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| Name | Class |
|---|---|
| Patient-Centered Outcomes Research Institute | OTHER |
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A prospective, large, pragmatic, randomized trial to study the impact of METFORMIN and healthy lifestyle intervention (LIFE) vs. LIFE alone on patient-centered outcomes of body weight, SGA-adherence and satisfaction, psychiatric symptom burden (e.g. mood/anxiety), and Quality of Life.
The investigators propose to recruit 1800 overweight/obese youth with Bipolar Spectrum Disorder (BSD) who are prescribed second generation anti psychotics (SGAs) from at least 24 public and private mental health practices in the Greater Cincinnati and New York City regions, (approximately 900 each from ~12 Cincinnati region and ~12 Long Island/New York mental health treatment sites) to participate in the proposed patient-centered large pragmatic trial examining the effectiveness of MET and LIFE vs. LIFE alone. Patients will be eligible if they are ages 8-17 years old, inclusive, overweight or obese (BMI > 85%), continuing or starting treatment with at least one SGA (i.e., olanzapine, clozapine, risperidone, quetiapine, aripiprazole, ziprasidone, iloperidone, lurasidone, paliperidone, or asenapine) and have a clinical diagnosis of BSD (bipolar I or II disorder, cyclothymia, or bipolar or mood disorder not otherwise specified [or by Diagnostic and Statistical Manual of Mental Disorders V (DSM-5), other specified bipolar or mood disorder). The enrollment rate will be 2-3 patients/month/site for a recruitment time of 30 months.](streamdown:incomplete-link)
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| MET and LIFE | Experimental | Participants randomized to this group will receive both Metformin and lifestyle intervention.Participants randomized to treatment with MET will start at a dose of 500 mg orally at night and slowly titrated in 2-week intervals to ensure that each patient achieves maximum insulin-sensitizing effects of the drug while minimizing the chance of side effects. Investigators will also recommend that MET be taken with food to minimize side effects. If a participant's BMI percentile <5% (=underweight) his/her treatment with MET will be discontinued. Although the risk of low vitamin B12 while taking MET is associated with age > 50 years and having type II diabetes, Investigator will monitor B12 levels and a CBC throughout study participation. |
|
| Healthy lifestyle intervention (LIFE) | Experimental | Participants randomized to this group will receive just lifestyle intervention alone.This healthy lifestyle intervention (LIFE) consists of counseling participants and families regarding a healthy eating plan, physical activity and sedentary activities. Prior to study initiation, clinical site staff will participate in a live (or taped) training session from a dietician to lean to administer LIFE. A trained site staff member (e.g. medical assistant or case manager) will meet with participants and their families for a 15-20 minute session at baseline that will focus on nutritional issues using the Traffic Light Plan (TLP). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Metformin | Drug | Metformin - to achieves maximum insulin-sensitizing effects |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in BMI Z-score From Baseline to Month 6 in ITT Sample | Raw body mass index (BMI) is calculated as (weight(kg)/ height(m)2). This raw BMI value is converted to a normalized BMI z-score, adjusted for age and sex using US Centers for Disease Control and Prevention growth charts. A z-score equal to 0 indicates the population mean and larger z-scores are heavier weights and worse outcomes. | Baseline to Month 6 |
| Change in BMI Z-score From Baseline to Month 24 in ITT Sample | Raw body mass index (BMI) is calculated as (weight(kg)/ height(m)2). This raw BMI value is converted to a normalized BMI z-score, adjusted for age and sex using US Centers for Disease Control and Prevention growth charts. A z-score equal to 0 indicates the population mean and larger z-scores are heavier weights and worse outcomes. | Baseline to Month 24 |
| Change in BMI Z-score From Baseline to Month 6 in Per Protocol Sample | Raw body mass index (BMI) is calculated as (weight(kg)/ height(m)2). This raw BMI value is converted to a normalized BMI z-score, adjusted for age and sex using US Centers for Disease Control and Prevention growth charts. A z-score equal to 0 indicates the population mean and larger z-scores are heavier weights and worse outcomes. | Baseline to Month 6 |
| Change in BMI Z-score From Baseline to Month 24 in Per Protocol Sample | Raw body mass index (BMI) is calculated as (weight(kg)/ height(m)2). This raw BMI value is converted to a normalized BMI z-score, adjusted for age and sex using US Centers for Disease Control and Prevention growth charts. A z-score equal to 0 indicates the population mean and larger z-scores are heavier weights and worse outcomes. | Baseline to Month 24 |
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Inclusion Criteria
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Melissa P DelBello, MD, MS | University of Cincinnati | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Children's Home of Northern Kentucky | Covington | Kentucky | 41011 | United States | ||
| Jersey Shore Medical Center |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41233082 | Derived | DelBello MP, Welge JA, Klein CC, Blom TJ, Fornari V, Higdon C, Sorter MT, Kurtz B, Starr C, Smith A, Huang B, Chen C, Modi AC, Crimmins N, Correll CU; MOBILITY Consortium. Metformin for overweight and obese children and adolescents with bipolar spectrum and related mood disorders treated with second-generation antipsychotics: a randomised, pragmatic trial. Lancet Psychiatry. 2025 Dec;12(12):893-905. doi: 10.1016/S2215-0366(25)00273-1. | |
| 40214755 |
| Label | URL |
|---|---|
| US Centers for Disease Control and Prevention growth charts | View source |
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1633 participants were screened. 68 did not meet criteria. Of the 1565 randomized patients, 228 patients did not have a visit after baseline and 38 patients, in the MET+LIFE group, did not start metformin per protocol by study day 137 post-randomization. These 266 patients were not included in the modified intent-to-treat (ITT) sample and results, giving an ITT sample size of 1299.
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| ID | Title | Description |
|---|---|---|
| FG000 | MET and LIFE | Participants randomized to this group will receive both Metformin and lifestyle intervention.Participants randomized to treatment with MET will start at a dose of 500 mg orally at night and slowly titrated in 2-week intervals to ensure that each patient achieves maximum insulin-sensitizing effects of the drug while minimizing the chance of side effects. Investigators will also recommend that MET be taken with food to minimize side effects. If a participant's BMI percentile <5% (=underweight) his/her treatment with MET will be discontinued. Although the risk of low vitamin B12 while taking MET is associated with age > 50 years and having type II diabetes, Investigator will monitor B12 levels and a CBC throughout study participation. Metformin: Metformin - to achieves maximum insulin-sensitizing effects healthy lifestyle intervention (LIFE): Healthy Life style intervention |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Aug 14, 2018 |
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| healthy lifestyle intervention (LIFE) | Behavioral | Healthy Life style intervention |
|
|
| Neptune City |
| New Jersey |
| 07753 |
| United States |
| South Oaks | Amityville | New York | 11701 | United States |
| SUNY Downstate/ Kings County Hospital | Brooklyn | New York | 11203 | United States |
| Maimonides | Brooklyn | New York | 11219 | United States |
| NYCCC | Brooklyn | New York | 11233 | United States |
| Northwell Zucker Long Island Jewish Hospital | Glen Oaks | New York | 11004 | United States |
| Mount Sinai | New York | New York | 10029 | United States |
| LIJ Zucker Hillside Hospital | New York | New York | 11004 | United States |
| Child Center of New York, | Queens | New York | 11373 | United States |
| NorthShore Child and Family Guidance | Roslyn Heights | New York | 11577 | United States |
| StonyBrook | Stony Brook | New York | 11794 | United States |
| Lighthouse Youth Services | Cincinnati | Ohio | 45206 | United States |
| Central Clinic | Cincinnati | Ohio | 45219 | United States |
| Children's Home | Cincinnati | Ohio | 45227 | United States |
| Cincinnati Children's Hospital Medical Center | Cincinnati | Ohio | 45229 | United States |
| Resident Mood Medication Clinic | Cincinnati | Ohio | 45229 | United States |
| St. Aloysius | Cincinnati | Ohio | 45237 | United States |
| Talbert House | Cincinnati | Ohio | 45238 | United States |
| St. Joseph's Orphanage | Cincinnati | Ohio | 45239 | United States |
| Child Focus | Cincinnati | Ohio | 45244 | United States |
| NECCO | Cincinnati | Ohio | 45246 | United States |
| University Hospital Medical Center Cleveland | Cleveland | Ohio | 44106 | United States |
| Nationwide Children's Hospital Columbus | Columbus | Ohio | 43205 | United States |
| Ohio State University | Columbus | Ohio | 43210 | United States |
| South Community | Dayton | Ohio | United States |
| Butler Behavioral Health Services | Hamilton | Ohio | 45011 | United States |
| TCN Family Solutions | Xenia | Ohio | 45385 | United States |
| Seton Family of Hospitals | Austin | Texas | 78712 | United States |
| Derived |
| Higdon C, Welge JA, Crimmins NA, Klein CC, Fornari VM, Sorter MT, Blom TJ, Kurtz BP, Correll CU, DelBello MP. Metabolic syndrome in youth with bipolar spectrum disorders treated with second-generation antipsychotics: baseline results from the community-based pragmatic MOBILITY Trial. Eur Child Adolesc Psychiatry. 2025 Sep;34(9):2917-2929. doi: 10.1007/s00787-025-02680-2. Epub 2025 Apr 11. |
| 39554834 | Derived | Welge JA, Correll CU, Sorter MT, Fornari VM, Blom TJ, Carle AC, Huang B, Klein CC, DelBello MP. Metformin for Overweight and Obese Children With Bipolar Spectrum Disorders Treated With Second-Generation Antipsychotics (MOBILITY): Protocol and Methodological Considerations for a Large Pragmatic Randomized Clinical Trial. JAACAP Open. 2023 Mar 13;1(1):60-73. doi: 10.1016/j.jaacop.2023.03.004. eCollection 2023 Jun. |
| FG001 | Healthy Lifestyle Intervention (LIFE) | Participants randomized to this group will receive just lifestyle intervention alone.This healthy lifestyle intervention (LIFE) consists of counseling participants and families regarding a healthy eating plan, physical activity and sedentary activities. Prior to study initiation, clinical site staff will participate in a live (or taped) training session from a dietician to lean to administer LIFE. A trained site staff member (e.g. medical assistant or case manager) will meet with participants and their families for a 15-20 minute session at baseline that will focus on nutritional issues using the Traffic Light Plan (TLP). healthy lifestyle intervention (LIFE): Healthy Life style intervention |
| Followed Randomized Treatment (Per-protocol Sample) |
|
| COMPLETED |
|
| NOT COMPLETED |
|
|
Modified intent-to-treat sample, which includes all randomized patients who had a post-randomization visit and started their randomized intervention.
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| ID | Title | Description |
|---|---|---|
| BG000 | MET and LIFE | Participants randomized to this group will receive both Metformin and lifestyle intervention.Participants randomized to treatment with MET will start at a dose of 500 mg orally at night and slowly titrated in 2-week intervals to ensure that each patient achieves maximum insulin-sensitizing effects of the drug while minimizing the chance of side effects. Investigators will also recommend that MET be taken with food to minimize side effects. If a participant's BMI percentile <5% (=underweight) his/her treatment with MET will be discontinued. Although the risk of low vitamin B12 while taking MET is associated with age > 50 years and having type II diabetes, Investigator will monitor B12 levels and a CBC throughout study participation. Metformin: Metformin - to achieves maximum insulin-sensitizing effects healthy lifestyle intervention (LIFE): Healthy Life style intervention |
| BG001 | Healthy Lifestyle Intervention (LIFE) | Participants randomized to this group will receive just lifestyle intervention alone.This healthy lifestyle intervention (LIFE) consists of counseling participants and families regarding a healthy eating plan, physical activity and sedentary activities. Prior to study initiation, clinical site staff will participate in a live (or taped) training session from a dietician to lean to administer LIFE. A trained site staff member (e.g. medical assistant or case manager) will meet with participants and their families for a 15-20 minute session at baseline that will focus on nutritional issues using the Traffic Light Plan (TLP). healthy lifestyle intervention (LIFE): Healthy Life style intervention |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | Years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| BMI Z-Score | Raw body mass index (BMI) is calculated as (weight(kg)/ height(m)2). This raw BMI value is converted to a normalized BMI z-score, adjusted for age and sex using US Centers for Disease Control and Prevention growth charts. A z-score equal to 0 indicates the population mean and larger z-scores are heavier weights and worse outcomes. | Mean | Standard Deviation | Z-score |
| ||||||||||||||
| Obesity | BMI greater or equal to 95th percentile for age and sex | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change in BMI Z-score From Baseline to Month 6 in ITT Sample | Raw body mass index (BMI) is calculated as (weight(kg)/ height(m)2). This raw BMI value is converted to a normalized BMI z-score, adjusted for age and sex using US Centers for Disease Control and Prevention growth charts. A z-score equal to 0 indicates the population mean and larger z-scores are heavier weights and worse outcomes. | Modified intention-to-treat (ITT) sample consisting of patients who initiated randomized treatment and had at least one post-baseline assessment. | Posted | Mean | Standard Deviation | Z-score | Baseline to Month 6 |
|
|
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Primary | Change in BMI Z-score From Baseline to Month 24 in ITT Sample | Raw body mass index (BMI) is calculated as (weight(kg)/ height(m)2). This raw BMI value is converted to a normalized BMI z-score, adjusted for age and sex using US Centers for Disease Control and Prevention growth charts. A z-score equal to 0 indicates the population mean and larger z-scores are heavier weights and worse outcomes. | Modified intention-to-treat (ITT) sample consisting of patients who initiated randomized treatment and had at least one post-baseline assessment. | Posted | Mean | Standard Deviation | Z-score | Baseline to Month 24 |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Primary | Change in BMI Z-score From Baseline to Month 6 in Per Protocol Sample | Raw body mass index (BMI) is calculated as (weight(kg)/ height(m)2). This raw BMI value is converted to a normalized BMI z-score, adjusted for age and sex using US Centers for Disease Control and Prevention growth charts. A z-score equal to 0 indicates the population mean and larger z-scores are heavier weights and worse outcomes. | Per protocol sample consisting of patients who had continuously followed their randomized treatment through month 6 | Posted | Mean | Standard Deviation | Z-score | Baseline to Month 6 |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Primary | Change in BMI Z-score From Baseline to Month 24 in Per Protocol Sample | Raw body mass index (BMI) is calculated as (weight(kg)/ height(m)2). This raw BMI value is converted to a normalized BMI z-score, adjusted for age and sex using US Centers for Disease Control and Prevention growth charts. A z-score equal to 0 indicates the population mean and larger z-scores are heavier weights and worse outcomes. | Per protocol sample consisting of patients who had continuously followed their randomized treatment through month 24 | Posted | Mean | Standard Deviation | Z-score | Baseline to Month 24 |
|
30 months
Other non-serious adverse events are reported for the per protocol sample, consisting of patients who had followed their randomized treatment.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | MET and LIFE | Participants randomized to this group will receive both Metformin and lifestyle intervention.Participants randomized to treatment with MET will start at a dose of 500 mg orally at night and slowly titrated in 2-week intervals to ensure that each patient achieves maximum insulin-sensitizing effects of the drug while minimizing the chance of side effects. Investigators will also recommend that MET be taken with food to minimize side effects. If a participant's BMI percentile <5% (=underweight) his/her treatment with MET will be discontinued. Although the risk of low vitamin B12 while taking MET is associated with age > 50 years and having type II diabetes, Investigator will monitor B12 levels and a CBC throughout study participation. Metformin: Metformin - to achieves maximum insulin-sensitizing effects healthy lifestyle intervention (LIFE): Healthy Life style intervention | 0 | 579 | 12 | 579 | 352 | 558 |
| EG001 | Healthy Lifestyle Intervention (LIFE) | Participants randomized to this group will receive just lifestyle intervention alone.This healthy lifestyle intervention (LIFE) consists of counseling participants and families regarding a healthy eating plan, physical activity and sedentary activities. Prior to study initiation, clinical site staff will participate in a live (or taped) training session from a dietician to lean to administer LIFE. A trained site staff member (e.g. medical assistant or case manager) will meet with participants and their families for a 15-20 minute session at baseline that will focus on nutritional issues using the Traffic Light Plan (TLP). healthy lifestyle intervention (LIFE): Healthy Life style intervention | 0 | 720 | 25 | 720 | 339 | 686 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| abdominal pain | General disorders | MedDRA | Systematic Assessment |
| |
| refractory headaches | General disorders | MedDRA | Systematic Assessment |
| |
| complications of tonsillectomy | General disorders | MedDRA | Systematic Assessment |
| |
| neck dystonia | General disorders | MedDRA | Systematic Assessment |
| |
| seizures | General disorders | MedDRA | Systematic Assessment |
| |
| hypoglycemia | General disorders | MedDRA | Systematic Assessment |
| |
| pneumonia | General disorders | MedDRA | Systematic Assessment |
| |
| pyelonephritis | General disorders | MedDRA | Systematic Assessment |
| |
| urethral/kidney stone | General disorders | MedDRA | Systematic Assessment |
| |
| infection | General disorders | MedDRA | Systematic Assessment |
| |
| hepatitis | General disorders | MedDRA | Systematic Assessment |
| |
| allergic reaction | General disorders | MedDRA | Systematic Assessment |
| |
| fractures due to motor vehicle accident | General disorders | MedDRA | Systematic Assessment |
| |
| thyroidectomy | General disorders | MedDRA | Systematic Assessment |
| |
| leukemia | General disorders | MedDRA | Systematic Assessment |
| |
| sickle-cell crisis | General disorders | MedDRA | Systematic Assessment |
| |
| Sydenham's Chorea | General disorders | MedDRA | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Increased Appetite | General disorders | MedDRA | Systematic Assessment |
| |
| Sedation | General disorders | MedDRA | Systematic Assessment |
| |
| Headache | General disorders | MedDRA | Systematic Assessment |
| |
| Somnolence | General disorders | MedDRA | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| Diarrhea | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| Stomach Cramps | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| Flatulence | Gastrointestinal disorders | MedDRA | Systematic Assessment |
|
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Casey Moore | University of Cincinnati | 513-558-6307 | casey.moore@uc.edu |
| Mar 22, 2024 |
| Prot_SAP_000.pdf |
| ID | Term |
|---|---|
| D001714 | Bipolar Disorder |
| ID | Term |
|---|---|
| D000068105 | Bipolar and Related Disorders |
| D019964 | Mood Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D008687 | Metformin |
| ID | Term |
|---|---|
| D001645 | Biguanides |
| D006146 | Guanidines |
| D000578 | Amidines |
| D009930 | Organic Chemicals |
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| Male |
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
Participants randomized to this group will receive just lifestyle intervention alone.This healthy lifestyle intervention (LIFE) consists of counseling participants and families regarding a healthy eating plan, physical activity and sedentary activities. Prior to study initiation, clinical site staff will participate in a live (or taped) training session from a dietician to lean to administer LIFE. A trained site staff member (e.g. medical assistant or case manager) will meet with participants and their families for a 15-20 minute session at baseline that will focus on nutritional issues using the Traffic Light Plan (TLP). healthy lifestyle intervention (LIFE): Healthy Life style intervention |
|
|
|
Participants randomized to this group will receive just lifestyle intervention alone.This healthy lifestyle intervention (LIFE) consists of counseling participants and families regarding a healthy eating plan, physical activity and sedentary activities. Prior to study initiation, clinical site staff will participate in a live (or taped) training session from a dietician to lean to administer LIFE. A trained site staff member (e.g. medical assistant or case manager) will meet with participants and their families for a 15-20 minute session at baseline that will focus on nutritional issues using the Traffic Light Plan (TLP). healthy lifestyle intervention (LIFE): Healthy Life style intervention |
|
|
|
Participants randomized to this group will receive just lifestyle intervention alone.This healthy lifestyle intervention (LIFE) consists of counseling participants and families regarding a healthy eating plan, physical activity and sedentary activities. Prior to study initiation, clinical site staff will participate in a live (or taped) training session from a dietician to lean to administer LIFE. A trained site staff member (e.g. medical assistant or case manager) will meet with participants and their families for a 15-20 minute session at baseline that will focus on nutritional issues using the Traffic Light Plan (TLP). healthy lifestyle intervention (LIFE): Healthy Life style intervention |
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