Physical and Cognitive Function - Look AHEAD Ancillary Study
Public ClinicalTrials.gov record NCT01410097. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
Intentional Weight Reduction and Physical and Cognitive Function - A Look AHEAD Ancillary Study
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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 physical and cognitive function than in those who are weight stable or who have gained weight. The number of obese older adults is rising rapidly and there are few data to guide an evidence-based clinical response to their management. The results of this study will provide the first direct evidence of the role of long-term intentional weight loss on the maintenance of physical and cognitive function in older obese adults with diabetes. Since this study is being done as an ancillary study to an on-going trial it can be done in a timely and cost-efficient manner.
Study identification
- NCT ID
- NCT01410097
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Not applicable
- Enrollment
- 1,089 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 45 Years to 74 Years
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Aug 31, 2009
- Primary completion
- Aug 31, 2015
- Completion
- Aug 31, 2015
- Last update posted
- Sep 9, 2018
2009 – 2015
United States locations
- U.S. sites
- 4
- U.S. states
- 4
- U.S. cities
- 4
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| University of Colorado Health Sciences Center | Aurora | Colorado | 80045 | — |
| Pennington Biomedical Research Center | Baton Rouge | Louisiana | 70801 | — |
| University of Pittsburgh | Pittsburgh | Pennsylvania | 15203 | — |
| The University of Tennessee-Memphis | Memphis | Tennessee | 38105 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT01410097, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Sep 9, 2018 · Synced Sep 6, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT01410097 live on ClinicalTrials.gov.