Effects of Weight Loss on Foot Structure and Function in Obese Adults: A Pilot Study
- Conditions
- Obesity
- Interventions
- Other: NutriSystem portion-controlled pre-packaged meals
- Registration Number
- NCT01782144
- Lead Sponsor
- Temple University
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 41
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description Education NutriSystem portion-controlled pre-packaged meals monthly behavior group weight loss education NutriSystem NutriSystem portion-controlled pre-packaged meals weekly behavior group weight loss education
- Primary Outcome Measures
Name Time Method Walking speed 3 months Change in walking speed at 3 month
Postural stability 3 months Change in Fall Risk Test Score as measured by the BioDex Balance System.
Peak plantar pressure 3 months Change in dynamic peak plantar pressure during barefoot walking.
Instruments of pain and disability 3 months Change in answers on the following questionnaires: Revised Foot Function Index, the Medical Outcomes Study Short Form 36 (SF-36), Western Ontario and McMaster Universities Osteoarthritis Index.
- Secondary Outcome Measures
Name Time Method Arch Height Drop 3 months Change in arch height in standing compared to sitting
Activities of Daily Living 3 months Change in 50' walk time and pain, stair ascend/descend time and pain, and sit-to-stand.
Trial Locations
- Locations (1)
Gait Study Center
🇺🇸Philadelphia, Pennsylvania, United States