The Mobile Health Platform

Obesity Clinical Trial

— mHealth  

Official title:

The Mobile Health Platform - Development and Feasibility Evaluation

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02099513
• Other study ID #: Pro00048816
• Status: Completed
• Phase: N/A
• First received: March 26, 2014
• Last updated: February 21, 2017
• Start date: March 2014
• Est. completion date: October 2014

Study information

• Verified date: October 2014
• Source: Duke University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study develops and pilots the initial interface of our mobile health platform that will allow for intra-individual tailoring and personalization of health interventions. This will allow for just-in-time interventions that adapt both the content and timing, not just initially, but also over time based upon prior outcome data, responses to an intervention, current environmental and social context, activity level, location, time, and an individual's psychophysiological state.1,2

Aim 1: To develop the initial interface of the mobile health platform that will allow patients to report and receive data representing multiple health domains including blood pressure, pO2 (pulse oximeter), values, weight, physical activity, calories burned, sleep, and self-report survey measures such as pain and fatigue.

Aim 2: To assess feasibility of the mobile health platform to receive and deliver data representing multiple health domains over 1 month through a single-case study design (N=6).3 Aim 3: To develop an algorithm using the diet data collected in Aim 1 that will facilitate adaptive work by providing patients with automated real time feedback on their progress.

Aim 4: To develop an algorithm using the diet data collected in Aim 1 that will that will facilitate adaptive approaches by alerting clinicians on the progress of their patients.

Description:

At baseline we will collect demographic variables and acceptance and use of technology from surveys, and biological variables including blood pressure, weight, and blood glucose from electronic medical records. Over a period of 1 month, participants will be asked to track and collect daily data on weight using the iHealth wireless scale. Participants will also collect blood pressure (BP), pO2, and pulse using the iHealth blood pressure device. Physical activity and sleep activity will be measured using the fitbit device. Participants will receive evidence-based daily nutrition and exercise weight loss messages via text messages.

Following the one-month observation participants will be asked to complete a follow-up survey on acceptance and use of technology and to undergo a post-formative semi-structure telephone interview to discuss their perception of the usefulness and attitudes toward the platform, technical difficulties and barriers, and recommendations for future development.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 6
• Est. completion date: October 2014
• Est. primary completion date: October 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patient of Picket primary care clinic

• All subjects will provide written informed consent.

• Three participants who have multiple chronic illnesses.

• Chronic illnesses of obesity (BMI>29)

• Chronic hypertension (SBP>140)

• Three healthy participants who do not have any chronic illnesses.

• Own a smartphone with a data and text messaging plan.

• Have Wifi available in the home.

Exclusion Criteria:

• No internet/Wifi available in the home.

• No Smartphone

Related Conditions & MeSH terms

• Diabetes
• Hypertension
• Obesity

Intervention

Device:
• The Mobile Health Platform

Locations

Country	Name	City	State
United States	Duke University Medical Center, Pickens Primary Care Clinic	Durham	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Duke University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in the Acceptance and use of technology survey	Subject will take survey at Baseline, and the 1 month mark.	Baseline, up to 1 Month
Primary	Perception of perceived usefulness, attitudes, and experiences	Questions will be asked in the interviews regarding perceived usefulness, attitudes, and experiences of the mHealth applications. The results will be divided into three main categories of positive, negative, and neutral perceptions.	1 month