Diabetes Clinical Trial
Official title:
Intentional Weight Reduction and Physical and Cognitive Function - A Look AHEAD Ancillary Study
Verified date | August 2018 |
Source | Wake Forest University Health Sciences |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 1089 |
Est. completion date | September 2015 |
Est. primary completion date | September 2015 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 45 Years to 74 Years |
Eligibility |
Inclusion Criteria: - The only inclusion criterion is that the participant is considered "active" at his/her Year 8 or Year 9 visit in the main study. Exclusion Criteria: - The only exclusion criterion is the person is not willing to participate in this ancillary study. |
Country | Name | City | State |
---|---|---|---|
United States | University of Colorado Health Sciences Center | Aurora | Colorado |
United States | Pennington Biomedical Research Center | Baton Rouge | Louisiana |
United States | The University of Tennessee-Memphis | Memphis | Tennessee |
United States | University of Pittsburgh | Pittsburgh | Pennsylvania |
Lead Sponsor | Collaborator |
---|---|
Wake Forest University | National Institute on Aging (NIA), Pennington Biomedical Research Center, University of Colorado, Denver, University of Pittsburgh, University of Tennessee |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Short Physical Performance Battery (SPPB) Score | 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. | Assessed 8 or 9 years post-randomization in Look AHEAD parent Study | |
Secondary | Gait Speed Over 400 m | 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 | Assessed 8 or 9 years post-randomization in Look AHEAD parent Study | |
Secondary | Grip Strength | 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. | Assessed 8 or 9 years post-randomization in Look AHEAD parent Study | |
Secondary | Knee Extensor Strength | Maximum knee extensor strength (one repetition maximum (1RM)) was assessed on a Nautilus Oneā¢ 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 | Assessed 8 or 9 years post-randomization in Look AHEAD parent Study | |
Secondary | Trail Making Test (Part A & B) | 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. | Assessed 8 or 9 years post-randomization in Look AHEAD parent Study | |
Secondary | Digit Symbol Substitution Test (DSST) | 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. | Assessed 8 or 9 years post-randomization in Look AHEAD parent Study | |
Secondary | Rey Auditory Verbal Learning Test (RAVLT) | 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. | Assessed 8 or 9 years post-randomization in Look AHEAD parent Study | |
Secondary | Modified Stroop Color and Word Test | 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. | Assessed 8 or 9 years post-randomization in Look AHEAD parent Study | |
Secondary | Modified Mini-Mental Status Exam (3MS) | 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. | Assessed 8 or 9 years post-randomization in Look AHEAD parent Study |
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