Mobile Health Intervention to Identify Early Responders to Treatment in Adolescent Obesity

Not Applicable

Completed

Conditions: Adolescent Obesity

Interventions: Behavioral: Mobile health intervention

Registration Number: NCT03561597

Lead Sponsor: KK Women's and Children's Hospital

Brief Summary: Background: The Expert Committee on the Assessment, Prevention and Treatment of Child and Adolescent Overweight and Obesity recommends a staged based approach to the management of adolescents with overweight and obesity from Stage 1-4 with increasing intensity of management in higher stages. Mobile health application is an attractive community based treatment for adolescent obesity due to its wide penetration and convenience. Early weight loss has been found to be the strongest predictor of good long term outcome in obesity. However there is currently no known study that use early weight loss as a predictor factor for a stepped up approach using a mobile health application.

Clinical significance: The current study use a mobile health intervention to identify participants with early weight loss in a stepped up approach.

Primary objective will be to examine the proportion of patients triaged to the low risk Weight Management Clinics (WMC) after brief intervention by a nurse coordination and completion of 4 sessions of Kurbo Program over a 12 month recruitment period.

Secondary objectives will be to examine changes in BMI z-score, metabolic profile, examine program feasibility and fidelity and explore other predictors of poor response to program.

Methodology:

Children aged 13-17 years old with BMI percentile of above 90th percentile, who are referred to the WMC, will receive a brief intervention by the WMC nurse coordinator followed by introduction to Kurbo program, a multifunctional mobile application, for more detailed dietary and physical activity recommendations and implementation of behavioural changes. Patients that are able to engage with Kurbo intervention and showed a decrease in BMI percentile over 4 sessions of Kurbo will be offered the low risk weight management clinic.

At baseline, month 3 and month 6, the patient's weight and height, body fat composition, waist circumference and blood pressure will be measured as per usual standard protocol. Questionnaires to assess eating, quality of life and dietary recall will be administered as part of the research. Accelerometers will also be fitted to assess physical activity.

At baseline and month 6, metabolic blood tests (HbA1C, fasting lipid panel, oral glucose tolerance test, fasting insulin level and liver function test) were collected after a minimum 8 hour fasting period together with bloods for aromatic amino acid, branch chain amino acid and long chain acylcarnitines .

Current low risk WMC patients will be offered 2 monthly follow up with optional dietician and exercise physiologists counselling and exercise sessions. The high risk WMC patients will be routinely offered the standard high risk follow up protocol consisting of weekly follow up with the multidisciplinary team for 4 weeks followed by 2 weekly appointments for 2 months and monthly appointment thereafter based on clinical response.

Detailed Description: Not available

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 40

Inclusion Criteria

Overweight as defined by BMI percentile of above 90th percentile
Age 13-17 years old in the year of referral
Ability to provide informed consent
Adolescents with a phone which is able to download the application to be used on their devices

Exclusion Criteria

Patients with secondary causes of obesity especially genetic syndromes e.g. Trisomy 21, Prader-Willi
Currently participating in a weight management program
Unable to understand and speak English sufficiently to give informed consent and complete the research assessments.

Study & Design

Study Type: INTERVENTIONAL

Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Mobile health application	Mobile health intervention	Participants will undergo Kurbo program, a Mobile health application, for more detailed dietary and physical activity recommendations and implementation of behavioural changes. The patient's progress will be reviewed by the nurse clinician at one month post intervention to determine whether the BMI percentile has shown a reduction through the Kurbo Program. Patients that declined Kurbo intervention, has a BMI of more than 99th percentile or continue to have increase in their BMI percentile in Kurbo program, will be offered the high risk weight management clinic appointment for a more detailed multidisciplinary evaluation for targeted intervention. Patients that are able to engage with Kurbo intervention and showed a decrease in BMI percentile over 4 sessions of Kurbo will be offered the low risk weight management clinic (WMC). There will be a month 3 and month 6 visit for study measurements in this study.

Primary Outcome Measures

Name	Time	Method
Proportion of Patients Triaged to the Low Risk Weight Management Clinics	6 month	Examine the proportion of patients triaged to the low risk weight management clinics after brief intervention by a nurse coordination and completion of 4 sessions of Kurbo Program.

Secondary Outcome Measures

Name	Time	Method
Changes in Aspartate Transaminase From Baseline to 6 Months	Baseline and 6 months	Changes in Aspartate transaminase from Baseline to 6 months, measured in U/L
Change in Weight From Baseline to 6 Months	Baseline and 6 months	Change in weight from baseline to 6 months
Change in Weight From Baseline to 3 Months	Baseline and 3 months	Change in weight from baseline to 3 months
Change in Body Fat Percentage From Baseline to 3 Months	Baseline and 3 months	Change in body fat percentage from Baseline to 3 months. Body fat percentage was assessed using a bioimpedance analysis.
Changes in Servings of Vegetables From Baseline to 6 Months	Baseline and 6 Months	To examine the effects of waitlist intervention on nutrition using a three day food diary at baseline and 6 months to assess number of servings of vegetables per day.
Attrition Rate	6 months	To examine the rate of attrition from weight management clinic after implementation of the waitlist intervention and new model of care in weight management clinic.
Kurbo Program Feasibility, Percentage of Participants Who Completed at Least One Health Coaching Session	6 months	To examine the feasibility of using Kurbo program as a waitlist intervention for the target population as measured by quantifying the percentage of patients offered the program who agreed to enrol and engaged in Kurbo coaching session
Kurbo Program Fidelity	6 months	To examine program fidelity as measured by the percentage of patients who complete all of the 12 sessions of online coaching by Kurbo coaches, as part of Kurbo programme.
Changes in Treatment Outcomes Using BMI Z-score	6 months	To examine changes in treatment outcomes as a function of program fidelity as measured by those who complete more online coaching show greater improvements in BMI z-score. Body mass index (BMI) will be calculated as kg/m2 and BMI-z score calculated using the L, M, S parameters published by the Centre for Disease Control and Prevention. BMI z-score are measures of relative weight adjusted for child age and sex. Reduction of more than 0.25 in childhood obesity has been found to be clinically significant for reduction of cardiovascular risk factors.
Change in %BMIp95 From Baseline to 3 Months	Baseline and 3 months
Change in Waist Circumference From Baseline to 6 Months	Baseline and 6 months	Change in waist circumference from Baseline to 6 months
Change in Waist Circumference From Baseline to 3 Months	Baseline and 3 months	Change in waist circumference from Baseline to 3 months
Change in Waist to Height Ratio From Baseline to 3 Months	Baseline and 3 months	To examine the effect of the waitlist intervention and WMC intervention on waist to height ratio at baseline and 3 months. Waist and height will be measured in cm and ratio of more than 0.5 is indicative of higher cardiometabolic risk. Reduction of the waist height ratio has been shown to be beneficial in cardiometabolic outcomes.
Change in Body Fat Percentage From Baseline to 6 Months	Baseline and 6 months	Change in body fat percentage from Baseline to 6 months. Body fat percentage was assessed using a bioimpedance analysis.
Changes in Treatment Outcomes Using BMI Z-score From Baseline to 3 Months	Baseline and 3 months	To examine changes in treatment outcomes as a function of program fidelity as measured by those who complete more online coaching show greater improvements in BMI z-score. Body mass index (BMI) will be calculated as kg/m2 and BMI-z score calculated using the L, M, S parameters published by the Centre for Disease Control and Prevention. BMI z-score are measures of relative weight adjusted for child age and sex. Reduction of more than 0.25 in childhood obesity has been found to be clinically significant for reduction of cardiovascular risk factors.
Change in %BMIp95 From Baseline to 6 Months	Baseline and 6 months
Change in Waist to Height Ratio From Baseline to 6 Months	Baseline and 6 months	To examine the effect of the waitlist intervention and WMC intervention on waist to height ratio at baseline and 6 months. Waist and height will be measured in cm and ratio of more than 0.5 is indicative of higher cardiometabolic risk. Reduction of the waist height ratio has been shown to be beneficial in cardiometabolic outcomes.
Changes in Systolic Blood Pressure Measurements From Baseline to 6 Months	Baseline and 6 months	Changes in systolic blood pressure at baseline and 6 month measured in mmHg
Changes in Diastolic Blood Pressure Measurements From Baseline to 3 Months	Baseline and 3 months	Changes in diastolicblood pressure at baseline and 3 month measured in mmHg
Changes in Nutrition From Baseline to 6 Months	Baseline and 6 months	To examine the effects of waitlist intervention on nutrition using a three day food diary at baseline and 6 months to assess total caloric intake and number of servings of fruits and vegetables.
Changes in Servings of Vegetables From Baseline to 3 Months	Baseline and 3 Months	To examine the effects of waitlist intervention on nutrition using a three day food diary at baseline and 3 months to assess number of servings of vegetables per day.
Changes in Physical Quality of Life From Baseline to 3 Months	Baseline and 3 months	To examine the effects of waitlist intervention on quality of life, physical domain, at baseline and 3 months using Pediatric Quality of Life Inventory (PedsQL; UK version 4). The self-report scale had a five-point response scale (0 = never a problem, 1 = almost never, 2 = sometimes, 3 = often and 4 = almost always). Items are linearly transformed to a 0-100 scale, so that higher scores indicate better quality of life.
Changes in School Quality of Life From Baseline to 3 Months	Baseline and 3 Months	To examine the effects of waitlist intervention on quality of life, school domain, at baseline and 3 months using Pediatric Quality of Life Inventory (PedsQL; UK version 4). The self-report scale had a five-point response scale (0 = never a problem, 1 = almost never, 2 = sometimes, 3 = often and 4 = almost always). Items are linearly transformed to a 0-100 scale, so that higher scores indicate better quality of life.
Changes in Systolic Blood Pressure Measurements From Baseline to 3 Months	Baseline and 3 months	Changes in systolic blood pressure at baseline and 3 month measured in mmHg
Changes in Diastolic Blood Pressure Measurements From Baseline to 6 Months	Baseline and 6 months	Changes in diastolic blood pressure at baseline and 6 month measured in mmHg
Changes in Physical Activity From Baseline to 6 Months	Baseline and 6 months	To examine the effects of waitlist intervention on physical activity using results from accelerometer to assess time spent on sedentary and moderate to vigorous physical activity at baseline and 6 months. The Actigraph data were processed using the Actilife 6 software. The Puyau cut-off point of 3200 counts per minute (cpm) was used to estimate time spent in moderate-to-vigorous physical activity (MVPA).
Changes in Psychosocial Quality of Life From Baseline to 3 Months	Baseline and 3 Months	To examine the effects of waitlist intervention on quality of life, psychosocial domain, at baseline and 3 months using Pediatric Quality of Life Inventory (PedsQL; UK version 4). The self-report scale had a five-point response scale (0 = never a problem, 1 = almost never, 2 = sometimes, 3 = often and 4 = almost always). Items are linearly transformed to a 0-100 scale, so that higher scores indicate better quality of life.
Changes in Fasting Blood Glucose From Baseline to 6 Months	Baseline and 6 months	Examine changes in fasting blood glucose result changes at baseline and month 6 measured in nmol/L
Changes in Fasting Lipid Measurements, Triglycerides (TG), From Baseline to 6 Months	Baseline and 6 months	Examine changes in fasting lipids, Triglycerides (TG), at month 6 measured in mg/dL
Changes in Disordered Eating, Dietary Restraint From Baseline to 3 Months	Baseline and 3 months	To examine the effects of waitlist intervention on disordered eating at baseline and 3 months. Psychological dimensions of eating behaviors were determined using a validated self-reporting Eating Pattern Inventory for Children (EPI-C). The 20-item questionnaire assessed four dimensions ((dietary restraint, external eating, parental pressure to eat, and emotional eating). Responses to each item were listed on a 4-point Likert scale (1 = not at all, 2 = sometimes, 3 = mostly, 4 = always). Higher scores are indicative of greater dietary restraint.
Changes in Disordered Eating, External Eating From Baseline to 3 Months	Baseline and 3 months	To examine the effects of waitlist intervention on External Eating dimension on disordered eating at baseline and 3 months. Psychological dimensions of eating behaviors were determined using a validated self-reporting Eating Pattern Inventory for Children (EPI-C). The 20-item questionnaire assessed four dimensions ((dietary restraint, external eating, parental pressure to eat, and emotional eating). Responses to each item were listed on a 4-point Likert scale (1 = not at all, 2 = sometimes, 3 = mostly, 4 = always). Higher scores are indicative of greater dietary restraint.
Changes in Disordered Eating, Emotional Eating, From Baseline to 3 Months	Baseline and 3 months	To examine the effects of waitlist intervention on Emotional Eating dimension on disordered eating at baseline and 3 months. Psychological dimensions of eating behaviors were determined using a validated self-reporting Eating Pattern Inventory for Children (EPI-C). The 20-item questionnaire assessed four dimensions ((dietary restraint, external eating, parental pressure to eat, and emotional eating). Responses to each item were listed on a 4-point Likert scale (1 = not at all, 2 = sometimes, 3 = mostly, 4 = always). Higher scores are indicative of greater dietary restraint.
Changes in Total Quality of Life From Baseline to 6 Months	Baseline and 6 months	To examine the effects of waitlist intervention on quality of life at baseline and 6 months using Pediatric Quality of Life Inventory (PedsQL; UK version 4) will be administered as a comprehensive and multi-dimensional construct that includes physical, emotional, and social functioning to assess quality of life in the adolescents. The self-report scale had a five-point response scale (0 = never a problem, 1 = almost never, 2 = sometimes, 3 = often and 4 = almost always). Items are linearly transformed to a 0-100 scale, so that higher scores indicate better quality of life.
Changes in Physical Domain of Quality of Life From Baseline to 6 Months	Baseline and 6 months	To examine the effects of waitlist intervention on quality of life, physical domain, at baseline and 6 months using Pediatric Quality of Life Inventory (PedsQL; UK version 4). The self-report scale had a five-point response scale (0 = never a problem, 1 = almost never, 2 = sometimes, 3 = often and 4 = almost always). Items are linearly transformed to a 0-100 scale, so that higher scores indicate better quality of life.
Changes in School Quality of Life From Baseline to 6 Months	Baseline and 6 months	To examine the effects of waitlist intervention on quality of life, school domain, at baseline and 6 months using Pediatric Quality of Life Inventory (PedsQL; UK version 4). The self-report scale had a five-point response scale (0 = never a problem, 1 = almost never, 2 = sometimes, 3 = often and 4 = almost always). Items are linearly transformed to a 0-100 scale, so that higher scores indicate better quality of life.
Changes in Disordered Eating, Parental Pressure to Eat, From Baseline to 3 Months	Baseline and 3 months	To examine the effects of waitlist intervention on Parental Pressure to Eat dimension on disordered eating at baseline and 3 months. Psychological dimensions of eating behaviors were determined using a validated self-reporting Eating Pattern Inventory for Children (EPI-C). The 20-item questionnaire assessed four dimensions ((dietary restraint, external eating, parental pressure to eat, and emotional eating). Responses to each item were listed on a 4-point Likert scale (1 = not at all, 2 = sometimes, 3 = mostly, 4 = always). Higher scores are indicative of greater dietary restraint.
Changes in Nutrition From Baseline to 3 Months	Baseline and 3 months	To examine the effects of waitlist intervention on nutrition using a three day food diary at baseline and 3 months to assess total caloric intake and number of servings of fruits and vegetables.
Changes in Total Quality of Life From Baseline to 3 Months	Baseline and 3 months	To examine the effects of waitlist intervention on quality of life at baseline and 3 months using Pediatric Quality of Life Inventory (PedsQL; UK version 4) will be administered as a comprehensive and multi-dimensional construct that includes physical, emotional, and social functioning to assess quality of life in the adolescents. The self-report scale had a five-point response scale (0 = never a problem, 1 = almost never, 2 = sometimes, 3 = often and 4 = almost always). Items are linearly transformed to a 0-100 scale, so that higher scores indicate better quality of life.
Changes in Emotional Quality of Life From Baseline to 3 Months	Baseline and 3 months	To examine the effects of waitlist intervention on quality of life, emotional domain, at baseline and 3 months using Pediatric Quality of Life Inventory (PedsQL; UK version 4). The self-report scale had a five-point response scale (0 = never a problem, 1 = almost never, 2 = sometimes, 3 = often and 4 = almost always). Items are linearly transformed to a 0-100 scale, so that higher scores indicate better quality of life.
Changes in Psychosocial Quality of Life From Baseline to 6 Months	Baseline and 6 Months	To examine the effects of waitlist intervention on quality of life, psychosocial domain, at baseline and 6 months using Pediatric Quality of Life Inventory (PedsQL; UK version 4). The self-report scale had a five-point response scale (0 = never a problem, 1 = almost never, 2 = sometimes, 3 = often and 4 = almost always). Items are linearly transformed to a 0-100 scale, so that higher scores indicate better quality of life.
Changes in Disordered Eating on Dietary Restraint From Baseline to 6 Months	Baseline and 6 months	To examine the effects of waitlist intervention on disordered eating at baseline and 6 months. Psychological dimensions of eating behaviors were determined using a validated self-reporting Eating Pattern Inventory for Children (EPI-C). The 20-item questionnaire assessed four dimensions ((dietary restraint, external eating, parental pressure to eat, and emotional eating). Responses to each item were listed on a 4-point Likert scale (1 = not at all, 2 = sometimes, 3 = mostly, 4 = always). Higher scores are indicative of greater dietary restraint.
Changes in Disordered Eating, External Eating From Baseline to 6 Months	Baseline and 6 months	To examine the effects of waitlist intervention on External Eating dimension on disordered eating at baseline and 6 months. Psychological dimensions of eating behaviors were determined using a validated self-reporting Eating Pattern Inventory for Children (EPI-C). The 20-item questionnaire assessed four dimensions ((dietary restraint, external eating, parental pressure to eat, and emotional eating). Responses to each item were listed on a 4-point Likert scale (1 = not at all, 2 = sometimes, 3 = mostly, 4 = always). Higher scores are indicative of greater dietary restraint.
Changes in Disordered Eating, Parental Pressure to Eat, From Baseline to 6 Months	Baseline and 6 months	To examine the effects of waitlist intervention on Parental Pressure to Eat dimension on disordered eating at baseline and 6 months. Psychological dimensions of eating behaviors were determined using a validated self-reporting Eating Pattern Inventory for Children (EPI-C). The 20-item questionnaire assessed four dimensions ((dietary restraint, external eating, parental pressure to eat, and emotional eating). Responses to each item were listed on a 4-point Likert scale (1 = not at all, 2 = sometimes, 3 = mostly, 4 = always). Higher scores are indicative of greater dietary restraint.
Changes in Physical Activity From Baseline to 3 Months	Baseline and 3 months	To examine the effects of waitlist intervention on physical activity using results from accelerometer to assess time spent on sedentary and moderate to vigorous physical activity at baseline and 3 months. The Actigraph data were processed using the Actilife 6 software. The Puyau cut-off point of 3200 counts per minute (cpm) was used to estimate time spent in moderate-to-vigorous physical activity (MVPA).
Changes in Emotional Quality of Life From Baseline to 6 Months	Baseline and 6 months	To examine the effects of waitlist intervention on quality of life, emotional domain, at baseline and 6 months using Pediatric Quality of Life Inventory (PedsQL; UK version 4). The self-report scale had a five-point response scale (0 = never a problem, 1 = almost never, 2 = sometimes, 3 = often and 4 = almost always). Items are linearly transformed to a 0-100 scale, so that higher scores indicate better quality of life.
Insulin Resistance Index Changes	Baseline and 6 months	Examine changes in insulin resistance index at baseline and 6 months. Insulin resistance index is calculated according to the formula: fasting insulin (microU/L) x fasting glucose (nmol/L)/22.5
Changes in 120 Minute Glucose Result in Oral Glucose Tolerance Test Measurements	Baseline and 6 months	Examine changes in 120 minute glucose result changes in oral glucose tolerance test at baseline and month 6 measured in nmol/L.
Changes in Fasting Lipid Measurements, Low Density Lipoprotein (LDL), From Baseline to 6 Months	Baseline and 6 months	Examine changes in fasting lipids, low density lipoprotein cholesterol (LDL), at month 6 measured in mg/dL
Changes in Alanine Transaminase From Baseline to 6 Months	Baseline and 6 months	Changes in Alanine transaminase from Baseline to 6 months measured in U/L
Changes in Disordered Eating, Emotional Eating, From Baseline to 6 Months	Baseline and 6 months	To examine the effects of waitlist intervention on Emotional Eating dimension on disordered eating at baseline and 6 months. Psychological dimensions of eating behaviors were determined using a validated self-reporting Eating Pattern Inventory for Children (EPI-C). The 20-item questionnaire assessed four dimensions ((dietary restraint, external eating, parental pressure to eat, and emotional eating). Responses to each item were listed on a 4-point Likert scale (1 = not at all, 2 = sometimes, 3 = mostly, 4 = always). Higher scores are indicative of greater dietary restraint.
Changes in Fasting Lipid Measurements, High Density Lipoprotein (HDL), From Baseline to 6 Months	Baseline and 6 months	Examine changes in fasting lipids, high density lipoprotein cholesterol (HDL), at month 6 measured in mg/dL
Metabolomic Profile Changes From Baseline to 6 Months (BCAA)	baseline and 6 months	Examine changes in branched chain amino acid(BCAA) at baseline and month 6. Metabolites to be analysed include BCAA which is a combination of isoleucine, leucine, valine. All metabolites concentrations will be reported in micro mol per litre
Metabolomic Profile Changes From Baseline to 6 Months (AAA)	baseline and 6 months	Examine changes in aromatic amino acid (AAA) at baseline and month 6. Metabolites to be analysed include AAA which is a combination of phenylalanine and tyrosine. All metabolites concentrations will be reported in micro mol per litre.