A Study to Assess the Compliance and Impact on Weight of Kurbo, a Pediatric Centered Weight Loss App (Kurbo)

September 3, 2019 updated by: Rushika Conroy, Baystate Medical Center

Kurbo is a health and fitness app that is targeted toward the pediatric population. It utilizes games and activities to educate children about healthy eating, portion control/size and exercise. It allows for food tracking by using servings of macronutrients and food groups and sets goals for achieving a healthy BMI through modification of diet intake. In addition to being created solely for children and adolescents, a unique feature of this app is an option to speak with a personal health coach on a regular basis to obtain feedback, advice and encouragement. Studies suggest that weight loss outcomes are best with more frequent contact hours but most weight loss clinics, including ours, are not equipped to meet with patients on a weekly basis or even monthly basis. The personal coaching aspect of Kurbo is expected to improve outcomes by increasing user access to feedback and advice.

The purpose of this pilot study is to assess the feasibility, compliance with and effects of a pediatric centered weight loss app on BMI z-scores in a group of children and adolescents in a pediatric weight management program. The investigators will assess the impact of the app as an adjunct to current weight management therapy, both with and without the personal health coach (PHC) option.

Study Overview

Status

Completed

Conditions

Detailed Description

As a result of childhood obesity and its comorbidities, this generation of children might be the first to not outlive its parents. The national prevalence of adolescent obesity has increased from 5% to 21% over the last five decades. Even more discouraging is that youth are being afflicted with the same obesity-related comorbidities that are affecting adults. Conditions such as type 2 diabetes, hypertension, non-alcoholic fatty liver disease, dyslipidemia, metabolic syndrome, and sleep apnea are being diagnosed in children at younger and younger ages.

Lifestyle modification continues to be the cornerstone of treatment for obesity and its associated conditions. The basic concept behind lifestyle modification is a balance of caloric intake and caloric output. Lifestyle modification alone has shown to result in on average 5-10% weight loss over a 6 month period in adults or a 1-2 kg weight loss over 6-12 months. In pediatrics, weight loss is generally not used a marker of success given that the child is still growing linearly in most cases. Thus, changes in BMI and/or BMI z-score are utilized to measure success. Pediatric studies cite improvements in BMI z-score ranging from 0.004 to 0.42 with most studies averaging a 0.1-0.2 decrease in BMI z- score over 6 to 12 months.

The pediatric weight management program at Baystate Medical Center sees children and adolescents from the ages of 2-20 years. Standard care for the program involves monthly visits with a physician (either a general pediatrician or pediatric endocrinologist) or a nurse practitioner in addition to visits every 3 months with a registered dietitian. During each visit, food and activity recalls are conducted and 1-2 goals are made with the patient and their caregivers that focus on improving the quality and quantity of the patient's intake as well as increasing physical activity. Goals are personalized and are adjusted to meet the social, psychological, financial and motivational needs of the patient.

Sixty four percent of Americans own smartphones. The use of smartphone apps for health and wellness has sky rocketed as more sophisticated and user friendly apps are being developed to assist with weight loss, healthy eating, exercise and tracking food and activity. Digital tools can allow one to be constantly aware of how much they are eating and expending, which may result in an improvement in overall weight loss. In adults weight loss of 1-5 kg over a 6 month period is achievable using tools such as food log apps. Such apps are generally suited for adults only and the few weight loss apps targeted toward the pediatric population have not been validated by weight loss programs. Apps that are available for younger patients have been criticized for containing inadequate expert recommended strategies for achieving a healthy weight, lack of goal setting, and poor provision of education.

Kurbo is a health and fitness app that is targeted toward the pediatric population. It utilizes games and activities to educate children about healthy eating, portion control/size and exercise. It allows for food tracking by using servings of macronutrients and food groups and sets goals for achieving a healthy BMI through modification of diet intake. In addition to being created solely for children and adolescents, a unique feature of this app is an option to speak with a personal health coach on a regular basis to obtain feedback, advice and encouragement. Studies suggest that weight loss outcomes are best with more frequent contact hours but most weight loss clinics, including ours, are not equipped to meet with patients on a weekly basis or even monthly basis. The personal coaching aspect of Kurbo is expected to improve outcomes by increasing user access to feedback and advice.

The purpose of this pilot study is to assess the feasibility, compliance with and effects of a pediatric centered weight loss app on BMI z-scores in a group of children and adolescents in a pediatric weight management program. The investigators will assess the impact of the app as an adjunct to current weight management therapy, both with and without the personal health coach (PHC) option.

The Primary aim is to assess 3 month compliance with the Kurbo app as well as the Kurbo app and PHC by a group of morbidly obese children and adolescents in a weight management program. The investigators hypothesize that compliance with the Kurbo app and Kurbo app plus PHC will be better than known compliance of the investigators standard of care group. The Secondary aim is to assess the effect of the Kurbo app as well as the Kurbo app and PHC on 3 month change in BMI-z score among morbidly obese children and adolescents undergoing a weight management program. The hypothesis is that the use of the Kurbo app and Kurbo app plus a personal health coach will result in a greater reduction in BMI z-score over 3 months than known change in a standard care group and that the use of the app and personal health coach will result in a greater reduction in BMI z-score over 3 months than with the use of the app without the personal health coach.

Study Type

Interventional

Enrollment (Actual)

27

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

10 years to 17 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. At least 10 years and no more than 17 years of age
  2. New patients presenting to the Baystate Children's Hospital pediatric weight management program

Exclusion Criteria:

  1. Do not own or have regular access to a smartphone
  2. Cannot read and understand English language as Kurbo is currently only designed for English speakers

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Kurbo only
use of app plus standard of care
health/weight loss app designed for children and adolescents to help them track intake, output and understand healthy eating habits
Active Comparator: Kurbo plus PHC
use of app, personal health coach and standard of care
health/weight loss app designed for children and adolescents to help them track intake, output and understand healthy eating habits
weekly health coach via facetime or Skype to motivate and counsel subjects during the weight loss process

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
3 Month Compliance With the Kurbo App as Well as the Kurbo App and PHC by a Group of Morbidly Obese Children and Adolescents in a Weight Management Program.
Time Frame: 3 months

A questionnaire will be handed out to each subject every month (see below) where applicable.we will utilize one-sample tests with a one-sided alpha of 0.025. One-sided tests will be used as we are only interested in whether the use of this app results in better outcomes than usual care. Compliance will utilize a binomial probability test to assess compliance against our known compliance of 50%.

Questionnaire is noted here:

Confidential Page 1 of 1 Kurbo Survey [baseline_arm_1][name], DOB [baseline_arm_1][dob] Please complete the survey below. Thank you! Group Allocation __________________________________ Who is completing this survey? Child / Patient Parent / Guardian Over the last month, abou

3 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
the Effect of the Kurbo App as Well as the Kurbo App and PHC on 3 Month Change in BMI Zscore Among Morbidly Obese Children and Adolescents Undergoing a Weight Management Program.
Time Frame: 3 months
BMI zscore will be determined from mathematical calculations derived from subject's height and weight. Z score is the number of standard deviations from the mean. A Z score of 0 is the mean. A change in z score in the positive direction reflects an increase in BMI Z score. A change in z score in the negative direction reflects a decrease in BMI Z score. A decrease in BMI z score indicates a change in BMI that favors weight loss.
3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Rushika Conroy, MD MS, Baystate Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2016

Primary Completion (Actual)

January 1, 2018

Study Completion (Actual)

March 1, 2018

Study Registration Dates

First Submitted

August 15, 2016

First Submitted That Met QC Criteria

August 23, 2016

First Posted (Estimate)

August 26, 2016

Study Record Updates

Last Update Posted (Actual)

September 25, 2019

Last Update Submitted That Met QC Criteria

September 3, 2019

Last Verified

September 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 891748

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Yes

IPD Plan Description

De-identified individual participant data for all primary and secondary outcome measures will be made available within 1 year of study completion.

IPD Sharing Supporting Information Type

  • Study Protocol
  • Statistical Analysis Plan (SAP)
  • Informed Consent Form (ICF)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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