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

NCT02880254 | Completed Results

• 1 other identifier: 891748
• Study Type: interventional
• Target: 27
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Obesity

Keywords

body mass index change; weight loss; patient compliance

Outcome Measures

Primary Outcomes (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.

  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 Outcomes (1)

• 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.

  3 months

Study Arms (2)

Kurbo only

ACTIVE COMPARATOR

use of app plus standard of care

Device: Kurbo

Kurbo plus PHC

ACTIVE COMPARATOR

use of app, personal health coach and standard of care

Device: Kurbo; Device: Personal Health Coach

Interventions

Kurbo DEVICE

health/weight loss app designed for children and adolescents to help them track intake, output and understand healthy eating habits

Kurbo only; Kurbo plus PHC

Personal Health Coach DEVICE

weekly health coach via facetime or Skype to motivate and counsel subjects during the weight loss process

Kurbo plus PHC

Eligibility Criteria

• Age: 10 Years - 17 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Baystate Medical Center: lead

Related Publications (7)

• Ogden CL, Carroll MD, Kit BK, Flegal KM. Prevalence of childhood and adult obesity in the United States, 2011-2012. JAMA. 2014 Feb 26;311(8):806-14. doi: 10.1001/jama.2014.732.

  PMID: 24570244 BACKGROUND

• Booth HP, Prevost TA, Wright AJ, Gulliford MC. Effectiveness of behavioural weight loss interventions delivered in a primary care setting: a systematic review and meta-analysis. Fam Pract. 2014 Dec;31(6):643-53. doi: 10.1093/fampra/cmu064. Epub 2014 Oct 8.

  PMID: 25298510 BACKGROUND

• Muhlig Y, Wabitsch M, Moss A, Hebebrand J. Weight loss in children and adolescents. Dtsch Arztebl Int. 2014 Nov 28;111(48):818-24. doi: 10.3238/arztebl.2014.0818.

  PMID: 25512008 BACKGROUND

• Cheng JK, Wen X, Coletti KD, Cox JE, Taveras EM. 2-Year BMI Changes of Children Referred for Multidisciplinary Weight Management. Int J Pediatr. 2014;2014:152586. doi: 10.1155/2014/152586. Epub 2014 Jan 30.

  PMID: 24672556 BACKGROUND

• Carter MC, Burley VJ, Nykjaer C, Cade JE. Adherence to a smartphone application for weight loss compared to website and paper diary: pilot randomized controlled trial. J Med Internet Res. 2013 Apr 15;15(4):e32. doi: 10.2196/jmir.2283.

  PMID: 23587561 BACKGROUND

• Flores Mateo G, Granado-Font E, Ferre-Grau C, Montana-Carreras X. Mobile Phone Apps to Promote Weight Loss and Increase Physical Activity: A Systematic Review and Meta-Analysis. J Med Internet Res. 2015 Nov 10;17(11):e253. doi: 10.2196/jmir.4836.

  PMID: 26554314 BACKGROUND

• Franz MJ, VanWormer JJ, Crain AL, Boucher JL, Histon T, Caplan W, Bowman JD, Pronk NP. Weight-loss outcomes: a systematic review and meta-analysis of weight-loss clinical trials with a minimum 1-year follow-up. J Am Diet Assoc. 2007 Oct;107(10):1755-67. doi: 10.1016/j.jada.2007.07.017.

  PMID: 17904936 BACKGROUND

Related Links

• 5\. Pew Research Center, April, 2015, "The Smartphone Difference"

MeSH Terms

Conditions

Obesity; Weight Loss; Patient Compliance

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Body Weight Changes; Patient Acceptance of Health Care; Treatment Adherence and Compliance; Health Behavior; Behavior

Results Point of Contact

• Title: Rushika Conroy MD
• Organization: Baystate Medical Center

rushika.conroy@bhs.org

413 794 5437

Study Officials

• Rushika Conroy, MD MS

  Baystate Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Pediatrics, Tufts University School of Medicine

Study Record Dates

• First Submitted: August 15, 2016
• First Posted: August 26, 2016
• Study Start: September 1, 2016
• Primary Completion: January 1, 2018
• Study Completion: March 1, 2018
• Last Updated: September 25, 2019
• Results First Posted: September 25, 2019

Record last verified: 2019-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF