NCT01752465

Brief Summary

Antipsychotic medications frequently cause metabolic side-effects, such as abdominal obesity, high blood pressure, cholesterol abnormalities, and blood sugar dysregulation, all of which can lead to what is known as the Metabolic Syndrome and serious long-term cardiovascular health problems. Therefore, it is important that metabolic issues be addressed as part of a holistic approach to the mental health treatment of these patients. As with the general population, improving metabolic health involves lifestyle changes - i.e., addressing daily habits regarding eating, physical exercise, stress and sleep management, and lifestyle habits such as smoking. However, there is growing recognition in the medical field that education is not enough for people to create meaningful and sustained lifestyle change. The emerging field of Integrative Health Coaching addresses this issue and provides a clinical framework for helping people successfully develop and achieve personalized lifestyle goals. The investigators have therefore decided to investigate whether health coaching techniques may have benefit in addressing metabolic health issues in people with psychosis disorders. The intent is to complement usual psychiatric and medical care, and also promote patient engagement in managing one's overall health. This study will investigate whether Integrative Health Coaching is a useful clinical tool to facilitate healthy lifestyle behaviour and thereby improve metabolic health in people with psychosis disorders.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2016

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

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

First Submitted

Initial submission to the registry

December 14, 2012

Completed
5 days until next milestone

First Posted

Study publicly available on registry

December 19, 2012

Completed
3 years until next milestone

Study Start

First participant enrolled

January 1, 2016

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2016

Completed
Last Updated

December 2, 2015

Status Verified

November 1, 2015

Enrollment Period

8 months

First QC Date

December 14, 2012

Last Update Submit

November 30, 2015

Conditions

Psychotic DisordersMetabolic Syndrome x

Keywords

Health behaviourAntipsychotic agentsAdverse effectsGoalsLife style

Outcome Measures

Primary Outcomes (3)

  • Scores on the Short-Form 36

    Scores on the Short-Form 36 (a standardized, validated questionnaire measuring general health) will be compared between patients in the Health Coaching group versus patients receiving only standard care.

    Baseline, month 1, month 2, month 3, and month 6

  • Scores on The Three Factor Eating Questionnaire (TFEQ)

    Scores on the Three Factor Eating Questionnaire (a questionnaire measuring cognitive restraint of eating, disinhibition, and hunger) will be compared between patients in the Health Coaching group, versus patients receiving only standard care.

    Baseline, month 1, month 2, month 3, and month 6

  • Scores on The Health Value Scale

    Scores on the Health Value Scale (a questionnaire measuring value placed on health) will be compared between patients in the Health Coaching group, versus patients receiving standard care only.

    Baseline, month 1, month 2, month 3, and month 6

Secondary Outcomes (8)

  • Waist circumference

    Baseline, month 1, month 2, month 3, and month 6

  • Blood Pressure

    Baseline, month 1, month 2, month 3, and month 6

  • Heart Rate

    Baseline, month 1, month 2, month 3, and month 6

  • Fasting plasma glucose

    Baseline, month 1, month 2, month 3, and month 6

  • Fasting total cholesterol

    Baseline, month 1, month 2, month 3, and month 6

  • +3 more secondary outcomes

Study Arms (2)

Standard Care

ACTIVE COMPARATOR

Patients in the standard care group will receive standard clinical care from their attending psychiatrist, including pharmacotherapy and education. Study assessments will be done at baseline, and once a month thereafter at Months 1, 2, 3, and 6.

Behavioral: Health CoachingBehavioral: Standard care

Health Coaching

EXPERIMENTAL

Patients in the Health Coaching group will receive both Health Coaching, and standard care. In addition to routine clinical appointments, patients receiving Health Coaching will attend Health Coaching sessions twice a month during Months 1, 2, and 3, and once a month during Months 4, 5, and 6. Study assessments will be conducted at baseline, and once a month thereafter during Health Coaching sessions at Months 1, 2, 3, and 6.

Behavioral: Health Coaching

Interventions

Health CoachingBEHAVIORAL

Health Coaching sessions are 2 hours long. Participants individually receive a physical assessment, and recent blood work and medications are reviewed. When everyone has been assessed, the group reconvenes to watch a video about the importance of making healthy lifestyle choices, participates in a 10 min. fitness activity, and receives training on making SMART goals (SMART stands for specific, measurable, achievable, realistic, and timely). Each participant individually creates a SMART goal for him/herself, and this goal is reviewed as a group. Each participant rates the importance of this goal, and rates their level of confidence in succeeding. Progress is tracked in subsequent sessions, and metabolic health is continually monitored through routine blood work.

Also known as: Integrative Health Coaching, EPI Metabolic Group
Health CoachingStandard Care
Standard careBEHAVIORAL

Standard clinical care will continue for all participants in the study, regardless of the study arm. This includes routine clinical visits to the attending psychiatrist, and receiving pharmacotherapy, standard patient education, and psychosocial training.

Standard Care

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Subjects must have a primary working diagnosis of schizophrenia/schizoaffective disorder, or bipolar disorder, or psychosis not otherwise specified (PNOS)
  • Subjects must be prescribed an atypical (or 'second-generation') antipsychotic drug

You may not qualify if:

  • None

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Vancouver/Richmond Early Psychosis Intervention Clinic

Vancouver, British Columbia, V5K 1Z9, Canada

Location

MeSH Terms

Conditions

Psychotic DisordersMetabolic Syndrome

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic DisordersMental DisordersInsulin ResistanceHyperinsulinismGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Quality Indicators, Health CareQuality of Health CareHealth Services AdministrationHealth Care Quality, Access, and Evaluation

Study Officials

  • Alasdair M Barr, Ph.D.

    The University of British Columbia

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 14, 2012

First Posted

December 19, 2012

Study Start

January 1, 2016

Primary Completion

September 1, 2016

Study Completion

September 1, 2016

Last Updated

December 2, 2015

Record last verified: 2015-11

Locations

CA(1)