Role of Apathy in the Effectiveness of Weight Loss Interventions

Obesity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00548652
• Other study ID #: 00469
• Status: Completed
• Phase: N/A
• Start date: August 2007
• Est. completion date: May 2009

Study information

• Verified date: October 2019
• Source: VA Nebraska Western Iowa Health Care System
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 101
• Est. completion date: May 2009
• Est. primary completion date: May 2009
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years to 70 Years

Eligibility

Inclusion Criteria:

• BMI >30

• Apathy score >40

Exclusion Criteria:

• History of cancer, except basal cell

• Cardiovascular event in last 6 months

• Renal failure

Related Conditions & MeSH terms

• Apathy
• Obesity
• Weight Loss

Intervention

Behavioral:
• MOVE
is a VA based multidesciplinary weight loss intervention
• medical crisis councelling
group counselling sessions
• MOVE
is a VA based multidesciplinary weight loss intervention

Drug:
• methyphenidate
methyphenidate will be used to treat apathy dose 10mg bid

Behavioral:
• MOVE
is a VA based multidesciplinary weight loss intervention

Drug:
• methyphenidate
methyphenidate will be used to treat apathy dose 10mg bid

Behavioral:
• medical crisis councelling
group counselling sessions
• MOVE
is a VA based multidesciplinary weight loss intervention

Locations

Country	Name	City	State
United States	VA Medical Center, Omaha	Omaha	Nebraska

Sponsors (1)

Lead Sponsor	Collaborator
VA Nebraska Western Iowa Health Care System

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
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	6 months
Secondary	Change in Weight	value at 6 months minus value at baseline	6 months