Effects of Weight Loss on Foot Structure and Function in Obese Adults: A Pilot Study (WLF)
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.
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Effect of Weight Loss on Foot Structure and Function in Obese Adults: A Pilot Study|
- Walking speed [ Time Frame: 3 months ] [ Designated as safety issue: No ]Change in walking speed at 3 month
- Postural stability [ Time Frame: 3 months ] [ Designated as safety issue: No ]Change in Fall Risk Test Score as measured by the BioDex Balance System.
- Peak plantar pressure [ Time Frame: 3 months ] [ Designated as safety issue: No ]Change in dynamic peak plantar pressure during barefoot walking.
- Instruments of pain and disability [ Time Frame: 3 months ] [ Designated as safety issue: No ]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.
- Arch Height Drop [ Time Frame: 3 months ] [ Designated as safety issue: No ]Change in arch height in standing compared to sitting
- Activities of Daily Living [ Time Frame: 3 months ] [ Designated as safety issue: No ]Change in 50' walk time and pain, stair ascend/descend time and pain, and sit-to-stand.
|Study Start Date:||January 2011|
|Study Completion Date:||September 2011|
|Primary Completion Date:||September 2011 (Final data collection date for primary outcome measure)|
Active Comparator: NutriSystem
weekly behavior group weight loss education
|Other: NutriSystem portion-controlled pre-packaged meals|
Placebo Comparator: Education
monthly behavior group weight loss education
Please refer to this study by its ClinicalTrials.gov identifier: NCT01782144
|United States, Pennsylvania|
|Gait Study Center|
|Philadelphia, Pennsylvania, United States, 19107|
|Principal Investigator:||Jinsup Song, DPM, PhD||Temple University|