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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01782144
Recruitment Status : Completed
First Posted : February 1, 2013
Last Update Posted : February 1, 2013
Sponsor:
Information provided by (Responsible Party):

Study Description
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.

Condition or disease Intervention/treatment
Obesity Other: NutriSystem portion-controlled pre-packaged meals

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 41 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Effect of Weight Loss on Foot Structure and Function in Obese Adults: A Pilot Study
Study Start Date : January 2011
Primary Completion Date : September 2011
Study Completion Date : September 2011

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
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


Outcome Measures

Primary Outcome Measures :
  1. Walking speed [ Time Frame: 3 months ]
    Change in walking speed at 3 month

  2. Postural stability [ Time Frame: 3 months ]
    Change in Fall Risk Test Score as measured by the BioDex Balance System.

  3. Peak plantar pressure [ Time Frame: 3 months ]
    Change in dynamic peak plantar pressure during barefoot walking.

  4. 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.


Secondary Outcome Measures :
  1. Arch Height Drop [ Time Frame: 3 months ]
    Change in arch height in standing compared to sitting

  2. 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.


Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   50 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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
Contacts and Locations

Information from the National Library of Medicine

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


Locations
United States, Pennsylvania
Gait Study Center
Philadelphia, Pennsylvania, United States, 19107
Sponsors and Collaborators
Temple University
Investigators
Principal Investigator: Jinsup Song, DPM, PhD Temple University
More Information

Responsible Party: Jinsup Song, Director, Gait Study Center, Temple University
ClinicalTrials.gov Identifier: NCT01782144     History of Changes
Other Study ID Numbers: 12887
First Posted: February 1, 2013    Key Record Dates
Last Update Posted: February 1, 2013
Last Verified: January 2013

Keywords provided by Jinsup Song, Temple University:
Obesity
Foot pain

Additional relevant MeSH terms:
Weight Loss
Body Weight Changes
Body Weight
Signs and Symptoms