NCT00548652

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
101

participants targeted

Target at P50-P75 for not_applicable obesity

Timeline
Completed

Started Aug 2007

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2007

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

October 23, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 24, 2007

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2009

Completed
10.4 years until next milestone

Results Posted

Study results publicly available

October 4, 2019

Completed
Last Updated

October 4, 2019

Status Verified

October 1, 2019

Enrollment Period

1.8 years

First QC Date

October 23, 2007

Results QC Date

June 19, 2018

Last Update Submit

October 2, 2019

Conditions

ObesityApathy

Keywords

apathyobesitymethylphenidateMOVEmedical crisis counselling

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • Change in Weight

    6 months

Study Arms (5)

1

NO INTERVENTION

standard nutrition counselling

2

EXPERIMENTAL

MOVE -weight loss intervention

Behavioral: MOVE

3

EXPERIMENTAL

MOVE plus medical crisis counselling

Behavioral: medical crisis councellingBehavioral: MOVE

4

EXPERIMENTAL

MOVE plus methylphenidate

Drug: methyphenidateBehavioral: MOVE

5

EXPERIMENTAL

MOVE plus methyphenidate plus medical crisis counselling

Drug: methyphenidateBehavioral: medical crisis councellingBehavioral: MOVE

Interventions

MOVEBEHAVIORAL

is a VA based multidesciplinary weight loss intervention

2
medical crisis councellingBEHAVIORAL

group counselling sessions

3
methyphenidateDRUG

methyphenidate will be used to treat apathy dose 10mg bid

4

Eligibility Criteria

Age21 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • BMI \>30
  • Apathy score \>40

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

VA Medical Center, Omaha

Omaha, Nebraska, 68105-1873, United States

Location

MeSH Terms

Conditions

ObesityLethargy

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsNeurobehavioral ManifestationsNeurologic ManifestationsNervous System Diseases

Results Point of Contact

Title
Cyrus Desouza
Organization
VANebraska
cyrus.desouza@va.gov
4023468800

Study Officials

  • Cyrus DeSouza, MD

    VA Medical Center, Omaha

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
FED
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Staff Physician

Study Record Dates

First Submitted

October 23, 2007

First Posted

October 24, 2007

Study Start

August 1, 2007

Primary Completion

May 1, 2009

Study Completion

May 1, 2009

Last Updated

October 4, 2019

Results First Posted

October 4, 2019

Record last verified: 2019-10

Locations

US(1)