NCT01782144

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
41

participants targeted

Target at P25-P50 for not_applicable obesity

Timeline
Completed

Started Jan 2011

Shorter than P25 for not_applicable obesity

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2011

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2011

Completed
1.4 years until next milestone

First Submitted

Initial submission to the registry

January 30, 2013

Completed
2 days until next milestone

First Posted

Study publicly available on registry

February 1, 2013

Completed
Last Updated

October 14, 2020

Status Verified

October 1, 2020

Enrollment Period

8 months

First QC Date

January 30, 2013

Last Update Submit

October 13, 2020

Conditions

Obesity

Keywords

ObesityFoot pain

Outcome Measures

Primary Outcomes (4)

  • 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 Outcomes (2)

  • Arch Height Drop

    3 months

  • Activities of Daily Living

    3 months

Study Arms (2)

NutriSystem

ACTIVE COMPARATOR

weekly behavior group weight loss education

Other: NutriSystem portion-controlled pre-packaged meals

Education

PLACEBO COMPARATOR

monthly behavior group weight loss education

Other: NutriSystem portion-controlled pre-packaged meals

Interventions

NutriSystem portion-controlled pre-packaged mealsOTHER
EducationNutriSystem

Eligibility Criteria

Age50 Years - 75 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Gait Study Center

Philadelphia, Pennsylvania, 19107, United States

Location

MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Jinsup Song, DPM, PhD

    Temple University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 30, 2013

First Posted

February 1, 2013

Study Start

January 1, 2011

Primary Completion

September 1, 2011

Study Completion

September 1, 2011

Last Updated

October 14, 2020

Record last verified: 2020-10

Locations

US(1)