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Role of Apathy in the Effectiveness of Weight Loss Interventions

Role of Apathy in the Effectiveness of Weight Loss Interventions in Obese Patients

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00548652
Enrollment
101
Registered
2007-10-24
Start date
2007-08-31
Completion date
2009-05-31
Last updated
2019-10-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Obesity, Apathy

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

BEHAVIORALMOVE

is a VA based multidesciplinary weight loss intervention

BEHAVIORALmedical crisis councelling

group counselling sessions

methyphenidate will be used to treat apathy dose 10mg bid

Sponsors

VA Nebraska Western Iowa Health Care System
Lead SponsorFED

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
21 Years to 70 Years
Healthy volunteers
No

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

MeasureTime frameDescription
Apathy Evaluation Scale6 monthsApathy 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

MeasureTime frameDescription
Change in Weight6 monthsvalue at 6 months minus value at baseline

Countries

United States

Participant flow

Participants by arm

ArmCount
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
Total101

Baseline characteristics

CharacteristicUsual CareVA MOVEInterventionTotal
Age, Continuous48.1 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 Scale41.89 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
BMI36.06 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 Participants0 Participants0 Participants1 Participants
Race (NIH/OMB)
Asian
0 Participants3 Participants0 Participants3 Participants
Race (NIH/OMB)
Black or African American
4 Participants3 Participants7 Participants14 Participants
Race (NIH/OMB)
More than one race
0 Participants0 Participants0 Participants0 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
1 Participants0 Participants0 Participants1 Participants
Race (NIH/OMB)
Unknown or Not Reported
0 Participants0 Participants0 Participants0 Participants
Race (NIH/OMB)
White
12 Participants32 Participants38 Participants82 Participants
Region of Enrollment
United States
18 participants38 participants45 participants101 participants
Sex: Female, Male
Female
9 Participants7 Participants16 Participants32 Participants
Sex: Female, Male
Male
9 Participants31 Participants29 Participants69 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
EG002
affected / at risk
deaths
Total, all-cause mortality
0 / 180 / 380 / 45
other
Total, other adverse events
0 / 180 / 380 / 45
serious
Total, serious adverse events
0 / 180 / 380 / 45

Outcome results

Primary

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

ArmMeasureValue (MEAN)Dispersion
Usual CareApathy Evaluation Scale-7.69 units on a scaleStandard Deviation 6.77
VA MOVEApathy Evaluation Scale-6.4 units on a scaleStandard Deviation 7.35
InterventionApathy Evaluation Scale-6.15 units on a scaleStandard Deviation 8.3
Secondary

Change in Weight

value at 6 months minus value at baseline

Time frame: 6 months

ArmMeasureValue (MEAN)Dispersion
Usual CareChange in Weight-0.6 KgStandard Deviation 3.73
VA MOVEChange in Weight-0.61 KgStandard Deviation 7.14
InterventionChange in Weight-4.61 KgStandard Deviation 9.42

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026