ObesityWLFNCT01782144
Effects of Weight Loss on Foot Structure and Function in Obese Adults: A Pilot Study
A study of Obesity, run by Temple University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 50 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Obesity
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 41 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2011to Sep 2011
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 12Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Obesity
- Being tested
- NutriSystem portion-controlled pre-packaged meals
- Keywords
- Obesity, Foot pain
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NutriSystem portion-controlled pre-packaged mealsOther
| Study group | Role | What they receive |
|---|---|---|
| NutriSystem | Active comparator | weekly behavior group weight loss education Receives: Other: NutriSystem portion-controlled pre-packaged meals |
| Education | Placebo comparator | monthly behavior group weight loss education Receives: Other: NutriSystem portion-controlled pre-packaged meals |
What is being measured
The primary outcome is the main question the study is designed to answer.
Walking speed
Change in walking speed at 3 month
Measured: 3 months
Postural stability
Change in Fall Risk Test Score as measured by the BioDex Balance System.
Measured: 3 months
Peak plantar pressure
Change in dynamic peak plantar pressure during barefoot walking.
Measured: 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.
Measured: 3 months
Secondary outcomes (2)
Arch Height Drop
Change in arch height in standing compared to sitting
Measured: 3 months
Activities of Daily Living
Change in 50' walk time and pain, stair ascend/descend time and pain, and sit-to-stand.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Feb 2013 (estimated)
- Study startJan 2011
- Primary completionSep 2011
- Study completionSep 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 41 participants (actual)
Sponsor and investigators
- Lead sponsor
- Temple University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jinsup Song, DPM, PhD, Principal investigator, Temple University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01782144
- Sponsor's protocol ID
- 12887
- Acronym
- WLF
- Status last verified
- Oct 2020
- First submitted
- 30 Jan 2013
- Last updated
- 14 Oct 2020
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Weight Loss on Foot Structure and Function in Obese Adults: A Pilot Study
- ClinicalTrials.gov ID
- NCT01782144
- Acronym / sponsor ID
- WLF / 12887
- Conditions
- Obesity
- Keywords
- Obesity, Foot pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 41 participants (actual)
- Lead sponsor
- Temple UniversityUniversity, hospital or other
- Study start
- Jan 2011
- Primary completion
- Sep 2011 (actual)
- Study completion
- Sep 2011 (actual)
- First posted
- 1 Feb 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| NutriSystem | Active comparator | Other: NutriSystem portion-controlled pre-packaged mealsweekly behavior group weight loss education |
| Education | Placebo comparator | Other: NutriSystem portion-controlled pre-packaged mealsmonthly behavior group weight loss education |
Who may qualify
- Ages
- 50 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NutriSystem portion-controlled pre-packaged meals | Other | Education, NutriSystem |
Primary outcome
Walking speed
Time frame: 3 months
Change in walking speed at 3 month
Postural stability
Time frame: 3 months
Change in Fall Risk Test Score as measured by the BioDex Balance System.
Peak plantar pressure
Time frame: 3 months
Change in dynamic peak plantar pressure during barefoot walking.
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.
2 secondary outcomes
Arch Height Drop
Time frame: 3 months
Activities of Daily Living
Time frame: 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Oct 2020.
Related trials for Obesity
Active, not recruitingPhase 2
Effects of Brain Stimulation on Food Intake and Behavioral Weight Loss Treatment
Electric Stimulation Therapy, Obesity
Not yet recruiting
High-Flow Nasal Oxygen-Assisted Deep Extubation Versus Awake Extubation in Morbidly Obese Patients
Deep Tracheal Extubation
Active, not recruiting
Adipocyte-Derived Extracellular Vesicles, Weight Loss, and Endothelial Function
Obesity, Weight Loss
Not yet recruitingPhase 2
Trial of the Combination of Alpha-Lipoic Acid and Mirabegron in Women and in Men With Obesity
Insulin Resistance, Obesity
Not yet recruitingObservational study
A Natural History of Genetic and Environmental Predictors of Pubertal Timing Among Youth With Obesity
Obesity
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jinsup Song, DPM, PhD principal investigator
Temple University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study of Obesity, run by Temple University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Walking speed (time frame: 3 months). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Oct 2020.