Sedentary LifestyleNCT00473044
An Intervention to Increase Physical Activity Among African American Women
A study testing Sisters in Motion in people with Sedentary Lifestyle and Inactivity, run by National Institute on Aging (NIA) at 1 site in United States.
Trial summary
The purpose of this study is to investigate whether a faith-based curriculum delivered in small groups, and emphasizing goal setting along with mutual responsibility, increases physical activity. Read more about this study
- Who is it for?
- Ages 60 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Sedentary Lifestyle, Inactivity
- What is being tested?
- Sisters in Motion
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 104 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2006to Jan 2008
- 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 60 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age greater than 60 years
- Female
- African American
Who cannot join
- Use of walker for ambulation
- Positive response on a modified Physical Activity Readiness Questionnaire, indicating potential risk of engaging in activity
- Withdrawal by primary physician
Trial locations and contacts
1 site in 1 country.
United States1 site
University of California, Los Angeles
Los Angeles, California, 90095
About this study
The purpose of this study is to investigate whether a faith-based curriculum delivered in small groups, and emphasizing goal setting along with mutual responsibility, increases physical activity.
Read the detailed description
Sedentary lifestyles are common among older adults in the United States, especially among minority women. Regular physical activity in older adults has been shown to prevent falls, maintain functional status, prevent both dementia and osteoporosis, and decrease mortality. A review of the literature has shown that current research approaches using exercise classes as the only means of behavior change are ineffective and do not produce long-term sustainable improvement. This study is testing a culturally appropriate behavior modification intervention using 1) group prayer, 2) the development of social support and mutual responsibility for exercise, and 3) group problem solving activities to increase aerobic and strength-related activities among older African American women.
Participants randomized into the intervention arm receive a 45-minute curriculum session and a 45 minute exercise class, while those randomized into the control arm receive a 45 minute session of interactive lectures on unrelated health topics along with the 45 minute exercise class. The exercise class includes both aerobic exercise and strength training using hand-held weights.
Data is collected from pedometers worn by participants, as well as from questionnaires before and after the intervention. Blood pressure, weight, and cholesterol are measured before and after the intervention.
- Conditions
- Sedentary Lifestyle, Inactivity
- Being tested
- Sisters in Motion
- Medical subject headings
- Sedentary Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sisters in MotionBehavioural
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in weekly steps walked as measured by pedometer
Measured: 10 weeks and 6 months
Secondary outcomes (2)
Change in weekly metabolic equivalents expended in physical activity
Measured: 10 weeks and 6 months
Change in blood pressure, weight, and low-density lipoprotein (LDL) cholesterol
Measured: 10 weeks and 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 May 2007 (estimated)
- Study startApr 2006
- Primary completionJan 2008
- Study completionJan 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Sedentary LifestyleStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Enrolment
- 104 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Institute on Aging (NIA)
- Sponsor type
- US National Institutes of Health
- Investigators
- Obidiugwu Kenrik Duru, MD, Principal investigator, David Geffen School of Medicine, University of California, Los Angeles
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00473044
- Sponsor's protocol ID
- AG0085
- Other IDs
- R01AG024460
- Status last verified
- Dec 2008
- First submitted
- 10 May 2007
- Last updated
- 31 Dec 2008
- Results posted
- No
- Data monitoring committee
- No
Publications
Dunn AL, Blair SN. Translating evidenced-based physical activity interventions into practice. The 2010 challenge. Am J Prev Med. 2002 May;22(4 Suppl):8-9. doi: 10.1016/s0749-3797(02)00432-4. No abstract available.
PubMed 11985931American College of Sports Medicine. Physical activity programs and behavior counseling in older adult populations. Med Sci Sports Exerc. 2004 Nov;36(11):1997-2003. doi: 10.1249/01.mss.0000145451.08166.97.
PubMed 15514518Brawley LR, Rejeski WJ, King AC. Promoting physical activity for older adults: the challenges for changing behavior. Am J Prev Med. 2003 Oct;25(3 Suppl 2):172-83. doi: 10.1016/s0749-3797(03)00182-x.
PubMed 14552942
Study at a glance
From the registry record, last updated by the sponsor on 31 Dec 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Intervention to Increase Physical Activity Among African American Women
- ClinicalTrials.gov ID
- NCT00473044
- Acronym / sponsor ID
- AG0085
- Conditions
- Sedentary Lifestyle, Inactivity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 104 participants (estimated)
- Lead sponsor
- National Institute on Aging (NIA)US National Institutes of Health
- Study start
- Apr 2006
- Primary completion
- Jan 2008 (actual)
- Study completion
- Jan 2008 (actual)
- First posted
- 14 May 2007 (estimated)
- 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.
The purpose of this study is to investigate whether a faith-based curriculum delivered in small groups, and emphasizing goal setting along with mutual responsibility, increases physical activity.
Detailed description
Sedentary lifestyles are common among older adults in the United States, especially among minority women. Regular physical activity in older adults has been shown to prevent falls, maintain functional status, prevent both dementia and osteoporosis, and decrease mortality. A review of the literature has shown that current research approaches using exercise classes as the only means of behavior change are ineffective and do not produce long-term sustainable improvement. This study is testing a culturally appropriate behavior modification intervention using 1) group prayer, 2) the development of social support and mutual responsibility for exercise, and 3) group problem solving activities to increase aerobic and strength-related activities among older African American women.
Participants randomized into the intervention arm receive a 45-minute curriculum session and a 45 minute exercise class, while those randomized into the control arm receive a 45 minute session of interactive lectures on unrelated health topics along with the 45 minute exercise class. The exercise class includes both aerobic exercise and strength training using hand-held weights.
Data is collected from pedometers worn by participants, as well as from questionnaires before and after the intervention. Blood pressure, weight, and cholesterol are measured before and after the intervention.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
Who may qualify
- Ages
- 60 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age greater than 60 years
- Female
- African American
Key exclusion criteria (3 listed)
- Use of walker for ambulation
- Positive response on a modified Physical Activity Readiness Questionnaire, indicating potential risk of engaging in activity
- Withdrawal by primary physician
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 |
|---|---|---|
| Sisters in Motion | Behavioural | – |
Primary outcome
Change in weekly steps walked as measured by pedometer
Time frame: 10 weeks and 6 months
2 secondary outcomes
Change in weekly metabolic equivalents expended in physical activity
Time frame: 10 weeks and 6 months
Change in blood pressure, weight, and low-density lipoprotein (LDL) cholesterol
Time frame: 10 weeks and 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Dec 2008.
- Background: PubMed 11985931Dunn AL, Blair SN. Translating evidenced-based physical activity interventions into practice. The 2010 challenge. Am J Prev Med. 2002 May;22(4 Suppl):8-9. doi: 10.1016/s0749-3797(02)00432-4. No abstract available.
- Background: PubMed 15514518American College of Sports Medicine. Physical activity programs and behavior counseling in older adult populations. Med Sci Sports Exerc. 2004 Nov;36(11):1997-2003. doi: 10.1249/01.mss.0000145451.08166.97.
- Background: PubMed 14552942Brawley LR, Rejeski WJ, King AC. Promoting physical activity for older adults: the challenges for changing behavior. Am J Prev Med. 2003 Oct;25(3 Suppl 2):172-83. doi: 10.1016/s0749-3797(03)00182-x.
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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.
Obidiugwu Kenrik Duru, MD principal investigator
David Geffen School of Medicine, University of California, Los Angeles
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sisters in Motion in people with Sedentary Lifestyle and Inactivity, run by National Institute on Aging (NIA) 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?
The sponsor lists 3 inclusion and 3 exclusion criteria. 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: finished, as of the sponsor's last update on 31 Dec 2008. 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. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Change in weekly steps walked as measured by pedometer (time frame: 10 weeks and 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00473044, which also lists 3 linked publications.
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 31 Dec 2008.