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| ID | Type | Description | Link |
|---|---|---|---|
| R01MH110965 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute of Mental Health (NIMH) | NIH |
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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).
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PeerFIT | Experimental | 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. |
|
| BEAT | Active Comparator | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PeerFIT | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline, 6 months, and 12 months |
| 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. | Baseline, 6 months, and 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Kelly A Aschbrenner, PhD | Dartmouth-Hitchcock and Geisel School of Medicine at Dartmouth College | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Community Mental Health Affiliates | New Britain | Connecticut | 06052 | United States | ||
| Greater Nashua Mental Health Center |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34189933 | Derived | Aschbrenner KA, Naslund JA, Gorin AA, Mueser KT, Browne J, Wolfe RS, Xie H, Bartels SJ. Group Lifestyle Intervention With Mobile Health for Young Adults With Serious Mental Illness: A Randomized Controlled Trial. Psychiatr Serv. 2022 Feb 1;73(2):141-148. doi: 10.1176/appi.ps.202100047. Epub 2021 Jun 30. | |
| 30316998 | Derived | Aschbrenner KA, Naslund JA, Gorin AA, Mueser KT, Scherer EA, Viron M, Kinney A, Bartels SJ. Peer support and mobile health technology targeting obesity-related cardiovascular risk in young adults with serious mental illness: Protocol for a randomized controlled trial. Contemp Clin Trials. 2018 Nov;74:97-106. doi: 10.1016/j.cct.2018.10.005. Epub 2018 Oct 11. |
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The proposed project involves human subject data, and all data collected on subjects (both positive and negative) will be submitted to the National Database for Clinical Trials Related to Mental Illness (NDCT). This will include individual level data from all subjects enrolled in both the active intervention and control conditions.
The NDCT is a secure data repository run by the National Institute of Mental Health (NIMH) that allows researchers to collect and share de-identified information with each other. This secure informatics platform facilitates scientific collaboration and data sharing, and enables effective communication of detailed research data, tools, and supporting documentation. The NDCT links data across research projects using Global Unique Identifiers (GUID) for each participant, and the NDCT Data Dictionary.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Participants at baseline, 6 months and 12 months | Posted | Mean | Standard Deviation | Kilogram | Baseline, 6 months, and 12 months |
|
1 year
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | PeerFIT | Group based lifestyle intervention | 0 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Kelly Aschbrenner | Dartmouth-Hitchcock | 603-440-7722 | kelly.a.aschbrenner@dartmouth.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | May 20, 2020 | Sep 13, 2024 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D012559 | Schizophrenia |
| D011618 | Psychotic Disorders |
| D001714 | Bipolar Disorder |
| D003865 | Depressive Disorder, Major |
| D050177 | Overweight |
| D009765 | Obesity |
| D009043 | Motor Activity |
| D015431 | Weight Loss |
| ID | Term |
|---|---|
| D019967 | Schizophrenia Spectrum and Other Psychotic Disorders |
| D001523 | Mental Disorders |
| D000068105 | Bipolar and Related Disorders |
| D019964 | Mood Disorders |
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|
| BEAT | Behavioral | 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. |
|
| Six months and 12 months |
| 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. | Six months and 12 months |
| Hemoglobin A1C | Hemoglobin A1C will be measured using the CardioChek PA Analyzer. | Baseline, 6 months, and 12 months |
| Nashua |
| New Hampshire |
| 03060 |
| United States |
| BG001 | 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. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | All participants in this study were enrolled from clinic sites located in the U.S. | Number | participants |
|
| OG001 | 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. |
|
|
|
| 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. | Posted | Mean | Standard Deviation | feet | Baseline, 6 months, and 12 months |
|
|
|
|
| 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. | Data analyzed at 6 months for both PeerFIT and BEAT arms. | Posted | Mean | Standard Deviation | score on a scale | Six months and 12 months |
|
|
|
| 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. | Data was collected on SPS for the PeerFIT group only at 6 and 12 months. | Posted | Mean | Standard Deviation | score on a scale | Six months and 12 months |
|
|
|
| Secondary | Hemoglobin A1C | Hemoglobin A1C will be measured using the CardioChek PA Analyzer. | Analyzed at baseline, 6 and 12 months | Posted | Mean | Standard Deviation | Percentage of HbA1c | Baseline, 6 months, and 12 months |
|
|
|
| 76 |
| 0 |
| 76 |
| 0 |
| 76 |
| EG001 | BEAT | Remote lifestyle intervention | 0 | 74 | 0 | 74 | 0 | 74 |
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| D003866 | Depressive Disorder |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001519 | Behavior |
| D001836 | Body Weight Changes |
| 12-months |
|
| 12 months |
|
|
|
| 12 months |
|