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

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.

Study Overview

• Status: Completed
• Conditions: Obesity
• Intervention / Treatment: Other: NutriSystem portion-controlled pre-packaged meals

• Study Type: Interventional
• Enrollment (Actual): 41
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19107
      • Gait Study Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / 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	Other: NutriSystem portion-controlled pre-packaged meals

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Walking speed	Change in walking speed at 3 month	3 months
Postural stability	Change in Fall Risk Test Score as measured by the BioDex Balance System.	3 months
Peak plantar pressure	Change in dynamic peak plantar pressure during barefoot walking.	3 months
Instruments of pain and disability	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.	3 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Arch Height Drop	Change in arch height in standing compared to sitting	3 months
Activities of Daily Living	Change in 50' walk time and pain, stair ascend/descend time and pain, and sit-to-stand.	3 months

Collaborators and Investigators

• Sponsor: Temple University
• Investigators: Principal Investigator: Jinsup Song, DPM, PhD, Temple University

Study record dates

Study Major Dates

• Study Start: January 1, 2011
• Primary Completion (Actual): September 1, 2011
• Study Completion (Actual): September 1, 2011

Study Registration Dates

• First Submitted: January 30, 2013
• First Submitted That Met QC Criteria: January 30, 2013
• First Posted (Estimate): February 1, 2013

Study Record Updates

• Last Update Posted (Actual): October 14, 2020
• Last Update Submitted That Met QC Criteria: October 13, 2020
• Last Verified: October 1, 2020

More Information

Terms related to this study

• Keywords: Obesity; Foot pain
• Additional Relevant MeSH Terms: Body Weight; Body Weight Changes; Weight Loss
• Other Study ID Numbers: 12887