search
Back to results

Role of Apathy in the Effectiveness of Weight Loss Interventions

Primary Purpose

Obesity, Apathy

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
MOVE
medical crisis councelling
MOVE
methyphenidate
MOVE
methyphenidate
medical crisis councelling
MOVE
Sponsored by
VA Nebraska Western Iowa Health Care System
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Obesity focused on measuring apathy, obesity, methylphenidate, MOVE, medical crisis counselling

Eligibility Criteria

21 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • VA Medical Center, Omaha

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm Type

No Intervention

Experimental

Experimental

Experimental

Experimental

Arm Label

1

2

3

4

5

Arm Description

standard nutrition counselling

MOVE -weight loss intervention

MOVE plus medical crisis counselling

MOVE plus methylphenidate

MOVE plus methyphenidate plus medical crisis counselling

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Change in Weight
value at 6 months minus value at baseline

Full Information

First Posted
October 23, 2007
Last Updated
October 2, 2019
Sponsor
VA Nebraska Western Iowa Health Care System
search

1. Study Identification

Unique Protocol Identification Number
NCT00548652
Brief Title
Role of Apathy in the Effectiveness of Weight Loss Interventions
Official Title
Role of Apathy in the Effectiveness of Weight Loss Interventions in Obese Patients
Study Type
Interventional

2. Study Status

Record Verification Date
October 2019
Overall Recruitment Status
Completed
Study Start Date
August 2007 (undefined)
Primary Completion Date
May 2009 (Actual)
Study Completion Date
May 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
VA Nebraska Western Iowa Health Care System

4. Oversight

Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity, Apathy
Keywords
apathy, obesity, methylphenidate, MOVE, medical crisis counselling

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
101 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
No Intervention
Arm Description
standard nutrition counselling
Arm Title
2
Arm Type
Experimental
Arm Description
MOVE -weight loss intervention
Arm Title
3
Arm Type
Experimental
Arm Description
MOVE plus medical crisis counselling
Arm Title
4
Arm Type
Experimental
Arm Description
MOVE plus methylphenidate
Arm Title
5
Arm Type
Experimental
Arm Description
MOVE plus methyphenidate plus medical crisis counselling
Intervention Type
Behavioral
Intervention Name(s)
MOVE
Intervention Description
is a VA based multidesciplinary weight loss intervention
Intervention Type
Behavioral
Intervention Name(s)
medical crisis councelling
Intervention Description
group counselling sessions
Intervention Type
Behavioral
Intervention Name(s)
MOVE
Intervention Description
is a VA based multidesciplinary weight loss intervention
Intervention Type
Drug
Intervention Name(s)
methyphenidate
Intervention Description
methyphenidate will be used to treat apathy dose 10mg bid
Intervention Type
Behavioral
Intervention Name(s)
MOVE
Intervention Description
is a VA based multidesciplinary weight loss intervention
Intervention Type
Drug
Intervention Name(s)
methyphenidate
Intervention Description
methyphenidate will be used to treat apathy dose 10mg bid
Intervention Type
Behavioral
Intervention Name(s)
medical crisis councelling
Intervention Description
group counselling sessions
Intervention Type
Behavioral
Intervention Name(s)
MOVE
Intervention Description
is a VA based multidesciplinary weight loss intervention
Primary Outcome Measure Information:
Title
Apathy Evaluation Scale
Description
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
Secondary Outcome Measure Information:
Title
Change in Weight
Description
value at 6 months minus value at baseline
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: BMI >30 Apathy score >40 Exclusion Criteria: History of cancer, except basal cell Cardiovascular event in last 6 months Renal failure
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Cyrus DeSouza, MD
Organizational Affiliation
VA Medical Center, Omaha
Official's Role
Principal Investigator
Facility Information:
Facility Name
VA Medical Center, Omaha
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68105-1873
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Role of Apathy in the Effectiveness of Weight Loss Interventions

We'll reach out to this number within 24 hrs