Placebo comparator | 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. Receives: Behavioral: LADIES online control (R33 phase) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Daily step counts
Daily walking over 14 consecutive days
Measured: Baseline and immediately post intervention
Bouts of moderate-to-vigorous physical activity
Daily bouts over 14 consecutive days using a wrist-worn accelerometer
Measured: Baseline and immediately post intervention
Secondary outcomes (3)
Sedentary behavior
Daily bouts over 14 consecutive days using a wrist-worn accelerometer
Measured: Baseline and immediately post intervention
Self-reported physical activity
Participant reported using the 7-item self-administered modifided International Physical Activity Questionnaire
Measured: Baseline and immediately post intervention
Clinical measures
Height, weight, seated blood pressure, waist circumference
Measured: Baseline and immediately post intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jul 2022
- Study start22 May 2022
- Primary completion30 Nov 2025 (estimated)
- Study completion30 Nov 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sedentary BehaviorStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Gramercy Research Group
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Melicia Whitt-Glover, Gramercy Research Group
- Investigators
- Melicia Whitt-Glover, PhD, Principal investigator, Gramercy Research GroupRobert Newton, PhD, Principal investigator, Pennington Biomedical Research Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05472402
- Sponsor's protocol ID
- R21AG070657
- Acronym
- LADIES Online
- Status last verified
- Apr 2024
- First submitted
- 18 Jul 2022
- Last updated
- 19 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility and Acceptability of an Online Program to Promote Physical Activity Among Black Women
- ClinicalTrials.gov ID
- NCT05472402
- Acronym / sponsor ID
- LADIES Online / R21AG070657
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Gramercy Research GroupUniversity, hospital or other
- Study start
- 22 May 2022 (actual)
- Primary completion
- 30 Nov 2025 (estimated)
- Study completion
- 30 Nov 2025 (estimated)
- First posted
- 25 Jul 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| LADIES online intervention (R33 phase) | Experimental | Behavioral: 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. |
| LADIES online control (R33 phase) | Placebo comparator | Behavioral: 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LADIES online intervention (R33 phase)Also: LADIES onlineParticipants 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. | Behavioural | LADIES online intervention (R33 phase) |
| 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. | Behavioural | LADIES online control (R33 phase) |
Primary outcome
Daily step counts
Time frame: Baseline and immediately post intervention
Daily walking over 14 consecutive days
Bouts of moderate-to-vigorous physical activity
Time frame: Baseline and immediately post intervention
Daily bouts over 14 consecutive days using a wrist-worn accelerometer
3 secondary outcomes
Sedentary behavior
Time frame: Baseline and immediately post intervention
Self-reported physical activity
Time frame: Baseline and immediately post intervention
Clinical measures
Time frame: Baseline and immediately post intervention
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Apr 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Melicia Whitt-Glover, PhD principal investigator
Gramercy Research Group
Robert Newton, PhD principal investigator
Pennington Biomedical Research Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing LADIES online intervention (R33 phase) in people with Sedentary Behavior and Lack of Physical Activity, run by Gramercy Research Group at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 19 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Daily step counts (time frame: Baseline and immediately post intervention). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Apr 2024.