Implementation of Medical Weight Management by Telemedicine

NCT ID: NCT03283618

Last Updated: 2017-09-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-11-16
• Study Completion Date: 2017-08-31

Brief Summary

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.

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.

Conditions

Obesity; Weight Loss; Telemedicine

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

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.

Group Type: EXPERIMENTAL

Video Conferencing Group

Intervention Type: BEHAVIORAL

Interventions

Video Conferencing Group

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

National Institute of General Medical Sciences (NIGMS)

NIH

Sponsor Role: collaborator

inHealth Medical Services, Inc.

INDUSTRY

Sponsor Role: collaborator

California State University, Long Beach

OTHER

Sponsor Role: lead

Responsible Party

Michelle Kulovitz Alencar

Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Virginia Gray, PhD, RD

Role: PRINCIPAL_INVESTIGATOR

California State University, Long Beach

Other Identifiers

8UL1GM118979-02

Identifier Type: NIH

Identifier Source: secondary_id

View Link

824851-2

Identifier Type: -

Identifier Source: org_study_id