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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
  Purpose

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 Intervention
Obesity
Other: NutriSystem portion-controlled pre-packaged meals

Study Type: Interventional
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

Resource links provided by NLM:


Further study details as provided by Temple University:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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.


Enrollment: 41
Study Start Date: January 2011
Study Completion Date: September 2011
Primary Completion Date: September 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   50 Years to 75 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Jinsup Song, Director, Gait Study Center, Temple University
ClinicalTrials.gov Identifier: NCT01782144     History of Changes
Other Study ID Numbers: 12887
Study First Received: January 30, 2013
Last Updated: January 30, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Temple University:
Obesity
Foot pain

Additional relevant MeSH terms:
Obesity
Weight Loss
Body Weight
Body Weight Changes
Nutrition Disorders
Overnutrition
Overweight
Signs and Symptoms

ClinicalTrials.gov processed this record on November 27, 2014