Clinical trial NCT01782144: Effects of Weight Loss on Foot Structure and Function in Obese Adults: A Pilot Study
Official title: Effect of Weight Loss on Foot Structure and Function in Obese Adults: A Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity
Keywords: Obesity
Foot pain
Lead sponsor: Temple University
Sponsor class: OTHER
First posted: 2013-02-01
Enrollment: 41
Sex: ALL
Minimum age (years): 50
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.


Eligibility 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

Primary outcomes:
measure: Walking speed
timeFrame: 3 months
measure: Postural stability
timeFrame: 3 months
measure: Peak plantar pressure
timeFrame: 3 months
measure: Instruments of pain and disability
timeFrame: 3 months
Secondary outcomes:
measure: Arch Height Drop
timeFrame: 3 months
measure: Activities of Daily Living
timeFrame: 3 months
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Gait Study Center
state: Pennsylvania
Study officials:
affiliation: Temple University
name: Jinsup Song, DPM, PhD
role: PRINCIPAL_INVESTIGATOR
References: