Ignite Creation Date:
2024-05-05 @ 11:23 AM
Last Modification Date:
2024-10-26 @ 9:06 AM
Study NCT ID:
NCT00017953
Status:
COMPLETED
Last Update Posted:
2023-08-02
First Post:
2001-06-21
Brief Title:
Look AHEAD Action for Health in Diabetes
Sponsor:
Wake Forest University Health Sciences
Organization:
Wake Forest University Health Sciences
Study Overview
Official Title:
Look AHEAD Action for Health in Diabetes
Status:
COMPLETED
Status Verified Date:
2023-05
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:
LookAHEAD
Brief Summary:
The Look AHEAD study is a multi-center randomized clinical trial to examine the long-term effects of a lifestyle intervention designed to achieve and maintain weight loss The study will investigate the effects of the intervention on heart attacks stroke and cardiovascular-related death in individuals with type 2 diabetes who are also overweight or obese
Detailed Description:
Look AHEAD is examining in overweight volunteers with type 2 diabetes the long-term effects of an intensive lifestyle intervention program designed to achieve and maintain weight loss by decreased caloric intake and increased physical activity This program will be compared to a control condition involving a program of diabetes support and education
The primary hypothesis is that the incidence rate of the first post-randomization occurrence of a composite outcome which includes
cardiovascular death including fatal myocardial infarction and stroke non-fatal myocardial infarction hospitalized angina and non-fatal stroke
over a planned follow-up period of up to 135 years will be reduced among participants assigned to the Lifestyle Intervention compared to those assigned to the control condition Diabetes Support and Education
Look AHEAD will also test for reductions in the incidence of three secondary composite outcomes and examine the effect of the intervention on cardiovascular disease risk factors diabetes control and complications general health and quality of life and psychological outcomes The cost and cost-effectiveness of the Lifestyle Intervention relative to Diabetes Support and Education will be assessed
The Look AHEAD intensive lifestyle intervention ended September 2012 Participants continue to be followed to determine the long-term effects of the intervention on health outcomes
The primary hypothesis is that the incidence rate of the first post-randomization occurrence of a composite outcome which includes
cardiovascular death including fatal myocardial infarction and stroke non-fatal myocardial infarction hospitalized angina and non-fatal stroke
over a planned follow-up period of up to 135 years will be reduced among participants assigned to the Lifestyle Intervention compared to those assigned to the control condition Diabetes Support and Education
Look AHEAD will also test for reductions in the incidence of three secondary composite outcomes and examine the effect of the intervention on cardiovascular disease risk factors diabetes control and complications general health and quality of life and psychological outcomes The cost and cost-effectiveness of the Lifestyle Intervention relative to Diabetes Support and Education will be assessed
The Look AHEAD intensive lifestyle intervention ended September 2012 Participants continue to be followed to determine the long-term effects of the intervention on health outcomes
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
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 |
|---|---|---|---|
| U01DK056992 | NIH | None | httpsreporternihgovquickSearchU01DK056992 |
| U01DK057136 | NIH | None | None |
| U01DK057149 | NIH | None | None |
| U01DK056990 | NIH | None | None |
| U01DK057177 | NIH | None | None |
| U01DK057171 | NIH | None | None |
| U01DK057151 | NIH | None | None |
| U01DK057182 | NIH | None | None |
| U01DK057131 | NIH | None | None |
| U01DK057002 | NIH | None | None |
| U01DK057078 | NIH | None | None |
| U01DK057154 | NIH | None | None |
| U01DK057178 | NIH | None | None |
| U01DK057219 | NIH | None | None |
| U01DK057008 | NIH | None | None |
| U01DK057135 | NIH | None | None |