Obesity, Mental Disorder
Conditions
Keywords
Obesity, Mental Disorder, Peer Navigator, Physical Health, Overweight, Serious Mental Illness
Brief summary
People with serious mental illness such as schizophrenia and bipolar disorder experience high rates of physical illness and die earlier than people without serious mental illness (WHO, 2005). Health differences seem to be worse among African Americans (Weber, Cowan, Millikan & Niebuhr, 2009). High rates of obesity among this group contribute to health and wellness concerns (de Hert et al., 2011), with African American women at higher risk of obesity than men. Behavioral weight loss interventions (BWLIs) may promote diet and physical activity that lead to weight loss, but healthy food and safe physical activity options are less available in low-income neighborhoods. Peer navigators have been found to be effective in addressing health differences, and may help people living in low-income communities find healthy food and activity resources (Fischer, Sauaia, & Kutner, 2007). In addition, traumatic experiences are common among persons with serious mental illness as well as African Americans, and may impact weight. Through this project, investigators will test two interventions designed to address overweight and obesity among African Americans with serious mental illness. The first is a BWLI designed for persons with serious mental illness and adapted to meet the needs of African Americans. This program has 8-month intervention phase and 4-month maintenance phase. The intervention includes group weight management classes, group physical activity, individual visits to address barriers to meeting weight goals, and weigh-ins. The second intervention is a peer navigator program that assists people with serious mental illness in meeting their health needs in the community. Two-hundred and seventy (270) research participants will be recruited and randomly assigned to one of three conditions: BWLI program, BWLI program plus peer navigator, and treatment as usual (integrated physical and mental health care). Investigators will evaluate these interventions over a 12-month period, and will track weight change, health behaviors, physical and mental health, recovery, and quality of life. Investigators also seek to understand the impact of gender and trauma on outcomes. Investigators hypothesize that peer navigators will improve outcomes over the BWLI program alone. Findings will advance knowledge and services to reduce racial disparities in obesity and comorbid health conditions for African Americans with serious mental illnesses.
Detailed description
Persons with serious mental illness experience disproportionate rates of physical health morbidity and mortality (WHO, 2005). One reason is a metabolic syndrome marked by significant obesity which seems even worse for African Americans. Although research suggests behavioral weight loss interventions (BWLIs) may promote healthy lifestyle behaviors (diet and exercise) that leads to weight loss, these programs are hindered by several social determinants of health found in low-income communities with food and activity deserts that undermine program goals. Preliminary evidence finds that peer navigators (service providers in recovery from serious mental illness) can help people to better avail existing healthcare programs, thereby improving health. Based on this evidence, our community-based participatory research (CBPR) project develops and tests two existing interventions to address the weight concerns of African Americans with serious mental illness: 1. A BWLI developed for persons with serious mental illness (Goldberg et al., 2013) that will be evaluated for its responsiveness to the needs of African Americans with serious mental illness 2. A peer navigator program (PNP) (Corrigan et al., 2017) that assists people with serious mental illness in meeting their health needs in the community; the PNP will be adapted so peer navigators can augment the impact of BWLI in food and activity deserts. As compared with men, African American women with serious mental illness are at an even higher risk for lifetime prevalence of obesity (Baskaran et al., 2014; Galletly et al., 2012). Through an administrative supplement, investigators have augmented the approach of our study to understand the role of gender on the attainment of weight goals, with a specific focus on trauma, an experience of particular importance to women's health. Two-hundred and seventy (270) African Americans with serious mental illness who are overweight or obese will be randomized to one of three conditions after baseline assessments: integrated physical and mental health care, integrated physical and mental health care plus BWLI, or integrated physical and mental health care plus BWLI and peer navigator (PN). The BWLI has a 8-month intervention phase followed by a 4-month maintenance phase. The intervention includes group weight management classes, physical activity, individual visits to address barriers to meeting goals and to develop skills, and weigh-ins. PNs will partner with participants on BWLI assignments, meet with participants and BWLI facilitators, or accompany participants to health care appointments and follow-up. In addition, PNs and participants will team up to assess community diet and activity resources, and based on this review, will develop strategies to address their diet and physical activity needs. Investigators seek 70 participants per condition (N=210) to reach statistical power goals. Investigators will recruit 270 participants to account for expected loss-to-followup. Investigators will enroll participants in discrete cohorts every nine months. Investigators will analyze fidelity, process, outcome and impact data, including the effect of BWLI and BWLI and PN on weight, waist circumference, blood pressure, health behavior, physical and mental health, recovery and quality of life. Measures will be repeated at 4, 8, and 12 months. To understand the impact of gender, investigators will stratify the sample on gender at recruitment and analyze all program outcome measures by gender. To better understand the impact of trauma, investigators will determine if trauma exposure moderates the effect of the study intervention. Investigators will also conduct post-hoc analyses to determine if gender matching between PNs and participants (e.g., female-female and male-male) led to better effects. Investigators' main hypothesis is that the BWLI and PN condition will lead to greater weight loss and enhanced health behaviors compared with the two other conditions. Findings will advance knowledge and services to reduce racial disparities in obesity and comorbid health conditions for African Americans with serious mental illnesses.
Interventions
BEHAVIORALBWLI
BWLI includes group weight management classes, physical activity classes, individual sessions with a facilitator to address goals and barriers to weight loss, and weigh-ins. A punch card system will be implemented to incentivize participation for BHL classes. Each participant from the BWLI condition will be given a punch card, each punch card contains 10 spaces of punches, and will receive a punch at the end of each class (either BHL or physical activity) they attend. No punch will be given if they are more than 15 minutes late for BHL class or more than 5 minutes late for physical activity class. Participants can earn $5 per punch for up to $250. They will be allowed to cash in for $50 Visa gift card every 10 punches. They cannot cash in for a partially filled card. They must have the 10 full punches to cash in.
BEHAVIORALBWLI & Peer Navigator
Participants receive the BWLI condition and partner with a peer navigator. Peer navigators will meet individually and face-to-face with participants to address their health and weight goals (i.e. working on BWLI homework, attending health care appointments, and facilitating diet and exercise activities). A punch card system will be implemented to incentivize participation for BHL classes. Each participant from BWLI & Peer Navigator will be given a punch card, each punch card contains 10 spaces of punches, and will receive a punch at the end of each class (either BHL or physical activity) they attend. No punch will be given if they are more than 15 minutes late for BHL class or more than 5 minutes late for physical activity class. Participants can earn $5 per punch for up to $250. They will be allowed to cash in for $50 Visa gift card every 10 punches. They cannot cash in for a partially filled card. They must have the 10 full punches to cash in.
BEHAVIORALIntegrated Care
Participants receive integrated physical and mental health care from their usual provider.
Sponsors
National Institute on Minority Health and Health Disparities (NIMHD)
ACCESS Community Health Network
Trilogy Inc. Behavioral Healthcare
Illinois Institute of Technology
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
The behavioral weight loss intervention (BWLI) consists of an 8-month intervention phase followed by a 4-month maintenance phase. The initial intervention phase comprises four types of contact: 1) One-hour to one and a half hour group weight management class led by facilitator (once per week); 2) 45-minute physical activity class led by facilitator (1-2 per week); 3) 20-minute, individual visit with facilitator (once per month); 4) Weigh-in (once each week). Persons are randomly assigned to peer navigators to begin simultaneously with BWLI and run concurrently across the eight months of the intervention. PNs may work with participants to partner on BWLI homework, meet with participant and BWLI facilitator individually, attend health care appointments, and partner on tasks that arise out of those appointments.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* African American * Age 18 or older * Serious mental illness (as indicated by disability) * Identifies as either male or female * Concerned about weight and health goals * Willing to attend * BMI of greater than or equal to 28
Exclusion criteria
* Currently receiving services from a peer support specialist or community health worker to work on weight-related goals * Weigh more than 440 pounds * Lifetime diagnosis of eating disorder * Pregnant or plan to become pregnant * Lifetime bariatric surgery * No doctor permission for exercise * Taking medication for weight loss
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Weight | 0, 4, 8 and 12 months | Change in Weight (pounds/lbs) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Recovery Assessment Scale-Revised (RAS-R) | 0, 8 months | Based on Original Recovery Assessment Scale. RAS-Revised is shorter 24 item scale with individual items representing aspects of recovery to which participants respond on a 5-point agreement scale (1=strongly disagree, 5=strongly agree).There are five factors (1) personal confidence and hope; (2) willingness to ask for help; (3) goal and success orientation; (4) reliance on others; (5) not dominated by symptoms. Range from 24-120. Higher scores indicate better outcome (better recovery). |
| Weight Efficacy Lifetime (WEL) Questionnaire | 0, 8 months | Weight Efficacy Lifestyle Questionnaire. 20 items. Assesses participant confidence in resisting eating in some typical eating situations. Items rated on scale from 0=Not confident at all to 9=Very confident. Scores range from 0 to 180. Higher scores indicate better outcome (greater eating self-efficacy). |
| Self-Efficacy for Exercise Scale | 0, 8 months | Assesses participant beliefs in their ability to continue exercising on a three-time per week basis at moderate intensities. Range from 0 to 90. Higher score = better. |
| Waist Circumference | 0, 4, 8, 12 months | Change in waist circumference |
| Blood Pressure | 0, 4, 8, 12 months | Mean diastolic and systolic blood pressure (BP), in millimeters of mercury (mmHg) across 4 time frames. |
| Quality of Life Scale (QLS) | 0, 8 months | Quality of Life Scale. Assesses life domains including general life, daily activities, and social contact. 6-items assessing how participants feel about different aspects of their lives including as a whole, accomplishments, how they handle problems, family, and activities (1=Terrible, 7=Delighted). Range from 0 to 126. Higher scores indicate better outcome (better quality of life). |
| 36-Item Short Form Health Survey (SF-36) | 0, 8 months | 36-Item Short Form Health Survey. Assess change in participants' health status and health related quality of life. Includes 4 subscales: (1) General health, (2) bodily pain, (3) physical functioning, (4) emotional well-being; range from 0-100 for each subscale. Higher score indicates better outcome. |
| Center for Epidemiologic Studies Depression Scale-Depression(CES-D) | 0, 8 months | Assess change in participants' experienced symptoms associated with depression. 10 items. Range from 0-60. Higher score indicates worse outcome (greater depressive symptoms). |
| Evidence-Based Practices Use (EBPU) | 0 months | Assess change in participants' enrollment in clinical and service interventions. Range from 0-10, higher scores = better outcome. |
| Emotional Eating Scale (EES) | 0, 8 months | Assess change in participants' experienced negative emotions and their relationships with desire to eat. 25 items. (0=No desire to eat, 5=Overwhelming urge to eat). Comprised of 3 subscales, added together for a total score. Range from 0 to 125. Higher scores indicate worse outcome (stronger desire to eat). |
| Life Events Checklist for DSM-5 | Baseline | Life Events Checklist (LEC) for Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5). Assess participants experiences of potential traumatic events on a 6-point nominal scale, across 16 types of traumatic events. No formal scoring protocol or interpretation recommended. Reported scores indicate average amount of distress by traumatic event type. Higher values indicate greater distress from exposure to trauma = worse outcomes (Minimum = 0, maximum = 7). |
| Height | 0 Month (Baseline) | Measure participants' height (inches) |
Countries
United States
Participant flow
Pre-assignment details
213 participants were assigned to an arm/group.
Participants by arm
| Arm | Count |
|---|---|
| Behavioral Weight Loss Intervention Participants will enroll in the BWLI program for 12 months. BWLI consists of a 8-month initial intervention phase followed by 4-month maintenance phase. The initial intervention phase comprises four types of contact:
* 1-hour to 1-hour, 30 minute group weight-management class led by facilitator (once per week; 26 classes followed by a one week break and an additional 8 weight management review classes)
* 45 minute, physical activity led by facilitator (one-two times per week);
* 20 minute, monthly individual visit with facilitator to address barriers to goals and appropriate skills; and
* weigh-in during weight management group and individual visits (once each week). | 69 |
| BWLI & Peer Navigator Participants randomly assigned to this condition will begin simultaneously with BWLI and run concurrently across the eight months of the intervention. Peer navigators will meet individually and face-to-face with research participants in time and places convenient to the person as needed. Specific practices are determined by the research participant with the peer navigator and may include:
* partnering with participant on BWLI homework;
* meeting with participant and BWLI facilitator individually;
* attending all other health care appointments; and
* partnering on tasks that arise out of those appointments. | 74 |
| Integrated Care (Treatment as Usual) Participants in this arm will receive integrated care from their usual provider, which is treatment as usual. Integrated care is mental health specialty and general medical care providers working together to address the physical and behavioral health care needs of patients. One-third of research participants will be randomized to integrated care alone.
Integrated Care: Participants receive integrated physical and mental health care from their usual provider. | 70 |
| Total | 213 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Cohort 1 | Withdrawal by Subject | 11 | 5 | 0 |
| Cohort 2 | Withdrawal by Subject | 1 | 1 | 0 |
| Cohort 3 | Withdrawal by Subject | 1 | 2 | 0 |
Baseline characteristics
| Characteristic | Behavioral Weight Loss Intervention | BWLI & Peer Navigator | Integrated Care (Treatment as Usual) | Total |
|---|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 3 Participants | 5 Participants | 2 Participants | 10 Participants |
| Age, Categorical Between 18 and 65 years | 66 Participants | 69 Participants | 68 Participants | 203 Participants |
| Age, Continuous | 49.93 years STANDARD_DEVIATION 10.48 | 52.91 years STANDARD_DEVIATION 8.81 | 51.37 years STANDARD_DEVIATION 8.55 | 51.4 years STANDARD_DEVIATION 9.3 |
| CES-D (Depression) | 23.79 units on a scale STANDARD_DEVIATION 11.87 | 23.67 units on a scale STANDARD_DEVIATION 10.97 | 21.93 units on a scale STANDARD_DEVIATION 11.25 | 23.15 units on a scale STANDARD_DEVIATION 11.24 |
| EES (Emotional Eating) | 42.14 units on a scale STANDARD_DEVIATION 23.25 | 43.14 units on a scale STANDARD_DEVIATION 21.15 | 40.90 units on a scale STANDARD_DEVIATION 21.15 | 43.00 units on a scale STANDARD_DEVIATION 21.52 |
| Healthy Lifestyle Behaviors: Diet Subscale | 18.12 units on a scale STANDARD_DEVIATION 4.78 | 18.20 units on a scale STANDARD_DEVIATION 4.56 | 18.54 units on a scale STANDARD_DEVIATION 4.87 | 18.29 units on a scale STANDARD_DEVIATION 4.74 |
| Healthy Lifestyle Behaviors: Physical Activity Subscale | 14.86 units on a scale STANDARD_DEVIATION 4.16 | 14.38 units on a scale STANDARD_DEVIATION 3.78 | 14.38 units on a scale STANDARD_DEVIATION 4.06 | 14.54 units on a scale STANDARD_DEVIATION 4 |
| Healthy Lifestyle Behaviors Total | 34.82 units on a scale STANDARD_DEVIATION 8.03 | 34.51 units on a scale STANDARD_DEVIATION 6.56 | 35.16 units on a scale STANDARD_DEVIATION 7.85 | 34.70 units on a scale STANDARD_DEVIATION 7.3 |
| QLS (Quality of Life) | 27.61 units on a scale STANDARD_DEVIATION 8.12 | 27.00 units on a scale STANDARD_DEVIATION 6.78 | 27.58 units on a scale STANDARD_DEVIATION 6.91 | 27.20 units on a scale STANDARD_DEVIATION 7.35 |
| Race/Ethnicity, Customized African American | 69 participants | 74 participants | 70 participants | 213 participants |
| Race/Ethnicity, Customized American Indian/Alaskan Native | 3 participants | 3 participants | 6 participants | 12 participants |
| Race/Ethnicity, Customized Asian | 1 participants | 1 participants | 0 participants | 2 participants |
| Race/Ethnicity, Customized Hispanic/Latino | 4 participants | 5 participants | 1 participants | 10 participants |
| Race/Ethnicity, Customized Native Hawaiian/Pacific Islander | 0 participants | 2 participants | 1 participants | 3 participants |
| Race/Ethnicity, Customized Other | 3 participants | 2 participants | 3 participants | 8 participants |
| Race/Ethnicity, Customized White/Caucasian | 9 participants | 2 participants | 4 participants | 15 participants |
| RAS-R (Recovery) | 95.73 units on a scale STANDARD_DEVIATION 13.81 | 95.32 units on a scale STANDARD_DEVIATION 12.44 | 98.21 units on a scale STANDARD_DEVIATION 11.96 | 96.24 units on a scale STANDARD_DEVIATION 12.61 |
| Region of Enrollment United States | 69 participants | 74 participants | 70 participants | 213 participants |
| Sex: Female, Male Female | 44 Participants | 40 Participants | 40 Participants | 124 Participants |
| Sex: Female, Male Male | 25 Participants | 34 Participants | 30 Participants | 89 Participants |
| SF-36 Subscale: Bodily Pain | 59.87 units on a scale STANDARD_DEVIATION 26.25 | 61.94 units on a scale STANDARD_DEVIATION 28.91 | 59.96 units on a scale STANDARD_DEVIATION 27.31 | 61.15 units on a scale STANDARD_DEVIATION 26.9 |
| SF-36 Subscale: Emotional Well-Being | 63.58 units on a scale STANDARD_DEVIATION 20.57 | 60.43 units on a scale STANDARD_DEVIATION 21.17 | 63.43 units on a scale STANDARD_DEVIATION 23.53 | 62.40 units on a scale STANDARD_DEVIATION 21.53 |
| SF-36 Subscale: General Health | 60.20 units on a scale STANDARD_DEVIATION 23.05 | 58.00 units on a scale STANDARD_DEVIATION 22.11 | 59.13 units on a scale STANDARD_DEVIATION 22.66 | 58.59 units on a scale STANDARD_DEVIATION 22.72 |
| SF-36 Subscale: Physical Functioning | 63.86 units on a scale STANDARD_DEVIATION 25.07 | 67.00 units on a scale STANDARD_DEVIATION 26.51 | 69.23 units on a scale STANDARD_DEVIATION 22.2 | 66.02 units on a scale STANDARD_DEVIATION 25.69 |
| WEL (Weight Efficacy Lifestyle) | 102.83 units on a scale STANDARD_DEVIATION 38.32 | 99.22 units on a scale STANDARD_DEVIATION 31.48 | 99.26 units on a scale STANDARD_DEVIATION 32.35 | 99.99 units on a scale STANDARD_DEVIATION 33.69 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 69 | 0 / 74 | 0 / 70 |
| other Total, other adverse events | 0 / 69 | 0 / 74 | 0 / 70 |
| serious Total, serious adverse events | 1 / 69 | 1 / 74 | 0 / 70 |
Outcome results
Primary
Weight
Change in Weight (pounds/lbs)
Time frame: 0, 4, 8 and 12 months
Population: Data collection for Weight variable was challenging (COVID, transition to online) and ultimately discontinued after Cohort 1. The results and intent-to-treat analyses for Weight are based on data from subset of participants before Weight data collection ceased.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Behavioral Weight Loss Intervention | Weight | 12-Month | 228.86 pounds (lbs) | Standard Deviation 41.29 |
| Behavioral Weight Loss Intervention | Weight | 4-Month | 225.63 pounds (lbs) | Standard Deviation 42.58 |
| Behavioral Weight Loss Intervention | Weight | 8-Month | 227.66 pounds (lbs) | Standard Deviation 42.12 |
| Behavioral Weight Loss Intervention | Weight | Baseline | 226.54 pounds (lbs) | Standard Deviation 41.22 |
| BWLI & Peer Navigator | Weight | 8-Month | 223.25 pounds (lbs) | Standard Deviation 50.63 |
| BWLI & Peer Navigator | Weight | 12-Month | 222.41 pounds (lbs) | Standard Deviation 50.13 |
| BWLI & Peer Navigator | Weight | Baseline | 225.46 pounds (lbs) | Standard Deviation 52.94 |
| BWLI & Peer Navigator | Weight | 4-Month | 223.21 pounds (lbs) | Standard Deviation 51.27 |
| Integrated Care (Treatment as Usual) | Weight | 12-Month | 216.65 pounds (lbs) | Standard Deviation 39.54 |
| Integrated Care (Treatment as Usual) | Weight | 4-Month | 214.85 pounds (lbs) | Standard Deviation 40.99 |
| Integrated Care (Treatment as Usual) | Weight | 8-Month | 216.03 pounds (lbs) | Standard Deviation 39.62 |
| Integrated Care (Treatment as Usual) | Weight | Baseline | 218.19 pounds (lbs) | Standard Deviation 40.41 |
p-value: 0.025ANOVA
Secondary
36-Item Short Form Health Survey (SF-36)
36-Item Short Form Health Survey. Assess change in participants' health status and health related quality of life. Includes 4 subscales: (1) General health, (2) bodily pain, (3) physical functioning, (4) emotional well-being; range from 0-100 for each subscale. Higher score indicates better outcome.
Time frame: 0, 8 months
Population: Analysis was performed on intention-to-treat. Participants were categorized based on research condition assigned at baseline regardless of BHL or PHN attendance.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Behavioral Weight Loss Intervention | 36-Item Short Form Health Survey (SF-36) | 0 Month-General Health Subscale (Baseline) | 60.20 score on a scale | Standard Deviation 23.05 |
| Behavioral Weight Loss Intervention | 36-Item Short Form Health Survey (SF-36) | 0 Month-Bodily Pain Subscale (Baseline) | 59.87 score on a scale | Standard Deviation 26.25 |
| Behavioral Weight Loss Intervention | 36-Item Short Form Health Survey (SF-36) | 0 Month-Physical Functioning Subscale (Baseline) | 63.86 score on a scale | Standard Deviation 25.07 |
| Behavioral Weight Loss Intervention | 36-Item Short Form Health Survey (SF-36) | 0 Month-Emotional Well-Being Subscale (Baseline) | 63.58 score on a scale | Standard Deviation 20.57 |
| Behavioral Weight Loss Intervention | 36-Item Short Form Health Survey (SF-36) | 8 Month-General Health Subscale | 62.11 score on a scale | Standard Deviation 20.53 |
| Behavioral Weight Loss Intervention | 36-Item Short Form Health Survey (SF-36) | 8 Month-Bodily Pain Subscale | 58.11 score on a scale | Standard Deviation 27.13 |
| Behavioral Weight Loss Intervention | 36-Item Short Form Health Survey (SF-36) | 8 Month-Physical Functioning Subscale | 59.74 score on a scale | Standard Deviation 27.72 |
| Behavioral Weight Loss Intervention | 36-Item Short Form Health Survey (SF-36) | 8 Month-Emotional Well-Being Subscale | 64.49 score on a scale | Standard Deviation 20.7 |
| BWLI & Peer Navigator | 36-Item Short Form Health Survey (SF-36) | 0 Month-Physical Functioning Subscale (Baseline) | 67.00 score on a scale | Standard Deviation 26.51 |
| BWLI & Peer Navigator | 36-Item Short Form Health Survey (SF-36) | 8 Month-Physical Functioning Subscale | 68.54 score on a scale | Standard Deviation 27.23 |
| BWLI & Peer Navigator | 36-Item Short Form Health Survey (SF-36) | 0 Month-Emotional Well-Being Subscale (Baseline) | 60.43 score on a scale | Standard Deviation 21.17 |
| BWLI & Peer Navigator | 36-Item Short Form Health Survey (SF-36) | 8 Month-General Health Subscale | 64.23 score on a scale | Standard Deviation 21.96 |
| BWLI & Peer Navigator | 36-Item Short Form Health Survey (SF-36) | 8 Month-Bodily Pain Subscale | 63.25 score on a scale | Standard Deviation 29.94 |
| BWLI & Peer Navigator | 36-Item Short Form Health Survey (SF-36) | 0 Month-General Health Subscale (Baseline) | 58.00 score on a scale | Standard Deviation 22.11 |
| BWLI & Peer Navigator | 36-Item Short Form Health Survey (SF-36) | 0 Month-Bodily Pain Subscale (Baseline) | 61.94 score on a scale | Standard Deviation 28.91 |
| BWLI & Peer Navigator | 36-Item Short Form Health Survey (SF-36) | 8 Month-Emotional Well-Being Subscale | 67.20 score on a scale | Standard Deviation 18.27 |
| Integrated Care (Treatment as Usual) | 36-Item Short Form Health Survey (SF-36) | 0 Month-Physical Functioning Subscale (Baseline) | 69.23 score on a scale | Standard Deviation 22.2 |
| Integrated Care (Treatment as Usual) | 36-Item Short Form Health Survey (SF-36) | 0 Month-Bodily Pain Subscale (Baseline) | 59.96 score on a scale | Standard Deviation 27.31 |
| Integrated Care (Treatment as Usual) | 36-Item Short Form Health Survey (SF-36) | 0 Month-General Health Subscale (Baseline) | 59.13 score on a scale | Standard Deviation 22.66 |
| Integrated Care (Treatment as Usual) | 36-Item Short Form Health Survey (SF-36) | 0 Month-Emotional Well-Being Subscale (Baseline) | 63.43 score on a scale | Standard Deviation 23.53 |
| Integrated Care (Treatment as Usual) | 36-Item Short Form Health Survey (SF-36) | 8 Month-Physical Functioning Subscale | 60.48 score on a scale | Standard Deviation 28.12 |
| Integrated Care (Treatment as Usual) | 36-Item Short Form Health Survey (SF-36) | 8 Month-Bodily Pain Subscale | 59.52 score on a scale | Standard Deviation 26.29 |
| Integrated Care (Treatment as Usual) | 36-Item Short Form Health Survey (SF-36) | 8 Month-General Health Subscale | 58.17 score on a scale | Standard Deviation 24.92 |
| Integrated Care (Treatment as Usual) | 36-Item Short Form Health Survey (SF-36) | 8 Month-Emotional Well-Being Subscale | 68.32 score on a scale | Standard Deviation 18.86 |
p-value: 0.121ANOVA
Comparison: As-treated analyses. General Health subscale.p-value: 0.193ANOVA
Comparison: Intention-to-treat analyses. Bodily Pain subscale.p-value: 0.835ANOVA
Comparison: As-treated analyses, Bodily Pain subscale.p-value: 0.513ANOVA
Comparison: Intention-to-treat analyses, Physical Functioning subscale.p-value: 0.097ANOVA
Comparison: As-treated analyses, Physical Functioning subscale.p-value: 0.184ANOVA
Comparison: Intention-to-treat analyses. Emotional Well-Being subscale.p-value: 0.347ANOVA
Comparison: As-treated analyses, Emotional Well-Being subscale.p-value: 0.549ANOVA
Secondary
Blood Pressure
Mean diastolic and systolic blood pressure (BP), in millimeters of mercury (mmHg) across 4 time frames.
Time frame: 0, 4, 8, 12 months
Population: Data collection for Blood Pressure variable was challenging (COVID, transition to online) and ultimately discontinued after Cohort 1. The results and intent-to-treat analyses for Blood Pressure are based on data from subset of participants before Blood Pressure data collection ceased.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Behavioral Weight Loss Intervention | Blood Pressure | 12 Month Mean diastolic BP | 86.70 millimeters of mercury (mmHg) | Standard Deviation 13.25 |
| Behavioral Weight Loss Intervention | Blood Pressure | 0 Month (Baseline) Mean systolic BP | 127.39 millimeters of mercury (mmHg) | Standard Deviation 15.52 |
| Behavioral Weight Loss Intervention | Blood Pressure | 4 Month Mean diastolic BP | 87.22 millimeters of mercury (mmHg) | Standard Deviation 14.13 |
| Behavioral Weight Loss Intervention | Blood Pressure | 12 Month Mean systolic BP | 130.06 millimeters of mercury (mmHg) | Standard Deviation 19.89 |
| Behavioral Weight Loss Intervention | Blood Pressure | 8 Month Mean systolic BP | 132.83 millimeters of mercury (mmHg) | Standard Deviation 21.3 |
| Behavioral Weight Loss Intervention | Blood Pressure | 4 Month Mean systolic BP | 129.35 millimeters of mercury (mmHg) | Standard Deviation 18.34 |
| Behavioral Weight Loss Intervention | Blood Pressure | 0 Month (Baseline) Mean diastolic BP | 89.11 millimeters of mercury (mmHg) | Standard Deviation 13.12 |
| Behavioral Weight Loss Intervention | Blood Pressure | 8 Month Mean diastolic BP | 86.87 millimeters of mercury (mmHg) | Standard Deviation 13.79 |
| BWLI & Peer Navigator | Blood Pressure | 4 Month Mean systolic BP | 129.12 millimeters of mercury (mmHg) | Standard Deviation 25.78 |
| BWLI & Peer Navigator | Blood Pressure | 0 Month (Baseline) Mean diastolic BP | 92.10 millimeters of mercury (mmHg) | Standard Deviation 12.55 |
| BWLI & Peer Navigator | Blood Pressure | 12 Month Mean systolic BP | 133.68 millimeters of mercury (mmHg) | Standard Deviation 24.34 |
| BWLI & Peer Navigator | Blood Pressure | 0 Month (Baseline) Mean systolic BP | 124.98 millimeters of mercury (mmHg) | Standard Deviation 25.97 |
| BWLI & Peer Navigator | Blood Pressure | 12 Month Mean diastolic BP | 87.46 millimeters of mercury (mmHg) | Standard Deviation 12.06 |
| BWLI & Peer Navigator | Blood Pressure | 8 Month Mean diastolic BP | 83.20 millimeters of mercury (mmHg) | Standard Deviation 12.31 |
| BWLI & Peer Navigator | Blood Pressure | 4 Month Mean diastolic BP | 86.62 millimeters of mercury (mmHg) | Standard Deviation 14.54 |
| BWLI & Peer Navigator | Blood Pressure | 8 Month Mean systolic BP | 124.80 millimeters of mercury (mmHg) | Standard Deviation 21.18 |
| Integrated Care (Treatment as Usual) | Blood Pressure | 12 Month Mean diastolic BP | 86.52 millimeters of mercury (mmHg) | Standard Deviation 9.26 |
| Integrated Care (Treatment as Usual) | Blood Pressure | 0 Month (Baseline) Mean systolic BP | 126.85 millimeters of mercury (mmHg) | Standard Deviation 25.79 |
| Integrated Care (Treatment as Usual) | Blood Pressure | 0 Month (Baseline) Mean diastolic BP | 90.27 millimeters of mercury (mmHg) | Standard Deviation 14.23 |
| Integrated Care (Treatment as Usual) | Blood Pressure | 4 Month Mean systolic BP | 125.93 millimeters of mercury (mmHg) | Standard Deviation 15.99 |
| Integrated Care (Treatment as Usual) | Blood Pressure | 8 Month Mean systolic BP | 125.43 millimeters of mercury (mmHg) | Standard Deviation 18.22 |
| Integrated Care (Treatment as Usual) | Blood Pressure | 8 Month Mean diastolic BP | 85.63 millimeters of mercury (mmHg) | Standard Deviation 13.16 |
| Integrated Care (Treatment as Usual) | Blood Pressure | 12 Month Mean systolic BP | 130.95 millimeters of mercury (mmHg) | Standard Deviation 14.02 |
| Integrated Care (Treatment as Usual) | Blood Pressure | 4 Month Mean diastolic BP | 84.50 millimeters of mercury (mmHg) | Standard Deviation 10.06 |
Comparison: Mean systolic blood pressurep-value: 0.09ANOVA
Comparison: Mean diastolic blood pressurep-value: 0.05ANOVA
Secondary
Center for Epidemiologic Studies Depression Scale-Depression(CES-D)
Assess change in participants' experienced symptoms associated with depression. 10 items. Range from 0-60. Higher score indicates worse outcome (greater depressive symptoms).
Time frame: 0, 8 months
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Behavioral Weight Loss Intervention | Center for Epidemiologic Studies Depression Scale-Depression(CES-D) | Baseline | 23.79 score on a scale | Standard Deviation 11.87 |
| Behavioral Weight Loss Intervention | Center for Epidemiologic Studies Depression Scale-Depression(CES-D) | 8-Month | 21.04 score on a scale | Standard Deviation 12.93 |
| BWLI & Peer Navigator | Center for Epidemiologic Studies Depression Scale-Depression(CES-D) | Baseline | 23.67 score on a scale | Standard Deviation 10.97 |
| BWLI & Peer Navigator | Center for Epidemiologic Studies Depression Scale-Depression(CES-D) | 8-Month | 20.53 score on a scale | Standard Deviation 12.09 |
| Integrated Care (Treatment as Usual) | Center for Epidemiologic Studies Depression Scale-Depression(CES-D) | 8-Month | 20.07 score on a scale | Standard Deviation 11.22 |
| Integrated Care (Treatment as Usual) | Center for Epidemiologic Studies Depression Scale-Depression(CES-D) | Baseline | 21.93 score on a scale | Standard Deviation 11.25 |
Comparison: Intention-to-treat analysesp-value: 0.855ANOVA
Comparison: As-treated analysesp-value: 0.915ANOVA
Secondary
Emotional Eating Scale (EES)
Assess change in participants' experienced negative emotions and their relationships with desire to eat. 25 items. (0=No desire to eat, 5=Overwhelming urge to eat). Comprised of 3 subscales, added together for a total score. Range from 0 to 125. Higher scores indicate worse outcome (stronger desire to eat).
Time frame: 0, 8 months
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Behavioral Weight Loss Intervention | Emotional Eating Scale (EES) | Baseline | 42.14 score on a scale | Standard Deviation 23.25 |
| Behavioral Weight Loss Intervention | Emotional Eating Scale (EES) | 8-Month | 35.60 score on a scale | Standard Deviation 20.58 |
| BWLI & Peer Navigator | Emotional Eating Scale (EES) | Baseline | 43.14 score on a scale | Standard Deviation 21.15 |
| BWLI & Peer Navigator | Emotional Eating Scale (EES) | 8-Month | 33.63 score on a scale | Standard Deviation 21.26 |
| Integrated Care (Treatment as Usual) | Emotional Eating Scale (EES) | Baseline | 40.90 score on a scale | Standard Deviation 21.15 |
| Integrated Care (Treatment as Usual) | Emotional Eating Scale (EES) | 8-Month | 36.61 score on a scale | Standard Deviation 21.38 |
Comparison: Intent-to-treat analysesp-value: 0.508ANOVA
Comparison: As-treated analysesp-value: 0.198ANOVA
Secondary
Evidence-Based Practices Use (EBPU)
Assess change in participants' enrollment in clinical and service interventions. Range from 0-10, higher scores = better outcome.
Time frame: 0 months
Population: Due to COVID-19, interviews were transitioned online to be conducted virtually. In order to minimize participant fatigue, secondary outcome measures including this Evidence-Based Practices Use (EBPU) were discontinued.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Behavioral Weight Loss Intervention | Evidence-Based Practices Use (EBPU) | 4.07 score on a scale | Standard Deviation 2.46 |
| BWLI & Peer Navigator | Evidence-Based Practices Use (EBPU) | 4.21 score on a scale | Standard Deviation 2.65 |
| Integrated Care (Treatment as Usual) | Evidence-Based Practices Use (EBPU) | 4.09 score on a scale | Standard Deviation 2.48 |
Secondary
Height
Measure participants' height (inches)
Time frame: 0 Month (Baseline)
Population: Physical measurement only collected once (at Baseline)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Behavioral Weight Loss Intervention | Height | 65.38 inches | Standard Deviation 3.65 |
| BWLI & Peer Navigator | Height | 66.68 inches | Standard Deviation 3.85 |
| Integrated Care (Treatment as Usual) | Height | 66.29 inches | Standard Deviation 4.7 |
Secondary
Life Events Checklist for DSM-5
Life Events Checklist (LEC) for Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5). Assess participants experiences of potential traumatic events on a 6-point nominal scale, across 16 types of traumatic events. No formal scoring protocol or interpretation recommended. Reported scores indicate average amount of distress by traumatic event type. Higher values indicate greater distress from exposure to trauma = worse outcomes (Minimum = 0, maximum = 7).
Time frame: Baseline
Population: Due to COVID-19, interviews were transitioned online to be conducted virtually. In order to minimize participant fatigue, secondary outcome measures, including this Life Events Checklist for DSM-5 was discontinued. Overall number of participants analyzed refers to those who completed the measure before it was discontinued. Number of participants analyzed in each row endorsed history of that trauma type. There was not enough data collected for further analysis.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Behavioral Weight Loss Intervention | Life Events Checklist for DSM-5 | Fire or Explosion | 3.86 score on a scale | Standard Deviation 2.21 |
| Behavioral Weight Loss Intervention | Life Events Checklist for DSM-5 | Serious Injury, Harm, or Death Caused | 5.67 score on a scale | Standard Deviation 1.21 |
| Behavioral Weight Loss Intervention | Life Events Checklist for DSM-5 | Sexual Assault | 5.82 score on a scale | Standard Deviation 1.68 |
| Behavioral Weight Loss Intervention | Life Events Checklist for DSM-5 | Natural Disaster | 4.08 score on a scale | Standard Deviation 2.53 |
| Behavioral Weight Loss Intervention | Life Events Checklist for DSM-5 | Severe Human Suffering | 5.41 score on a scale | Standard Deviation 1.42 |
| Behavioral Weight Loss Intervention | Life Events Checklist for DSM-5 | Other Unwanted or Uncomfortable Sexual Experience | 5.12 score on a scale | Standard Deviation 1.5 |
| Behavioral Weight Loss Intervention | Life Events Checklist for DSM-5 | Serious Accident at Work/Home/Recreational | 4.06 score on a scale | Standard Deviation 1.53 |
| Behavioral Weight Loss Intervention | Life Events Checklist for DSM-5 | Life-threatening Illness or Injury | 5.00 score on a scale | Standard Deviation 1.8 |
| Behavioral Weight Loss Intervention | Life Events Checklist for DSM-5 | Combat | 2.80 score on a scale | Standard Deviation 1.3 |
| Behavioral Weight Loss Intervention | Life Events Checklist for DSM-5 | Any Other Very Stressful Event | 6.67 score on a scale | Standard Deviation 0.52 |
| Behavioral Weight Loss Intervention | Life Events Checklist for DSM-5 | Captivity | 5.62 score on a scale | Standard Deviation 2.07 |
| Behavioral Weight Loss Intervention | Life Events Checklist for DSM-5 | Involuntary Hospitalization | 4.26 score on a scale | Standard Deviation 2.33 |
| Behavioral Weight Loss Intervention | Life Events Checklist for DSM-5 | Exposure to Toxic Substance | 4.00 score on a scale | Standard Deviation 2.97 |
| Behavioral Weight Loss Intervention | Life Events Checklist for DSM-5 | Exposure to Neighborhood Violence | 4.61 score on a scale | Standard Deviation 2.31 |
| Behavioral Weight Loss Intervention | Life Events Checklist for DSM-5 | Homelessness | 4.60 score on a scale | Standard Deviation 2.16 |
| Behavioral Weight Loss Intervention | Life Events Checklist for DSM-5 | Physical Assault Without a Weapon | 4.96 score on a scale | Standard Deviation 1.97 |
| Behavioral Weight Loss Intervention | Life Events Checklist for DSM-5 | Transportation Accident | 4.28 score on a scale | Standard Deviation 1.9 |
| Behavioral Weight Loss Intervention | Life Events Checklist for DSM-5 | Incarceration | 4.52 score on a scale | Standard Deviation 2.15 |
| Behavioral Weight Loss Intervention | Life Events Checklist for DSM-5 | Assault With a Weapon | 4.82 score on a scale | Standard Deviation 1.97 |
| BWLI & Peer Navigator | Life Events Checklist for DSM-5 | Involuntary Hospitalization | 3.94 score on a scale | Standard Deviation 2.72 |
| BWLI & Peer Navigator | Life Events Checklist for DSM-5 | Natural Disaster | 3.71 score on a scale | Standard Deviation 2.05 |
| BWLI & Peer Navigator | Life Events Checklist for DSM-5 | Fire or Explosion | 3.52 score on a scale | Standard Deviation 2.48 |
| BWLI & Peer Navigator | Life Events Checklist for DSM-5 | Transportation Accident | 3.84 score on a scale | Standard Deviation 2.49 |
| BWLI & Peer Navigator | Life Events Checklist for DSM-5 | Serious Accident at Work/Home/Recreational | 4.67 score on a scale | Standard Deviation 2.54 |
| BWLI & Peer Navigator | Life Events Checklist for DSM-5 | Exposure to Toxic Substance | 4.88 score on a scale | Standard Deviation 2.64 |
| BWLI & Peer Navigator | Life Events Checklist for DSM-5 | Physical Assault Without a Weapon | 4.66 score on a scale | Standard Deviation 2.43 |
| BWLI & Peer Navigator | Life Events Checklist for DSM-5 | Assault With a Weapon | 5.04 score on a scale | Standard Deviation 2.29 |
| BWLI & Peer Navigator | Life Events Checklist for DSM-5 | Sexual Assault | 5.60 score on a scale | Standard Deviation 2.31 |
| BWLI & Peer Navigator | Life Events Checklist for DSM-5 | Other Unwanted or Uncomfortable Sexual Experience | 5.05 score on a scale | Standard Deviation 2.46 |
| BWLI & Peer Navigator | Life Events Checklist for DSM-5 | Combat | 4.00 score on a scale | Standard Deviation 4.24 |
| BWLI & Peer Navigator | Life Events Checklist for DSM-5 | Captivity | 5.33 score on a scale | Standard Deviation 1.51 |
| BWLI & Peer Navigator | Life Events Checklist for DSM-5 | Life-threatening Illness or Injury | 4.63 score on a scale | Standard Deviation 2.36 |
| BWLI & Peer Navigator | Life Events Checklist for DSM-5 | Severe Human Suffering | 5.14 score on a scale | Standard Deviation 2.32 |
| BWLI & Peer Navigator | Life Events Checklist for DSM-5 | Serious Injury, Harm, or Death Caused | 3.56 score on a scale | Standard Deviation 2.83 |
| BWLI & Peer Navigator | Life Events Checklist for DSM-5 | Incarceration | 3.86 score on a scale | Standard Deviation 2.7 |
| BWLI & Peer Navigator | Life Events Checklist for DSM-5 | Homelessness | 5.06 score on a scale | Standard Deviation 2.59 |
| BWLI & Peer Navigator | Life Events Checklist for DSM-5 | Exposure to Neighborhood Violence | 4.45 score on a scale | Standard Deviation 2.34 |
| BWLI & Peer Navigator | Life Events Checklist for DSM-5 | Any Other Very Stressful Event | 6.27 score on a scale | Standard Deviation 1.27 |
| Integrated Care (Treatment as Usual) | Life Events Checklist for DSM-5 | Severe Human Suffering | 5.57 score on a scale | Standard Deviation 1.79 |
| Integrated Care (Treatment as Usual) | Life Events Checklist for DSM-5 | Assault With a Weapon | 3.81 score on a scale | Standard Deviation 2.35 |
| Integrated Care (Treatment as Usual) | Life Events Checklist for DSM-5 | Any Other Very Stressful Event | 5.71 score on a scale | Standard Deviation 1.38 |
| Integrated Care (Treatment as Usual) | Life Events Checklist for DSM-5 | Serious Injury, Harm, or Death Caused | 6.11 score on a scale | Standard Deviation 1.36 |
| Integrated Care (Treatment as Usual) | Life Events Checklist for DSM-5 | Physical Assault Without a Weapon | 4.24 score on a scale | Standard Deviation 2.31 |
| Integrated Care (Treatment as Usual) | Life Events Checklist for DSM-5 | Exposure to Neighborhood Violence | 4.97 score on a scale | Standard Deviation 2 |
| Integrated Care (Treatment as Usual) | Life Events Checklist for DSM-5 | Incarceration | 4.15 score on a scale | Standard Deviation 2.49 |
| Integrated Care (Treatment as Usual) | Life Events Checklist for DSM-5 | Exposure to Toxic Substance | 5.00 score on a scale | Standard Deviation 1.89 |
| Integrated Care (Treatment as Usual) | Life Events Checklist for DSM-5 | Natural Disaster | 2.94 score on a scale | Standard Deviation 2.21 |
| Integrated Care (Treatment as Usual) | Life Events Checklist for DSM-5 | Homelessness | 4.75 score on a scale | Standard Deviation 2.34 |
| Integrated Care (Treatment as Usual) | Life Events Checklist for DSM-5 | Serious Accident at Work/Home/Recreational | 5.36 score on a scale | Standard Deviation 1.43 |
| Integrated Care (Treatment as Usual) | Life Events Checklist for DSM-5 | Combat | 3.30 score on a scale | Standard Deviation 2.41 |
| Integrated Care (Treatment as Usual) | Life Events Checklist for DSM-5 | Transportation Accident | 3.09 score on a scale | Standard Deviation 2.25 |
| Integrated Care (Treatment as Usual) | Life Events Checklist for DSM-5 | Captivity | 6.00 score on a scale | Standard Deviation 1.31 |
| Integrated Care (Treatment as Usual) | Life Events Checklist for DSM-5 | Other Unwanted or Uncomfortable Sexual Experience | 5.08 score on a scale | Standard Deviation 2.47 |
| Integrated Care (Treatment as Usual) | Life Events Checklist for DSM-5 | Involuntary Hospitalization | 4.65 score on a scale | Standard Deviation 2.18 |
| Integrated Care (Treatment as Usual) | Life Events Checklist for DSM-5 | Life-threatening Illness or Injury | 4.38 score on a scale | Standard Deviation 2.33 |
| Integrated Care (Treatment as Usual) | Life Events Checklist for DSM-5 | Sexual Assault | 4.73 score on a scale | Standard Deviation 2.27 |
| Integrated Care (Treatment as Usual) | Life Events Checklist for DSM-5 | Fire or Explosion | 3.09 score on a scale | Standard Deviation 2.37 |
Secondary
Quality of Life Scale (QLS)
Quality of Life Scale. Assesses life domains including general life, daily activities, and social contact. 6-items assessing how participants feel about different aspects of their lives including as a whole, accomplishments, how they handle problems, family, and activities (1=Terrible, 7=Delighted). Range from 0 to 126. Higher scores indicate better outcome (better quality of life).
Time frame: 0, 8 months
Population: Analysis was performed on intention-to-treat. Participants were categorized based on research condition assigned at baseline regardless of BHL or PHN attendance.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Behavioral Weight Loss Intervention | Quality of Life Scale (QLS) | Baseline | 27.61 score on a scale | Standard Deviation 8.12 |
| Behavioral Weight Loss Intervention | Quality of Life Scale (QLS) | 8-Month | 28.63 score on a scale | Standard Deviation 7.69 |
| BWLI & Peer Navigator | Quality of Life Scale (QLS) | Baseline | 27.00 score on a scale | Standard Deviation 6.78 |
| BWLI & Peer Navigator | Quality of Life Scale (QLS) | 8-Month | 28.53 score on a scale | Standard Deviation 6.83 |
| Integrated Care (Treatment as Usual) | Quality of Life Scale (QLS) | Baseline | 27.58 score on a scale | Standard Deviation 6.91 |
| Integrated Care (Treatment as Usual) | Quality of Life Scale (QLS) | 8-Month | 29.49 score on a scale | Standard Deviation 6.84 |
Comparison: Intent-to-treat analysesp-value: 0.784ANOVA
Comparison: As-treated analysesp-value: 0.81ANOVA
Secondary
Recovery Assessment Scale-Revised (RAS-R)
Based on Original Recovery Assessment Scale. RAS-Revised is shorter 24 item scale with individual items representing aspects of recovery to which participants respond on a 5-point agreement scale (1=strongly disagree, 5=strongly agree).There are five factors (1) personal confidence and hope; (2) willingness to ask for help; (3) goal and success orientation; (4) reliance on others; (5) not dominated by symptoms. Range from 24-120. Higher scores indicate better outcome (better recovery).
Time frame: 0, 8 months
Population: Analysis was performed on intention-to-treat. Participants were categorized based on research condition assigned at baseline regardless of BHL or PHN attendance.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Behavioral Weight Loss Intervention | Recovery Assessment Scale-Revised (RAS-R) | Baseline | 95.73 score on a scale | Standard Deviation 13.81 |
| Behavioral Weight Loss Intervention | Recovery Assessment Scale-Revised (RAS-R) | 8-Month | 98.72 score on a scale | Standard Deviation 14.33 |
| BWLI & Peer Navigator | Recovery Assessment Scale-Revised (RAS-R) | Baseline | 95.32 score on a scale | Standard Deviation 12.44 |
| BWLI & Peer Navigator | Recovery Assessment Scale-Revised (RAS-R) | 8-Month | 98.85 score on a scale | Standard Deviation 13.01 |
| Integrated Care (Treatment as Usual) | Recovery Assessment Scale-Revised (RAS-R) | Baseline | 98.21 score on a scale | Standard Deviation 11.96 |
| Integrated Care (Treatment as Usual) | Recovery Assessment Scale-Revised (RAS-R) | 8-Month | 97.65 score on a scale | Standard Deviation 13.92 |
Comparison: Intent-to-treat analysesp-value: 0.174ANOVA
Comparison: As-treated analysesp-value: 0.286ANOVA
Secondary
Self-Efficacy for Exercise Scale
Assesses participant beliefs in their ability to continue exercising on a three-time per week basis at moderate intensities. Range from 0 to 90. Higher score = better.
Time frame: 0, 8 months
Population: Due to COVID-19, interviews were transitioned online to be conducted virtually. In order to minimize participant fatigue, secondary outcome measures including this Self-Efficacy for Exercise Scale were discontinued. The 8 Month values refer to subset of participants who completed 8 Month interview before the Self-Efficacy for Exercise Scale was discontinued.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Behavioral Weight Loss Intervention | Self-Efficacy for Exercise Scale | 0 Month | 74.05 score on a scale | Standard Deviation 24.5 |
| Behavioral Weight Loss Intervention | Self-Efficacy for Exercise Scale | 8 Month | 66.34 score on a scale | Standard Deviation 24.28 |
| BWLI & Peer Navigator | Self-Efficacy for Exercise Scale | 0 Month | 69.02 score on a scale | Standard Deviation 23.88 |
| BWLI & Peer Navigator | Self-Efficacy for Exercise Scale | 8 Month | 62.10 score on a scale | Standard Deviation 25.62 |
| Integrated Care (Treatment as Usual) | Self-Efficacy for Exercise Scale | 0 Month | 76.56 score on a scale | Standard Deviation 22.7 |
| Integrated Care (Treatment as Usual) | Self-Efficacy for Exercise Scale | 8 Month | 67.15 score on a scale | Standard Deviation 23.82 |
Secondary
Waist Circumference
Change in waist circumference
Time frame: 0, 4, 8, 12 months
Population: Data collection for Waist Circumference variable was challenging (COVID, transition to online) and ultimately discontinued after Cohort 1. The results and intent-to-treat analyses for Waist Circumference are based on data from subset of participants before Waist Circumference data collection ceased.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Behavioral Weight Loss Intervention | Waist Circumference | 0 Months (Baseline) | 46.00 inches | Standard Deviation 4.54 |
| Behavioral Weight Loss Intervention | Waist Circumference | 4 Months | 45.56 inches | Standard Deviation 4.9 |
| Behavioral Weight Loss Intervention | Waist Circumference | 8 Months | 46.23 inches | Standard Deviation 4.69 |
| Behavioral Weight Loss Intervention | Waist Circumference | 12 Months | 45.98 inches | Standard Deviation 5.04 |
| BWLI & Peer Navigator | Waist Circumference | 12 Months | 44.13 inches | Standard Deviation 6.58 |
| BWLI & Peer Navigator | Waist Circumference | 0 Months (Baseline) | 43.85 inches | Standard Deviation 6.18 |
| BWLI & Peer Navigator | Waist Circumference | 8 Months | 44.36 inches | Standard Deviation 6.44 |
| BWLI & Peer Navigator | Waist Circumference | 4 Months | 44.78 inches | Standard Deviation 6.9 |
| Integrated Care (Treatment as Usual) | Waist Circumference | 12 Months | 43.99 inches | Standard Deviation 5.59 |
| Integrated Care (Treatment as Usual) | Waist Circumference | 4 Months | 44.60 inches | Standard Deviation 6.34 |
| Integrated Care (Treatment as Usual) | Waist Circumference | 8 Months | 43.82 inches | Standard Deviation 6.16 |
| Integrated Care (Treatment as Usual) | Waist Circumference | 0 Months (Baseline) | 44.99 inches | Standard Deviation 5.61 |
p-value: 0.11ANOVA
Secondary
Weight Efficacy Lifetime (WEL) Questionnaire
Weight Efficacy Lifestyle Questionnaire. 20 items. Assesses participant confidence in resisting eating in some typical eating situations. Items rated on scale from 0=Not confident at all to 9=Very confident. Scores range from 0 to 180. Higher scores indicate better outcome (greater eating self-efficacy).
Time frame: 0, 8 months
Population: Analysis was performed on intention-to-treat. Participants were categorized based on research condition assigned at baseline regardless of BHL or PHN attendance.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Behavioral Weight Loss Intervention | Weight Efficacy Lifetime (WEL) Questionnaire | Baseline | 102.83 score on a scale | Standard Deviation 38.32 |
| Behavioral Weight Loss Intervention | Weight Efficacy Lifetime (WEL) Questionnaire | 8-Month | 124.72 score on a scale | Standard Deviation 33.81 |
| BWLI & Peer Navigator | Weight Efficacy Lifetime (WEL) Questionnaire | Baseline | 99.22 score on a scale | Standard Deviation 31.48 |
| BWLI & Peer Navigator | Weight Efficacy Lifetime (WEL) Questionnaire | 8-Month | 116.13 score on a scale | Standard Deviation 32.4 |
| Integrated Care (Treatment as Usual) | Weight Efficacy Lifetime (WEL) Questionnaire | Baseline | 99.26 score on a scale | Standard Deviation 32.35 |
| Integrated Care (Treatment as Usual) | Weight Efficacy Lifetime (WEL) Questionnaire | 8-Month | 109.93 score on a scale | Standard Deviation 39.06 |
Comparison: Intent-to-treat analysesp-value: 0.261ANOVA
Comparison: As-treated analysesp-value: 0.912ANOVA