Bipolar Disorder, Major Depressive Disorder, Obesity, Overweight, Schizoaffective Disorder, Schizophrenia
Conditions
Keywords
Serious Mental Illness, Young Adults, Obesity, Cardiometabolic Risk, Physical Activity, Weight Loss, Fitness, Peer Support, Smartphone, Mobile Technology, mHealth, Social Media, Facebook, Lifestyle Intervention
Brief 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).
Detailed description
The objective of this study is to evaluate the effectiveness of a group-based lifestyle intervention (PeerFIT) supported by mobile health (mHealth) technology and social media to promote weight loss and improved fitness in young adults with serious mental illness (SMI). The study is a two-arm randomized controlled trial conducted in real world mental health settings to evaluate the effectiveness of the 12-month PeerFIT intervention 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. The investigators will enroll 144 overweight and obese (BMI ≥ 25) young adults ages 18 to 35 with SMI attending one of two community mental health who are interested in losing weight and improving fitness. The investigators hypothesize that PeerFIT compared to BEAT will be associated with a greater proportion of participants who achieve cardiovascular risk reduction at 6 and 12 months follow-up as indicated by either clinically significant weight loss (5% or greater) or increased fitness (\>50 m on the six-minute walk test). The investigators also hypothesize that PeerFIT compared to BEAT will be associated with greater improvements in A1c and lipid profiles at 6 and 12 months follow-up. They will also investigate two theoretical mechanisms of action hypothesized to account for greater weight loss and increased cardiorespiratory fitness among participants assigned to PeerFIT: 1) improved self-efficacy and 2) increased peer support for health behavior change. The investigators hypothesize that the relationship between PeerFIT and weight loss and improved fitness will be mediated by improved self-efficacy and peer support for health behavior change.
Interventions
BEHAVIORALPeerFIT
The 12-month PeerFIT intervention consists of a 6-month intensive phase including: (a) once weekly 60-minute group weight management and exercise session led by a lifestyle coach; (b) once weekly one-hour physical activity session delivered in community settings; and (c) Facebook and mHealth technology (i.e., Fitbits, text messaging support) to increase motivation and facilitate self-monitoring and peer social support for health behavior change. Participants then transition to a 6-month lower intensity phase in which the 90-minute weight management sessions are discontinued. The groups will be conducted as open groups with a minimum of 4 and maximum of 18 participants at any given time.
BEHAVIORALBEAT
Participants in BEAT will receive monthly individual lifestyle sessions delivered by a lifestyle coach including education, guidance, and support for self-monitoring behaviors (i.e., daily self-weighing and tracking daily steps) during the first six months of the study, plus text message reminders and encouragement for self-monitoring weight loss behaviors during the entire 12-month study period. Participants will receive materials with tips and strategies for healthy eating and increasing physical activity. They will also be given a wearable activity tracker (i.e., Fitbit Zip) to use with instructions for using the device. The first session with the lifestyle coach will be in person and thereafter by phone.
Sponsors
National Institute of Mental Health (NIMH)
Dartmouth-Hitchcock Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 35 Years
Healthy volunteers
No
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 consent, complete study questionnaires, or participate in a group intervention as indicated by a Mini Mental Status Examination score \<24 * Active substance use determined to be incompatible with participation in the intervention identified by screening questionnaire that assesses for excessive use according to intake limits by gender * Use of anabolic steroids with the drug taken at least most days of the week for the previous month * Planning to leave agency or move out of geographic area within 12 months * People who are non-English speakers or who have major visual or hearing impairment will be excluded given the need to read the program materials and interact with technology.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Weight | Baseline, 6 months, and 12 months | Participants' weight will be measured in pounds (lbs.) on a flat, even surface with the use of a high-quality, calibrated professional medical scale, with the participant wearing indoor clothing and no shoes. |
| 6-minute Walk Test | Baseline, 6 months, and 12 months | After a baseline blood pressure has been obtained, participants are asked to walk a measured distance as far as they are able in 6 minutes. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Self-efficacy for Exercise Behaviors Assessed Using the Self-efficacy for Exercise Behaviors (SEB) Scale | Six months and 12 months | The Self-efficacy for Exercise Behaviors (SEB) scale was used to measure participants' self-efficacy related to the ability to exercise despite common barriers. Five items represent the following areas: negative affect, resisting relapse, and making time for exercise. Respondents rate their confidence on a five-point Likert scale from 1 = I know I cannot to 4 = I know I can. Total scores range from 5 to 20. Higher overall scores indicate higher exercise self efficacy. |
| Social Provisions Scale (SPS) | Six months and 12 months | Participants' level of perceived peer support was measured with the Social Provisions Scale (SPS). The SPS consists of 10 questions items assessing an individual's perceived social support across different dimensions like attachment, guidance, social integration, reliable alliance, and reassurance of worth; essentially assessing how much support they feel they receive from their social network. The items are rated on a 4-point Likert scale from 1 (strongly disagree) to 4 (strongly agree) as it pertains to relationships with group members. Scores range from 10 to 40. Higher scores indicate greater perceived support from group relationships. |
| Hemoglobin A1C | Baseline, 6 months, and 12 months | Hemoglobin A1C will be measured using the CardioChek PA Analyzer. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| PeerFIT PeerFIT is a group-based lifestyle intervention enhanced by mobile health technology and social media designed to achieve clinically significant improvements in weight loss and cardiorespiratory fitness in young adults with serious mental illness.
PeerFIT: The 12-month PeerFIT intervention consists of a 6-month intensive phase including: (a) once weekly 60-minute group weight management and exercise session led by a lifestyle coach; (b) once weekly one-hour physical activity session delivered in community settings; and (c) Facebook and mHealth technology (i.e., Fitbits, text messaging support) to increase motivation and facilitate self-monitoring and peer social support for health behavior change. Participants then transition to a 6-month lower intensity phase in which the 90-minute weight management sessions are discontinued. The groups will be conducted as open groups with a minimum of 4 and maximum of 18 participants at any given time. | 76 |
| BEAT BEAT involves basic education in fitness and nutrition supported by a wearable activity tracking device designed to achieve clinically significant improvements in weight loss and cardiorespiratory fitness in young adults with serious mental illness.
BEAT: Participants in BEAT will receive monthly individual lifestyle sessions delivered by a lifestyle coach including education, guidance, and support for self-monitoring behaviors (i.e., daily self-weighing and tracking daily steps) during the first six months of the study, plus text message reminders and encouragement for self-monitoring weight loss behaviors during the entire 12-month study period. Participants will receive materials with tips and strategies for healthy eating and increasing physical activity. They will also be given a wearable activity tracker (i.e., Fitbit Zip) to use with instructions for using the device. The first session with the lifestyle coach will be in person and thereafter by phone. | 74 |
| Total | 150 |
Baseline characteristics
| Characteristic | PeerFIT | Total | BEAT |
|---|---|---|---|
| Age, Continuous | 28.2 years STANDARD_DEVIATION 4.4 | 28.4 years STANDARD_DEVIATION 4.5 | 28.5 years STANDARD_DEVIATION 4.7 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 22 Participants | 45 Participants | 23 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 54 Participants | 105 Participants | 51 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 1 Participants | 1 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 18 Participants | 39 Participants | 21 Participants |
| Race (NIH/OMB) More than one race | 6 Participants | 12 Participants | 6 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 7 Participants | 16 Participants | 9 Participants |
| Race (NIH/OMB) White | 44 Participants | 82 Participants | 38 Participants |
| Region of Enrollment United States | 76 participants | 150 participants | 74 participants |
| Sex: Female, Male Female | 41 Participants | 83 Participants | 42 Participants |
| Sex: Female, Male Male | 35 Participants | 67 Participants | 32 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 76 | 0 / 74 |
| other Total, other adverse events | 0 / 76 | 0 / 74 |
| serious Total, serious adverse events | 0 / 76 | 0 / 74 |
Outcome results
Primary
6-minute Walk Test
After a baseline blood pressure has been obtained, participants are asked to walk a measured distance as far as they are able in 6 minutes.
Time frame: Baseline, 6 months, and 12 months
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| PeerFIT | 6-minute Walk Test | Baseline | 1398 feet | Standard Deviation 296 |
| PeerFIT | 6-minute Walk Test | 6-months | 1386 feet | Standard Deviation 296 |
| PeerFIT | 6-minute Walk Test | 12-months | 1357 feet | Standard Deviation 271 |
| BEAT | 6-minute Walk Test | Baseline | 1424 feet | Standard Deviation 250 |
| BEAT | 6-minute Walk Test | 6-months | 1426 feet | Standard Deviation 248 |
| BEAT | 6-minute Walk Test | 12-months | 1319 feet | Standard Deviation 332 |
p-value: <0.01GLMM
Primary
Weight
Participants' weight will be measured in pounds (lbs.) on a flat, even surface with the use of a high-quality, calibrated professional medical scale, with the participant wearing indoor clothing and no shoes.
Time frame: Baseline, 6 months, and 12 months
Population: Participants at baseline, 6 months and 12 months
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| PeerFIT | Weight | Baseline weight | 107.6 Kilogram | Standard Deviation 26.9 |
| PeerFIT | Weight | 6-month weight | 109.7 Kilogram | Standard Deviation 26.3 |
| PeerFIT | Weight | 12-month weight | 109.2 Kilogram | Standard Deviation 27.6 |
| BEAT | Weight | Baseline weight | 105.1 Kilogram | Standard Deviation 20.9 |
| BEAT | Weight | 6-month weight | 106.7 Kilogram | Standard Deviation 22.1 |
| BEAT | Weight | 12-month weight | 106.9 Kilogram | Standard Deviation 22.5 |
p-value: <0.01GLMM
Secondary
Hemoglobin A1C
Hemoglobin A1C will be measured using the CardioChek PA Analyzer.
Time frame: Baseline, 6 months, and 12 months
Population: Analyzed at baseline, 6 and 12 months
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| PeerFIT | Hemoglobin A1C | Baseline | 5.3 Percentage of HbA1c | Standard Deviation 0.8 |
| PeerFIT | Hemoglobin A1C | 6 months | 5.3 Percentage of HbA1c | Standard Deviation 0.7 |
| PeerFIT | Hemoglobin A1C | 12 months | 5.6 Percentage of HbA1c | Standard Deviation 1.4 |
| BEAT | Hemoglobin A1C | Baseline | 5.3 Percentage of HbA1c | Standard Deviation 1 |
| BEAT | Hemoglobin A1C | 6 months | 5.3 Percentage of HbA1c | Standard Deviation 0.6 |
| BEAT | Hemoglobin A1C | 12 months | 5.5 Percentage of HbA1c | Standard Deviation 0.7 |
Secondary
Self-efficacy for Exercise Behaviors Assessed Using the Self-efficacy for Exercise Behaviors (SEB) Scale
The Self-efficacy for Exercise Behaviors (SEB) scale was used to measure participants' self-efficacy related to the ability to exercise despite common barriers. Five items represent the following areas: negative affect, resisting relapse, and making time for exercise. Respondents rate their confidence on a five-point Likert scale from 1 = I know I cannot to 4 = I know I can. Total scores range from 5 to 20. Higher overall scores indicate higher exercise self efficacy.
Time frame: Six months and 12 months
Population: Data analyzed at 6 months for both PeerFIT and BEAT arms.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| PeerFIT | Self-efficacy for Exercise Behaviors Assessed Using the Self-efficacy for Exercise Behaviors (SEB) Scale | 6 months | 11 score on a scale | Standard Deviation 3.4 |
| PeerFIT | Self-efficacy for Exercise Behaviors Assessed Using the Self-efficacy for Exercise Behaviors (SEB) Scale | 12 months | 11.2 score on a scale | Standard Deviation 3.5 |
| BEAT | Self-efficacy for Exercise Behaviors Assessed Using the Self-efficacy for Exercise Behaviors (SEB) Scale | 6 months | 10.7 score on a scale | Standard Deviation 4.3 |
| BEAT | Self-efficacy for Exercise Behaviors Assessed Using the Self-efficacy for Exercise Behaviors (SEB) Scale | 12 months | 10.2 score on a scale | Standard Deviation 3.4 |
Secondary
Social Provisions Scale (SPS)
Participants' level of perceived peer support was measured with the Social Provisions Scale (SPS). The SPS consists of 10 questions items assessing an individual's perceived social support across different dimensions like attachment, guidance, social integration, reliable alliance, and reassurance of worth; essentially assessing how much support they feel they receive from their social network. The items are rated on a 4-point Likert scale from 1 (strongly disagree) to 4 (strongly agree) as it pertains to relationships with group members. Scores range from 10 to 40. Higher scores indicate greater perceived support from group relationships.
Time frame: Six months and 12 months
Population: Data was collected on SPS for the PeerFIT group only at 6 and 12 months.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| PeerFIT | Social Provisions Scale (SPS) | 6 months | 29.2 score on a scale | Standard Deviation 5.2 |
| PeerFIT | Social Provisions Scale (SPS) | 12 months | 27.1 score on a scale | Standard Deviation 5.9 |