Cardiovascular DiseasesNCT00005744
Increased Physical Activity in African-American Women
An observational study of Cardiovascular Diseases and Heart Diseases, run by National Heart, Lung, and Blood Institute (NHLBI).
Trial summary
To conduct a randomized demonstration and education trial of churches in East Baltimore testing a self-help, minimal intervention compared with an intensive physical activity intervention. Read more about this study
- Who is it for?
- Ages 50 to 70 years, women only
- Conditions the study is for
- Cardiovascular Diseases, Heart Diseases
- How many people
- Not given
- Where
- No sites listed yet
- Study dates
- Sep 1996to Aug 2001
- Phase
- Observational
- 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 50 to 70 years
- Women only
- No healthy volunteers
- Adult, Older adult
No eligibility criteria
About this study
To conduct a randomized demonstration and education trial of churches in East Baltimore testing a self-help, minimal intervention compared with an intensive physical activity intervention.
Read the detailed description
BACKGROUND:
The study filled an existing gap by examining how a culturally sensitive physical activity intervention conducted in a community setting was associated with increased daily energy expenditure in African American women -- a group of women who are sedentary and at risk for health problems for which regular physical activity can provide benefits.
DESIGN NARRATIVE:
An evaluation was conducted of the effectiveness of a six-month moderate-intensity physical activity intervention for increasing total daily energy expenditure of sedentary African-American women who were between the ages of 50 and 70 years. The goal of the intervention was to increase total daily energy expenditure by 150 kilocalories per day and time spent in moderate-intensity physical activity by 30 minutes per day. Effects of increased physical activity on selected cardiovascular risk factors (e.g., peak oxygen uptake, blood pressure, HDL cholesterol, serum insulin and plasma glucose) were also determined. Six churches were randomized into intensive or minimal intervention status, and 33 women per church were recruited, for a total of 100 women in each condition. The physical activity intervention consisted of twice-weekly aerobics classes conducted at the churches and additional group-and home-based programming. Volunteer lay leaders were trained as neighborhood exercise specialists to supplement certified aerobics instructors in conducting the intervention.
The study completion date listed in this record was obtained from the "End Date" entered in the Protocol Registration and Results System (PRS) record.
- Conditions
- Cardiovascular Diseases, Heart Diseases
- Medical subject headings
- Cardiovascular Diseases, Heart Diseases
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 May 2000 (estimated)
- Study startSep 1996
- Study completionAug 2001
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 Cardiovascular DiseasesStudies of the same condition, open and under way.
- More trials run by National Heart, Lung, and Blood Institute (NHLBI)The sponsor's other registered studies.
- 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
- Observational
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
- Investigators
- Deborah Young, Johns Hopkins University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00005744
- Sponsor's protocol ID
- 4968
- Other IDs
- R29HL056968
- Status last verified
- Aug 2004
- First submitted
- 25 May 2000
- Last updated
- 18 Feb 2016
- Results posted
- No
Publications
Young DR, Gittelsohn J, Charleston J, Felix-Aaron K, Appel LJ. Motivations for exercise and weight loss among African-American women: focus group results and their contribution towards program development. Ethn Health. 2001 Aug-Nov;6(3-4):227-45. doi: 10.1080/13557850120078143.
PubMed 11696933Young DR, Jee SH, Appel LJ. A comparison of the Yale Physical Activity Survey with other physical activity measures. Med Sci Sports Exerc. 2001 Jun;33(6):955-61. doi: 10.1097/00005768-200106000-00015.
PubMed 11404661Young DR, King AC, Sheehan M, Stefanick ML. Stage of motivational readiness: predictive ability for exercise behavior. Am J Health Behav. 2002 Sep-Oct;26(5):331-41. doi: 10.5993/ajhb.26.5.2.
PubMed 12206443
Study at a glance
From the registry record, last updated by the sponsor on 18 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Increased Physical Activity in African-American Women
- ClinicalTrials.gov ID
- NCT00005744
- Acronym / sponsor ID
- 4968
- Conditions
- Cardiovascular Diseases, Heart Diseases
- Study type
- Observational
- Recruitment status
- Completed
- Lead sponsor
- National Heart, Lung, and Blood Institute (NHLBI)US National Institutes of Health
- Study start
- Sep 1996
- Study completion
- Aug 2001 (actual)
- First posted
- 26 May 2000 (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.
To conduct a randomized demonstration and education trial of churches in East Baltimore testing a self-help, minimal intervention compared with an intensive physical activity intervention.
Detailed description
BACKGROUND:
The study filled an existing gap by examining how a culturally sensitive physical activity intervention conducted in a community setting was associated with increased daily energy expenditure in African American women -- a group of women who are sedentary and at risk for health problems for which regular physical activity can provide benefits.
DESIGN NARRATIVE:
An evaluation was conducted of the effectiveness of a six-month moderate-intensity physical activity intervention for increasing total daily energy expenditure of sedentary African-American women who were between the ages of 50 and 70 years. The goal of the intervention was to increase total daily energy expenditure by 150 kilocalories per day and time spent in moderate-intensity physical activity by 30 minutes per day. Effects of increased physical activity on selected cardiovascular risk factors (e.g., peak oxygen uptake, blood pressure, HDL cholesterol, serum insulin and plasma glucose) were also determined. Six churches were randomized into intensive or minimal intervention status, and 33 women per church were recruited, for a total of 100 women in each condition. The physical activity intervention consisted of twice-weekly aerobics classes conducted at the churches and additional group-and home-based programming. Volunteer lay leaders were trained as neighborhood exercise specialists to supplement certified aerobics instructors in conducting the intervention.
The study completion date listed in this record was obtained from the "End Date" entered in the Protocol Registration and Results System (PRS) record.
Study design
Who may qualify
- Ages
- 50 to 70 years
- Sex
- Female only
- Healthy volunteers
- Not 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.
Primary outcome
Not reported in the source record.
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 18 Feb 2016.
- Background: PubMed 11696933Young DR, Gittelsohn J, Charleston J, Felix-Aaron K, Appel LJ. Motivations for exercise and weight loss among African-American women: focus group results and their contribution towards program development. Ethn Health. 2001 Aug-Nov;6(3-4):227-45. doi: 10.1080/13557850120078143.
- Background: PubMed 11404661Young DR, Jee SH, Appel LJ. A comparison of the Yale Physical Activity Survey with other physical activity measures. Med Sci Sports Exerc. 2001 Jun;33(6):955-61. doi: 10.1097/00005768-200106000-00015.
- Background: PubMed 12206443Young DR, King AC, Sheehan M, Stefanick ML. Stage of motivational readiness: predictive ability for exercise behavior. Am J Health Behav. 2002 Sep-Oct;26(5):331-41. doi: 10.5993/ajhb.26.5.2.
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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.
Deborah Young
Johns Hopkins University
Questions about this trial
What is this clinical trial studying?
An observational study of Cardiovascular Diseases and Heart Diseases, run by National Heart, Lung, and Blood Institute (NHLBI).
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: finished, as of the sponsor's last update on 18 Feb 2016. Status can change between updates, so confirm with the study contact before making plans.
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.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00005744, 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 18 Feb 2016.