Mobile Device Biomonitoring to Prevent and Treat Obesity in Underserved Youth

NCT02017223 | Completed Results DMC

• 2 other identifiers: KM-NCMHD3P60MD002254-02S1
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 2

Brief Summary

This project proposes to use mobile devices to develop new tools for pediatric obesity prevention and treatment targeting underserved minority adolescent populations at high risk for obesity and related diseases. We will use off the shelf, validated and wearable wireless sensors to measure physical activity, blood pressure, sleep, heart rate, galvanic skin response and blood glucose levels and communicate the measured information to a mobile phone using a wireless interface. This will deliver a record of behavior and health data that is time-stamped, synchronized, and geographically localized using GPS to a secure server. Data will then be analyzed and displayed to participating health professionals to provide them with readily interpretable records of continuously monitored energy expenditure, recorded and synchronized with other essential biological, behavioral and geographical data. To accomplish this project, 50 African American and Hispanic youth (50% female, ages 12-17) will be recruited into the research in advisory capacities, to test the sensors during development, and to wear the sensors for three non-contiguous weeks. To test the sensors prior to use with minority youth, 30 college students age 18 and above will be recruited to try out the sensors in and outside of the laboratory in order to make sure that all sensors are in perfect working order before testing them in minority youth populations. An advisory group of medical professionals will be assembled to guide us through the process of developing a web interface that will ensure that the right information will be displayed in an easily interpretable fashion. The advisory group will participate in regular meetings to develop and test the web interface. Using the data acquired, health professionals will be able to visualize average amounts of physical activity, sleep, sedentary behaviors (daily or weekly) as well as daily patterns. Average blood glucose, heart rate, and stress levels (daily or weekly) as well as daily patterns will also be available. Practitioners will be able to see when and where activity and metabolic events are occurring, enabling preemptive and preventive strategies as well as targeted interventions to prevent and treat pediatric obesity in underserved and at-risk minority youth.

Conditions

Obesity

Keywords

Physical activity

Outcome Measures

Primary Outcomes (1)

• Objectively Measured Physical Activity From Accelerometer and KNOWME Network

  Participants will wear an accelerometer on the waist for 3 days to gather baseline data on habitual physical activity, and then wear KNOWME for one weekend, along with an accelerometer - no more than two weeks after baseline. Outcome is the difference between baseline and KNOWME wear (differences in moderate to vigorous physical activity and sedentary time).

  Pretest for one weekend (Friday-Sunday) and during KNOWME wear for one weekend (Friday-Sunday

Study Arms (1)

Knowme Device Wear

EXPERIMENTAL

Participants wear KNOWME devices and use mobile phone interface for three days outside of school. This is a pre-post design with no control group

Device: Knowme Device Wear

Interventions

Knowme Device Wear DEVICE

Knowme Device Wear

Eligibility Criteria

• Age: 12 Years - 17 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Self-identification as either Hispanic or African American, between the ages of 12-17, and without any disabilities that would disallow wear of sensors and normal physical activity

Sponsors & Collaborators

• University of Southern California: lead
• National Institute on Minority Health and Health Disparities (NIMHD): collaborator

Study Sites (2)

University of Southern California University Park Campus

Los Angeles, California, 90015, United States

Location

University of Southern California Health Science Campus

Los Angeles, California, 90033, United States

Location

Related Publications (6)

• Kim S, Li M, Lee S, Mitra U, Emken A, Spruijt-Metz D, Annavaram M, Narayanan S. Modeling high-level descriptions of real-life physical activities using latent topic modeling of multimodal sensor signals. Annu Int Conf IEEE Eng Med Biol Soc. 2011;2011:6033-6. doi: 10.1109/IEMBS.2011.6091491.

  PMID: 22255715 BACKGROUND

• Emken BA, Li M, Thatte G, Lee S, Annavaram M, Mitra U, Narayanan S, Spruijt-Metz D. Recognition of physical activities in overweight Hispanic youth using KNOWME Networks. J Phys Act Health. 2012 Mar;9(3):432-41. doi: 10.1123/jpah.9.3.432. Epub 2011 May 11.

  PMID: 21934162 BACKGROUND

• Thatte G, Li M, Lee S, Emken BA, Annavaram M, Narayanan S, Spruijt-Metz D, Mitra U. Optimal Time-Resource Allocation for Energy-Efficient Physical Activity Detection. IEEE Trans Signal Process. 2011;59(4):1843-1857. doi: 10.1109/TSP.2010.2104144.

  PMID: 21796237 BACKGROUND

• Li M, Rozgica V, Thatte G, Lee S, Emken A, Annavaram M, Mitra U, Spruijt-Metz D, Narayanan S. Multimodal physical activity recognition by fusing temporal and cepstral information. IEEE Trans Neural Syst Rehabil Eng. 2010 Aug;18(4):369-80. doi: 10.1109/TNSRE.2010.2053217.

  PMID: 20699202 BACKGROUND

• Thatte G, Li M, Emken A, Mitra U, Narayanan S, Annavaram M, Spruijt-Metz D. Energy-efficient multihypothesis activity-detection for health-monitoring applications. Annu Int Conf IEEE Eng Med Biol Soc. 2009;2009:4678-81. doi: 10.1109/IEMBS.2009.5334222.

  PMID: 19964828 BACKGROUND

• Spruijt-Metz D, Wen CK, O'Reilly G, Li M, Lee S, Emken BA, Mitra U, Annavaram M, Ragusa G, Narayanan S. Innovations in the Use of Interactive Technology to Support Weight Management. Curr Obes Rep. 2015 Dec;4(4):510-9. doi: 10.1007/s13679-015-0183-6.

  PMID: 26364308 RESULT

MeSH Terms

Conditions

Obesity; Motor Activity

Condition Hierarchy (Ancestors)

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

Results Point of Contact

• Title: Donna Spruijt-Metz, MFA PhD
• Organization: University of Southern California

dmetz@usc.edu

310-577-6248

Study Officials

• Donna Spruijt-Metz, PhD

  University of Southern California

  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: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Scientist

Study Record Dates

• First Submitted: December 9, 2013
• First Posted: December 20, 2013
• Study Start: October 1, 2008
• Primary Completion: March 1, 2012
• Study Completion: March 1, 2012
• Last Updated: May 15, 2019
• Results First Posted: May 15, 2019

Record last verified: 2019-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)