Ignite Creation Date:
2025-12-24 @ 7:12 PM
Ignite Modification Date:
2025-12-31 @ 8:37 AM
Study NCT ID:
NCT01687803
Status:
COMPLETED
Last Update Posted:
2012-09-19
First Post:
2012-09-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluating the Health Benefits of Physical Activity Recommendations in the Dietary Guidelines
Sponsor:
USDA, Western Human Nutrition Research Center
Organization:
Study Overview
Official Title:
Evaluating the Health Benefits of Physical Activity Recommendations in the Dietary Guidelines
Status:
COMPLETED
Status Verified Date:
2012-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
FL52
Brief Summary:
The overall goal of this study is to determine the health benefits associated with the 2005 Dietary Guidelines physical activity prescription in healthy, peri-menopausal women. The 2005 Dietary Guidelines specifically state that to avoid unhealthy weight gain, adults should participate in 60 minutes of moderate to vigorous intensity physical activity on most days of the week.
Detailed Description:
This study will be a randomized controlled trial conducted over a 6 to 7 month period. Subjects will be enrolled by cohorts and randomly assigned to one of two groups.
* Group 1 (PA): physical activity intervention that will consist of brisk walking or other aerobic-type activities (6 days per week), resistance exercise (using free weights, resistance bands or weight stacks for weight lifting, 3 days per week), and 'active lifestyle' activities such as gardening, dancing, participation in sporting activities. The total time spent in these activities will add up to \~60 min/day for 6 days/week (\~360 minutes per week).
* Group 2 (CON): control group will maintain their usual level of physical activity and participate in testing protocols, record keeping, and interviews on the same schedule as PA. This group will be offered an opportunity to have a gym membership/access to the training facility after completion of the 6-month period of serving as controls.
The specific aims of this pilot study are to:
* Assess each participant's level of compliance/adherence
* Assess the dietary habits of study participants as they become more physically active.
* Identify barriers to physical activity in this specific population.
* Measure changes in body composition, physical fitness and energy expenditure.
* Evaluate changes in chronic disease risk factors.
* Determine if regular physical activity reduces chronic stress.
* Group 1 (PA): physical activity intervention that will consist of brisk walking or other aerobic-type activities (6 days per week), resistance exercise (using free weights, resistance bands or weight stacks for weight lifting, 3 days per week), and 'active lifestyle' activities such as gardening, dancing, participation in sporting activities. The total time spent in these activities will add up to \~60 min/day for 6 days/week (\~360 minutes per week).
* Group 2 (CON): control group will maintain their usual level of physical activity and participate in testing protocols, record keeping, and interviews on the same schedule as PA. This group will be offered an opportunity to have a gym membership/access to the training facility after completion of the 6-month period of serving as controls.
The specific aims of this pilot study are to:
* Assess each participant's level of compliance/adherence
* Assess the dietary habits of study participants as they become more physically active.
* Identify barriers to physical activity in this specific population.
* Measure changes in body composition, physical fitness and energy expenditure.
* Evaluate changes in chronic disease risk factors.
* Determine if regular physical activity reduces chronic stress.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: