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NCT01410097 · ClinicalTrials.gov registry record · NA
Physical and Cognitive Function - Look AHEAD Ancillary Study
A NA study, sponsored by Wake Forest University.
- Completed
- Registry status
- NA
- Development phase
- 1,089
- Enrollment target
NCT01410097 is a NA study that has completed, run by Wake Forest University. The registered enrollment target is 1,089 participants.
The verdict
NCT01410097, a NA study, has completed, sponsored by Wake Forest University.
- COMPLETED
- Registry status
- NA
- Development phase
- 1,089 participants
- Enrollment target
Study Summary
Obesity is associated with physical disability through both direct pathways (e.g., lower extremity pain, insufficient muscle strength) and indirect pathways (obesity-related comorbidities and inflammation). Furthermore, diabetes, a major obesity-related health condition, is associated with increased risk of disability and accelerated declines in physical and cognitive function. The investigators preliminary data suggest that intentional weight loss improves physical function, and there is strong circumstantial evidence that it would also benefit cognitive function. To evaluate the role of intentional weight loss on physical and cognitive function, the investigators propose an ancillary study to the on-going Look AHEAD (Action for Health in Diabetes) trial. Look AHEAD is a multi-center, randomized clinical trial to examine the effects of a 4-year lifestyle intervention designed to achieve and maintain weight loss through decreased caloric intake and exercise in overweight or obese men and women aged 45-74 years with type 2 diabetes. The investigators propose to add validated and well-established measures of physical and cognitive performance to the year 8 follow-up visit - during the trial's weight maintenance phase - in \~1000 participants at 4 of the 16 Look AHEAD field sites (Colorado, Memphis, Pennington and Pittsburgh). The specific aims of this ancillary study are: 1) To determine the long-term effects of a lifestyle intervention designed to achieve and maintain weight loss on physical function; and 2) To determine the long-term effects of a lifestyle intervention designed to achieve and maintain weight loss on cognitive function. In addition, the investigators hypothesize that in the intervention group, larger initial weight loss, better weight loss maintenance, and higher physical activity will be associated with better physical and cognitive function. The investigators also hypothesize that in the control group weight loss will be associated with worse phy
Interventions
- BEHAVIORAL Lifestyle intervention
- BEHAVIORAL Diabetes Support Education
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1,089 participants |
| Start Date | 2009-09 |
| Est. Completion | 2015-09 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01410097
The ClinicalTrials.gov registry entry for NCT01410097 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 1,089 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Wake Forest University, which has 100 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Lifestyle intervention is the first listed.
NCT01410097 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01410097 about?
NCT01410097 is a clinical study titled "Physical and Cognitive Function - Look AHEAD Ancillary Study". Obesity is associated with physical disability through both direct pathways (e.g., lower extremity pain, insufficient muscle strength) and indirect pathways (obesity-related comorbidities and inflammation). Furthermore, diabetes, a major obesity-related health condition, is associated with increased...
What is the current status of trial NCT01410097?
This trial is currently completed. It is a NA study. The enrollment target is 1,089 participants. The study started on 2009-09. Estimated completion is 2015-09.
What interventions are being tested in trial NCT01410097?
The interventions under investigation include: Lifestyle intervention (BEHAVIORAL), Diabetes Support Education (BEHAVIORAL).
Who is sponsoring clinical trial NCT01410097?
This trial is sponsored by Wake Forest University, which has 100 total clinical trials registered on ClinicalTrials.gov.
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