Examining an Exercise and Nutrition Program for Reducing Weight in People With Severe Mental Illnesses (The ACHIEVE Study)

Obesity and being overweight are prevalent states in people with severe mental illnesses
(SMIs). These weight conditions may contribute to premature cardiovascular disease and the
20% shortened life expectancy of people with SMIs. Physical activity and dietary changes
have proven effective in reducing weight in people without SMIs who are obese and
overweight. This study will determine whether an exercise and nutrition program for people
with SMIs results in weight loss and maintenance of any weight loss.

Participation in this study will last 18 months, with follow-up visits continuing for 24
months. Participants will be randomly assigned to receive either the ACHIEVE intervention—an
exercise and nutrition program adapted for people with SMIs—or usual care as part of a
control group. Those receiving the ACHIEVE intervention will complete three types of
activities: weight management groups, in which participants meet in groups with a
nutritionist to receive information and motivation and to set goals; individual sessions
with a nutritionist for further counseling; and group physical activity, in which they will
perform aerobic activity. For the first 6 months, participants will complete weight
management group sessions weekly, individual sessions monthly, and group activity sessions
three times per week. For the next 12 months, participants will complete weight management
group sessions monthly, individual sessions every 2 months, and group activity sessions up
to three times per week. Participants will also weigh in to check their weight weekly.
Participants in the control group will complete an individual session with a nutritionist at
the beginning of the study and will be allowed to participate in group health classes
several times per year.

All participants will complete study assessments at baseline and after 6 and 18 months.
These assessments will include a blood draw; measurements of weight, waist circumference,
and blood pressure; a bicycle test; 7 days of activity monitoring through an accelerometry
device; and questionnaires on nutrition, exercise, mood, and quality of life. Additional
weighing sessions will occur at 12 and 24 months after study enrollment.

Inclusion Criteria:

- Overweight, defined as a body mass index (BMI) greater than or equal to 25 kg/m2

- Taking the same psychotropic medications for 90 days

- Able to attend two intervention sessions per week

Exclusion Criteria:

- Contraindication to weight loss, such as active cancer treatment, liver failure, or
anorexia

- Presence of a cardiovascular event within the past 6 months

- Inability to walk to participate in exercise

- Active alcohol or substance use disorder

- Planning to leave rehabilitation center within 6 months