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Implementation of Medical Weight Management by Telemedicine

Primary Purpose

Obesity, Weight Loss, Telemedicine

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Video Conferencing Group
Sponsored by
California State University, Long Beach
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Obesity focused on measuring Weight loss, Video conferencing, Health coaching, Telemedicine, mHealth, Obesity

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    No Intervention

    Experimental

    Arm Label

    Control Group

    Video Conference-based Health Coaching

    Arm Description

    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.

    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.

    Outcomes

    Primary Outcome Measures

    Body weight loss (kg)
    The investigators examined body weight changes between groups baseline (week 0) and post intervention (week12).

    Secondary Outcome Measures

    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.
    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.
    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.
    Dietary Quality change from pre to post intervention.
    The investigators examined dietary quality measured via survey at week 0 and at week 12.

    Full Information

    First Posted
    September 13, 2017
    Last Updated
    September 13, 2017
    Sponsor
    California State University, Long Beach
    Collaborators
    National Institute of General Medical Sciences (NIGMS), inHealth Medical Services, Inc.
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03283618
    Brief Title
    Implementation of Medical Weight Management by Telemedicine
    Official Title
    Implementation of Medical Weight Management by Telemedicine
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    September 2017
    Overall Recruitment Status
    Completed
    Study Start Date
    November 16, 2015 (Actual)
    Primary Completion Date
    August 31, 2017 (Actual)
    Study Completion Date
    August 31, 2017 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    California State University, Long Beach
    Collaborators
    National Institute of General Medical Sciences (NIGMS), inHealth Medical Services, Inc.

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    Yes

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Obesity, Weight Loss, Telemedicine
    Keywords
    Weight loss, Video conferencing, Health coaching, Telemedicine, mHealth, Obesity

    7. Study Design

    Primary Purpose
    Other
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    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
    Participant
    Masking Description
    Following baseline visits, participants were randomized to a video conference or control groups.
    Allocation
    Randomized
    Enrollment
    30 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Control Group
    Arm Type
    No Intervention
    Arm Description
    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.
    Arm Title
    Video Conference-based Health Coaching
    Arm Type
    Experimental
    Arm Description
    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.
    Intervention Type
    Behavioral
    Intervention Name(s)
    Video Conferencing Group
    Primary Outcome Measure Information:
    Title
    Body weight loss (kg)
    Description
    The investigators examined body weight changes between groups baseline (week 0) and post intervention (week12).
    Time Frame
    Change in body weight between week 0 and week 12
    Secondary Outcome Measure Information:
    Title
    Comparison of daily step average per day by group.
    Description
    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.
    Time Frame
    Change in average steps per day between week 0 and week 12
    Title
    Comparison of resting systolic and diastolic blood pressure average per day by group.
    Description
    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.
    Time Frame
    Change in systolic and diastolic blood pressure per day between week 0 and week 12
    Title
    Quality of Life change from pre to post intervention.
    Description
    The investigators examined quality of life measured via survey at week 0 and at week 12.
    Time Frame
    Pre and Post (a 12 week study)
    Title
    Dietary Quality change from pre to post intervention.
    Description
    The investigators examined dietary quality measured via survey at week 0 and at week 12.
    Time Frame
    Pre and Post (a 12 week study)

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    65 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility 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.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Virginia Gray, PhD, RD
    Organizational Affiliation
    California State University, Long Beach
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    Undecided
    IPD Sharing Plan Description
    It is not yet known if there will be a plan to make IPD available.

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    Implementation of Medical Weight Management by Telemedicine

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