Adolescent ObesityNCT03561597
Mobile Health Intervention to Identify Early Responders to Treatment in Adolescent Obesity
A study testing Mobile health intervention in people with Adolescent Obesity, run by KK Women's and Children's Hospital at 1 site in Singapore.
Trial 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. Read more about this study
- Who is it for?
- Ages 13 to 17 years
- Conditions the study is for
- Adolescent Obesity
- What is being tested?
- Mobile health intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteSingapore
- Study dates
- 10 Apr 2018to 21 Oct 2019
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 13 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Pilot Evaluation of a Mobile Health Intervention to Identify Early Responders to Treatment in Adolescent Obesity as a Triage Approach
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.
Read more
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.
- Conditions
- Adolescent Obesity
- Being tested
- Mobile health intervention
- Keywords
- stepped care, mobile application
- Medical subject headings
- Pediatric Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mobile health interventionBehavioural
The Kurbo program is a multifunctional mobile application that aid adolescents and their families to learn healthy eating habits and weight management through the use of a mobile application with dietary self-monitoring and weekly interactive coaching sessions. Using the Kurbo app, adolescents track their food and exercise, as well as learn about healthy behaviours through games and videos. The Kurbo coaches check in with adolescents for 15 minutes once a week via video, phone or text over a 12 weeks period.
| Study group | Role | What they receive |
|---|---|---|
| Mobile health application | Experimental | 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. Receives: Behavioral: Mobile health intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of Patients Triaged to the Low Risk Weight Management Clinics
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.
Measured: 6 month
Secondary outcomes (53)
Kurbo Program Feasibility, Percentage of Participants Who Completed at Least One Health Coaching Session
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
Measured: 6 months
Kurbo Program Fidelity
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.
Measured: 6 months
Attrition Rate
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.
Measured: 6 months
Change in Weight From Baseline to 6 Months
Change in weight from baseline to 6 months
Measured: Baseline and 6 months
Change in Weight From Baseline to 3 Months
Change in weight from baseline to 3 months
Measured: Baseline and 3 months
Changes in Treatment Outcomes Using BMI Z-score
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.
Measured: 6 months
Changes in Treatment Outcomes Using BMI Z-score From Baseline to 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.
Measured: Baseline and 3 months
Change in %BMIp95 From Baseline to 6 Months
Measured: Baseline and 6 months
Change in %BMIp95 From Baseline to 3 Months
Measured: Baseline and 3 months
Change in Waist Circumference From Baseline to 6 Months
Change in waist circumference from Baseline to 6 months
Measured: Baseline and 6 months
Change in Waist Circumference From Baseline to 3 Months
Change in waist circumference from Baseline to 3 months
Measured: Baseline and 3 months
Change in Waist to Height Ratio From Baseline to 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.
Measured: Baseline and 6 months
Change in Waist to Height Ratio From Baseline to 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.
Measured: Baseline and 3 months
Change in Body Fat Percentage From Baseline to 6 Months
Change in body fat percentage from Baseline to 6 months. Body fat percentage was assessed using a bioimpedance analysis.
Measured: Baseline and 6 months
Change in Body Fat Percentage From Baseline to 3 Months
Change in body fat percentage from Baseline to 3 months. Body fat percentage was assessed using a bioimpedance analysis.
Measured: Baseline and 3 months
Changes in Systolic Blood Pressure Measurements From Baseline to 6 Months
Changes in systolic blood pressure at baseline and 6 month measured in mmHg
Measured: Baseline and 6 months
Changes in Systolic Blood Pressure Measurements From Baseline to 3 Months
Changes in systolic blood pressure at baseline and 3 month measured in mmHg
Measured: Baseline and 3 months
Changes in Diastolic Blood Pressure Measurements From Baseline to 6 Months
Changes in diastolic blood pressure at baseline and 6 month measured in mmHg
Measured: Baseline and 6 months
Changes in Diastolic Blood Pressure Measurements From Baseline to 3 Months
Changes in diastolicblood pressure at baseline and 3 month measured in mmHg
Measured: Baseline and 3 months
Changes in Nutrition From Baseline to 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.
Measured: Baseline and 6 months
Changes in Nutrition From Baseline to 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.
Measured: Baseline and 3 months
Changes in Servings of Vegetables From Baseline to 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.
Measured: Baseline and 6 Months
Changes in Servings of Vegetables From Baseline to 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.
Measured: Baseline and 3 Months
Changes in Physical Activity From Baseline to 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).
Measured: Baseline and 6 months
Changes in Physical Activity From Baseline to 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).
Measured: Baseline and 3 months
Changes in Total Quality of Life From Baseline to 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.
Measured: Baseline and 6 months
Changes in Total Quality of Life From Baseline to 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.
Measured: Baseline and 3 months
Changes in Physical Domain of Quality of Life From Baseline to 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.
Measured: Baseline and 6 months
Changes in Physical Quality of Life From Baseline to 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.
Measured: Baseline and 3 months
Changes in Emotional Quality of Life From Baseline to 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.
Measured: Baseline and 6 months
Changes in Emotional Quality of Life From Baseline to 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.
Measured: Baseline and 3 months
Changes in School Quality of Life From Baseline to 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.
Measured: Baseline and 6 months
Changes in School Quality of Life From Baseline to 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.
Measured: Baseline and 3 Months
Changes in Psychosocial Quality of Life From Baseline to 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.
Measured: Baseline and 6 Months
Changes in Psychosocial Quality of Life From Baseline to 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.
Measured: Baseline and 3 Months
Insulin Resistance Index Changes
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
Measured: Baseline and 6 months
Changes in Fasting Blood Glucose From Baseline to 6 Months
Examine changes in fasting blood glucose result changes at baseline and month 6 measured in nmol/L
Measured: Baseline and 6 months
Changes in 120 Minute Glucose Result in Oral Glucose Tolerance Test Measurements
Examine changes in 120 minute glucose result changes in oral glucose tolerance test at baseline and month 6 measured in nmol/L.
Measured: Baseline and 6 months
Changes in Fasting Lipid Measurements, High Density Lipoprotein (HDL), From Baseline to 6 Months
Examine changes in fasting lipids, high density lipoprotein cholesterol (HDL), at month 6 measured in mg/dL
Measured: Baseline and 6 months
Changes in Fasting Lipid Measurements, Low Density Lipoprotein (LDL), From Baseline to 6 Months
Examine changes in fasting lipids, low density lipoprotein cholesterol (LDL), at month 6 measured in mg/dL
Measured: Baseline and 6 months
Changes in Fasting Lipid Measurements, Triglycerides (TG), From Baseline to 6 Months
Examine changes in fasting lipids, Triglycerides (TG), at month 6 measured in mg/dL
Measured: Baseline and 6 months
Changes in Alanine Transaminase From Baseline to 6 Months
Changes in Alanine transaminase from Baseline to 6 months measured in U/L
Measured: Baseline and 6 months
Changes in Aspartate Transaminase From Baseline to 6 Months
Changes in Aspartate transaminase from Baseline to 6 months, measured in U/L
Measured: Baseline and 6 months
Changes in Disordered Eating on Dietary Restraint From Baseline to 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.
Measured: Baseline and 6 months
Changes in Disordered Eating, Dietary Restraint From Baseline to 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.
Measured: Baseline and 3 months
Changes in Disordered Eating, External Eating From Baseline to 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.
Measured: Baseline and 6 months
Changes in Disordered Eating, External Eating From Baseline to 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.
Measured: Baseline and 3 months
Changes in Disordered Eating, Parental Pressure to Eat, From Baseline to 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.
Measured: Baseline and 6 months
Changes in Disordered Eating, Parental Pressure to Eat, From Baseline to 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.
Measured: Baseline and 3 months
Changes in Disordered Eating, Emotional Eating, From Baseline to 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.
Measured: Baseline and 6 months
Changes in Disordered Eating, Emotional Eating, From Baseline to 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.
Measured: Baseline and 3 months
Metabolomic Profile Changes From Baseline to 6 Months (BCAA)
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
Measured: baseline and 6 months
Metabolomic Profile Changes From Baseline to 6 Months (AAA)
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.
Measured: baseline and 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jun 2018
- Study start10 Apr 2018
- Primary completion21 Oct 2019
- Study completion21 Oct 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Adolescent ObesityStudies of the same condition, open and under way.
- More trials run by KK Women's and Children's HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- prospective single arm study
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- KK Women's and Children's Hospital
- Sponsor type
- Other government
- Collaborators
- National Institute of Education, Singapore, National Dental Centre, Singapore, Duke-NUS Graduate Medical School
- Responsible party
- Sponsor
- Investigators
- Elaine Chew, MBBS, Principal investigator, KK Women's and Children's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03561597
- Sponsor's protocol ID
- 006100317
- Status last verified
- Apr 2018
- First submitted
- 7 Mar 2018
- Last updated
- 6 Dec 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Not available to other researchers
Study at a glance
From the registry record, last updated by the sponsor on 6 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Evaluation of a Mobile Health Intervention to Identify Early Responders to Treatment in Adolescent Obesity as a Triage Approach
- ClinicalTrials.gov ID
- NCT03561597
- Acronym / sponsor ID
- 006100317
- Conditions
- Adolescent Obesity
- Keywords
- stepped care, mobile application
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- KK Women's and Children's HospitalOther government
- Collaborators
- National Institute of Education, Singapore, National Dental Centre, Singapore, Duke-NUS Graduate Medical School
- Study start
- 10 Apr 2018 (actual)
- Primary completion
- 21 Oct 2019 (actual)
- Study completion
- 21 Oct 2019 (actual)
- First posted
- 19 Jun 2018 (actual)
- Results
- Posted 6 Dec 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- prospective single arm study
| Arm | Type | Receives |
|---|---|---|
| Mobile health application | Experimental | Behavioral: Mobile health interventionParticipants 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. |
Who may qualify
- Ages
- 13 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mobile health interventionThe Kurbo program is a multifunctional mobile application that aid adolescents and their families to learn healthy eating habits and weight management through the use of a mobile application with dietary self-monitoring and weekly interactive coaching sessions. Using the Kurbo app, adolescents track their food and exercise, as well as learn about healthy behaviours through games and videos. The Kurbo coaches check in with adolescents for 15 minutes once a week via video, phone or text over a 12 weeks period. | Behavioural | Mobile health application |
Primary outcome
Proportion of Patients Triaged to the Low Risk Weight Management Clinics
Time frame: 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.
53 secondary outcomes
Kurbo Program Feasibility, Percentage of Participants Who Completed at Least One Health Coaching Session
Time frame: 6 months
Kurbo Program Fidelity
Time frame: 6 months
Attrition Rate
Time frame: 6 months
Change in Weight From Baseline to 6 Months
Time frame: Baseline and 6 months
Change in Weight From Baseline to 3 Months
Time frame: Baseline and 3 months
Changes in Treatment Outcomes Using BMI Z-score
Time frame: 6 months
Changes in Treatment Outcomes Using BMI Z-score From Baseline to 3 Months
Time frame: Baseline and 3 months
Change in %BMIp95 From Baseline to 6 Months
Time frame: Baseline and 6 months
Change in %BMIp95 From Baseline to 3 Months
Time frame: Baseline and 3 months
Change in Waist Circumference From Baseline to 6 Months
Time frame: Baseline and 6 months
Change in Waist Circumference From Baseline to 3 Months
Time frame: Baseline and 3 months
Change in Waist to Height Ratio From Baseline to 6 Months
Time frame: Baseline and 6 months
Change in Waist to Height Ratio From Baseline to 3 Months
Time frame: Baseline and 3 months
Change in Body Fat Percentage From Baseline to 6 Months
Time frame: Baseline and 6 months
Change in Body Fat Percentage From Baseline to 3 Months
Time frame: Baseline and 3 months
Changes in Systolic Blood Pressure Measurements From Baseline to 6 Months
Time frame: Baseline and 6 months
Changes in Systolic Blood Pressure Measurements From Baseline to 3 Months
Time frame: Baseline and 3 months
Changes in Diastolic Blood Pressure Measurements From Baseline to 6 Months
Time frame: Baseline and 6 months
Changes in Diastolic Blood Pressure Measurements From Baseline to 3 Months
Time frame: Baseline and 3 months
Changes in Nutrition From Baseline to 6 Months
Time frame: Baseline and 6 months
Changes in Nutrition From Baseline to 3 Months
Time frame: Baseline and 3 months
Changes in Servings of Vegetables From Baseline to 6 Months
Time frame: Baseline and 6 Months
Changes in Servings of Vegetables From Baseline to 3 Months
Time frame: Baseline and 3 Months
Changes in Physical Activity From Baseline to 6 Months
Time frame: Baseline and 6 months
Changes in Physical Activity From Baseline to 3 Months
Time frame: Baseline and 3 months
Changes in Total Quality of Life From Baseline to 6 Months
Time frame: Baseline and 6 months
Changes in Total Quality of Life From Baseline to 3 Months
Time frame: Baseline and 3 months
Changes in Physical Domain of Quality of Life From Baseline to 6 Months
Time frame: Baseline and 6 months
Changes in Physical Quality of Life From Baseline to 3 Months
Time frame: Baseline and 3 months
Changes in Emotional Quality of Life From Baseline to 6 Months
Time frame: Baseline and 6 months
Changes in Emotional Quality of Life From Baseline to 3 Months
Time frame: Baseline and 3 months
Changes in School Quality of Life From Baseline to 6 Months
Time frame: Baseline and 6 months
Changes in School Quality of Life From Baseline to 3 Months
Time frame: Baseline and 3 Months
Changes in Psychosocial Quality of Life From Baseline to 6 Months
Time frame: Baseline and 6 Months
Changes in Psychosocial Quality of Life From Baseline to 3 Months
Time frame: Baseline and 3 Months
Insulin Resistance Index Changes
Time frame: Baseline and 6 months
Changes in Fasting Blood Glucose From Baseline to 6 Months
Time frame: Baseline and 6 months
Changes in 120 Minute Glucose Result in Oral Glucose Tolerance Test Measurements
Time frame: Baseline and 6 months
Changes in Fasting Lipid Measurements, High Density Lipoprotein (HDL), From Baseline to 6 Months
Time frame: Baseline and 6 months
Changes in Fasting Lipid Measurements, Low Density Lipoprotein (LDL), From Baseline to 6 Months
Time frame: Baseline and 6 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Dec 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No. Not available to other researchers
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Elaine Chew, MBBS principal investigator
KK Women's and Children's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mobile health intervention in people with Adolescent Obesity, run by KK Women's and Children's Hospital at 1 site in Singapore.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Dec 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Singapore. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 6 Dec 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of Patients Triaged to the Low Risk Weight Management Clinics (time frame: 6 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Dec 2021.