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Role of Apathy in the Effectiveness of Weight Loss Interventions

V

VA Nebraska Western Iowa Health Care System

Status

Completed

Conditions

Apathy
Obesity

Treatments

Drug: methyphenidate
Behavioral: MOVE
Behavioral: medical crisis councelling

Study type

Interventional

Funder types

Other U.S. Federal agency

Identifiers

Details and patient eligibility

About

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

Full 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

Enrollment

101 patients

Sex

All

Ages

21 to 70 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • BMI >30
  • Apathy score >40

Exclusion criteria

  • History of cancer, except basal cell
  • Cardiovascular event in last 6 months
  • Renal failure

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

101 participants in 5 patient groups

1
No Intervention group
Description:
standard nutrition counselling
2
Experimental group
Description:
MOVE -weight loss intervention
Treatment:
Behavioral: MOVE
Behavioral: MOVE
Behavioral: MOVE
Behavioral: MOVE
3
Experimental group
Description:
MOVE plus medical crisis counselling
Treatment:
Behavioral: medical crisis councelling
Behavioral: MOVE
Behavioral: MOVE
Behavioral: medical crisis councelling
Behavioral: MOVE
Behavioral: MOVE
4
Experimental group
Description:
MOVE plus methylphenidate
Treatment:
Behavioral: MOVE
Drug: methyphenidate
Behavioral: MOVE
Behavioral: MOVE
Drug: methyphenidate
Behavioral: MOVE
5
Experimental group
Description:
MOVE plus methyphenidate plus medical crisis counselling
Treatment:
Behavioral: medical crisis councelling
Behavioral: MOVE
Drug: methyphenidate
Behavioral: MOVE
Behavioral: medical crisis councelling
Behavioral: MOVE
Drug: methyphenidate
Behavioral: MOVE

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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