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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2020-02687 | Registry Identifier | CTRP (Clinical Trial Reporting Program) |
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| Name | Class |
|---|---|
| eHealth International, INC. | UNKNOWN |
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This early phase I trial studies how well a behavioral weight loss intervention consisting of a smartphone application and coaching works for the promotion of weight loss in adolescents and young adults after a stem cell transplant. This study may help researchers learn more about how adolescents and young adults can lose weight and develop healthy eating habits.
PRIMARY OBJECTIVE:
I. To evaluate the effectiveness of an addiction-based weight loss intervention, embodied as a smartphone application (app) with telephone coaching, on weight outcomes of overweight and obese post hematopoietic stem cell transplantation (HSCT) adolescents and young adults.
SECONDARY OBJECTIVES:
I. To evaluate the changes in metabolic parameters and physical activity levels, in addition to modifications in addictive eating behaviors, motivation, and self-regulatory behaviors.
II. To evaluate the feasibility, adherence, and satisfaction of this intervention.
OUTLINE:
Patients receive an iPhone with W8Loss2Go app, a body scale and a digital food scale to weigh themselves and food daily. Patients interact with coaches via text messages for 4 days weekly and receive weekly 15 minute phone calls for appointment reminders, emotional support, progress discussion, and follow up on items discussed in a prior visit or phone call. Patients also have telemedicine interviews with the coach lasting 60 minutes at 2 and 4 months to elicit both positive and negative impacts on weight management and to identify barriers such as emotional eating, displacement behaviors, poor coping skills to life stressors, and social challenges. Patients who opt to extend the intervention until month 12 attend an additional telemedicine meeting with the coach. Patients also complete questionnaires over approximately 1.5 hours.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Supportive Care (app, scales, coaching, questionnaire) | Experimental | Patients receive an iPhone with W8Loss2Go app, a body scale and a digital food scale to weigh themselves and food daily. Patients interact with coaches via text messages for 4 days weekly and receive weekly 15 minute phone calls for appointment reminders, emotional support, progress discussion, and follow up on items discussed in a prior visit or phone call. Patients also have telemedicine interviews with the coach lasting 60 minutes at 2 and 4 months to elicit both positive and negative impacts on weight management and to identify barriers such as emotional eating, displacement behaviors, poor coping skills to life stressors, and social challenges. Patients who opt to extend the intervention until month 12 attend an additional telemedicine meeting with the coach. Patients also complete questionnaires over approximately 1.5 hours. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Interview | Other | Participate in interviews |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Change in body mass index (BMI) status | The main outcomes measures will be height (meters), weight (kg), and BMI (kg/m^2). Height will be measured to assess consistency in height measurements. Weight will be measured to assess trends in weight over the time span of the intervention. BMI will be measured as a product of weight and height to obtain an appropriate metric that accounts for these measures, and is the standard measure to assess weight progression in weight intervention studies. | Baseline up to 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Adherence | Compliance with app intervention will be measured by daily interaction with the application and the coach. A point system has been designed in the application to measure compliance with the app intervention, measured by +/- weight measured daily, logging of problem foods, logging of snacking panel, and logging of meals. The coach interacts with the participants through text daily, and through phone calls weekly. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Theodore B Moore | UCLA / Jonsson Comprehensive Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UCLA / Jonsson Comprehensive Cancer Center | Recruiting | Los Angeles | California | 90095 | United States |
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| Media Intervention |
| Other |
Receive iPhone with W8Loss2Go app |
|
| Questionnaire Administration | Other | Complete questionnaires |
|
| Scale Device | Other | Receive body scale and food scale |
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| Telephone-Based Intervention | Behavioral | Receive telephone calls |
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| Text Message | Other | Receive text message |
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| Up to 12 months |
| Fasting lab test analysis: HbA1c | HbA1c: Glycated hemoglobin (A1C) test result reflects your average blood sugar level for the past two to three months. Specifically, the A1C test measures what percentage of your hemoglobin is coated with sugar. The healthy range is between 4% and 5.6% | At four months up to 12 months |
| Fasting lab test analysis: Total cholesterol | Total cholesterol: This measures the overall amount of cholesterol in your blood. The healthy range is < 170 mg/dL | At four months up to 12 months |
| Fasting lab test analysis: Low density lipoprotein | LDL: low density lipoprotein (LDL) is the bad cholesterol in your blood. The healthy range is <100 mg/dL | At four months up to 12 months |
| Fasting lab test analysis: High density lipoprotein | HDL: high density lipoprotein (HDL) is the good cholesterol in your blood. The healthy range is > 45 mg/dL | At four months up to 12 months |
| Fasting lab test analysis: triglycerides | TG: triglycerides (TG) are a type of lipid in your blood. The healthy range is < 150 mg/dL | At four months up to 12 months |
| Fasting lab test analysis: aspartate/alanine aminotransferase | AST/ALT: aspartate/alanine aminotransferase (AST/ALT) are liver enzymes to measure liver health. The healthy range or AST is 10-34 IU/L and the healthy range for ALT is 8-37 IU/L. | At four months up to 12 months |
| Fasting lab test analysis: glucose | Glucose: This measures the amount of sugar in your blood. We measure this after fasting for 8 hours. The healthy range is 70-99 mg/dL | At four months up to 12 months |
| Yale Food Addiction Scale | visual analog scale (1: never to 5:always). Higher scores may suggest more addictive like eating | Up to 12 months |
| Center for epidemiologic studies depression scale | 4 categorical options (never/rarely, sometimes, moderately, all of the time). A higher score suggests utility for screening for depression | Up to 12 months |
| Perceived stress scale | Likert Scale (0: never to 4:very often). Higher scores suggests higher stress | Up to 12 months |
| Satisfaction with program | Measured by "Satisfaction Survey". This Likert Scale will be completed by the participant and their parent at the end of the study. This scale uses a Likert Scale where 1 = completely disagree to 7 = completely agree. Higher scores suggest greater satisfaction with the intervention. | Up to 12 months |
| Demographic questionnaire | 10 questions with varying options to inquire about common demographic questions (gender, age, primary language, etc). Questions are descriptive in nature and no score is assigned. | Up to 12 months |
| Food craving questionnaire | Likert scale (1: never to 5: always). A higher score suggests higher degrees of food cravings | Up to 12 months |
| Binge eating disorder screen | 4 categorical options (never/rarely, sometimes, often, always). A higher score suggests utility for screening for binge eating disorder | Up to 12 months |
| Physical activity questionnaire | participants identify number of times (0 to more than 7) that they conducted a particular physical activity in the past 7 days. This includes skipping, rowing, etc. | Up to 12 months |
| S weight | Likert scale (1: strongly disagree to 5: strongly agree). Higher scores indicates more motivation for change in weight | Up to 12 months |
| Height encounters questionnaire | six questions about the participants health care utilization in the past month. Questions are descriptive in nature and no score is assigned. | Up to 12 months |
| ID | Term |
|---|---|
| D009765 | Obesity |
| D009369 | Neoplasms |
| ID | Term |
|---|---|
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D007407 | Interviews as Topic |
| D014894 | Weights and Measures |
| D013097 | Spermine Synthase |
| D003143 | Communication Devices for People with Disabilities |
| ID | Term |
|---|---|
| D003625 | Data Collection |
| D004812 | Epidemiologic Methods |
| D008919 | Investigative Techniques |
| D017531 | Health Care Evaluation Mechanisms |
| D011787 | Quality of Health Care |
| D017530 | Health Care Quality, Access, and Evaluation |
| D011634 | Public Health |
| D004778 | Environment and Public Health |
| D019883 | Alkyl and Aryl Transferases |
| D014166 | Transferases |
| D004798 | Enzymes |
| D045762 | Enzymes and Coenzymes |
| D012656 | Self-Help Devices |
| D004864 | Equipment and Supplies |
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