Clinical trial NCT03561597: Mobile Health Intervention to Identify Early Responders to Treatment in Adolescent Obesity
Official title: Pilot Evaluation of a Mobile Health Intervention to Identify Early Responders to Treatment in Adolescent Obesity as a Triage Approach
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Adolescent Obesity
Keywords: stepped care
mobile application
Lead sponsor: KK Women's and Children's Hospital
Sponsor class: OTHER_GOV
Collaborators: name: National Institute of Education, Singapore
name: National Dental Centre, Singapore
name: Duke-NUS Graduate Medical School
First posted: 2018-06-19
Enrollment: 40
Sex: ALL
Minimum age (years): 13
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: prospective single arm study
Primary purpose: HEALTH_SERVICES_RESEARCH

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.


Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

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

Primary outcomes:
measure: Proportion of Patients Triaged to the Low Risk Weight Management Clinics
timeFrame: 6 month
Secondary outcomes:
measure: Kurbo Program Feasibility, Percentage of Participants Who Completed at Least One Health Coaching Session
timeFrame: 6 months
measure: Kurbo Program Fidelity
timeFrame: 6 months
measure: Attrition Rate
timeFrame: 6 months
measure: Change in Weight From Baseline to 6 Months
timeFrame: Baseline and 6 months
measure: Change in Weight From Baseline to 3 Months
timeFrame: Baseline and 3 months
measure: Changes in Treatment Outcomes Using BMI Z-score
timeFrame: 6 months
measure: Changes in Treatment Outcomes Using BMI Z-score From Baseline to 3 Months
timeFrame: Baseline and 3 months
measure: Change in %BMIp95 From Baseline to 6 Months
timeFrame: Baseline and 6 months
measure: Change in %BMIp95 From Baseline to 3 Months
timeFrame: Baseline and 3 months
measure: Change in Waist Circumference From Baseline to 6 Months
timeFrame: Baseline and 6 months
measure: Change in Waist Circumference From Baseline to 3 Months
timeFrame: Baseline and 3 months
measure: Change in Waist to Height Ratio From Baseline to 6 Months
timeFrame: Baseline and 6 months
measure: Change in Waist to Height Ratio From Baseline to 3 Months
timeFrame: Baseline and 3 months
measure: Change in Body Fat Percentage From Baseline to 6 Months
timeFrame: Baseline and 6 months
measure: Change in Body Fat Percentage From Baseline to 3 Months
timeFrame: Baseline and 3 months
measure: Changes in Systolic Blood Pressure Measurements From Baseline to 6 Months
timeFrame: Baseline and 6 months
measure: Changes in Systolic Blood Pressure Measurements From Baseline to 3 Months
timeFrame: Baseline and 3 months
measure: Changes in Diastolic Blood Pressure Measurements From Baseline to 6 Months
timeFrame: Baseline and 6 months
measure: Changes in Diastolic Blood Pressure Measurements From Baseline to 3 Months
timeFrame: Baseline and 3 months
measure: Changes in Nutrition From Baseline to 6 Months
timeFrame: Baseline and 6 months
measure: Changes in Nutrition From Baseline to 3 Months
timeFrame: Baseline and 3 months
measure: Changes in Servings of Vegetables From Baseline to 6 Months
timeFrame: Baseline and 6 Months
measure: Changes in Servings of Vegetables From Baseline to 3 Months
timeFrame: Baseline and 3 Months
measure: Changes in Physical Activity From Baseline to 6 Months
timeFrame: Baseline and 6 months
measure: Changes in Physical Activity From Baseline to 3 Months
timeFrame: Baseline and 3 months
measure: Changes in Total Quality of Life From Baseline to 6 Months
timeFrame: Baseline and 6 months
measure: Changes in Total Quality of Life From Baseline to 3 Months
timeFrame: Baseline and 3 months
measure: Changes in Physical Domain of Quality of Life From Baseline to 6 Months
timeFrame: Baseline and 6 months
measure: Changes in Physical Quality of Life From Baseline to 3 Months
timeFrame: Baseline and 3 months
measure: Changes in Emotional Quality of Life From Baseline to 6 Months
timeFrame: Baseline and 6 months
measure: Changes in Emotional Quality of Life From Baseline to 3 Months
timeFrame: Baseline and 3 months
measure: Changes in School Quality of Life From Baseline to 6 Months
timeFrame: Baseline and 6 months
measure: Changes in School Quality of Life From Baseline to 3 Months
timeFrame: Baseline and 3 Months
measure: Changes in Psychosocial Quality of Life From Baseline to 6 Months
timeFrame: Baseline and 6 Months
measure: Changes in Psychosocial Quality of Life From Baseline to 3 Months
timeFrame: Baseline and 3 Months
measure: Insulin Resistance Index Changes
timeFrame: Baseline and 6 months
measure: Changes in Fasting Blood Glucose From Baseline to 6 Months
timeFrame: Baseline and 6 months
measure: Changes in 120 Minute Glucose Result in Oral Glucose Tolerance Test Measurements
timeFrame: Baseline and 6 months
measure: Changes in Fasting Lipid Measurements, High Density Lipoprotein (HDL), From Baseline to 6 Months
timeFrame: Baseline and 6 months
measure: Changes in Fasting Lipid Measurements, Low Density Lipoprotein (LDL), From Baseline to 6 Months
timeFrame: Baseline and 6 months
measure: Changes in Fasting Lipid Measurements, Triglycerides (TG), From Baseline to 6 Months
timeFrame: Baseline and 6 months
measure: Changes in Alanine Transaminase From Baseline to 6 Months
timeFrame: Baseline and 6 months
measure: Changes in Aspartate Transaminase From Baseline to 6 Months
timeFrame: Baseline and 6 months
measure: Changes in Disordered Eating on Dietary Restraint From Baseline to 6 Months
timeFrame: Baseline and 6 months
measure: Changes in Disordered Eating, Dietary Restraint From Baseline to 3 Months
timeFrame: Baseline and 3 months
measure: Changes in Disordered Eating, External Eating From Baseline to 6 Months
timeFrame: Baseline and 6 months
measure: Changes in Disordered Eating, External Eating From Baseline to 3 Months
timeFrame: Baseline and 3 months
measure: Changes in Disordered Eating, Parental Pressure to Eat, From Baseline to 6 Months
timeFrame: Baseline and 6 months
measure: Changes in Disordered Eating, Parental Pressure to Eat, From Baseline to 3 Months
timeFrame: Baseline and 3 months
measure: Changes in Disordered Eating, Emotional Eating, From Baseline to 6 Months
timeFrame: Baseline and 6 months
measure: Changes in Disordered Eating, Emotional Eating, From Baseline to 3 Months
timeFrame: Baseline and 3 months
measure: Metabolomic Profile Changes From Baseline to 6 Months (BCAA)
timeFrame: baseline and 6 months
measure: Metabolomic Profile Changes From Baseline to 6 Months (AAA)
timeFrame: baseline and 6 months
Other outcomes:
Locations:
city: Singapore
country: Singapore
facility: KKWCH
Study officials:
affiliation: KK Women's and Children's Hospital
name: Elaine Chew, MBBS
role: PRINCIPAL_INVESTIGATOR
References: