Trial Outcomes & Findings for Weight Management Program for Patients With First Episode Psychosis (NCT NCT05207982)
NCT ID: NCT05207982
Last Updated: 2025-01-14
Results Overview
Change in weight will be assessed at baseline, weekly during study period, end point, and follow up.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
10 participants
Primary outcome timeframe
7 months
Results posted on
2025-01-14
Participant Flow
Dyads consisting of patients and their support person (one patient and one support person per dyad) were recruited from an outpatient clinic between 7/15/22 and 6/30/23
Participant milestones
| Measure |
Patients
Patients with first episode psychosis (FEP) participating in the weight management program
|
Supporting Person
Supporting person assisting the FEP patient in the weight management program
|
|---|---|---|
|
Overall Study
STARTED
|
5
|
5
|
|
Overall Study
COMPLETED
|
5
|
5
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Weight Management Program for Patients With First Episode Psychosis
Baseline characteristics by cohort
| Measure |
Patients
n=5 Participants
Patients with first episode psychosis (FEP) participating in the weight management program
|
Supporting Person
n=5 Participants
Supporting person assisting the FEP patient in the weight management program
|
Total
n=10 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
4 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Continuous
|
21.8 years
STANDARD_DEVIATION 3.1 • n=5 Participants
|
38.2 years
STANDARD_DEVIATION 15.5 • n=7 Participants
|
30 years
STANDARD_DEVIATION 13.6 • n=5 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
4 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
4 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
2 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
5 participants
n=5 Participants
|
5 participants
n=7 Participants
|
10 participants
n=5 Participants
|
|
Weight
|
217.3 Lbs
n=5 Participants
|
201.5 Lbs
n=7 Participants
|
209.4 Lbs
n=5 Participants
|
PRIMARY outcome
Timeframe: 7 monthsPopulation: This is a single case experimental, within-subject, design study, in which participants' weight at baseline and after intervention is being measured. Separate models were used for each participant and total weight loss (number) were examined.
Change in weight will be assessed at baseline, weekly during study period, end point, and follow up.
Outcome measures
| Measure |
Patients
n=5 Participants
Patients with first episode psychosis (FEP) participating in the weight management program
|
Supporting Person
n=5 Participants
Supporting person assisting the FEP patient in the weight management program
|
|---|---|---|
|
Weight
Dyad 1
|
-6 Lbs
|
-3 Lbs
|
|
Weight
Dyad 2
|
-5 Lbs
|
-4 Lbs
|
|
Weight
Dyad 3
|
11 Lbs
|
5 Lbs
|
|
Weight
Dyad 4
|
-4 Lbs
|
-14 Lbs
|
|
Weight
Dyad 5
|
0 Lbs
|
-7 Lbs
|
Adverse Events
Patients
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Supporting Person
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
Daniel Antonius
University at Buffalo, Department of Psychiatry
Phone: 7168582792
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place