Obesity
Conditions
Keywords
Obesity, Foot pain
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.
Interventions
OTHERNutriSystem portion-controlled pre-packaged meals
Sponsors
Temple University
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
50 Years to 75 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
United States
Outcome results
None listed