Role of Apathy in the Effectiveness of Weight Loss Interventions
Study Details
Study Description
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
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
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
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| No Intervention: 1 standard nutrition counselling |
|
| Experimental: 2 MOVE -weight loss intervention |
Behavioral: MOVE
is a VA based multidesciplinary weight loss intervention
|
| Experimental: 3 MOVE plus medical crisis counselling |
Behavioral: medical crisis councelling
group counselling sessions
Behavioral: MOVE
is a VA based multidesciplinary weight loss intervention
|
| Experimental: 4 MOVE plus methylphenidate |
Drug: methyphenidate
methyphenidate will be used to treat apathy dose 10mg bid
Behavioral: MOVE
is a VA based multidesciplinary weight loss intervention
|
| Experimental: 5 MOVE plus methyphenidate plus medical crisis counselling |
Drug: methyphenidate
methyphenidate will be used to treat apathy dose 10mg bid
Behavioral: medical crisis councelling
group counselling sessions
Behavioral: MOVE
is a VA based multidesciplinary weight loss intervention
|
Outcome Measures
Primary Outcome Measures
- 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 Outcome Measures
- Change in Weight [6 months]
value at 6 months minus value at baseline
Eligibility Criteria
Criteria
Inclusion Criteria:
-
BMI >30
-
Apathy score >40
Exclusion Criteria:
-
History of cancer, except basal cell
-
Cardiovascular event in last 6 months
-
Renal failure
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | VA Medical Center, Omaha | Omaha | Nebraska | United States | 68105-1873 |
Sponsors and Collaborators
- VA Nebraska Western Iowa Health Care System
Investigators
- Principal Investigator: Cyrus DeSouza, MD, VA Medical Center, Omaha
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 00469
Study Results
Participant Flow
| Recruitment Details | |
|---|---|
| Pre-assignment Detail |
| Arm/Group Title | Usual Care | VA MOVE | Intervention |
|---|---|---|---|
| Arm/Group Description | standard nutrition counselling | MOVE -weight loss intervention MOVE: is a VA based multidesciplinary weight loss intervention | MOVE plus methylphenidate methyphenidate: methyphenidate will be used to treat apathy dose 10mg bid MOVE: is a VA based multidesciplinary weight loss intervention |
| Period Title: Overall Study | |||
| STARTED | 18 | 38 | 45 |
| COMPLETED | 16 | 29 | 34 |
| NOT COMPLETED | 2 | 9 | 11 |
Baseline Characteristics
| Arm/Group Title | Usual Care | VA MOVE | Intervention | Total |
|---|---|---|---|---|
| Arm/Group Description | standard nutrition counselling | MOVE -weight loss intervention MOVE: is a VA based multidesciplinary weight loss intervention | MOVE plus methylphenidate methyphenidate: methyphenidate will be used to treat apathy dose 10mg bid MOVE: is a VA based multidesciplinary weight loss intervention | Total of all reporting groups |
| Overall Participants | 18 | 38 | 45 | 101 |
| Age (years) [Mean (Standard Deviation) ] | ||||
| Mean (Standard Deviation) [years] |
48.1
(14.3)
|
55.2
(10.1)
|
52.5
(10.4)
|
52.34
(10.66)
|
| Sex: Female, Male (Count of Participants) | ||||
| Female |
9
50%
|
7
18.4%
|
16
35.6%
|
32
31.7%
|
| Male |
9
50%
|
31
81.6%
|
29
64.4%
|
69
68.3%
|
| Race (NIH/OMB) (Count of Participants) | ||||
| American Indian or Alaska Native |
1
5.6%
|
0
0%
|
0
0%
|
1
1%
|
| Asian |
0
0%
|
3
7.9%
|
0
0%
|
3
3%
|
| Native Hawaiian or Other Pacific Islander |
1
5.6%
|
0
0%
|
0
0%
|
1
1%
|
| Black or African American |
4
22.2%
|
3
7.9%
|
7
15.6%
|
14
13.9%
|
| White |
12
66.7%
|
32
84.2%
|
38
84.4%
|
82
81.2%
|
| More than one race |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| Unknown or Not Reported |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| Region of Enrollment (participants) [Number] | ||||
| United States |
18
100%
|
38
100%
|
45
100%
|
101
100%
|
| BMI (kg/m^2) [Mean (Standard Deviation) ] | ||||
| Mean (Standard Deviation) [kg/m^2] |
36.06
(5.91)
|
38.78
(5.6)
|
37.58
(5.69)
|
37.21
(5.55)
|
| Apathy Evaluation Scale (units on a scale) [Mean (Standard Deviation) ] | ||||
| Mean (Standard Deviation) [units on a scale] |
41.89
(8.2)
|
42.12
(7.93)
|
42.96
(8.94)
|
42.06
(7.94)
|
Outcome Measures
| Title | Apathy Evaluation Scale |
|---|---|
| Description | 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 |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | Usual Care | VA MOVE | Intervention |
|---|---|---|---|
| Arm/Group Description | standard nutrition counselling | MOVE -weight loss intervention MOVE: is a VA based multidesciplinary weight loss intervention | MOVE plus methylphenidate methyphenidate: methyphenidate will be used to treat apathy dose 10mg bid MOVE: is a VA based multidesciplinary weight loss intervention |
| Measure Participants | 16 | 29 | 34 |
| Mean (Standard Deviation) [units on a scale] |
-7.69
(6.77)
|
-6.4
(7.35)
|
-6.15
(8.3)
|
| Title | Change in Weight |
|---|---|
| Description | value at 6 months minus value at baseline |
| Time Frame | 6 months |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | Usual Care | VA MOVE | Intervention |
|---|---|---|---|
| Arm/Group Description | standard nutrition counselling | MOVE -weight loss intervention MOVE: is a VA based multidesciplinary weight loss intervention | MOVE plus methylphenidate methyphenidate: methyphenidate will be used to treat apathy dose 10mg bid MOVE: is a VA based multidesciplinary weight loss intervention |
| Measure Participants | 16 | 29 | 34 |
| Mean (Standard Deviation) [Kg] |
-0.6
(3.73)
|
-0.61
(7.14)
|
-4.61
(9.42)
|
Adverse Events
| Time Frame | ||||||
|---|---|---|---|---|---|---|
| Adverse Event Reporting Description | ||||||
| Arm/Group Title | Usual Care | VA MOVE | Intervention | |||
| Arm/Group Description | standard nutrition counselling | MOVE -weight loss intervention MOVE: is a VA based multidesciplinary weight loss intervention | MOVE plus methylphenidate methyphenidate: methyphenidate will be used to treat apathy dose 10mg bid MOVE: is a VA based multidesciplinary weight loss intervention | |||
All Cause Mortality |
||||||
| Usual Care | VA MOVE | Intervention | ||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 0/18 (0%) | 0/38 (0%) | 0/45 (0%) | |||
Serious Adverse Events |
||||||
| Usual Care | VA MOVE | Intervention | ||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 0/18 (0%) | 0/38 (0%) | 0/45 (0%) | |||
Other (Not Including Serious) Adverse Events |
||||||
| Usual Care | VA MOVE | Intervention | ||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 0/18 (0%) | 0/38 (0%) | 0/45 (0%) | |||
Limitations/Caveats
More Information
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
| Name/Title | Cyrus Desouza |
|---|---|
| Organization | VANebraska |
| Phone | 4023468800 ext 5506 |
| cyrus.desouza@va.gov |
- 00469