Effects of Weight Loss on Foot Structure and Function in Obese Adults: A Pilot Study (WLF)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Jinsup Song, Temple University
ClinicalTrials.gov Identifier:
NCT01782144
First received: January 30, 2013
Last updated: NA
Last verified: January 2013
History: No changes posted

January 30, 2013
January 30, 2013
January 2011
September 2011   (final data collection date for primary outcome measure)
  • 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.
Same as current
No Changes Posted
  • 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.
Same as current
Not Provided
Not Provided
 
Effects of Weight Loss on Foot Structure and Function in Obese Adults: A Pilot Study
Effect of Weight Loss on Foot Structure and Function in Obese Adults: A Pilot Study

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.

Not Provided
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Obesity
Other: NutriSystem portion-controlled pre-packaged meals
  • Active Comparator: NutriSystem
    weekly behavior group weight loss education
    Intervention: Other: NutriSystem portion-controlled pre-packaged meals
  • Placebo Comparator: Education
    monthly behavior group weight loss education
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
41
September 2011
September 2011   (final data collection date for primary outcome measure)

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
Both
50 Years to 75 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01782144
12887
No
Jinsup Song, Temple University
Temple University
Not Provided
Principal Investigator: Jinsup Song, DPM, PhD Temple University
Temple University
January 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP