Role of Apathy in the Effectiveness of Weight Loss Interventions

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

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

Study Overview

• Status: Completed
• Conditions: Obesity; Apathy
• Intervention / Treatment: Behavioral: MOVE; Behavioral: medical crisis councelling; Drug: methyphenidate

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 Type: Interventional
• Enrollment (Actual): 101
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Nebraska
    • Omaha, Nebraska, United States, 68105-1873
      • VA Medical Center, Omaha

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• BMI >30
• Apathy score >40

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

5

Arms and Interventions

Participant Group / 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: MOVE; is a VA based multidesciplinary weight loss intervention; Behavioral: medical crisis councelling; group counselling sessions
Experimental: 4; MOVE plus methylphenidate	Behavioral: MOVE; is a VA based multidesciplinary weight loss intervention; Drug: methyphenidate; methyphenidate will be used to treat apathy dose 10mg bid
Experimental: 5; MOVE plus methyphenidate plus medical crisis counselling	Behavioral: MOVE; is a VA based multidesciplinary weight loss intervention; Behavioral: medical crisis councelling; group counselling sessions; Drug: methyphenidate; methyphenidate will be used to treat apathy dose 10mg bid

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Weight	value at 6 months minus value at baseline	6 months

Collaborators and Investigators

• Sponsor: VA Nebraska Western Iowa Health Care System
• Investigators: Principal Investigator: Cyrus DeSouza, MD, VA Medical Center, Omaha

Study record dates

Study Major Dates

• Study Start: August 1, 2007
• Primary Completion (Actual): May 1, 2009
• Study Completion (Actual): May 1, 2009

Study Registration Dates

• First Submitted: October 23, 2007
• First Submitted That Met QC Criteria: October 23, 2007
• First Posted (Estimate): October 24, 2007

Study Record Updates

• Last Update Posted (Actual): October 4, 2019
• Last Update Submitted That Met QC Criteria: October 2, 2019
• Last Verified: October 1, 2019

More Information

Terms related to this study

• Keywords: obesity; apathy; methylphenidate; MOVE; medical crisis counselling
• Additional Relevant MeSH Terms: Body Weight; Body Weight Changes; Weight Loss
• Other Study ID Numbers: 00469