Lifestyle Intervention, Metabolic Syndrome, Obesity, Pre Diabetes
Conditions
Keywords
Latino, Male
Brief summary
The purpose of this study is to test a flexible lifestyle program designed to help Latino men make healthy lifestyle changes to lower their risk of developing diabetes and heart disease. The program is called HOMBRE (Hombres con Opciones para Mejorar el Bienestar y bajar el Riesgo de Enfermedades crónicas; English translation: Men with choices to improve well being and decrease chronic disease risk).
Detailed description
This study is a comparative effectiveness trial where obese Latino men will receive, by random assignment, the HOMBRE intervention or a minimal intensity intervention. The study is designed to test whether a flexible lifestyle program with choices for program engagement will lead to better health outcomes, compared to a minimal intensity self-directed lifestyle program. If proven successful, this study has the potential to significantly impact health outcomes that matter to Latino men through the innovative design of lifestyle interventions to prevent chronic disease.
Interventions
BEHAVIORALMinimal intensity intervention
The minimal intensity intervention control includes the Group Lifestyle Balance (GLB) videos (DVD or online), standardized messages, and access to a lifestyle coach if initiated by the participant.
BEHAVIORALHOMBRE
HOMBRE is a Group Lifestyle Balance (GLB)-based intervention tailored for men and available in 3 delivery modalities (coach-facilitated individual approach, coach-led online virtual groups, and coach-led in-person groups). A lifestyle coach will support men in making an informed choice of modality and will provide ongoing individualized feedback. All delivery modalities provide the same evidence-based curriculum and include self-monitoring and individualized feedback from the lifestyle coach.
Sponsors
Patient-Centered Outcomes Research Institute
University of Illinois at Chicago
RTI International
University of Pittsburgh
Arizona State University
Stanford University
Palo Alto Medical Foundation
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
DOUBLE (Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Latino of any race * BMI \>27 kg/m2 * One or more metabolic syndrome component (high triglycerides, blood pressure, fasting glucose, central obesity, or low HDL cholesterol) * Primary Care Physician approval of patient study contact * Able and willing to enroll and provide informed consent, i.e., to meet the time and data collection requirements of the study, be randomized to one of tow study arms, participate in follow-up for 18 months, and authorize the extraction of relevant information form the Electronic Health Record.
Exclusion criteria
Medical exclusions: * Previous diagnosis of diabetes or diabetes diagnosed as a result of fasting blood glucose or hemoglobin A1c levels obtained through study screening; * Diagnosis of cancer (other than non-melanoma skin cancer) that is/was active or treated with radiation or chemotherapy within the past 2 years; * Inability to walk without the assistance of another person; * Severe medical co-morbidities that require aggressive treatment: e.g., stage 4 or greater renal disease, class III or greater heart failure, unstable coronary artery disease, liver or renal failure; * Diagnosis of a terminal illness and/or in hospice care; * Diagnosis of bipolar disorder or psychotic disorder within the last 2 years, or currently taking a mood stabilizer or antipsychotic medication * Initiation or change in type or dosing of antidepressant medications within 2 months prior to enrollment (The patient will be re-contacted for a later cohort once his/her regimen has been stable for at least 2 months unless the person declines to participate altogether.) * Have had or plan to undergo bariatric surgery during the study period Other exclusions: * Having no reliable telephone service * Plan to move out of the area during the study period * Family/household member of another study participant or of a study staff member * Investigator discretion for clinical safety or protocol adherence reasons
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number and Percentage of Men Achieving 5% Weight Loss or More | Baseline, 18 months | Number and Percentage of men who achieve 5% or more of weight loss compared to their baseline weight |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Changes in Weight From Baseline | 6 months | Weight measurements were abstracted from EHR. |
| Change in Waist Circumference From Baseline | Baseline, 18 months | Waist circumference at 18 months - waist circumference at baseline |
| Change in Systolic Blood Pressure From Baseline | Baseline, 18 months | Systolic blood pressure at 18 months - systolic blood pressure at baseline |
| Change in Diastolic Blood Pressure From Baseline | Baseline, 18 months | Diastolic blood pressure at 18 months - diastolic blood pressure at baseline |
| Change in Health Behavior: Leisure Time Physical Activity | Baseline, 18 months | Physical activity measured at 18 months minus physical activity measured at baseline using Stanford 7-day physical activity recall |
| Change in Health Behavior: Energy Expenditure | Baseline, 18 months | The Stanford 7-day Physical Activity Recall data also provided estimates of total daily energy expenditures. Total energy expenditure = sleep hours × 1 MET + light activity hours × 1.5 METs + moderate activity hours × 4 METs + hard activity hours × 6 METs + very hard activity hours × 10 METs. Total daily energy expenditure at 18 months - Total daily energy expenditure at baseline. |
| Change in Health Behavior: Sedentary Behavior | Baseline, 18 months | Weekly hours of sedentary behavior measured at 18 months minus weekly hours of sedentary behavior at baseline using the Sedentary behavior Questionnaire |
| Change in Health Behavior: Diet Quality | Baseline, 18 months | Dietary intake was measured using the gold-standard approach of multiple pass 24-hour recalls in Spanish or English using Nutrition Data System for Research (NDSR). Diet quality was assessed by the Dietary Approaches to Stop Hypertension (DASH) score. DASH scores were calculated based on combining nine nutrient targets (i.e. total fat, saturated fat, protein, cholesterol, fiber, magnesium, calcium, sodium and potassium). A higher score reflects higher diet quality. The minimum score is 8 and the maximum is 40. DASH score at 18 months - DASH score at baseline. |
| Change in Health Behavior: Fruit and Vegetable Intake | Baseline, 18 months | Fruit and vegetable intake measured at 18 months minus fruit and vegetable intake measured at baseline using 24-hour multiple pass recalls. Fruit and vegetable intake is measured in servings per day. |
| Change in Health Behavior: Total Calorie Intake | Baseline, 18 months | Total calorie intake per day measured at 18 months minus total calorie intake per day measured at baseline using 24-hour multiple pass dietary recalls. |
| Trajectory of Weight Change From Baseline Through 18 Months | 18 months | Slope of changes in weights abstracted from EHR from baseline through 18 months |
| Change in Psychosocial Well-being: Obesity-specific Quality of Life | Baseline, 18 months | Obesity-related Problem Scale, average scores of 8 questions with a range from 0 (no at all) to 3 (extremely). The average score is then multiplied by 100 and divided by 3 to convert to a scale of 0-100, with a higher score indicating more obesity-related problems. Obesity-related quality of life measured at 18 months - obesity-related quality of life measured at baseline. |
| Change in Psychosocial Well-being: Depressive Symptoms | Baseline, 18 months | The Patient Health Questionnaire PHQ-9 is a self-report questionnaire with 9 items. Respondents answered questions regarding how often a symptom has bothered them over the last two weeks. Each item is rated on a 4-point scale (0 = not at all, 1 = several days, 2 = more than half the days, 3 = nearly every day). PHQ-9 total score is the sum of the nine items, ranging from 0 to 27. Scores of 5, 10, 15, and 20 represent cutpoints for mild, moderate, moderately severe and severe depression, respectively. PHQ-9 score at 18 months - PHQ-9 score at baseline. |
| Change in Perceived Stress | Baseline, 18 months | Perceived stress scale with a range of 0 to 40 with higher scores indicating higher stress. Perceived stress at 18 months - Perceived stress at baseline. |
| Change in Psychosocial Well-being: Sleep Disturbance T-score | Baseline, 18 months | Sleep disturbance T-score, a population scale with a range from 25 (extreme disturbance or impairment) to 80 (not at all) converted from the raw total score of 8-item questionnaire. A score of 50 represents the average of the calibration sample, which was generally more enriched for chronic illness. Sleep disturbance score at 18 months - sleep disturbance score at baseline. |
| Change in Psychosocial Well-being: Sleep Impairment T-score | Baseline, 18 months | Sleep Impairment T-score, a population scale with a range from 25 (extreme disturbance or impairment) to 80 (not at all) converted from the raw total score of 8-item questionnaire. A score of 50 represents the average of the calibration sample, which was generally more enriched for chronic illness. Sleep impairment score at 18 months - sleep impairment at baseline. |
| Psychosocial Well-being: Number and Percentage of Participants Who Had no Problems With Mobility Domain in Utility-based Quality of Life Measured by EuroQol EQ-5D | 18 months | Utility-based quality of life was measured by EuroQol EQ-5D. Number and percentage of participants who had no problems with mobility. |
| Change in Psychosocial Well-being: Number and Percentage of Participants Who Had no Problems With Self Care Domain in Utility-based Quality of Life Measured by EuroQol EQ-5D | 18 months | Number and percentage of participants who had no problems with self care was measured using the Euro-QoL 5D (EQ-5D-5L), which includes 5 domains (mobility, self-care, usual activities, pain and discomfort, and depression and anxiety) scored on 5 levels (no, slight, moderate, severe, or extreme problems) and current health rated on a visual analogue scale from 0 to 100. |
| Change in Psychosocial Well-being: Number and Percentage of Participants Who Had no Problems With Usual Activities Domain in Utility-based Quality of Life Measured by EuroQol EQ-5D | 18 months | Number and percentage of participants who had no problems with usual activities (e.g. work, study, housework, family or leisure activities). |
| Change in Psychosocial Well-being: Number and Percentage of Participants Who Had no Problems With Pain/Discomfort Domain in Utility-based Quality of Life Measured by EuroQol EQ-5D | 18 months | Number and percentage of participants who had no problems with pain was measured using the Euro-QoL 5D (EQ-5D-5L), which includes 5 domains (mobility, self-care, usual activities, pain and discomfort, and depression and anxiety) scored on 5 levels (no, slight, moderate, severe, or extreme problems) and current health rated on a visual analogue scale from 0 to 100. |
| Change in Psychosocial Well-being: Number and Percentage of Participants Who Had no Problems With Anxiety and Depression Domain in Utility-based Quality of Life Measured by EuroQol EQ-5D | 18 months | Number and percentage of participants who had no problems with anxiety and depression was measured using the Euro-QoL 5D (EQ-5D-5L), which includes 5 domains (mobility, self-care, usual activities, pain and discomfort, and depression and anxiety) scored on 5 levels (no, slight, moderate, severe, or extreme problems) and current health rated on a visual analogue scale from 0 to 100. |
| Change in Health Behavior: Total Fat | Baseline, 18 months | Total fat consumption per day measured at 18 months minus total fat consumption per day measured at baseline using 24-hour multiple pass dietary recalls. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Minimal Intensity Intervention Patients assigned to this group will received the Minimal intensity intervention.
Minimal intensity intervention: The minimal intensity intervention control includes the Group Lifestyle Balance (GLB) videos (DVD or online), standardized messages, and access to a lifestyle coach if initiated by the participant. | 212 |
| HOMBRE Patients assigned to this group will receive the HOMBRE intervention
HOMBRE: HOMBRE is a Group Lifestyle Balance (GLB)-based intervention tailored for men and available in 3 delivery modalities (coach-facilitated individual approach, coach-led online virtual groups, and coach-led in-person groups). A lifestyle coach will support men in making an informed choice of modality and will provide ongoing individualized feedback. All delivery modalities provide the same evidence-based curriculum and include self-monitoring and individualized feedback from the lifestyle coach. | 212 |
| Total | 424 |
Baseline characteristics
| Characteristic | HOMBRE | Total | Minimal Intensity Intervention |
|---|---|---|---|
| Age, Continuous | 47.0 years STANDARD_DEVIATION 11.8 | 47.0 years STANDARD_DEVIATION 11.9 | 47.1 years STANDARD_DEVIATION 12.1 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 212 Participants | 424 Participants | 212 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 0 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Region of Enrollment United States | 212 participants | 424 participants | 212 participants |
| Sex: Female, Male Female | 0 Participants | 0 Participants | 0 Participants |
| Sex: Female, Male Male | 212 Participants | 424 Participants | 212 Participants |
| Weight, kg | 101.5 kg STANDARD_DEVIATION 33 | 100.4 kg STANDARD_DEVIATION 26.6 | 99.2 kg STANDARD_DEVIATION 17.9 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 212 | 0 / 212 |
| other Total, other adverse events | 48 / 212 | 52 / 212 |
| serious Total, serious adverse events | 15 / 212 | 14 / 212 |
Outcome results
Primary
Number and Percentage of Men Achieving 5% Weight Loss or More
Number and Percentage of men who achieve 5% or more of weight loss compared to their baseline weight
Time frame: Baseline, 18 months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Minimal Intensity Intervention | Number and Percentage of Men Achieving 5% Weight Loss or More | 37 Participants |
| HOMBRE | Number and Percentage of Men Achieving 5% Weight Loss or More | 51 Participants |
Secondary
Change in Diastolic Blood Pressure From Baseline
Diastolic blood pressure at 18 months - diastolic blood pressure at baseline
Time frame: Baseline, 18 months
Population: At 18 months, 186 in HOMBRE and 180 in Minimal Intensity intervention had either study-measured weight, EHR-abstracted weight, or self-reported weight, therefore were counted in retention in the Participant Flow module. Among them 147 in the HOMBRE intervention and 145 in the Minimal Intensity intervention had blood pressure data at 18 months.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Minimal Intensity Intervention | Change in Diastolic Blood Pressure From Baseline | -2.7 mm Hg | Standard Deviation 9.4 |
| HOMBRE | Change in Diastolic Blood Pressure From Baseline | -2.3 mm Hg | Standard Deviation 9 |
Secondary
Change in Health Behavior: Diet Quality
Dietary intake was measured using the gold-standard approach of multiple pass 24-hour recalls in Spanish or English using Nutrition Data System for Research (NDSR). Diet quality was assessed by the Dietary Approaches to Stop Hypertension (DASH) score. DASH scores were calculated based on combining nine nutrient targets (i.e. total fat, saturated fat, protein, cholesterol, fiber, magnesium, calcium, sodium and potassium). A higher score reflects higher diet quality. The minimum score is 8 and the maximum is 40. DASH score at 18 months - DASH score at baseline.
Time frame: Baseline, 18 months
Population: At 18 months, 186 in HOMBRE and 180 in Minimal Intensity intervention had either study-measured weight, EHR-abstracted weight, or self-reported weight, therefore were counted in retention in the Participant Flow module. Among them 80 in the HOMBRE intervention and 90 in the Minimal Intensity intervention had diet data at 18 months.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Minimal Intensity Intervention | Change in Health Behavior: Diet Quality | 0.2 score on a scale | Standard Deviation 1.9 |
| HOMBRE | Change in Health Behavior: Diet Quality | 0.3 score on a scale | Standard Deviation 1.8 |
Secondary
Change in Health Behavior: Energy Expenditure
The Stanford 7-day Physical Activity Recall data also provided estimates of total daily energy expenditures. Total energy expenditure = sleep hours × 1 MET + light activity hours × 1.5 METs + moderate activity hours × 4 METs + hard activity hours × 6 METs + very hard activity hours × 10 METs. Total daily energy expenditure at 18 months - Total daily energy expenditure at baseline.
Time frame: Baseline, 18 months
Population: At 18 months, 186 in HOMBRE and 180 in Minimal Intensity intervention had either study-measured weight, EHR-abstracted weight, or self-reported weight, therefore were counted in retention in the Participant Flow module. Among them 174 in the HOMBRE intervention and 177 in the Minimal Intensity intervention had physical activity data at 18 months.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Minimal Intensity Intervention | Change in Health Behavior: Energy Expenditure | -1.1 kcal/kg/day | Standard Deviation 5.3 |
| HOMBRE | Change in Health Behavior: Energy Expenditure | -2.1 kcal/kg/day | Standard Deviation 6 |
Secondary
Change in Health Behavior: Fruit and Vegetable Intake
Fruit and vegetable intake measured at 18 months minus fruit and vegetable intake measured at baseline using 24-hour multiple pass recalls. Fruit and vegetable intake is measured in servings per day.
Time frame: Baseline, 18 months
Population: At 18 months, 186 in HOMBRE and 180 in Minimal Intensity intervention had either study-measured weight, EHR-abstracted weight, or self-reported weight, therefore were counted in retention in the Participant Flow module. Among them 80 in the HOMBRE intervention and 90 in the Minimal Intensity intervention had diet data at 18 months.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Minimal Intensity Intervention | Change in Health Behavior: Fruit and Vegetable Intake | 0.3 servings/day | Standard Deviation 4.1 |
| HOMBRE | Change in Health Behavior: Fruit and Vegetable Intake | -0.4 servings/day | Standard Deviation 3.8 |
Secondary
Change in Health Behavior: Leisure Time Physical Activity
Physical activity measured at 18 months minus physical activity measured at baseline using Stanford 7-day physical activity recall
Time frame: Baseline, 18 months
Population: At 18 months, 186 in HOMBRE and 180 in Minimal Intensity intervention had either study-measured weight, EHR-abstracted weight, or self-reported weight, therefore were counted in retention in the Participant Flow module. Among them 174 in the HOMBRE intervention and 177 in the Minimal Intensity intervention had physical activity data at 18 months.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Minimal Intensity Intervention | Change in Health Behavior: Leisure Time Physical Activity | -113 MET minutes/week | Standard Deviation 1410 |
| HOMBRE | Change in Health Behavior: Leisure Time Physical Activity | -369 MET minutes/week | Standard Deviation 1436 |
Secondary
Change in Health Behavior: Sedentary Behavior
Weekly hours of sedentary behavior measured at 18 months minus weekly hours of sedentary behavior at baseline using the Sedentary behavior Questionnaire
Time frame: Baseline, 18 months
Population: At 18 months, 186 in HOMBRE and 180 in Minimal Intensity intervention had either study-measured weight, EHR-abstracted weight, or self-reported weight, therefore were counted in retention in the Participant Flow module. Among them 136 in the HOMBRE intervention and 137 in the Minimal Intensity intervention had sedentary behavior data at 18 months.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Minimal Intensity Intervention | Change in Health Behavior: Sedentary Behavior | -1.5 hours/week | Standard Deviation 31.5 |
| HOMBRE | Change in Health Behavior: Sedentary Behavior | -2.4 hours/week | Standard Deviation 47.5 |
Secondary
Change in Health Behavior: Total Calorie Intake
Total calorie intake per day measured at 18 months minus total calorie intake per day measured at baseline using 24-hour multiple pass dietary recalls.
Time frame: Baseline, 18 months
Population: At 18 months, 186 in HOMBRE and 180 in Minimal Intensity intervention had either study-measured weight, EHR-abstracted weight, or self-reported weight, therefore were counted in retention in the Participant Flow module. Among them 80 in the HOMBRE intervention and 90 in the Minimal Intensity intervention had diet data at 18 months.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Minimal Intensity Intervention | Change in Health Behavior: Total Calorie Intake | 4.0 kilocalories/day | Standard Deviation 3.8 |
| HOMBRE | Change in Health Behavior: Total Calorie Intake | 4.1 kilocalories/day | Standard Deviation 3 |
Secondary
Change in Health Behavior: Total Fat
Total fat consumption per day measured at 18 months minus total fat consumption per day measured at baseline using 24-hour multiple pass dietary recalls.
Time frame: Baseline, 18 months
Population: At 18 months, 186 in HOMBRE and 180 in Minimal Intensity intervention had either study-measured weight, EHR-abstracted weight, or self-reported weight, therefore were counted in retention in the Participant Flow module. Among them 80 in the HOMBRE intervention and 90 in the Minimal Intensity intervention had diet data at 18 months.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Minimal Intensity Intervention | Change in Health Behavior: Total Fat | -23.2 g/day | Standard Deviation 121 |
| HOMBRE | Change in Health Behavior: Total Fat | -14.8 g/day | Standard Deviation 44.9 |
Secondary
Change in Perceived Stress
Perceived stress scale with a range of 0 to 40 with higher scores indicating higher stress. Perceived stress at 18 months - Perceived stress at baseline.
Time frame: Baseline, 18 months
Population: At 18 months, 186 in HOMBRE and 180 in Minimal Intensity intervention had either study-measured weight, EHR-abstracted weight, or self-reported weight, therefore were counted in retention in the Participant Flow module. Among them 105 in the HOMBRE intervention and 101 in the Minimal Intensity intervention had perceived stress data at 18 months.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Minimal Intensity Intervention | Change in Perceived Stress | 0.0 score on a scale | Standard Deviation 5.6 |
| HOMBRE | Change in Perceived Stress | -1.1 score on a scale | Standard Deviation 5.6 |
Secondary
Change in Psychosocial Well-being: Depressive Symptoms
The Patient Health Questionnaire PHQ-9 is a self-report questionnaire with 9 items. Respondents answered questions regarding how often a symptom has bothered them over the last two weeks. Each item is rated on a 4-point scale (0 = not at all, 1 = several days, 2 = more than half the days, 3 = nearly every day). PHQ-9 total score is the sum of the nine items, ranging from 0 to 27. Scores of 5, 10, 15, and 20 represent cutpoints for mild, moderate, moderately severe and severe depression, respectively. PHQ-9 score at 18 months - PHQ-9 score at baseline.
Time frame: Baseline, 18 months
Population: At 18 months, 186 in HOMBRE and 180 in Minimal Intensity intervention had either study-measured weight, EHR-abstracted weight, or self-reported weight, therefore were counted in retention in the Participant Flow module. Among them 104 in the HOMBRE intervention and 101 in the Minimal Intensity intervention had depression symptom data at 18 months.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Minimal Intensity Intervention | Change in Psychosocial Well-being: Depressive Symptoms | -0.8 score on a scale | Standard Deviation 3.9 |
| HOMBRE | Change in Psychosocial Well-being: Depressive Symptoms | -0.6 score on a scale | Standard Deviation 3.8 |
Secondary
Change in Psychosocial Well-being: Number and Percentage of Participants Who Had no Problems With Anxiety and Depression Domain in Utility-based Quality of Life Measured by EuroQol EQ-5D
Number and percentage of participants who had no problems with anxiety and depression was measured using the Euro-QoL 5D (EQ-5D-5L), which includes 5 domains (mobility, self-care, usual activities, pain and discomfort, and depression and anxiety) scored on 5 levels (no, slight, moderate, severe, or extreme problems) and current health rated on a visual analogue scale from 0 to 100.
Time frame: 18 months
Population: At 18 months, 186 in HOMBRE and 180 in Minimal Intensity intervention had either study-measured weight, EHR-abstracted weight, or self-reported weight, therefore were counted in retention in the Participant Flow module. Among them 108 in the HOMBRE intervention and 104 in the Minimal Intensity intervention had utility-based quality of life anxiety/depression data at 18 months.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Minimal Intensity Intervention | Change in Psychosocial Well-being: Number and Percentage of Participants Who Had no Problems With Anxiety and Depression Domain in Utility-based Quality of Life Measured by EuroQol EQ-5D | 72 Participants |
| HOMBRE | Change in Psychosocial Well-being: Number and Percentage of Participants Who Had no Problems With Anxiety and Depression Domain in Utility-based Quality of Life Measured by EuroQol EQ-5D | 85 Participants |
Secondary
Change in Psychosocial Well-being: Number and Percentage of Participants Who Had no Problems With Pain/Discomfort Domain in Utility-based Quality of Life Measured by EuroQol EQ-5D
Number and percentage of participants who had no problems with pain was measured using the Euro-QoL 5D (EQ-5D-5L), which includes 5 domains (mobility, self-care, usual activities, pain and discomfort, and depression and anxiety) scored on 5 levels (no, slight, moderate, severe, or extreme problems) and current health rated on a visual analogue scale from 0 to 100.
Time frame: 18 months
Population: At 18 months, 186 in HOMBRE and 180 in Minimal Intensity intervention had either study-measured weight, EHR-abstracted weight, or self-reported weight, therefore were counted in retention in the Participant Flow module. Among them 108 in the HOMBRE intervention and 104 in the Minimal Intensity intervention had utility-based quality of life pain/discomfort data at 18 months.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Minimal Intensity Intervention | Change in Psychosocial Well-being: Number and Percentage of Participants Who Had no Problems With Pain/Discomfort Domain in Utility-based Quality of Life Measured by EuroQol EQ-5D | 55 Participants |
| HOMBRE | Change in Psychosocial Well-being: Number and Percentage of Participants Who Had no Problems With Pain/Discomfort Domain in Utility-based Quality of Life Measured by EuroQol EQ-5D | 66 Participants |
Secondary
Change in Psychosocial Well-being: Number and Percentage of Participants Who Had no Problems With Self Care Domain in Utility-based Quality of Life Measured by EuroQol EQ-5D
Number and percentage of participants who had no problems with self care was measured using the Euro-QoL 5D (EQ-5D-5L), which includes 5 domains (mobility, self-care, usual activities, pain and discomfort, and depression and anxiety) scored on 5 levels (no, slight, moderate, severe, or extreme problems) and current health rated on a visual analogue scale from 0 to 100.
Time frame: 18 months
Population: At 18 months, 186 in HOMBRE and 180 in Minimal Intensity intervention had either study-measured weight, EHR-abstracted weight, or self-reported weight, therefore were counted in retention in the Participant Flow module. Among them 108 in the HOMBRE intervention and 104 in the Minimal Intensity intervention had utility-based quality of life - self care data at 18 months.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Minimal Intensity Intervention | Change in Psychosocial Well-being: Number and Percentage of Participants Who Had no Problems With Self Care Domain in Utility-based Quality of Life Measured by EuroQol EQ-5D | 101 Participants |
| HOMBRE | Change in Psychosocial Well-being: Number and Percentage of Participants Who Had no Problems With Self Care Domain in Utility-based Quality of Life Measured by EuroQol EQ-5D | 106 Participants |
Secondary
Change in Psychosocial Well-being: Number and Percentage of Participants Who Had no Problems With Usual Activities Domain in Utility-based Quality of Life Measured by EuroQol EQ-5D
Number and percentage of participants who had no problems with usual activities (e.g. work, study, housework, family or leisure activities).
Time frame: 18 months
Population: At 18 months, 186 in HOMBRE and 180 in Minimal Intensity intervention had either study-measured weight, EHR-abstracted weight, or self-reported weight, therefore were counted in retention in the Participant Flow module. Among them 108 in the HOMBRE intervention and 104 in the Minimal Intensity intervention had utility-based quality of life usual activity data at 18 months.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Minimal Intensity Intervention | Change in Psychosocial Well-being: Number and Percentage of Participants Who Had no Problems With Usual Activities Domain in Utility-based Quality of Life Measured by EuroQol EQ-5D | 96 Participants |
| HOMBRE | Change in Psychosocial Well-being: Number and Percentage of Participants Who Had no Problems With Usual Activities Domain in Utility-based Quality of Life Measured by EuroQol EQ-5D | 97 Participants |
Secondary
Change in Psychosocial Well-being: Obesity-specific Quality of Life
Obesity-related Problem Scale, average scores of 8 questions with a range from 0 (no at all) to 3 (extremely). The average score is then multiplied by 100 and divided by 3 to convert to a scale of 0-100, with a higher score indicating more obesity-related problems. Obesity-related quality of life measured at 18 months - obesity-related quality of life measured at baseline.
Time frame: Baseline, 18 months
Population: At 18 months, 186 in HOMBRE and 180 in Minimal Intensity intervention had either study-measured weight, EHR-abstracted weight, or self-reported weight, therefore were counted in retention in the Participant Flow module. Among them 105 in the HOMBRE intervention and 101 in the Minimal Intensity intervention had obesity-related quality of life data at 18 months.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Minimal Intensity Intervention | Change in Psychosocial Well-being: Obesity-specific Quality of Life | -6.3 units on a scale | Standard Deviation 21.4 |
| HOMBRE | Change in Psychosocial Well-being: Obesity-specific Quality of Life | -7.4 units on a scale | Standard Deviation 19.9 |
Secondary
Change in Psychosocial Well-being: Sleep Disturbance T-score
Sleep disturbance T-score, a population scale with a range from 25 (extreme disturbance or impairment) to 80 (not at all) converted from the raw total score of 8-item questionnaire. A score of 50 represents the average of the calibration sample, which was generally more enriched for chronic illness. Sleep disturbance score at 18 months - sleep disturbance score at baseline.
Time frame: Baseline, 18 months
Population: At 18 months, 186 in HOMBRE and 180 in Minimal Intensity intervention had either study-measured weight, EHR-abstracted weight, or self-reported weight, therefore were counted in retention in the Participant Flow module. Among them 103 in the HOMBRE intervention and 100 in the Minimal Intensity intervention had sleep disturbance data at 18 months.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Minimal Intensity Intervention | Change in Psychosocial Well-being: Sleep Disturbance T-score | -0.7 score on a scale | Standard Deviation 8.2 |
| HOMBRE | Change in Psychosocial Well-being: Sleep Disturbance T-score | -0.2 score on a scale | Standard Deviation 7.7 |
Secondary
Change in Psychosocial Well-being: Sleep Impairment T-score
Sleep Impairment T-score, a population scale with a range from 25 (extreme disturbance or impairment) to 80 (not at all) converted from the raw total score of 8-item questionnaire. A score of 50 represents the average of the calibration sample, which was generally more enriched for chronic illness. Sleep impairment score at 18 months - sleep impairment at baseline.
Time frame: Baseline, 18 months
Population: At 18 months, 186 in HOMBRE and 180 in Minimal Intensity intervention had either study-measured weight, EHR-abstracted weight, or self-reported weight, therefore were counted in retention in the Participant Flow module. Among them 103 in the HOMBRE intervention and 100 in the Minimal Intensity intervention had sleep impairment data at 18 months.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Minimal Intensity Intervention | Change in Psychosocial Well-being: Sleep Impairment T-score | -0.1 score on a scale | Standard Deviation 9.3 |
| HOMBRE | Change in Psychosocial Well-being: Sleep Impairment T-score | -2.9 score on a scale | Standard Deviation 9.2 |
Secondary
Change in Systolic Blood Pressure From Baseline
Systolic blood pressure at 18 months - systolic blood pressure at baseline
Time frame: Baseline, 18 months
Population: At 18 months, 186 in HOMBRE and 180 in Minimal Intensity intervention had either study-measured weight, EHR-abstracted weight, or self-reported weight, therefore were counted in retention in the Participant Flow module. Among them 147 in the HOMBRE intervention and 145 in the Minimal Intensity intervention had blood pressure data at 18 months.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Minimal Intensity Intervention | Change in Systolic Blood Pressure From Baseline | 0.4 mm Hg | Standard Deviation 12.5 |
| HOMBRE | Change in Systolic Blood Pressure From Baseline | 0.8 mm Hg | Standard Deviation 11.6 |
Secondary
Change in Waist Circumference From Baseline
Waist circumference at 18 months - waist circumference at baseline
Time frame: Baseline, 18 months
Population: At 18 months, 186 in HOMBRE and 180 in Minimal Intensity intervention had either study-measured weight, EHR-abstracted weight, or self-reported weight, therefore were counted in retention in the Participant Flow module. Among them 83 in the HOMBRE intervention and 88 in the Minimal Intensity intervention had waist circumference data at 18 months.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Minimal Intensity Intervention | Change in Waist Circumference From Baseline | -0.0 cm | Standard Deviation 6.7 |
| HOMBRE | Change in Waist Circumference From Baseline | -0.8 cm | Standard Deviation 5.7 |
Secondary
Changes in Weight From Baseline
Weight measurements were abstracted from EHR.
Time frame: 6 months
Population: At 18 months, 186 in HOMBRE and 180 in Minimal Intensity had either study-measured weight, EHR-abstracted weight, or self-reported weight, therefore were counted in retention in the Participant Flow module. We used same model as first secondary outcome to examine changes in EHR weight at 6 months. We abstracted weight from the EHR from 3 months prior to randomization to 24 months post randomization. 209 in HOMBRE and 209 in Minimal Intensity had EHR-abstracted weight during this 27-month period.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Minimal Intensity Intervention | Changes in Weight From Baseline | -1.79 kg | Standard Deviation 6.1 |
| HOMBRE | Changes in Weight From Baseline | -2.78 kg | Standard Deviation 5.45 |
Secondary
Changes in Weight From Baseline
Weight measurements were abstracted from EHR.
Time frame: 12 months
Population: At 18 months, 186 in HOMBRE and 180 in Minimal Intensity had either study-measured, EHR-abstracted, or self-reported weight, therefore were counted in retention in the Participant Flow module. We used same model as first secondary outcome to examine changes in EHR weight at 12 months. We abstracted weight from the EHR from 3 months prior to randomization to 24 months post randomization. 209 in HOMBRE and 209 in Minimal Intensity had EHR-abstracted weight during this 27-month period.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Minimal Intensity Intervention | Changes in Weight From Baseline | -1.56 kg | Standard Deviation 7 |
| HOMBRE | Changes in Weight From Baseline | -2.77 kg | Standard Deviation 6.47 |
Secondary
Changes in Weight From Baseline
Weight measurements were abstracted from EHR.
Time frame: 18 months
Population: At 18 months, 186 in HOMBRE and 180 in Minimal Intensity had either study-measured, EHR-abstracted, or self-reported weight, therefore were counted in retention in the Participant Flow module. We used same model as first secondary outcome to examine changes in EHR weight at 18 months. We abstracted weight from the EHR from 3 months prior to randomization to 24 months post randomization. 209 in HOMBRE and 209 in Minimal Intensity had EHR-abstracted weight during this 27-month period.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Minimal Intensity Intervention | Changes in Weight From Baseline | -1.67 kg | Standard Deviation 6.16 |
| HOMBRE | Changes in Weight From Baseline | -2.46 kg | Standard Deviation 6.6 |
Secondary
Psychosocial Well-being: Number and Percentage of Participants Who Had no Problems With Mobility Domain in Utility-based Quality of Life Measured by EuroQol EQ-5D
Utility-based quality of life was measured by EuroQol EQ-5D. Number and percentage of participants who had no problems with mobility.
Time frame: 18 months
Population: At 18 months, 186 in HOMBRE and 180 in Minimal Intensity intervention had either study-measured weight, EHR-abstracted weight, or self-reported weight, therefore were counted in retention in the Participant Flow module. Among them 107 in the HOMBRE intervention and 104 in the Minimal Intensity intervention had utility-based quality of life mobility data at 18 months.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Minimal Intensity Intervention | Psychosocial Well-being: Number and Percentage of Participants Who Had no Problems With Mobility Domain in Utility-based Quality of Life Measured by EuroQol EQ-5D | 91 Participants |
| HOMBRE | Psychosocial Well-being: Number and Percentage of Participants Who Had no Problems With Mobility Domain in Utility-based Quality of Life Measured by EuroQol EQ-5D | 96 Participants |
Secondary
Trajectory of Weight Change From Baseline Through 18 Months
Slope of changes in weights abstracted from EHR from baseline through 18 months
Time frame: 18 months
Population: At 18 months, 186 in HOMBRE and 180 in Minimal Intensity intervention had either study-measured weight, EHR-abstracted weight, or self-reported weight, therefore were counted in retention in the Participant Flow module. For examining weight loss trajectory over time, we abstracted weight measurements from the EHR from 3 months prior to randomization to 24 months post randomization. 209 in HOMBRE and 209 in Minimal Intensity intervention had EHR-abstracted weight during this 27-month period.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Minimal Intensity Intervention | Trajectory of Weight Change From Baseline Through 18 Months | -0.11 kg/month | Standard Deviation 0.04 |
| HOMBRE | Trajectory of Weight Change From Baseline Through 18 Months | -0.13 kg/month | Standard Deviation 0.04 |