Effects of Weight Loss on Foot Structure and Function in Obese Adults: A Pilot Study (WLF)

Temple University

Status

Completed

Conditions

Obesity

Treatments

Other: NutriSystem portion-controlled pre-packaged meals

Study type

Interventional

Funder types

Other

Identifiers

NCT01782144

12887

Details and patient eligibility

About

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.

Enrollment

41 patients

Sex

All

Ages

50 to 75 years old

Volunteers

Accepts Healthy Volunteers

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