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Trial record 2 of 2 for:    17904936 [PUBMED-IDS]

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

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ClinicalTrials.gov Identifier: NCT02880254
Recruitment Status : Unknown
Verified August 2016 by Rushika Conroy, Baystate Medical Center.
Recruitment status was:  Not yet recruiting
First Posted : August 26, 2016
Last Update Posted : August 26, 2016
Sponsor:
Information provided by (Responsible Party):
Rushika Conroy, Baystate Medical Center

Brief Summary:

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.


Condition or disease Intervention/treatment Phase
Obesity Device: Kurbo Device: Personal Health Coach Not Applicable

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 70 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Official Title: A Study to Assess the Compliance and Impact on Weight of Kurbo, a Pediatric Centered Weight Loss App
Study Start Date : September 2016
Estimated Primary Completion Date : September 2018
Estimated Study Completion Date : September 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Kurbo only
use of app plus standard of care
Device: Kurbo
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
Device: Kurbo
health/weight loss app designed for children and adolescents to help them track intake, output and understand healthy eating habits

Device: Personal Health Coach
weekly health coach via facetime or Skype to motivate and counsel subjects during the weight loss process




Primary Outcome Measures :
  1. 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 inquiring about use of the app, tracking intake and exercise, use of the app features and health coach, where applicable.


Secondary Outcome Measures :
  1. 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. [ Time Frame: 3 months ]
    BMI z-score will be determined from mathematical calculations derived from subject's height and weight



Information from the National Library of Medicine

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Ages Eligible for Study:   10 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02880254


Contacts
Contact: rushika conroy, MD 413-794-5437 rushika.conroy@baystatehealth.org
Contact: victoria cobb, bs 413-794-5437 victoria.cobb@baystatehealth.org

Sponsors and Collaborators
Baystate Medical Center

Additional Information:
Publications:

Responsible Party: Rushika Conroy, Assistant Professor of Pediatrics, Tufts University School of Medicine, Baystate Medical Center
ClinicalTrials.gov Identifier: NCT02880254     History of Changes
Other Study ID Numbers: 891748
First Posted: August 26, 2016    Key Record Dates
Last Update Posted: August 26, 2016
Last Verified: August 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: De-identified individual participant data for all primary and secondary outcome measures will be made available within 1 year of study completion.

Keywords provided by Rushika Conroy, Baystate Medical Center:
body mass index change
weight loss
patient compliance

Additional relevant MeSH terms:
Weight Loss
Body Weight Changes
Body Weight
Signs and Symptoms