Trial Outcomes & Findings for Role of Apathy in the Effectiveness of Weight Loss Interventions (NCT NCT00548652)

Last Updated: 2019-10-04

Results Overview

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

Recruitment status

COMPLETED

Study phase

Target enrollment

101 participants

Primary outcome timeframe

6 months

Results posted on

2019-10-04

Participant Flow

Participant milestones

Participant milestones
Measure	Usual Care standard nutrition counselling	VA MOVE MOVE -weight loss intervention MOVE: is a VA based multidesciplinary weight loss intervention	Intervention MOVE plus methylphenidate methyphenidate: methyphenidate will be used to treat apathy dose 10mg bid MOVE: is a VA based multidesciplinary weight loss intervention
Overall Study STARTED	18	38	45
Overall Study COMPLETED	16	29	34
Overall Study NOT COMPLETED	2	9	11

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Role of Apathy in the Effectiveness of Weight Loss Interventions

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Usual Care n=18 Participants standard nutrition counselling	VA MOVE n=38 Participants MOVE -weight loss intervention MOVE: is a VA based multidesciplinary weight loss intervention	Intervention n=45 Participants MOVE plus methylphenidate methyphenidate: methyphenidate will be used to treat apathy dose 10mg bid MOVE: is a VA based multidesciplinary weight loss intervention	Total n=101 Participants Total of all reporting groups
Age, Continuous	48.1 years STANDARD_DEVIATION 14.3 • n=99 Participants	55.2 years STANDARD_DEVIATION 10.1 • n=107 Participants	52.5 years STANDARD_DEVIATION 10.4 • n=206 Participants	52.34 years STANDARD_DEVIATION 10.66 • n=7 Participants
Sex: Female, Male Female	9 Participants n=99 Participants	7 Participants n=107 Participants	16 Participants n=206 Participants	32 Participants n=7 Participants
Sex: Female, Male Male	9 Participants n=99 Participants	31 Participants n=107 Participants	29 Participants n=206 Participants	69 Participants n=7 Participants
Race (NIH/OMB) American Indian or Alaska Native	1 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants	1 Participants n=7 Participants
Race (NIH/OMB) Asian	0 Participants n=99 Participants	3 Participants n=107 Participants	0 Participants n=206 Participants	3 Participants n=7 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	1 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants	1 Participants n=7 Participants
Race (NIH/OMB) Black or African American	4 Participants n=99 Participants	3 Participants n=107 Participants	7 Participants n=206 Participants	14 Participants n=7 Participants
Race (NIH/OMB) White	12 Participants n=99 Participants	32 Participants n=107 Participants	38 Participants n=206 Participants	82 Participants n=7 Participants
Race (NIH/OMB) More than one race	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants	0 Participants n=7 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants	0 Participants n=7 Participants
Region of Enrollment United States	18 participants n=99 Participants	38 participants n=107 Participants	45 participants n=206 Participants	101 participants n=7 Participants
BMI	36.06 kg/m^2 STANDARD_DEVIATION 5.91 • n=99 Participants	38.78 kg/m^2 STANDARD_DEVIATION 5.6 • n=107 Participants	37.58 kg/m^2 STANDARD_DEVIATION 5.69 • n=206 Participants	37.21 kg/m^2 STANDARD_DEVIATION 5.55 • n=7 Participants
Apathy Evaluation Scale	41.89 units on a scale STANDARD_DEVIATION 8.2 • n=99 Participants	42.12 units on a scale STANDARD_DEVIATION 7.93 • n=107 Participants	42.96 units on a scale STANDARD_DEVIATION 8.94 • n=206 Participants	42.06 units on a scale STANDARD_DEVIATION 7.94 • n=7 Participants

PRIMARY outcome

Timeframe: 6 months

Outcome measures

Outcome measures
Measure	Usual Care n=16 Participants standard nutrition counselling	VA MOVE n=29 Participants MOVE -weight loss intervention MOVE: is a VA based multidesciplinary weight loss intervention	Intervention n=34 Participants MOVE plus methylphenidate methyphenidate: methyphenidate will be used to treat apathy dose 10mg bid MOVE: is a VA based multidesciplinary weight loss intervention
Apathy Evaluation Scale	-7.69 units on a scale Standard Deviation 6.77	-6.4 units on a scale Standard Deviation 7.35	-6.15 units on a scale Standard Deviation 8.3

SECONDARY outcome

Timeframe: 6 months

value at 6 months minus value at baseline

Outcome measures

Outcome measures
Measure	Usual Care n=16 Participants standard nutrition counselling	VA MOVE n=29 Participants MOVE -weight loss intervention MOVE: is a VA based multidesciplinary weight loss intervention	Intervention n=34 Participants MOVE plus methylphenidate methyphenidate: methyphenidate will be used to treat apathy dose 10mg bid MOVE: is a VA based multidesciplinary weight loss intervention
Change in Weight	-0.6 Kg Standard Deviation 3.73	-0.61 Kg Standard Deviation 7.14	-4.61 Kg Standard Deviation 9.42

Adverse Events

Usual Care

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

VA MOVE

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Intervention

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Cyrus Desouza

VANebraska

Phone: 4023468800

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place