Philadelphia, Pennsylvania 19107

  • Obesity

Purpose:

Obesity is a serious medical, social, and economic problem and is becoming even greater concern, as the prevalence of overweight and obese individuals has steadily increased over the years. Excessive body weight can have a profound influence on lower extremities, including pain, degenerative disease, and compromised quality of life. However, no study to-date has examined the effects of weight change on foot structure and function in individuals over time. The purpose of this study is to determine the effects of weight reduction on foot structure and function in obese adults. Improved understanding of the relationship between body weight and foot biomechanics is needed to promote health and healthier lifestyles.


Criteria:

Inclusion Criteria: - Men and women between the ages of 50 to 75, inclusive - Body Mass Index is ≥ 30 kg/m2 but < 45 kg/m2 and body weight < 300 pounds - Able to ambulate safely without the use of a walking aid (cane, crutches, or walker) - Able to understand the information in the informed consent form and is willing and able to comply with the study-related procedures Exclusion Criteria: - Diabetes, stroke, end stage kidney disease requiring hemodialysis, or widespread malignant disease, gallbladder disease - Severe peripheral vascular disease (defined as 1 < palpable pedal pulse and claudication pain in less than two blocks) - Pregnant or nursing, as weight and hormonal changes during pregnancy may affect foot structure and function, which could confound the results of the study. Therefore, women who are pregnant or nursing will be excluded from the study. - Not willing or able to make the required quarterly follow-up visits - Insufficient (corrected) vision to complete the questionnaires - Food allergies to the Nutrisystem, Inc. meal plan used in this protocol - Participation in another formal weight loss program within last 6 months - Uncontrolled hypertension (systolic blood pressure > 180 or diastolic blood pressure > 100 mmHg). Participants on medication treating hypertension for at least three months are allowable. - Known atherosclerotic cardiovascular disease - History of congestive heart failure - History of a non-skin malignancy within the previous 5 years - Any major active rheumatologic, pulmonary, hepatic, renal, dermatologic disease or inflammatory condition


NCT ID:

NCT01782144


Primary Contact:

Principal Investigator
Jinsup Song, DPM, PhD
Temple University


Backup Contact:

N/A


Location Contact:

Philadelphia, Pennsylvania 19107
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: June 21, 2021

Modifications to this listing: Only selected fields are shown, please use the link below to view all information about this clinical trial.


Click to view Full Listing

This study is not currently recruiting Study Participants on ClinicalConnection.com. The form below is not enabled.