Effects of Weight Loss on Foot Structure and Function in Obese Adults: A Pilot Study (WLF)
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|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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
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|