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

NCT03561597 | Completed Results

• 1 other identifier: 006100317
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Adolescent Obesity

Keywords

stepped care; mobile application

Outcome Measures

Primary Outcomes (1)

• 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.

  6 month

Secondary Outcomes (53)

• Kurbo Program Feasibility, Percentage of Participants Who Completed at Least One Health Coaching Session

  6 months

• Kurbo Program Fidelity

  6 months

• Attrition Rate

  6 months

• Change in Weight From Baseline to 6 Months

  Baseline and 6 months

• Change in Weight From Baseline to 3 Months

  Baseline and 3 months

Study Arms (1)

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.

Behavioral: Mobile health intervention

Interventions

Mobile health intervention BEHAVIORAL

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.

Mobile health application

Eligibility Criteria

• Age: 13 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• KK Women's and Children's Hospital: lead
• National Institute of Education, Singapore: collaborator
• National Dental Centre, Singapore: collaborator
• Duke-NUS Graduate Medical School: collaborator

Study Sites (1)

KKWCH

Singapore, Singapore

Location

MeSH Terms

Conditions

Pediatric Obesity

Condition Hierarchy (Ancestors)

Obesity; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Dr Chew Chu Shan Elaine
• Organization: KKWCH

elaine.chew.c.s@singhealth.com.sg

63946042

Study Officials

• Elaine Chew, MBBS

  KK Women's and Children's Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Model Details: prospective single arm study

Study Record Dates

• First Submitted: March 7, 2018
• First Posted: June 19, 2018
• Study Start: April 10, 2018
• Primary Completion: October 21, 2019
• Study Completion: October 21, 2019
• Last Updated: December 6, 2021
• Results First Posted: December 6, 2021

Record last verified: 2018-04

Data Sharing

• IPD Sharing: Will not share

Locations

SG (1)