Trial Outcomes & Findings for Physical and Cognitive Function - Look AHEAD Ancillary Study (NCT NCT01410097)
NCT ID: NCT01410097
Last Updated: 2018-09-10
Results Overview
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.
COMPLETED
NA
1089 participants
Assessed 8 or 9 years post-randomization in Look AHEAD parent Study
2018-09-10
Participant Flow
Participants who enrolled in the main Look AHEAD study were eligible to participate in this ancillary study. Starting at year 8 clinic visits of the main study at 4 sites (Pennington, Denver, Pittsburgh, and Memphis) participants were asked if they would participate in this study (9/09-06/12). Those who agreed \& consented were then enrolled.
Participant milestones
| Measure |
Lifestyle Intervention
Intensive Lifestyle Intervention that includes diet, physical activity, and behavior modification. The goal of the ILI intervention was for individuals to achieve and maintain a loss of at least 7% of initial body weight.
Lifestyle intervention: Intensive Lifestyle Intervention that includes diet, physical activity, and behavior modification. The goal of the ILI intervention was for individuals to achieve and maintain a loss of at least 7% of initial body weight.
|
Diabetes Support and Education (DSE)
It offers an educational program to participants including developing support groups. Providing such benefits helps retain these participants in the trial.
Diabetes Support Education: It offers an educational program to participants including developing support groups. Providing such benefits helps retain these participants in the trial.
|
|---|---|---|
|
Overall Study
STARTED
|
556
|
533
|
|
Overall Study
COMPLETED
|
551
|
530
|
|
Overall Study
NOT COMPLETED
|
5
|
3
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Physical and Cognitive Function - Look AHEAD Ancillary Study
Baseline characteristics by cohort
| Measure |
Intensive Lifestyle Intervention (ILI)
n=553 Participants
Intensive Lifestyle Intervention that includes diet, physical activity, and behavior modification. The goal of the ILI intervention was for individuals to achieve and maintain a loss of at least 7% of initial body weight.
|
Diabetes Support and Education (DSE)
n=528 Participants
Diabetes Support and Education offers an educational program to participants focusing on diet, physical activity, and social support (information on behavioral strategies are not presented).
|
Total
n=1081 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Race/Ethnicity, Customized
African American
|
110 Participants
n=5 Participants
|
108 Participants
n=7 Participants
|
218 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
239 Participants
n=5 Participants
|
224 Participants
n=7 Participants
|
463 Participants
n=5 Participants
|
|
Age, Continuous
|
58.9 years
STANDARD_DEVIATION 6.8 • n=5 Participants
|
59.1 years
STANDARD_DEVIATION 6.7 • n=7 Participants
|
59.0 years
STANDARD_DEVIATION 6.8 • n=5 Participants
|
|
Sex: Female, Male
Female
|
314 Participants
n=5 Participants
|
304 Participants
n=7 Participants
|
618 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Non Hispanic White
|
401 Participants
n=5 Participants
|
378 Participants
n=7 Participants
|
779 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Other/multiple
|
42 Participants
n=5 Participants
|
42 Participants
n=7 Participants
|
84 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Assessed 8 or 9 years post-randomization in Look AHEAD parent StudyPopulation: Only participants who attended the ancillary clinic visit and were able to do the SPPB were included in the analysis (n=954)
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.
Outcome measures
| Measure |
Intensive Lifestyle Intervention (ILI)
n=486 Participants
Intensive Lifestyle Intervention includes diet, physical activity, and behavior modification. The goal of the ILI intervention was for individuals to achieve and maintain a loss of at least 7% of initial body weight.
|
Diabetes Support and Education (DSE)
n=468 Participants
Diabetes Support and Education offers an educational program to participants focusing on diet, physical activity, and social support (information on behavioral strategies are not presented).
|
|---|---|---|
|
Short Physical Performance Battery (SPPB) Score
|
10.1 Score on a scale
Standard Error 1.9
|
10.0 Score on a scale
Standard Error 2.1
|
SECONDARY outcome
Timeframe: Assessed 8 or 9 years post-randomization in Look AHEAD parent StudyPopulation: Only participants who attended the ancillary clinic visit and were able to complete the 400 m walk were included in the analysis (n=869)
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
Outcome measures
| Measure |
Intensive Lifestyle Intervention (ILI)
n=447 Participants
Intensive Lifestyle Intervention includes diet, physical activity, and behavior modification. The goal of the ILI intervention was for individuals to achieve and maintain a loss of at least 7% of initial body weight.
|
Diabetes Support and Education (DSE)
n=422 Participants
Diabetes Support and Education offers an educational program to participants focusing on diet, physical activity, and social support (information on behavioral strategies are not presented).
|
|---|---|---|
|
Gait Speed Over 400 m
|
1.07 m/sec
Standard Deviation .19
|
1.05 m/sec
Standard Deviation .19
|
SECONDARY outcome
Timeframe: Assessed 8 or 9 years post-randomization in Look AHEAD parent StudyPopulation: Only participants who attended the ancillary clinic visit and were able to do the grip strength test were included in the analysis (n=907)
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.
Outcome measures
| Measure |
Intensive Lifestyle Intervention (ILI)
n=462 Participants
Intensive Lifestyle Intervention includes diet, physical activity, and behavior modification. The goal of the ILI intervention was for individuals to achieve and maintain a loss of at least 7% of initial body weight.
|
Diabetes Support and Education (DSE)
n=445 Participants
Diabetes Support and Education offers an educational program to participants focusing on diet, physical activity, and social support (information on behavioral strategies are not presented).
|
|---|---|---|
|
Grip Strength
|
31 kg
Standard Deviation 10.2
|
30.7 kg
Standard Deviation 10.7
|
SECONDARY outcome
Timeframe: Assessed 8 or 9 years post-randomization in Look AHEAD parent StudyPopulation: 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)
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
Outcome measures
| Measure |
Intensive Lifestyle Intervention (ILI)
n=359 Participants
Intensive Lifestyle Intervention includes diet, physical activity, and behavior modification. The goal of the ILI intervention was for individuals to achieve and maintain a loss of at least 7% of initial body weight.
|
Diabetes Support and Education (DSE)
n=342 Participants
Diabetes Support and Education offers an educational program to participants focusing on diet, physical activity, and social support (information on behavioral strategies are not presented).
|
|---|---|---|
|
Knee Extensor Strength
|
23.4 kg
Standard Deviation 11.9
|
23.4 kg
Standard Deviation 12.5
|
SECONDARY outcome
Timeframe: Assessed 8 or 9 years post-randomization in Look AHEAD parent StudyPopulation: Only participants who attended the ancillary clinic visit and completed the cognitive battery were included in the analysis (n=978)
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.
Outcome measures
| Measure |
Intensive Lifestyle Intervention (ILI)
n=499 Participants
Intensive Lifestyle Intervention includes diet, physical activity, and behavior modification. The goal of the ILI intervention was for individuals to achieve and maintain a loss of at least 7% of initial body weight.
|
Diabetes Support and Education (DSE)
n=479 Participants
Diabetes Support and Education offers an educational program to participants focusing on diet, physical activity, and social support (information on behavioral strategies are not presented).
|
|---|---|---|
|
Trail Making Test (Part A & B)
|
62.87 secs
Standard Deviation 46.14
|
62.85 secs
Standard Deviation 46.34
|
SECONDARY outcome
Timeframe: Assessed 8 or 9 years post-randomization in Look AHEAD parent StudyPopulation: Only participants who attended the ancillary clinic visit and completed the cognitive battery were included in the analysis (n=978)
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.
Outcome measures
| Measure |
Intensive Lifestyle Intervention (ILI)
n=499 Participants
Intensive Lifestyle Intervention includes diet, physical activity, and behavior modification. The goal of the ILI intervention was for individuals to achieve and maintain a loss of at least 7% of initial body weight.
|
Diabetes Support and Education (DSE)
n=479 Participants
Diabetes Support and Education offers an educational program to participants focusing on diet, physical activity, and social support (information on behavioral strategies are not presented).
|
|---|---|---|
|
Digit Symbol Substitution Test (DSST)
|
41.61 number correct
Standard Deviation 10.38
|
41.14 number correct
Standard Deviation 10.84
|
SECONDARY outcome
Timeframe: Assessed 8 or 9 years post-randomization in Look AHEAD parent StudyPopulation: Only participants who attended the ancillary clinic visit and completed the cognitive battery were included in the analysis (n=978)
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.
Outcome measures
| Measure |
Intensive Lifestyle Intervention (ILI)
n=499 Participants
Intensive Lifestyle Intervention includes diet, physical activity, and behavior modification. The goal of the ILI intervention was for individuals to achieve and maintain a loss of at least 7% of initial body weight.
|
Diabetes Support and Education (DSE)
n=479 Participants
Diabetes Support and Education offers an educational program to participants focusing on diet, physical activity, and social support (information on behavioral strategies are not presented).
|
|---|---|---|
|
Rey Auditory Verbal Learning Test (RAVLT)
|
7.51 number correct
Standard Deviation 3.28
|
7.30 number correct
Standard Deviation 3.22
|
SECONDARY outcome
Timeframe: Assessed 8 or 9 years post-randomization in Look AHEAD parent StudyPopulation: Only participants who attended the ancillary clinic visit and completed the cognitive battery were included in the analysis (n=978)
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.
Outcome measures
| Measure |
Intensive Lifestyle Intervention (ILI)
n=499 Participants
Intensive Lifestyle Intervention includes diet, physical activity, and behavior modification. The goal of the ILI intervention was for individuals to achieve and maintain a loss of at least 7% of initial body weight.
|
Diabetes Support and Education (DSE)
n=479 Participants
Diabetes Support and Education offers an educational program to participants focusing on diet, physical activity, and social support (information on behavioral strategies are not presented).
|
|---|---|---|
|
Modified Stroop Color and Word Test
|
39.17 score on a scale
Standard Deviation 17.71
|
38.47 score on a scale
Standard Deviation 18.68
|
SECONDARY outcome
Timeframe: Assessed 8 or 9 years post-randomization in Look AHEAD parent StudyPopulation: Only participants who attended the ancillary clinic visit and completed the cognitive battery were included in the analysis (n=978)
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.
Outcome measures
| Measure |
Intensive Lifestyle Intervention (ILI)
n=499 Participants
Intensive Lifestyle Intervention includes diet, physical activity, and behavior modification. The goal of the ILI intervention was for individuals to achieve and maintain a loss of at least 7% of initial body weight.
|
Diabetes Support and Education (DSE)
n=479 Participants
Diabetes Support and Education offers an educational program to participants focusing on diet, physical activity, and social support (information on behavioral strategies are not presented).
|
|---|---|---|
|
Modified Mini-Mental Status Exam (3MS)
|
92.25 Score on a scale
Standard Deviation 5.94
|
92.19 Score on a scale
Standard Deviation 6.66
|
Adverse Events
Lifestyle Intervention
Diabetes Support and Education (DSE)
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place