Trial Outcomes & Findings for Lifestyle Intervention for Weight Gain Management for Patients With Schizophrenia (NCT NCT01368406)

Last Updated: 2013-05-22

Results Overview

All patients were weighed in the morning, on the same scale, without shoes, with the individuals wearing light clothes.Measures were collected by the same investigator in all assessments.

Recruitment status

COMPLETED

Study phase

Target enrollment

160 participants

Primary outcome timeframe

baseline, 3-month

Results posted on

2013-05-22

Participant Flow

Patients were drawn from: a) the Schizophrenia Program- Universidade Federal de São Paulo); b) the Schizophrenia Program of Institute of Psychiatry PROJESQ (Universidade de São Paulo); c) the CAISM (Centro de Atenção Integrada à Saúde Mental) from Irmandade Santa Casa de São Paulo; and d) the Community Psychosocial Center Luiz da Rocha Cerqueira.

Participant milestones

Participant milestones
Measure	Wellness Program 12-week weight management intervention in patients with severe mental disorders. In the 1-hour weekly group sessions topics like dietary choices, lifestyle, physical activity and self-esteem were discussed with outpatients and their relatives	Treatment as Usual treatment as usual received by the patients
Overall Study STARTED	81	79
Overall Study COMPLETED	60	66
Overall Study NOT COMPLETED	21	13

Reasons for withdrawal

Reasons for withdrawal
Measure	Wellness Program 12-week weight management intervention in patients with severe mental disorders. In the 1-hour weekly group sessions topics like dietary choices, lifestyle, physical activity and self-esteem were discussed with outpatients and their relatives	Treatment as Usual treatment as usual received by the patients
Overall Study Lost to Follow-up	8	4
Overall Study Withdrawal by Subject	8	4
Overall Study relapse of the disease	3	2
Overall Study started working	2	3

Baseline Characteristics

Lifestyle Intervention for Weight Gain Management for Patients With Schizophrenia

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Wellness Program n=81 Participants 12-week weight management intervention in patients with severe mental disorders. In the 1-hour weekly group sessions topics like dietary choices, lifestyle, physical activity and self-esteem were discussed with outpatients and their relatives	Treatment as Usual n=79 Participants treatment as usual received by the patients	Total n=160 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	81 Participants n=5 Participants	79 Participants n=7 Participants	160 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	36.2 years STANDARD_DEVIATION 9.9 • n=5 Participants	38.3 years STANDARD_DEVIATION 10.7 • n=7 Participants	37.3 years STANDARD_DEVIATION 10.4 • n=5 Participants
Sex: Female, Male Female	31 Participants n=5 Participants	33 Participants n=7 Participants	64 Participants n=5 Participants
Sex: Female, Male Male	50 Participants n=5 Participants	46 Participants n=7 Participants	96 Participants n=5 Participants
Region of Enrollment Brazil	81 participants n=5 Participants	79 participants n=7 Participants	160 participants n=5 Participants

PRIMARY outcome

Timeframe: baseline, 3-month

All patients were weighed in the morning, on the same scale, without shoes, with the individuals wearing light clothes.Measures were collected by the same investigator in all assessments.

Outcome measures

Outcome measures
Measure	Wellness Program n=81 Participants lifestyle intervention for 12 weeks	Treatment as Usual n=79 Participants treatment as usual received by the patients
Change in Weight From Baseline to Endpoint	0.48 kg Interval -0.65 to 1.13	0.48 kg 95% Confidence Interval 17.8 • Interval 0.13 to 0.83

Adverse Events

Wellness Program

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Treatment as Usual

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

Cecilia Attux

Programa de Esquizofrenia PROESQ UNIFESP

Phone: 551155733599

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place