ObesityOPTIFASTNCT02079051
Impact of Weight Loss on Physical Function
A study testing Moderate intensity weight loss and High intensity medical weight loss in people with Obesity, run by Wake Forest University Health Sciences at 1 site in United States.
Trial summary
We are proposing a trial to directly compare a high intensity weight loss protocol to a moderate intensity weight loss protocol to determine which leads to greater improvements in physical function in severely obese older adults. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Obesity
- What is being tested?
- Moderate intensity weight loss and High intensity medical weight loss
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2014to Nov 2014
- 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 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- At least 65 years old at the time of the initial screening visit
- BMI greater than or equal to 35 kg/m2
Who cannot join
- Cognitive impairment (Montreal Cognitive Assessment < 20)
- Depression (Centers for Epidemiologic Studies Depression Scale score >16
- Recent weight change (+/- 10 lbs. in the last 12 months)
- History of non-skin cancer in the last 2 years
- Cardiovascular disease event or unstable angina within the past six months, severe pulmonary disease, renal failure
- Major liver dysfunction within the last 2 years
Show all 12Show fewer
- Recently quit smoking less than 12 months prior
- Use of estrogen or testosterone replacement therapy
- Current use of medications for psychosis or manic-depressive illness
- Use of weight-loss medications in previous 3 months
- Dependence on others for food procurement or preparation
- Poorly controlled diabetes (HgA1c greater than or equal to 9%) or blood pressure (greater than or equal to 159 mm Hg systolic or 99 mm Hg diastolic)
Trial locations and contacts
1 site in 1 country.
United States1 site
Wake Forest Baptist Health
Winston-Salem, North Carolina, 27157
About this study
Official title: Impact of Medical Weight Loss on Physical Function in Severely Obese Older Adults
We are proposing a trial to directly compare a high intensity weight loss protocol to a moderate intensity weight loss protocol to determine which leads to greater improvements in physical function in severely obese older adults.
Read the detailed description
We are proposing a trial to directly compare a high intensity weight loss protocol to a moderate intensity weight loss protocol to determine which leads to greater improvements in physical function in severely obese older adults. We are also interested in comparing the safety of the two approaches. If we can demonstrate effective weight reduction that happens with sufficient expediency and impact to improve physical functioning without increasing adverse events in severely obese older adults, a sizable percentage of the population would benefit and there would be significant reductions in disability resulting in cost savings for the healthcare system.
This application specifically addresses objective 3 as detailed in the announcement of this pilot funding mechanism (Objective 3. To develop and reliably test in clinical or pre-clinical studies novel interventions which target adiposity, peripheral or central nervous system, vascular, body composition and/or musculoskeletal related factors for preventing the age-related decline in physical function and preventing or reversing the progression to disability). This application describes a pilot randomized, controlled trial designed to address the following aims:
- Assess efficacy and safety of high intensity medical weight management in severely obese (= stage II BMI) older adults for functional outcomes (i.e., functional weight loss) compared to a moderate intensity weight loss intervention.
- Determine if a potential dose response relationship exists between weight loss volume (primarily as excess fat) and improvements in several measures of physical function.
- Identify changes in body composition (fat and lean including bone) that are associated with changes in physical function.
- Identify biomarkers (specific focus on markers of inflammation) that provide potential mechanistic links between weight reduction and changes in physical function in severely obese older adults.
Our primary hypothesis is that there is a greater improvement in physical function with a high intensity weight loss intervention compared to a moderate intensity intervention.
- Conditions
- Obesity
- Being tested
- Moderate intensity weight loss, High intensity medical weight loss
- Keywords
- Obesity Physical Performance Weight loss Optifast
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Moderate intensity weight lossBehavioural
A calorie restricted diet based on estimates of total energy expenditure (TEE) obtained from the measured resting metabolic rate (RMR) during a wt stable period. TEE will be estimated by multiplying RMR by a factor of 1.1-1.3 to cover activity energy expenditure based on an assessment of physical activity levels at baseline using accelerometry. We will use the TEE to create an individualized dietary rx for each pt, subtracting up to 500 calories from the estimated TEE. To ensure micronutrient needs are being met, total calories will not be decreased below 1200 kcal per day, regardless of the estimated TEE. They will receive a standard exercise program that will be designed to promote exercise energy expenditure of approximately 1200 kcal/week. We will prescribe resistance training for 2 days per week with a loading intensity of 60% of 1 rep max and volume of 3 sets at 8 reps per exercise. Aerobic training will be prescribed for 3 days per week.
High intensity medical weight lossBehavioural
Placed on complete meal replacement (MR) using the OPTIFAST medical wt loss protocol. Pts will consume a min of 86 g of protein daily in 5-6 servings of MR. Min caloric intake will be 960 kcal/day with adjustments in intake made based on BMI and activity levels, holding the percent of calories from protein constant at 35%. The MRs provide 100% of daily recommended needs for micronutrients and will be supplied weekly at clinic visits by the study. Pts will begin to incorporate food into their routine beginning at week 13 with guidance from a dietitian. From weeks 13-26, caloric prescriptions will be between 1100 to 1600 kcal/day, using a combo of MRs and food. Will receive an exercise program designed to promote exercise energy expenditure of approximately 1200 kcal/week. We will prescribe resistance training for 2 days per week with a loading intensity of 60% of 1 rep max and volume of 3 sets at 8 reps per exercise. Aerobic training will be prescribed for 3 days per wk.
| Study group | Role | What they receive |
|---|---|---|
| High Intensity Weight Loss | Experimental | High intensity medical weight loss Receives: Behavioral: High intensity medical weight loss |
| Moderate Intensity Weight Loss | Active comparator | Moderate intensity weight loss Receives: Behavioral: Moderate intensity weight loss |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Short Physical Performance Battery (SPPB)
It is a measure of lower-extremity function consisting of walking speed, balance, and repeated chair stands. These 3 performance measures are scored from 0 to 4, with 4 indicating the highest level of performance and 0 the inability to complete the task. The summary score ranges from 0 (worst) to 12 (best). The SPPB is a well-studied composite measure and a strong predictor of disability, institutionalization, morbidity and mortality in initially non-disabled older persons. The reliability of the individual components, as well as the summary score, are good, with intra-class correlation coefficients above 0.88, and the measure is sensitive to change. Even small changes of 0.5-0.6 points have been shown to be clinically meaningful. Importantly, it has recently been advocated as an important primary outcome to be used in RCTs designed to develop evidenced-based interventions to prevent or postpone functional decline.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Mar 2014 (estimated)
- Study startFeb 2014
- Primary completionNov 2014
- Study completionNov 2014
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.
- More trials run by Wake Forest University Health SciencesThe sponsor's other registered studies.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wake Forest University Health Sciences
- Sponsor type
- University, hospital or other
- Collaborators
- Société des Produits Nestlé (SPN), National Institute on Aging (NIA)
- Responsible party
- Sponsor
- Investigators
- Jamy Ard, MD, Principal investigator, Wake Forest University Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02079051
- Sponsor's protocol ID
- IRB00025897
- Acronym
- OPTIFAST
- Status last verified
- Aug 2018
- First submitted
- 26 Feb 2014
- Last updated
- 9 Aug 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Medical Weight Loss on Physical Function in Severely Obese Older Adults
- ClinicalTrials.gov ID
- NCT02079051
- Acronym / sponsor ID
- OPTIFAST / IRB00025897
- Conditions
- Obesity
- Keywords
- Obesity Physical Performance Weight loss Optifast
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- Wake Forest University Health SciencesUniversity, hospital or other
- Collaborators
- Société des Produits Nestlé (SPN), National Institute on Aging (NIA)
- Study start
- Feb 2014
- Primary completion
- Nov 2014 (actual)
- Study completion
- Nov 2014 (actual)
- First posted
- 5 Mar 2014 (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.
We are proposing a trial to directly compare a high intensity weight loss protocol to a moderate intensity weight loss protocol to determine which leads to greater improvements in physical function in severely obese older adults.
Detailed description
We are proposing a trial to directly compare a high intensity weight loss protocol to a moderate intensity weight loss protocol to determine which leads to greater improvements in physical function in severely obese older adults. We are also interested in comparing the safety of the two approaches. If we can demonstrate effective weight reduction that happens with sufficient expediency and impact to improve physical functioning without increasing adverse events in severely obese older adults, a sizable percentage of the population would benefit and there would be significant reductions in disability resulting in cost savings for the healthcare system.
This application specifically addresses objective 3 as detailed in the announcement of this pilot funding mechanism (Objective 3. To develop and reliably test in clinical or pre-clinical studies novel interventions which target adiposity, peripheral or central nervous system, vascular, body composition and/or musculoskeletal related factors for preventing the age-related decline in physical function and preventing or reversing the progression to disability). This application describes a pilot randomized, controlled trial designed to address the following aims:
- Assess efficacy and safety of high intensity medical weight management in severely obese (= stage II BMI) older adults for functional outcomes (i.e., functional weight loss) compared to a moderate intensity weight loss intervention.
- Determine if a potential dose response relationship exists between weight loss volume (primarily as excess fat) and improvements in several measures of physical function.
- Identify changes in body composition (fat and lean including bone) that are associated with changes in physical function.
- Identify biomarkers (specific focus on markers of inflammation) that provide potential mechanistic links between weight reduction and changes in physical function in severely obese older adults.
Our primary hypothesis is that there is a greater improvement in physical function with a high intensity weight loss intervention compared to a moderate intensity intervention.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| High Intensity Weight Loss | Experimental | Behavioral: High intensity medical weight lossHigh intensity medical weight loss |
| Moderate Intensity Weight Loss | Active comparator | Behavioral: Moderate intensity weight lossModerate intensity weight loss |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (2 listed)
- At least 65 years old at the time of the initial screening visit
- BMI greater than or equal to 35 kg/m2
Key exclusion criteria (12 listed)
- Cognitive impairment (Montreal Cognitive Assessment < 20)
- Depression (Centers for Epidemiologic Studies Depression Scale score >16
- Recent weight change (+/- 10 lbs. in the last 12 months)
- History of non-skin cancer in the last 2 years
- Cardiovascular disease event or unstable angina within the past six months, severe pulmonary disease, renal failure
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 |
|---|---|---|
| Moderate intensity weight lossA calorie restricted diet based on estimates of total energy expenditure (TEE) obtained from the measured resting metabolic rate (RMR) during a wt stable period. TEE will be estimated by multiplying RMR by a factor of 1.1-1.3 to cover activity energy expenditure based on an assessment of physical activity levels at baseline using accelerometry. We will use the TEE to create an individualized dietary rx for each pt, subtracting up to 500 calories from the estimated TEE. To ensure micronutrient needs are being met, total calories will not be decreased below 1200 kcal per day, regardless of the estimated TEE. They will receive a standard exercise program that will be designed to promote exercise energy expenditure of approximately 1200 kcal/week. We will prescribe resistance training for 2 days per week with a loading intensity of 60% of 1 rep max and volume of 3 sets at 8 reps per exercise. Aerobic training will be prescribed for 3 days per week. | Behavioural | Moderate Intensity Weight Loss |
| High intensity medical weight lossPlaced on complete meal replacement (MR) using the OPTIFAST medical wt loss protocol. Pts will consume a min of 86 g of protein daily in 5-6 servings of MR. Min caloric intake will be 960 kcal/day with adjustments in intake made based on BMI and activity levels, holding the percent of calories from protein constant at 35%. The MRs provide 100% of daily recommended needs for micronutrients and will be supplied weekly at clinic visits by the study. Pts will begin to incorporate food into their routine beginning at week 13 with guidance from a dietitian. From weeks 13-26, caloric prescriptions will be between 1100 to 1600 kcal/day, using a combo of MRs and food. Will receive an exercise program designed to promote exercise energy expenditure of approximately 1200 kcal/week. We will prescribe resistance training for 2 days per week with a loading intensity of 60% of 1 rep max and volume of 3 sets at 8 reps per exercise. Aerobic training will be prescribed for 3 days per wk. | Behavioural | High Intensity Weight Loss |
Primary outcome
Change in Short Physical Performance Battery (SPPB)
Time frame: 6 months
It is a measure of lower-extremity function consisting of walking speed, balance, and repeated chair stands. These 3 performance measures are scored from 0 to 4, with 4 indicating the highest level of performance and 0 the inability to complete the task. The summary score ranges from 0 (worst) to 12 (best). The SPPB is a well-studied composite measure and a strong predictor of disability, institutionalization, morbidity and mortality in initially non-disabled older persons. The reliability of the individual components, as well as the summary score, are good, with intra-class correlation coefficients above 0.88, and the measure is sensitive to change. Even small changes of 0.5-0.6 points have been shown to be clinically meaningful. Importantly, it has recently been advocated as an important primary outcome to be used in RCTs designed to develop evidenced-based interventions to prevent or postpone functional decline.
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 9 Aug 2018.
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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.
Jamy Ard, MD 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 Moderate intensity weight loss and High intensity medical weight loss in people with Obesity, 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 2 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 Aug 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?
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?
Change in Short Physical Performance Battery (SPPB) (time frame: 6 months). 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 Aug 2018.