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Completed

NCT Number: NCT01782144

Effects 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.

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Key information

Age range

50 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Gait Study Center

Philadelphia, Pennsylvania, 19107, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

NutriSystem portion-controlled pre-packaged meals

Other

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Temple University

Other

Registry information

Official study title

Effect of Weight Loss on Foot Structure and Function in Obese Adults: A Pilot Study

Acronym: WLF

Important dates

Study start
2011
Primary completion
2011
Study completion
2011
First posted
Feb 1, 2013
Registry last updated
Oct 14, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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