Ignite Creation Date:
2024-05-05 @ 11:48 AM
Last Modification Date:
2024-10-26 @ 9:13 AM
Study NCT ID:
NCT00131105
Status:
COMPLETED
Last Update Posted:
2008-12-23
First Post:
2005-08-15
Brief Title:
The TLC2 Teaching Healthy Lifestyles to Caregivers 2CALM Counseling Advice for Lifestyle Management Study
Sponsor:
National Institute on Aging NIA
Organization:
National Institute on Aging NIA
Study Overview
Official Title:
Combining Exercise and Diet in Older Adults
Status:
COMPLETED
Status Verified Date:
2008-12
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:
None
Brief Summary:
The purpose of this study is to evaluate the effects of a 12-month telephone-supervised home-based physical activity and dietary intervention conducted in either a sequential or simultaneous fashion on improving physical activity and dietary patterns in a high-stress population
Detailed Description:
This study combines elements of two previous studies--Teaching Healthy Lifestyles for Caregivers TLC2 and Counseling Advice for Lifestyle Management CALM--to compare exercise and diet interventions in caregivers and non-caregivers Two hundred and forty healthy men and women ages 50 and older half caregivers and half non-caregivers will be randomly assigned to one of four conditions
a 12-month physical activity intervention and a 12-month dietary counseling intervention delivered simultaneously
a 12-month counseling intervention first focusing on physical activity followed by the addition of dietary counseling
a 12-month counseling intervention first focusing on dietary counseling followed by the addition of physical activity counseling or
a 12-month attention-control condition focusing on stress-management skills training
Data on physical activity participation saturated fat consumption and related quality of life indicators eg improved physical functioning fitness sleep and psychological well-being will be collected at baseline 4 months 8 months and 12 months post-test The primary hypotheses are
participants assigned to the physical activity and dietary counseling conditions will show greater improvements in physical activity participation and saturated fat consumption at 12 months compared to the attention-control condition and
participants in the sequentially-delivered counseling interventions will show greater improvements in physical activity and saturated fat consumption compared to participants in the simultaneously-delivered interventions
a 12-month physical activity intervention and a 12-month dietary counseling intervention delivered simultaneously
a 12-month counseling intervention first focusing on physical activity followed by the addition of dietary counseling
a 12-month counseling intervention first focusing on dietary counseling followed by the addition of physical activity counseling or
a 12-month attention-control condition focusing on stress-management skills training
Data on physical activity participation saturated fat consumption and related quality of life indicators eg improved physical functioning fitness sleep and psychological well-being will be collected at baseline 4 months 8 months and 12 months post-test The primary hypotheses are
participants assigned to the physical activity and dietary counseling conditions will show greater improvements in physical activity participation and saturated fat consumption at 12 months compared to the attention-control condition and
participants in the sequentially-delivered counseling interventions will show greater improvements in physical activity and saturated fat consumption compared to participants in the simultaneously-delivered interventions
Study Oversight
Has Oversight DMC:
None
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?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| R01AG021010 | NIH | None | httpsreporternihgovquickSearchR01AG021010 |