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Implementation of Medical Weight Management by Telemedicine

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ClinicalTrials.gov Identifier: NCT03283618
Recruitment Status : Completed
First Posted : September 14, 2017
Last Update Posted : September 14, 2017
Sponsor:
Collaborators:
National Institute of General Medical Sciences (NIGMS)
inHealth Medical Services, Inc.
Information provided by (Responsible Party):
Michelle Kulovitz Alencar, California State University, Long Beach

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.

Condition or disease Intervention/treatment Phase
Obesity Weight Loss Telemedicine Behavioral: Video Conferencing Group Not Applicable

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  (Clinical Trial)
Actual Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: All subjects were randomized in a balanced fashion and stratified by sex into either one of the two groups video conferencing or a control group.
Masking: Single (Participant)
Masking Description: Following baseline visits, participants were randomized to a video conference or control groups.
Primary Purpose: Other
Official Title: Implementation of Medical Weight Management by Telemedicine
Actual Study Start Date : November 16, 2015
Actual Primary Completion Date : August 31, 2017
Actual Study Completion Date : August 31, 2017

Resource links provided by the National Library of Medicine


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



Primary Outcome Measures :
  1. Body weight loss (kg) [ Time Frame: Change in body weight between week 0 and week 12 ]
    The investigators examined body weight changes between groups baseline (week 0) and post intervention (week12).


Secondary Outcome Measures :
  1. Comparison of daily step average per day by group. [ Time Frame: Change in average steps per day between week 0 and week 12 ]
    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.

  2. Comparison of resting systolic and diastolic blood pressure average per day by group. [ Time Frame: Change in systolic and diastolic blood pressure per day between week 0 and week 12 ]
    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.

  3. Quality of Life change from pre to post intervention. [ Time Frame: Pre and Post (a 12 week study) ]
    The investigators examined quality of life measured via survey at week 0 and at week 12.

  4. Dietary Quality change from pre to post intervention. [ Time Frame: Pre and Post (a 12 week study) ]
    The investigators examined dietary quality measured via survey at week 0 and at week 12.



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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03283618


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

Responsible Party: Michelle Kulovitz Alencar, Assistant Professor, California State University, Long Beach
ClinicalTrials.gov Identifier: NCT03283618     History of Changes
Other Study ID Numbers: 824851-2
8UL1GM118979-02 ( U.S. NIH Grant/Contract )
First Posted: September 14, 2017    Key Record Dates
Last Update Posted: September 14, 2017
Last Verified: September 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: It is not yet known if there will be a plan to make IPD available.

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Michelle Kulovitz Alencar, California State University, Long Beach:
Weight loss
Video conferencing
Health coaching
Telemedicine
mHealth
Obesity

Additional relevant MeSH terms:
Body Weight
Weight Loss
Signs and Symptoms
Body Weight Changes