Effects of Weight Loss on Foot Structure and Function in Obese Adults: A Pilot Study (WLF)
|ClinicalTrials.gov Identifier: NCT01782144|
Recruitment Status : Completed
First Posted : February 1, 2013
Last Update Posted : February 1, 2013
|Condition or disease||Intervention/treatment||Phase|
|Obesity||Other: NutriSystem portion-controlled pre-packaged meals||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||41 participants|
|Intervention Model:||Crossover Assignment|
|Masking:||None (Open Label)|
|Official Title:||Effect of Weight Loss on Foot Structure and Function in Obese Adults: A Pilot Study|
|Study Start Date :||January 2011|
|Actual Primary Completion Date :||September 2011|
|Actual Study Completion Date :||September 2011|
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
- Walking speed [ Time Frame: 3 months ]Change in walking speed at 3 month
- Postural stability [ Time Frame: 3 months ]Change in Fall Risk Test Score as measured by the BioDex Balance System.
- Peak plantar pressure [ Time Frame: 3 months ]Change in dynamic peak plantar pressure during barefoot walking.
- Instruments of pain and disability [ Time Frame: 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.
- Arch Height Drop [ Time Frame: 3 months ]Change in arch height in standing compared to sitting
- Activities of Daily Living [ Time Frame: 3 months ]Change in 50' walk time and pain, stair ascend/descend time and pain, and sit-to-stand.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01782144
|United States, Pennsylvania|
|Gait Study Center|
|Philadelphia, Pennsylvania, United States, 19107|
|Principal Investigator:||Jinsup Song, DPM, PhD||Temple University|