Physical and Cognitive Function - Look AHEAD Ancillary Study
NCT01410097, Not applicable, Completed, Wake Forest University; results first posted 2017-11-17
Trial 11
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
| Field | Value | Source |
|---|---|---|
| Title | Physical and Cognitive Function - Look AHEAD Ancillary Study | ClinicalTrials.gov |
| NCT number | NCT01410097 | ClinicalTrials.gov |
| Status | Completed | ClinicalTrials.gov |
| Phases | Not applicable | ClinicalTrials.gov |
| Enrollment | 1,089 participants, actual | ClinicalTrials.gov |
| Lead sponsor | Wake Forest University | ClinicalTrials.gov |
| Conditions | Diabetes, Weight Loss, Physical Function, Cognitive Function | ClinicalTrials.gov |
| Interventions | Lifestyle intervention, Diabetes Support Education | ClinicalTrials.gov |
| First posted | 2011-08-04 | ClinicalTrials.gov |
| Last updated | 2018-09-10 | ClinicalTrials.gov |
| Results first posted | 2017-11-17 | ClinicalTrials.gov |
Registered outcomes 9
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description | Source |
|---|---|---|---|---|
| Primary | Short Physical Performance Battery (SPPB) Score | Assessed 8 or 9 years post-randomization in Look AHEAD parent Study | The Short Physical Performance Battery (SPPB) was administered to assess lower extremity physical performance and consisted of standing balance tasks (side-by-side, semi- and full-tandem stands for 10 seconds each), time to complete 5 repeated chair stands, and a 6-m walk to assess usual gait speed. Each of the three performance measures was assigned a score ranging from 0 (inability to perform the task) to 4 (the highest level of performance) and summed to create an SPPB score ranging from 0 to 12 (best). Assessed 8 or 9 years post-randomization in Look AHEAD parent Study. | ClinicalTrials.gov |
| Secondary | Gait Speed Over 400 m | Assessed 8 or 9 years post-randomization in Look AHEAD parent Study | A 400 m walk was administered to assess endurance. Participants were instructed to walk at their usual pace and time to complete the 400-m walk was recorded. The 400-m walk test was terminated if the participant reported chest pain, tightness or pressure, significant shortness of breath or difficulty breathing, feeling faint, lightheaded or dizzy, or other pain (e.g., leg pain).Assessed 8 or 9 years post-randomization in Look AHEAD parent Study | ClinicalTrials.gov |
| Secondary | Grip Strength | Assessed 8 or 9 years post-randomization in Look AHEAD parent Study | Grip strength (kg) was measured twice in each hand using an isometric Hydraulic Hand Dynamometer (Jamar, Bolingbrook, IL). The maximum of the force from two trials for the stronger hand was used in the analyses. Participants with severe hand pain or recent surgery in both hands were excluded from testing. Assessed 8 or 9 years post-randomization in Look AHEAD parent Study. | ClinicalTrials.gov |
| Secondary | Knee Extensor Strength | Assessed 8 or 9 years post-randomization in Look AHEAD parent Study | Maximum knee extensor strength (one repetition maximum (1RM)) was assessed on a Nautilus One™ Leg Extension machine. Participants with prior knee surgery on both knees where all or part of the joint was replaced were excluded from testing. The right leg was tested unless there was a contraindication (e.g., prior knee surgery). If participants experienced knee pain during the test and there were no contraindications to test the other leg, the other leg was tested; if participants experienced knee pain on the other leg, the test was terminated. Assessed 8 or 9 years post-randomization in Look AHEAD parent Study | ClinicalTrials.gov |
| Secondary | Trail Making Test (Part A & B) | Assessed 8 or 9 years post-randomization in Look AHEAD parent Study | Trail Making Tests A and B was used to assess attention and concentration (Part A) and executive function (Part B). Part A measures the time (in seconds) to draw lines to connect circled numbers in a numerical sequence and Part B measures the time (in seconds) to draw lines to connect circled numbers and letters in an alternating numeric and alphabetic sequence as rapidly as possible. The difference (in seconds; greater time indicates worse performance) in performance on Part B minus Part A was used in analysis to represent the contrast between performance on the simple (Part A) and alternating conditions (Part B). Assessed 8 or 9 years post-randomization in Look AHEAD parent Study. | ClinicalTrials.gov |
| Secondary | Digit Symbol Substitution Test (DSST) | Assessed 8 or 9 years post-randomization in Look AHEAD parent Study | The Digit Symbol Substitution Test (DSST) was used to assess working memory. Participants were presented with a legend at the top of the page showing the boxes each with a number from 1 to 9 and below each numbered box is a unique symbol. As rapidly as possible, the participant fills in the randomly ordered boxes with numbers paired with blank boxes with the symbol that corresponds to the number in the legend. The score is the total number of correctly entered symbols completed in 90 seconds (range, 0-133; higher score indicates better performance). Assessed 8 or 9 years post-randomization in Look AHEAD parent Study. | ClinicalTrials.gov |
| Secondary | Rey Auditory Verbal Learning Test (RAVLT) | Assessed 8 or 9 years post-randomization in Look AHEAD parent Study | The Rey Auditory Verbal Learning Test (RAVLT) was used to assess verbal memory. The participant is read a list of 15 words five times. After each time the list is given, the participant is asked to immediately recall as many words as possible. Following the fifth recall, an interference list is presented, after which the participant is asked to spontaneously recall words from the original list. After a 10-minute interval has passed, the participant is asked again to recall as many words as possible from the original list. The number of words correctly recalled on the delayed recall were used in the analysis (range, 0-15; higher number correct indicates better performance). Assessed 8 or 9 years post-randomization in Look AHEAD parent Study. | ClinicalTrials.gov |
| Secondary | Modified Stroop Color and Word Test | Assessed 8 or 9 years post-randomization in Look AHEAD parent Study | The Modified Stroop Color and Word Test was used to assess executive function. The test measures a participant's ability to view complex visual stimuli and to respond to one stimulus dimension while suppressing response to another competitive stimulation. The participant first reads aloud words denoting colors printed in black ink (Subtest 1), then names aloud the color of blocks printed in colored ink (Subtest 2), and finally names aloud the color ink in which the words are printed in which are incongruent to the word (Subtest 3). The amount of time to complete each subtest and the number of errors are recorded and interference calculated as time to complete Subtest 3 - Subtest 1 + errors (lower interference scores indicate better cognitive performance). Assessed 8 or 9 years post-randomization in Look AHEAD parent Study. | ClinicalTrials.gov |
| Secondary | Modified Mini-Mental Status Exam (3MS) | Assessed 8 or 9 years post-randomization in Look AHEAD parent Study | The Modified Mini-Mental Status Exam (3MS) was used to assess global cognitive function. Scores range from 0 to 100 with higher scores indicating better cognitive function. Assessed 8 or 9 years post-randomization in Look AHEAD parent Study. | ClinicalTrials.gov |
Outcomes 9
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as | Source |
|---|---|---|---|---|---|---|
| PRIMARY | Short Physical Performance Battery (SPPB) Score | Assessed 8 or 9 years post-randomization in Look AHEAD parent Study | Only participants who attended the ancillary clinic visit and were able to do the SPPB were included in the analysis (n=954) | Score on a scale | MEAN | ClinicalTrials.gov |
| SECONDARY | Gait Speed Over 400 m | Assessed 8 or 9 years post-randomization in Look AHEAD parent Study | Only participants who attended the ancillary clinic visit and were able to complete the 400 m walk were included in the analysis (n=869) | m/sec | MEAN | ClinicalTrials.gov |
| SECONDARY | Grip Strength | Assessed 8 or 9 years post-randomization in Look AHEAD parent Study | Only participants who attended the ancillary clinic visit and were able to do the grip strength test were included in the analysis (n=907) | kg | MEAN | ClinicalTrials.gov |
| SECONDARY | Knee Extensor Strength | Assessed 8 or 9 years post-randomization in Look AHEAD parent Study | Only participants who attended the ancillary clinic visit and were able to achieve maximum knee extensor strength (1RM) were included in the analysis (n=701) | kg | MEAN | ClinicalTrials.gov |
| SECONDARY | Trail Making Test (Part A & B) | Assessed 8 or 9 years post-randomization in Look AHEAD parent Study | Only participants who attended the ancillary clinic visit and completed the cognitive battery were included in the analysis (n=978) | secs | MEAN | ClinicalTrials.gov |
| SECONDARY | Digit Symbol Substitution Test (DSST) | Assessed 8 or 9 years post-randomization in Look AHEAD parent Study | Only participants who attended the ancillary clinic visit and completed the cognitive battery were included in the analysis (n=978) | number correct | MEAN | ClinicalTrials.gov |
| SECONDARY | Rey Auditory Verbal Learning Test (RAVLT) | Assessed 8 or 9 years post-randomization in Look AHEAD parent Study | Only participants who attended the ancillary clinic visit and completed the cognitive battery were included in the analysis (n=978) | number correct | MEAN | ClinicalTrials.gov |
| SECONDARY | Modified Stroop Color and Word Test | Assessed 8 or 9 years post-randomization in Look AHEAD parent Study | Only participants who attended the ancillary clinic visit and completed the cognitive battery were included in the analysis (n=978) | score on a scale | MEAN | ClinicalTrials.gov |
| SECONDARY | Modified Mini-Mental Status Exam (3MS) | Assessed 8 or 9 years post-randomization in Look AHEAD parent Study | Only participants who attended the ancillary clinic visit and completed the cognitive battery were included in the analysis (n=978) | Score on a scale | MEAN | ClinicalTrials.gov |
Results by group 18
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units | Source |
|---|---|---|---|---|---|---|
| Short Physical Performance Battery (SPPB) Score | Intensive Lifestyle Intervention (ILI) | 10.1 | Standard Error 1.9 | Score on a scale | ClinicalTrials.gov | |
| Short Physical Performance Battery (SPPB) Score | Diabetes Support and Education (DSE) | 10.0 | Standard Error 2.1 | Score on a scale | ClinicalTrials.gov | |
| Gait Speed Over 400 m | Intensive Lifestyle Intervention (ILI) | 1.07 | Standard Deviation .19 | m/sec | ClinicalTrials.gov | |
| Gait Speed Over 400 m | Diabetes Support and Education (DSE) | 1.05 | Standard Deviation .19 | m/sec | ClinicalTrials.gov | |
| Grip Strength | Intensive Lifestyle Intervention (ILI) | 31 | Standard Deviation 10.2 | kg | ClinicalTrials.gov | |
| Grip Strength | Diabetes Support and Education (DSE) | 30.7 | Standard Deviation 10.7 | kg | ClinicalTrials.gov | |
| Knee Extensor Strength | Intensive Lifestyle Intervention (ILI) | 23.4 | Standard Deviation 11.9 | kg | ClinicalTrials.gov | |
| Knee Extensor Strength | Diabetes Support and Education (DSE) | 23.4 | Standard Deviation 12.5 | kg | ClinicalTrials.gov | |
| Trail Making Test (Part A & B) | Intensive Lifestyle Intervention (ILI) | 62.87 | Standard Deviation 46.14 | secs | ClinicalTrials.gov | |
| Trail Making Test (Part A & B) | Diabetes Support and Education (DSE) | 62.85 | Standard Deviation 46.34 | secs | ClinicalTrials.gov | |
| Digit Symbol Substitution Test (DSST) | Intensive Lifestyle Intervention (ILI) | 41.61 | Standard Deviation 10.38 | number correct | ClinicalTrials.gov | |
| Digit Symbol Substitution Test (DSST) | Diabetes Support and Education (DSE) | 41.14 | Standard Deviation 10.84 | number correct | ClinicalTrials.gov | |
| Rey Auditory Verbal Learning Test (RAVLT) | Intensive Lifestyle Intervention (ILI) | 7.51 | Standard Deviation 3.28 | number correct | ClinicalTrials.gov | |
| Rey Auditory Verbal Learning Test (RAVLT) | Diabetes Support and Education (DSE) | 7.30 | Standard Deviation 3.22 | number correct | ClinicalTrials.gov | |
| Modified Stroop Color and Word Test | Intensive Lifestyle Intervention (ILI) | 39.17 | Standard Deviation 17.71 | score on a scale | ClinicalTrials.gov | |
| Modified Stroop Color and Word Test | Diabetes Support and Education (DSE) | 38.47 | Standard Deviation 18.68 | score on a scale | ClinicalTrials.gov | |
| Modified Mini-Mental Status Exam (3MS) | Intensive Lifestyle Intervention (ILI) | 92.25 | Standard Deviation 5.94 | Score on a scale | ClinicalTrials.gov | |
| Modified Mini-Mental Status Exam (3MS) | Diabetes Support and Education (DSE) | 92.19 | Standard Deviation 6.66 | Score on a scale | ClinicalTrials.gov |
Participant flow 6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted | Source |
|---|---|---|---|---|---|
| Overall Study | STARTED | Lifestyle Intervention | 556 | ClinicalTrials.gov | |
| Overall Study | STARTED | Diabetes Support and Education (DSE) | 533 | ClinicalTrials.gov | |
| Overall Study | COMPLETED | Lifestyle Intervention | 551 | ClinicalTrials.gov | |
| Overall Study | COMPLETED | Diabetes Support and Education (DSE) | 530 | ClinicalTrials.gov | |
| Overall Study | NOT COMPLETED | Lifestyle Intervention | 5 | ClinicalTrials.gov | |
| Overall Study | NOT COMPLETED | Diabetes Support and Education (DSE) | 3 | ClinicalTrials.gov |
Adverse events 0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events | Source |
|---|
Adverse event totals 6
The totals the trial posted for each group.
| Total | Group | Affected | At risk | Source |
|---|---|---|---|---|
| Total, all-cause mortality | Lifestyle Intervention | ClinicalTrials.gov | ||
| Total, all-cause mortality | Diabetes Support and Education (DSE) | ClinicalTrials.gov | ||
| Total, other adverse events | Lifestyle Intervention | 0 | 556 | ClinicalTrials.gov |
| Total, other adverse events | Diabetes Support and Education (DSE) | 0 | 533 | ClinicalTrials.gov |
| Total, serious adverse events | Lifestyle Intervention | 0 | 556 | ClinicalTrials.gov |
| Total, serious adverse events | Diabetes Support and Education (DSE) | 0 | 533 | ClinicalTrials.gov |
Papers 2
The papers the trial lists on ClinicalTrials.gov.
Grants 1
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years | Source |
|---|---|---|---|---|---|---|
| R01AG033087 | Intentional weight reduction and physical and cognitive function | HOUSTON, DENISE KATHRYN | WAKE FOREST UNIVERSITY HEALTH SCIENCES | NATIONAL INSTITUTE ON AGING | 2009 to 2013 | NIH RePORTER |
Trial comparisons 1
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Lifestyle Intervention vs Diabetes Support and Education (DSE): serious adverse events | Trial comparisons |
Tests 4
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
| Test | Named as | Source |
|---|---|---|
| Stroop Color-Word Test | Secondary outcome | ConductCognition |
| Symbol Coding | Secondary outcome | ConductCognition |
| Trail Making Test A | Secondary outcome | ConductCognition |
| Verbal Learning | Secondary outcome | ConductCognition |
Source 5
| Field | Value | Source |
|---|---|---|
| Release | trials-2026-11-12-0.4.0 | ClinicalTrials.gov |
| Release manifest SHA-256 | 0f4a8d8c48aee2a7573ae0fa94ecbeab70c1adbe449bbc95c424bc7d3e97b9d4 | ClinicalTrials.gov |
| Registry capture | 2026-11-12 | ClinicalTrials.gov |
| Results copy, AACT | 2026-03-23 | ClinicalTrials.gov |
| NIH clinical studies file | 2026-11-13 | ClinicalTrials.gov |
Release trials-2026-11-12-0.4.0
ClinicalTrials.gov's posted results, through CTTI's AACT: ClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299 ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
ClinicalTrials.gov: none stated ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
NIH RePORTER's clinical studies and project files: Public domain (NIH RePORTER)