Implementation of Medical Weight Management by Telemedicine

As the prevalence and associated healthcare costs of obesity continue to increase, the need for obesity treatments that contribute to weight loss maintenance are needed. Through the functionality of a smart device, telehealth can provide quality healthcare to individuals of different socioeconomic communities, expand healthcare access, as well as reduce overall healthcare costs. This research program will uncover the effects of a 12-week commercially available telehealth-based weight management program (inHealth Medical Services, Inc.) on body weight, blood pressure, and steps.

Study Overview

• Status: Completed
• Conditions: Obesity; Weight Loss; Telemedicine
• Intervention / Treatment: Behavioral: Video Conferencing Group

Detailed Description

Solutions for convenient and cost saving healthcare services are needed in order to control costs to the public. Currently, there is a gap in weight management research involving telemedicine as a potential tool for obesity treatment. The use of technology will promote general health awareness, dietary intake and exercise practices, as well as patient compliance. Successful weight management program components learned from hallmark clinical trials include: frequent contact with the patient, frequent measurements, patient education, and monitoring tools to help alleviate barriers to adherence.

The purpose of this study is to examine the effect of a fully on-line, 12-week, medically monitored weight management program on obesity-related health outcomes. These obesity related outcomes include body weight, body fat, blood pressure and physical activity. Our central hypothesis is that this video conferencing (video conference similar to skype) platform will significantly improve health outcomes of quality of life, and participant adherence when coupled with a multidisciplinary team. The primary objective of this study is to determine the effect of a fully on-line medical weight management program on cardiometabolic outcome measures directly associated with obesity. Data collection will be conducted prospectively with all patient information and data will be secured through a HIPAA compliant server database accessible only by the research team.

There are two specific aims proposed for this fully on-line 12-week medically monitored weight management program: 1) to investigate the changes in body weight in response to health coaching via telemedicine using the inHealth Medical Services, Inc, online program structure and 2) to examine changes in steps and dietary eating quality. The central hypothesis is that telehealth functions will improve health outcomes, quality of life, behaviors, and participant adherence.

The public health benefits of weight management via telehealth are vast. Through the functionality of a mHealth (mobile health) devices, quality health coaching can be provided to individuals in different socioeconomic communities, expand healthcare access, as well as reduce overall healthcare costs.

• Study Type: Interventional
• Enrollment (Actual): 30
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Inclusion criteria include the following: participants must be ambulatory, be fluent in English spoken and written at a high-school age level, have a BMI of > 30 kg/m2, have been weight stable or gaining weight for the last 6 months, Weigh less than 396 pounds, have voluntarily signed and dated an informed consent form. Fluent in English spoken and written at a high-school level, live a sedentary lifestyle defined as < 7,000 steps per day. Have access to an Apple® iPhone smart phone

Exclusion Criteria:

• Exclusion criteria includes the following: participants has stated an immunodeficiency disorder, kidney disease, history of uncontrollable blood pressure, heart attack within the last 3 months, presence of partial or full artificial limb, has known dementia, brain cancer, eating disorders, history of significant neurological or psychiatric disorder or any other psychological condition, currently taking medications/dietary supplements/substances that could profoundly modify metabolism or body weight, has undergone major surgery, less than 4 weeks prior to enrollment in the study, or is actively losing weight. Although not anticipated for this study population, women cannot be or suspect they may be pregnant.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Control Group; The control group will receive the mHealth devices (scale, blood pressure cuff, and accelerometer watch) as well as caloric and step goals, but no health coaching. They will complete the same pre- and post-intervention measurements and consultations with the medical doctor and registered dietitian.
Experimental: Video Conference-based Health Coaching; The video conference-based health coaching group will receive the mHealth devices (scale, blood pressure cuff, and accelerometer watch) meet the medical doctor at baseline and at 12 weeks via the Amwell® app using their smartphone. The participants will receive health coaching by meeting weekly (12 times) with the registered dietitian (RD) to discuss behavior modification, exercise, and nutrition goals.	Behavioral: Video Conferencing Group

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Body weight loss (kg)	The investigators examined body weight changes between groups baseline (week 0) and post intervention (week12).	Change in body weight between week 0 and week 12

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Comparison of daily step average per day by group.	The investigators examined steps per day and averaged them every week. The investigators then graphed each time point (weeks) and presented them as adjusted average and standard deviation.	Change in average steps per day between week 0 and week 12
Comparison of resting systolic and diastolic blood pressure average per day by group.	The investigators examined resting blood pressure per day and averaged systolic and diastolic blood pressure every week. The investigators then graphed each time point (weeks) and presented them adjusted average and standard deviation.	Change in systolic and diastolic blood pressure per day between week 0 and week 12
Quality of Life change from pre to post intervention.	The investigators examined quality of life measured via survey at week 0 and at week 12.	Pre and Post (a 12 week study)
Dietary Quality change from pre to post intervention.	The investigators examined dietary quality measured via survey at week 0 and at week 12.	Pre and Post (a 12 week study)

Collaborators and Investigators

• Sponsor: California State University, Long Beach
• Collaborators: National Institute of General Medical Sciences (NIGMS); inHealth Medical Services, Inc.
• Investigators: Principal Investigator: Virginia Gray, PhD, RD, California State University, Long Beach

Study record dates

Study Major Dates

• Study Start (Actual): November 16, 2015
• Primary Completion (Actual): August 31, 2017
• Study Completion (Actual): August 31, 2017

Study Registration Dates

• First Submitted: September 13, 2017
• First Submitted That Met QC Criteria: September 13, 2017
• First Posted (Actual): September 14, 2017

Study Record Updates

• Last Update Posted (Actual): September 14, 2017
• Last Update Submitted That Met QC Criteria: September 13, 2017
• Last Verified: September 1, 2017

More Information

Terms related to this study

• Keywords: Telemedicine; Obesity; Weight loss; mHealth; Health coaching; Video conferencing
• Additional Relevant MeSH Terms: Body Weight Changes; Weight Loss; Body Weight
• Other Study ID Numbers: 824851-2; 8UL1GM118979-02 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: It is not yet known if there will be a plan to make IPD available.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No