Lifestyle Intervention for Young Adults With Serious Mental Illness (NCT02815813) | Clinical Trial Compass
CompletedNot Applicable
Lifestyle Intervention for Young Adults With Serious Mental Illness
United States150 participantsStarted 2017-07-03
Plain-language summary
This is a four year project evaluating the effectiveness of a group-based lifestyle intervention (PeerFIT) supported by mobile health (mHealth) technology and social media compared to Basic Education in fitness and nutrition supported by a wearable Activity Tracking device (BEAT) in achieving clinically significant improvements in weight loss and cardiorespiratory fitness in young adults with serious mental illness (SMI).
Who can participate
Age range18 Years – 35 Years
SexALL
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Inclusion Criteria:
* Young adults ages 18 to 35
* Chart diagnosis of schizophrenia, schizoaffective disorder, bipolar disorder, or major depression
* Overweight or obese defined as BMI ≥25
* Enrolled in treatment at the agency for at least 3 months prior to study recruitment
* Have not started taking Clozapine or Olanzapine antipsychotic medications over the prior 2 months (dose changes are allowed)
* Able and willing to give written informed consent to participate in the study or able to assent with guardian consent
* Willingness to be randomized to either of the two conditions
* Able and willing to attend the weekly 60-minute weight management session, participate in the weekly 1-hour physical activity sessions, and use the Facebook and mHealth (i.e., Fitbits and text messaging) components of the PeerFIT program
Exclusion Criteria:
* Medical contraindication to weight loss (e.g., cancer, stroke, liver failure)
* Medical conditions (e.g., diabetes, angina) that do not receive medical clearance by a primary care provider
* Major surgery planned or likely to occur within the next 6 months
* Prior or planned bariatric surgery
* Use of prescription weight loss medication within the past 6 months
* 5% or greater weight loss in 3 months prior to baseline
* Currently enrolled in another weight reduction program
* Pregnant or planning a pregnancy, or breastfeeding during study period
* Cognitive impairment sufficient to interfere with participant's ability to provide informed co…