ObesityAPPLENCT02239939
Arthritis Pilot for Preserving Muscle While Losing Weight
A study testing Vest and Diet in people with Obesity and Osteoarthritis, run by Wake Forest University Health Sciences at 1 site in United States.
Trial summary
The purpose of this research study is to see whether wearing a weighted vest during a period of active weight loss can decrease the loss of muscle and bone that occurs during weight loss. Read more about this study
- Who is it for?
- Ages 65 to 79 yearsHealthy volunteers can take part
- Conditions the study is for
- Obesity, Osteoarthritis
- What is being tested?
- Vest and Diet
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 37 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2014to Jan 2016
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 65 to 79 years
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- BMI=30-40 kg/m2; Wt<135 kg,
- self- reported MD diagnosis of osteoarthritis
- No evidence of clinical depression or other contraindications for participation in voluntary weight loss,
- Sedentary lifestyle (<30 min, 3 d/wk of exercise),
- Able to provide own transportation to study visits and intervention,
- Not dependent on a cane or walker,
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- Willing and able to consume meal replacement products,
- Not involved in other research study,
- Approved for participation by Medical Director,
- Willing to provide informed consent.
Who cannot join
- Weight loss or gain (±5%) in past 6 mos,
- Excessive alcohol use (> 14 drinks/wk),
- Smoker (>1 cigarette/d or 4/wk within yr),
- Evidence of cognitive impairment (MoCA score <22) or difficulty with hearing or vision that would interfere with study participation, Insulin-dependent or uncontrolled diabetes (FBG >125 mg/dl) or Hypertriglyceridemia (TG>400 mg/dl),
- Osteoporosis (T-score< -2.5 on hip or spine); Hip fracture, joint replacement, or spinal surgery in past 6 mos, or hyperkyphosis,
- Uncontrolled hypertension (BP>160/90 mmHg) or abnormal kidney or liver tests per Medical Director discretion,
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- Self- reported hepatitis B or C,
- Severe anemia (Hb<10 g/100 ml),
- Past or current uncontrolled endocrine/metabolic disease, neurological or hematological disease, fibromyalgia, chronic pulmonary disease, hyperparathyroidism, rheumatoid arthritis, unstable angina, MI, cardiac surgery within 3 months,
- Cancer requiring treatment in past year except non-melanoma skin cancers,
- Regular use of medications that may influence body weight, hormones, weight loss medications, bone remodeling medication, prior use of medications that affect bone, insulin-dependent,
- Unable to tolerate vest run-in.
Trial locations and contacts
1 site in 1 country.
United States1 site
Wake Forest Baptist Health Sticht Center on Aging
Winston-Salem, North Carolina, 27157
About this study
Official title: Weighted Vest Use to Preserve Muscle and Bone During Obesity Treatment for Osteoarthritis
The purpose of this research study is to see whether wearing a weighted vest during a period of active weight loss can decrease the loss of muscle and bone that occurs during weight loss. We will also determine if study participants who wear the weighted vest will have greater improvements in physical function and self-reported disability, pain, stiffness, fatigue and quality of life. This knowledge could impact weight loss programs designed for older adults.
Hypothesis: Participants randomized to VEST will experience similar weight loss, but less loss of lean mass and bone density, than participants randomized to Control.
Read the detailed description
The loss of muscle mass and bone density during weight loss is partially attributed to the decrease in mechanical stress on these tissues as weight is reduced. As a result, performing exercises that enhance muscle and gravitational loading during the period of caloric restriction usually diminishes the relative amount of muscle and bone loss for a given weight loss, but these interventions do not fully prevent all muscle and bone loss.In addition, conventional exercise training interventions often require expensive equipment, on-site participation, and, ideally for older, obese adults, safety supervision by trained exercise leaders. Moreover, the exercises performed may not fully translate into improvement in daily tasks due to training specificity, and are not always tolerated or sustained, especially in obese persons with OA. On the other hand, it is conceivable that treating the decrease in mechanical load from weight loss by externally replacing lost weight via use of a weighted vest may also be effective for reducing muscle and bone loss during caloric restriction. In animal models, mechanisms regulating skeletal tissue structure and function respond in a similar fashion to increases in actual or externally-added body mass. Also, research shows that exercising while wearing weighted vests can improve bone density, muscle mass, and lower extremity strength in older adults. However, no prior studies have examined the effects of weighted vest use on muscle mass and bone density during a period of intentional weight loss.
The main objective of this pilot study is to assess feasibility (accrual, retention, compliance) of daily use of a weighted vest during a diet intervention, to estimate the variability of outcome measures, and to obtain preliminary estimates of treatment efficacy. A controlled, randomized design will be used so we can obtain a realistic estimate of accrual and an unbiased estimate of treatment efficacy.
A total of 36 older (age=65-79 yrs), obese (BMI=30-40 kg/m2), sedentary men and women with x-ray evidence of knee OA will undergo a 22 week weight loss intervention (targeting 10% weight loss) with randomization to one of two groups (n=18/grp): 1) No vest use (Control); or 2) Progressive weighted vest use during normal daily activities (VEST).
- Conditions
- Obesity, Osteoarthritis
- Being tested
- Vest, Diet
- Keywords
- older adults, body composition, weight loss, muscle mass
- Medical subject headings
- Obesity, Osteoarthritis, Weight Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VestBehavioural
Also called Hyperwear Vest Pro
light weight, adjustable, vest to be worn underneath clothes that weight can be added to
DietBehavioural
Also called Medifast 4&2&1
Participants will undergo a 22 week dietary weight loss intervention which will incorporate dietary practices for achieving weight loss while minimizing muscle and bone loss. Participants will be instructed by the Registered Dietitian to follow a low calorie diet. Individual calorie goals will be adjusted during the study if necessary to achieve a targeted weight loss goal of at least 8%, but no more than 12%, within the intervention time frame.
| Study group | Role | What they receive |
|---|---|---|
| Vest + Diet | Experimental | All participants will undergo a 22 week dietary weight loss. In addition, participants will be asked to wear a weighted vest for >10 hours a day. Weight in the vest is adjusted to match weight lost during the intervention. Receives: Behavioral: Vest; Behavioral: Diet |
| No Vest + Diet | Active comparator | All participants will undergo a 22 week dietary weight loss intervention. Participants in this group will be asked not to change their daily habits other than adherence to the diet protocol. Receives: Behavioral: Diet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Lean Mass Measured by DXA
Lean body mass (Whole body and lower-extremity lean mass are used in total calculation).
Measured: Baseline and 22 weeks
Secondary outcomes (2)
Change in Hip Bone Density
Hip bone density as measured by DXA.
Measured: Basleine and 22 weeks
Changes in Self-report on Fatigue Using Pittsburgh Fatigability Scale (PFS)
Pittsburgh Fatigability Scale (PFS) is a self-administered 10 item assessment. It asks participants to rate the level of physical and mental fatigue they experience or imagine after completing a set of hypothetical activities related to daily life at a fixed intensity and duration. The participant provides a score from 0-5 where "0' equals no fatigue at all, and "5" equals extreme fatigue.
Measured: baseline and 22 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Sep 2014 (estimated)
- Study startOct 2014
- Primary completionJan 2016
- Study completionJan 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- 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
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 37 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wake Forest University Health Sciences
- Sponsor type
- University, hospital or other
- Collaborators
- Medifast, Inc.
- Responsible party
- Sponsor
- Investigators
- Barbara J. Nicklas, PhD, Principal investigator, Wake Forest University Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02239939
- Sponsor's protocol ID
- IRB00028928
- Acronym
- APPLE
- Status last verified
- Feb 2018
- First submitted
- 9 Sep 2014
- Last updated
- 9 Mar 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All data will be made available upon email request to the study PI and upon completion of a data-sharing agreement. This agreement will require that data be used only for research purposes, that no attempts be made to identify individual patients, that the data will be kept secure, that the user will not distribute the data to other researchers, that the user will return the files or destroy them once the project is completed, and that the user will acknowledge the data source. All data files will be de-identified. In addition, variables that could permit linkages to individual research participants and variables that could lead to deductive disclosure of the identity of individual subjects will be removed or recoded. We will create a link on our website that describes our study and the data available for data sharing with descriptions.
Study at a glance
From the registry record, last updated by the sponsor on 9 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Weighted Vest Use to Preserve Muscle and Bone During Obesity Treatment for Osteoarthritis
- ClinicalTrials.gov ID
- NCT02239939
- Acronym / sponsor ID
- APPLE / IRB00028928
- Conditions
- Obesity, Osteoarthritis
- Keywords
- older adults, body composition, weight loss, muscle mass
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 37 participants (actual)
- Lead sponsor
- Wake Forest University Health SciencesUniversity, hospital or other
- Collaborators
- Medifast, Inc.
- Study start
- Oct 2014
- Primary completion
- Jan 2016 (actual)
- Study completion
- Jan 2016 (actual)
- First posted
- 15 Sep 2014 (estimated)
- Results
- Posted 29 Jan 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this research study is to see whether wearing a weighted vest during a period of active weight loss can decrease the loss of muscle and bone that occurs during weight loss. We will also determine if study participants who wear the weighted vest will have greater improvements in physical function and self-reported disability, pain, stiffness, fatigue and quality of life. This knowledge could impact weight loss programs designed for older adults.
Hypothesis: Participants randomized to VEST will experience similar weight loss, but less loss of lean mass and bone density, than participants randomized to Control.
Detailed description
The loss of muscle mass and bone density during weight loss is partially attributed to the decrease in mechanical stress on these tissues as weight is reduced. As a result, performing exercises that enhance muscle and gravitational loading during the period of caloric restriction usually diminishes the relative amount of muscle and bone loss for a given weight loss, but these interventions do not fully prevent all muscle and bone loss.In addition, conventional exercise training interventions often require expensive equipment, on-site participation, and, ideally for older, obese adults, safety supervision by trained exercise leaders. Moreover, the exercises performed may not fully translate into improvement in daily tasks due to training specificity, and are not always tolerated or sustained, especially in obese persons with OA. On the other hand, it is conceivable that treating the decrease in mechanical load from weight loss by externally replacing lost weight via use of a weighted vest may also be effective for reducing muscle and bone loss during caloric restriction. In animal models, mechanisms regulating skeletal tissue structure and function respond in a similar fashion to increases in actual or externally-added body mass. Also, research shows that exercising while wearing weighted vests can improve bone density, muscle mass, and lower extremity strength in older adults. However, no prior studies have examined the effects of weighted vest use on muscle mass and bone density during a period of intentional weight loss.
The main objective of this pilot study is to assess feasibility (accrual, retention, compliance) of daily use of a weighted vest during a diet intervention, to estimate the variability of outcome measures, and to obtain preliminary estimates of treatment efficacy. A controlled, randomized design will be used so we can obtain a realistic estimate of accrual and an unbiased estimate of treatment efficacy.
A total of 36 older (age=65-79 yrs), obese (BMI=30-40 kg/m2), sedentary men and women with x-ray evidence of knee OA will undergo a 22 week weight loss intervention (targeting 10% weight loss) with randomization to one of two groups (n=18/grp): 1) No vest use (Control); or 2) Progressive weighted vest use during normal daily activities (VEST).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Vest + Diet | Experimental | Behavioral: Vest, Behavioral: DietAll participants will undergo a 22 week dietary weight loss. In addition, participants will be asked to wear a weighted vest for >10 hours a day. Weight in the vest is adjusted to match weight lost during the intervention. |
| No Vest + Diet | Active comparator | Behavioral: DietAll participants will undergo a 22 week dietary weight loss intervention. Participants in this group will be asked not to change their daily habits other than adherence to the diet protocol. |
Who may qualify
- Ages
- 65 to 79 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (10 listed)
- BMI=30-40 kg/m2; Wt<135 kg,
- self- reported MD diagnosis of osteoarthritis
- No evidence of clinical depression or other contraindications for participation in voluntary weight loss,
- Sedentary lifestyle (<30 min, 3 d/wk of exercise),
- Able to provide own transportation to study visits and intervention,
Key exclusion criteria (12 listed)
- Weight loss or gain (±5%) in past 6 mos,
- Excessive alcohol use (> 14 drinks/wk),
- Smoker (>1 cigarette/d or 4/wk within yr),
- Evidence of cognitive impairment (MoCA score <22) or difficulty with hearing or vision that would interfere with study participation, Insulin-dependent or uncontrolled diabetes (FBG >125 mg/dl) or Hypertriglyceridemia (TG>400 mg/dl),
- Osteoporosis (T-score< -2.5 on hip or spine); Hip fracture, joint replacement, or spinal surgery in past 6 mos, or hyperkyphosis,
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 |
|---|---|---|
| VestAlso: Hyperwear Vest Prolight weight, adjustable, vest to be worn underneath clothes that weight can be added to | Behavioural | Vest + Diet |
| DietAlso: Medifast 4&2&1Participants will undergo a 22 week dietary weight loss intervention which will incorporate dietary practices for achieving weight loss while minimizing muscle and bone loss. Participants will be instructed by the Registered Dietitian to follow a low calorie diet. Individual calorie goals will be adjusted during the study if necessary to achieve a targeted weight loss goal of at least 8%, but no more than 12%, within the intervention time frame. | Behavioural | No Vest + Diet, Vest + Diet |
Primary outcome
Change in Lean Mass Measured by DXA
Time frame: Baseline and 22 weeks
Lean body mass (Whole body and lower-extremity lean mass are used in total calculation).
2 secondary outcomes
Change in Hip Bone Density
Time frame: Basleine and 22 weeks
Changes in Self-report on Fatigue Using Pittsburgh Fatigability Scale (PFS)
Time frame: baseline and 22 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Mar 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Yes. All data will be made available upon email request to the study PI and upon completion of a data-sharing agreement. This agreement will require that data be used only for research purposes, that no attempts be made to identify individual patients, that the data will be kept secure, that the user will not distribute the data to other researchers, that the user will return the files or destroy them once the project is completed, and that the user will acknowledge the data source. All data files will be de-identified. In addition, variables that could permit linkages to individual research participants and variables that could lead to deductive disclosure of the identity of individual subjects will be removed or recoded. We will create a link on our website that describes our study and the data available for data sharing with descriptions.
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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.
Barbara J. Nicklas, PhD principal investigator
Wake Forest University Health Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Vest and Diet in people with Obesity and Osteoarthritis, run by Wake Forest University Health Sciences 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 10 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 9 Mar 2018. 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. 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?
Yes. Results are posted in the registry (first posted 29 Jan 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Change in Lean Mass Measured by DXA (time frame: Baseline and 22 weeks). 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 9 Mar 2018.