Ignite Creation Date:
2024-05-05 @ 4:41 PM
Last Modification Date:
2024-10-26 @ 9:23 AM
Study NCT ID:
NCT00292994
Status:
UNKNOWN
Last Update Posted:
2006-02-16
First Post:
2006-02-15
Brief Title:
Study of How Exercise or Weight Loss Effects Metabolic Syndrome
Sponsor:
Yankton Clinical Research Alliance
Organization:
Yankton Clinical Research Alliance
Study Overview
Official Title:
Exercise and Diet With Weight Loss in Metabolic Syndrome
Status:
UNKNOWN
Status Verified Date:
2006-01
Last Known Status:
ACTIVE_NOT_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The Metabolic Syndrome MS is prevalent in the American population and is strongly associated with premature coronary disease Lifestyle intervention primarily exercise and dietary changes are foundational treatment strategies for independent components of MS but these interventions have not been thoroughly evaluated in MS Even with very modest weight loss in the setting of caloric restriction and exercise marked improvement MS parameters have been noted However it is not known whether it is diet with weight loss or exercise that improves the metabolic derangements associated with MS We propose a study designed to examine the relative impact of diet or exercise on the components of MS Furthermore it is known that psychological factors significantly impact the ability of patients to initiate and sustain lifestyle changes We will monitor certain psychological states to evaluate their impact on the success of weight loss and sustainability of lifestyle changes throughout this study Specific Aims 1 Evaluate the relative efficacy of diet with weight loss or exercise on improving the markers of metabolic syndrome 2 Determine of pre-existing psychological factors influence the effectiveness of diet with weight loss or exercise on the markers of metabolic syndrome Design Adult women 18 yrs with a body-mass index BMI 30 kgm2 will be assessed for MS and randomized to one of three groups n 34group Control C diet with weight loss alone D or exercise alone E The intervention groups will participate in supervised dietary changes designed for weight loss or exercise for 6 months Anthropomorphic serologic and psychological parameters will be monitored and compared using ANOVA Hypothesis As indexed by the improvement in the laboratory markers of the components of metabolic syndrome exercise alone has a more profound positive impact on Metabolic Syndrome then diet with weight loss alone
Detailed Description:
Research procedures The interventions in this study will be caloric dietary restrictions intended to result in a 10 reduction of body weight within 6 months or a supervised aerobic exercise program designed to improve cardiovascular fitness The diet with weight loss group will meet with a registered dietician on a weekly basis for the first 2 months and then bi-weekly for the duration of the study for education and review of the subjects caloric intake Similarly the exercise group subjects will participate in weekly supervised aerobic exercise sessions At these visits a food logbook and an exercise logbook will be turned into the study staff to review Prior to inclusion in the study the patients medical record will be reviewed for evidence of metabolic syndrome specifically recent lipid analysis blood sugar weight height waist circumference and blood pressure A self-report history and physical examination form Perceived Behavior Control Scale Self-Efficacy Scale Beck Depression Inventory will also be included as part of the enrollment process and ongoing participation Pre-interventioninitial screening includes fasting triglycerides HDL glucose hs-CRP Uric Acid insulin and plasma creatinine 24-hour urine collection blood pressure waist and hip circumference height weight VO2 max estimated from sub maximal standardized treadmill exercise test Beck Depression Inventory Perceived Behavioral Control Scale Self-Efficacy Scale and Pre-intervention 3-day food record and physical activity questionnaire to assess baseline diet and activity levels During study monitoring daily exercise log exercise group assessed weekly determine the intensity duration and frequency of aerobic exercise daily food log diet with weight loss group assessed for caloric intake quarterly 3-day food records assessed for caloric intake and composition of fats carbohydrates and proteins quarterly blood pressure weight height waist and hip circumference quarterly fasting serum triglyceride HDL fasting serum glucose and uric acid and quarterly physical activity questionnaire Beck Depression Inventory Perceived Behavioral Control Scale and Self-Efficacy Scale Post-study assessment fasting serum triglycerides HDL serum glucose uric acid hs-CRP insulin and plasma creatinine 24-hour urine collection body weight height and waist and hip circumference VO2 max estimated from sub maximal standardized treadmill exercise test and 3-day food record physical activity questionnaire Beck Depression Inventory Perceived Behavioral Control Scale and Self-Efficacy Scale The control group will complete the pre and post measurements and the 3-day food record and physical activity questionnaire as required by the diet and exercise groups
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None