Role of Apathy in the Effectiveness of Weight Loss Interventions

This study has been completed.
Sponsor:
Information provided by:
VA Nebraska Western Iowa Health Care System
ClinicalTrials.gov Identifier:
NCT00548652
First received: October 23, 2007
Last updated: March 19, 2014
Last verified: April 2011
  Purpose

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 Intervention
Obesity
Apathy
Behavioral: MOVE
Behavioral: medical crisis councelling
Drug: methyphenidate

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Role of Apathy in the Effectiveness of Weight Loss Interventions in Obese Patients

Resource links provided by NLM:


Further study details as provided by VA Nebraska Western Iowa Health Care System:

Primary Outcome Measures:
  • change in Apathy score and change in Weight (lbs) [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • lipids, adherence measures [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Enrollment: 125
Study Start Date: August 2007
Study Completion Date: May 2009
Primary Completion Date: May 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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

  Eligibility

Ages Eligible for Study:   21 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00548652

Locations
United States, Nebraska
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
  More Information

No publications provided

Responsible Party: DeSouza, Cyrus - Principal Investigator, Department of Veterans Affairs
ClinicalTrials.gov Identifier: NCT00548652     History of Changes
Other Study ID Numbers: 00469
Study First Received: October 23, 2007
Last Updated: March 19, 2014
Health Authority: United States: Federal Government

Keywords provided by VA Nebraska Western Iowa Health Care System:
apathy
obesity
methylphenidate
MOVE
medical crisis counselling

Additional relevant MeSH terms:
Obesity
Weight Loss
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms
Body Weight Changes

ClinicalTrials.gov processed this record on September 22, 2014