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

Primary Purpose

Obesity

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

NutriSystem portion-controlled pre-packaged meals

About this trial

This is an interventional treatment trial for Obesity focused on measuring Obesity, Foot pain

Eligibility Criteria

50 Years - 75 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

Gait Study Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

NutriSystem

Education

Arm Description

weekly behavior group weight loss education

monthly behavior group weight loss education

Outcomes

Primary Outcome Measures

Walking speed

Change in walking speed at 3 month

Postural stability

Change in Fall Risk Test Score as measured by the BioDex Balance System.

Peak plantar pressure

Change in dynamic peak plantar pressure during barefoot walking.

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.

Secondary Outcome Measures

Arch Height Drop

Change in arch height in standing compared to sitting

Activities of Daily Living

Change in 50' walk time and pain, stair ascend/descend time and pain, and sit-to-stand.

Full Information

NCT ID

NCT01782144

First Posted

January 30, 2013

Last Updated

October 13, 2020

Sponsor

Temple University

1. Study Identification

Unique Protocol Identification Number

NCT01782144

Brief Title

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

Acronym

WLF

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

October 2020

Overall Recruitment Status

Completed

Study Start Date

January 2011 (undefined)

Primary Completion Date

September 2011 (Actual)

Study Completion Date

September 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Temple University

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Obesity

Keywords

Obesity, Foot pain

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Crossover Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

41 (Actual)

8. Arms, Groups, and Interventions

Arm Title

NutriSystem

Arm Type

Active Comparator

Arm Description

weekly behavior group weight loss education

Arm Title

Education

Arm Type

Placebo Comparator

Arm Description

monthly behavior group weight loss education

Intervention Type

Other

Intervention Name(s)

NutriSystem portion-controlled pre-packaged meals

Primary Outcome Measure Information:

Title

Walking speed

Description

Change in walking speed at 3 month

Time Frame

3 months

Title

Postural stability

Description

Change in Fall Risk Test Score as measured by the BioDex Balance System.

Time Frame

3 months

Title

Peak plantar pressure

Description

Change in dynamic peak plantar pressure during barefoot walking.

Time Frame

3 months

Title

Instruments of pain and disability

Description

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.

Time Frame

3 months

Secondary Outcome Measure Information:

Title

Arch Height Drop

Description

Change in arch height in standing compared to sitting

Time Frame

3 months

Title

Activities of Daily Living

Description

Change in 50' walk time and pain, stair ascend/descend time and pain, and sit-to-stand.

Time Frame

3 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

50 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

Eligibility 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Jinsup Song, DPM, PhD

Organizational Affiliation

Temple University

Official's Role

Principal Investigator

Facility Information:

Facility Name

Gait Study Center

City

Philadelphia

State/Province

Pennsylvania

ZIP/Postal Code

19107

Country

United States

12. IPD Sharing Statement

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

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