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:

MedlinePlus related topics: Foot Health Obesity Weight Control

U.S. FDA Resources

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

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
Overnutrition
Nutrition Disorders

Overweight
Body Weight
Signs and Symptoms
Body Weight Changes

ClinicalTrials.gov processed this record on May 16, 2013

To Top