ObesityNCT00548652
Role of Apathy in the Effectiveness of Weight Loss Interventions
A study testing MOVE, medical crisis councelling and methyphenidate in people with Obesity and Apathy, run by VA Nebraska Western Iowa Health Care System at 1 site in United States.
Trial summary
The purpose of this study is to determine whether treating apathy with methylphenidate or medical Crisis counselling will increase adherence to weight loss programs thereby increasing their effectiveness Read more about this study
- Who is it for?
- Ages 21 to 70 years
- What is being tested?
- MOVE, medical crisis councelling and methyphenidate
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 101 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2007to May 2009
- 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 21 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- BMI >30
- Apathy score >40
Who cannot join
- History of cancer, except basal cell
- Cardiovascular event in last 6 months
- Renal failure
Trial locations and contacts
1 site in 1 country.
United States1 site
VA Medical Center, Omaha
Omaha, Nebraska, 68105-1873
About this study
Official title: Role of Apathy in the Effectiveness of Weight Loss Interventions in Obese Patients
The purpose of this study is to determine whether treating apathy with methylphenidate or medical Crisis counselling will increase adherence to weight loss programs thereby increasing their effectiveness
Read the detailed description
Title: The role of Apathy in the effectiveness of weight loss interventions in obese patients
Objective: Obesity is a major public health problem. Apathy is a common behavioral problem characterized by loss of initiative, poor motivation and persistence. Presence of apathy impairs the self-care behavior in obese patients. Lack of novelty might impair a patient's ability to seek new interactions, life styles and new treatment options for obesity. Lack of motivation might impair a patient's ability to initiate exercise regimen or diet whereas lack of persistence impairs the compliance with these regimens. Thus, apathy influences all stages of self-care. We hypothesize that the treatment of apathy will result in better adherence to weight loss interventions in obese veterans enrolled in the MOVE program.
Research Design: A prospective open label randomized study. Group 1 will have patients with obesity as defined as BMI>30, and apathy defined as AES score of > 40. This group will be treated with standard nutrition counseling. Group 2 will have patients with obesity and apathy as defined above and will receive the MOVE enhancement program alone (The MOVE program is a national VA weight loss program). Group 3 will be treated with methylphenidate along with the MOVE enhancement program. Group 4 will be treated with medical crisis counseling along with the MOVE enhancement program. Group 5 will be treated with methylphenidate, and the medical crisis counseling along with the MOVE enhancement program.
Methodology: 30 patients meeting the criteria will be enrolled in each of the five arms. All patients will be in the study for duration of six months. All patients in the methylphenidate arm will be started at 5mg twice daily and titrated to 10mg twice daily at two weeks. Patients will be assessed on regular intervals using the Apathy Evaluation Scale, Hamilton Depression Scale and the Patient activation measure. MOVE sessions will be held once weekly from the 2nd visit to the end of the study. Medical Crisis Counseling visits will be every week for nine sessions and then every other week till the end of the study
Clinical Relationships/Significance: The prevalence of obesity in the general population is over 30%. However the prevalence of obesity in the VA health system is almost 70%. Since obesity predisposes to several co-morbid conditions such as hypertension, diabetes and cardiovascular disease, it is important to develop interventions that are effective in inducing weight loss. Since apathy plays a large role in the self care behaviours that lead to obesity, treating apathy may improve adherence to weight loss programs
- Being tested
- MOVE, medical crisis councelling, methyphenidate
- Keywords
- apathy, obesity, methylphenidate, MOVE, medical crisis counselling
- Medical subject headings
- Obesity, Lethargy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MOVEBehavioural
is a VA based multidesciplinary weight loss intervention
medical crisis councellingBehavioural
group counselling sessions
MOVEBehavioural
is a VA based multidesciplinary weight loss intervention
methyphenidateDrug
methyphenidate will be used to treat apathy dose 10mg bid
MOVEBehavioural
is a VA based multidesciplinary weight loss intervention
methyphenidateDrug
methyphenidate will be used to treat apathy dose 10mg bid
medical crisis councellingBehavioural
group counselling sessions
MOVEBehavioural
is a VA based multidesciplinary weight loss intervention
| Study group | Role | What they receive |
|---|---|---|
| 1 | No intervention | standard nutrition counselling |
| 2 | Experimental | MOVE -weight loss intervention Receives: Behavioral: MOVE |
| 3 | Experimental | MOVE plus medical crisis counselling Receives: Behavioral: medical crisis councelling; Behavioral: MOVE |
| 4 | Experimental | MOVE plus methylphenidate Receives: Drug: methyphenidate; Behavioral: MOVE |
| 5 | Experimental | MOVE plus methyphenidate plus medical crisis counselling Receives: Drug: methyphenidate; Behavioral: medical crisis councelling; Behavioral: MOVE |
What is being measured
The primary outcome is the main question the study is designed to answer.
Apathy Evaluation Scale
Apathy Evaluation Scale (AES) measures apathy over the previous four weeks Scale range: 18 (minimum score)- 72 (Maximum score) Higher scores indicate higher apathy Better outcome would be reduction in the score
Measured: 6 months
Secondary outcomes (1)
Change in Weight
value at 6 months minus value at baseline
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 posted24 Oct 2007 (estimated)
- Study startAug 2007
- Primary completionMay 2009
- Study completionMay 2009
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
- None (open label)
- Enrolment
- 101 participants (actual)
Sponsor and investigators
- Lead sponsor
- VA Nebraska Western Iowa Health Care System
- Sponsor type
- US federal agency
- Responsible party
- Principal investigator, Prasad R. Padala, VA Nebraska Western Iowa Health Care System
- Investigators
- Cyrus DeSouza, MD, Principal investigator, VA Medical Center, Omaha
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00548652
- Sponsor's protocol ID
- 00469
- Status last verified
- Oct 2019
- First submitted
- 23 Oct 2007
- Last updated
- 4 Oct 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Role of Apathy in the Effectiveness of Weight Loss Interventions in Obese Patients
- ClinicalTrials.gov ID
- NCT00548652
- Acronym / sponsor ID
- 00469
- Keywords
- apathy, obesity, methylphenidate, MOVE, medical crisis counselling
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 101 participants (actual)
- Lead sponsor
- VA Nebraska Western Iowa Health Care SystemUS federal agency
- Study start
- Aug 2007
- Primary completion
- May 2009 (actual)
- Study completion
- May 2009 (actual)
- First posted
- 24 Oct 2007 (estimated)
- Results
- Posted 4 Oct 2019
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 study is to determine whether treating apathy with methylphenidate or medical Crisis counselling will increase adherence to weight loss programs thereby increasing their effectiveness
Detailed description
Title: The role of Apathy in the effectiveness of weight loss interventions in obese patients
Objective: Obesity is a major public health problem. Apathy is a common behavioral problem characterized by loss of initiative, poor motivation and persistence. Presence of apathy impairs the self-care behavior in obese patients. Lack of novelty might impair a patient's ability to seek new interactions, life styles and new treatment options for obesity. Lack of motivation might impair a patient's ability to initiate exercise regimen or diet whereas lack of persistence impairs the compliance with these regimens. Thus, apathy influences all stages of self-care. We hypothesize that the treatment of apathy will result in better adherence to weight loss interventions in obese veterans enrolled in the MOVE program.
Research Design: A prospective open label randomized study. Group 1 will have patients with obesity as defined as BMI>30, and apathy defined as AES score of > 40. This group will be treated with standard nutrition counseling. Group 2 will have patients with obesity and apathy as defined above and will receive the MOVE enhancement program alone (The MOVE program is a national VA weight loss program). Group 3 will be treated with methylphenidate along with the MOVE enhancement program. Group 4 will be treated with medical crisis counseling along with the MOVE enhancement program. Group 5 will be treated with methylphenidate, and the medical crisis counseling along with the MOVE enhancement program.
Methodology: 30 patients meeting the criteria will be enrolled in each of the five arms. All patients will be in the study for duration of six months. All patients in the methylphenidate arm will be started at 5mg twice daily and titrated to 10mg twice daily at two weeks. Patients will be assessed on regular intervals using the Apathy Evaluation Scale, Hamilton Depression Scale and the Patient activation measure. MOVE sessions will be held once weekly from the 2nd visit to the end of the study. Medical Crisis Counseling visits will be every week for nine sessions and then every other week till the end of the study
Clinical Relationships/Significance: The prevalence of obesity in the general population is over 30%. However the prevalence of obesity in the VA health system is almost 70%. Since obesity predisposes to several co-morbid conditions such as hypertension, diabetes and cardiovascular disease, it is important to develop interventions that are effective in inducing weight loss. Since apathy plays a large role in the self care behaviours that lead to obesity, treating apathy may improve adherence to weight loss programs
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| 1 | No intervention | –standard nutrition counselling |
| 2 | Experimental | Behavioral: MOVEMOVE -weight loss intervention |
| 3 | Experimental | Behavioral: medical crisis councelling, Behavioral: MOVEMOVE plus medical crisis counselling |
| 4 | Experimental | Drug: methyphenidate, Behavioral: MOVEMOVE plus methylphenidate |
| 5 | Experimental | Drug: methyphenidate, Behavioral: medical crisis councelling, Behavioral: MOVEMOVE plus methyphenidate plus medical crisis counselling |
Who may qualify
- Ages
- 21 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- BMI >30
- Apathy score >40
Key exclusion criteria (3 listed)
- History of cancer, except basal cell
- Cardiovascular event in last 6 months
- 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 |
|---|---|---|
| MOVEis a VA based multidesciplinary weight loss intervention | Behavioural | 2 |
| medical crisis councellinggroup counselling sessions | Behavioural | 3 |
| MOVEis a VA based multidesciplinary weight loss intervention | Behavioural | 3 |
| methyphenidatemethyphenidate will be used to treat apathy dose 10mg bid | Drug | 4 |
| MOVEis a VA based multidesciplinary weight loss intervention | Behavioural | 4 |
| methyphenidatemethyphenidate will be used to treat apathy dose 10mg bid | Drug | 5 |
| medical crisis councellinggroup counselling sessions | Behavioural | 5 |
| MOVEis a VA based multidesciplinary weight loss intervention | Behavioural | 5 |
Primary outcome
Apathy Evaluation Scale
Time frame: 6 months
Apathy Evaluation Scale (AES) measures apathy over the previous four weeks Scale range: 18 (minimum score)- 72 (Maximum score) Higher scores indicate higher apathy Better outcome would be reduction in the score
1 secondary outcome
Change in Weight
Time frame: 6 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Oct 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Cyrus DeSouza, MD principal investigator
VA Medical Center, Omaha
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MOVE, medical crisis councelling and methyphenidate in people with Obesity and Apathy, run by VA Nebraska Western Iowa Health Care System 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 3 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 4 Oct 2019. 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 4 Oct 2019). 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?
Apathy Evaluation Scale (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 4 Oct 2019.