Obesity, Apathy
Conditions
Keywords
apathy, obesity, methylphenidate, MOVE, medical crisis counselling
Brief 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
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
Interventions
is a VA based multidesciplinary weight loss intervention
group counselling sessions
methyphenidate will be used to treat apathy dose 10mg bid
Sponsors
Study design
Eligibility
Inclusion criteria
* BMI \>30 * Apathy score \>40
Exclusion criteria
* History of cancer, except basal cell * Cardiovascular event in last 6 months * Renal failure
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Apathy Evaluation Scale | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Weight | 6 months | value at 6 months minus value at baseline |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Usual Care standard nutrition counselling | 18 |
| VA MOVE MOVE -weight loss intervention
MOVE: is a VA based multidesciplinary weight loss intervention | 38 |
| Intervention MOVE plus methylphenidate
methyphenidate: methyphenidate will be used to treat apathy dose 10mg bid
MOVE: is a VA based multidesciplinary weight loss intervention | 45 |
| Total | 101 |
Baseline characteristics
| Characteristic | Usual Care | VA MOVE | Intervention | Total |
|---|---|---|---|---|
| Age, Continuous | 48.1 years STANDARD_DEVIATION 14.3 | 55.2 years STANDARD_DEVIATION 10.1 | 52.5 years STANDARD_DEVIATION 10.4 | 52.34 years STANDARD_DEVIATION 10.66 |
| Apathy Evaluation Scale | 41.89 units on a scale STANDARD_DEVIATION 8.2 | 42.12 units on a scale STANDARD_DEVIATION 7.93 | 42.96 units on a scale STANDARD_DEVIATION 8.94 | 42.06 units on a scale STANDARD_DEVIATION 7.94 |
| BMI | 36.06 kg/m^2 STANDARD_DEVIATION 5.91 | 38.78 kg/m^2 STANDARD_DEVIATION 5.6 | 37.58 kg/m^2 STANDARD_DEVIATION 5.69 | 37.21 kg/m^2 STANDARD_DEVIATION 5.55 |
| Race (NIH/OMB) American Indian or Alaska Native | 1 Participants | 0 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 3 Participants | 0 Participants | 3 Participants |
| Race (NIH/OMB) Black or African American | 4 Participants | 3 Participants | 7 Participants | 14 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 1 Participants | 0 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 12 Participants | 32 Participants | 38 Participants | 82 Participants |
| Region of Enrollment United States | 18 participants | 38 participants | 45 participants | 101 participants |
| Sex: Female, Male Female | 9 Participants | 7 Participants | 16 Participants | 32 Participants |
| Sex: Female, Male Male | 9 Participants | 31 Participants | 29 Participants | 69 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 18 | 0 / 38 | 0 / 45 |
| other Total, other adverse events | 0 / 18 | 0 / 38 | 0 / 45 |
| serious Total, serious adverse events | 0 / 18 | 0 / 38 | 0 / 45 |
Outcome results
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
Time frame: 6 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Usual Care | Apathy Evaluation Scale | -7.69 units on a scale | Standard Deviation 6.77 |
| VA MOVE | Apathy Evaluation Scale | -6.4 units on a scale | Standard Deviation 7.35 |
| Intervention | Apathy Evaluation Scale | -6.15 units on a scale | Standard Deviation 8.3 |
Change in Weight
value at 6 months minus value at baseline
Time frame: 6 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Usual Care | Change in Weight | -0.6 Kg | Standard Deviation 3.73 |
| VA MOVE | Change in Weight | -0.61 Kg | Standard Deviation 7.14 |
| Intervention | Change in Weight | -4.61 Kg | Standard Deviation 9.42 |