ObesityNCT03283618
Implementation of Medical Weight Management by Telemedicine
A study testing Video Conferencing Group in people with Obesity and Weight Loss, run by California State University, Long Beach.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Obesity, Weight Loss, Telemedicine
- What is being tested?
- Video Conferencing Group
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- 16 Nov 2015to 31 Aug 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
About this study
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.
Read the 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
- Being tested
- Video Conferencing Group
- Keywords
- Weight loss, Video conferencing, Health coaching, Telemedicine, mHealth, Obesity
- Medical subject headings
- Obesity, Weight Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Video Conferencing GroupBehavioural
| Study group | Role | What they receive |
|---|---|---|
| Control Group | No intervention | 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. |
| Video Conference-based Health Coaching | Experimental | 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. Receives: Behavioral: Video Conferencing Group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Body weight loss (kg)
The investigators examined body weight changes between groups baseline (week 0) and post intervention (week12).
Measured: Change in body weight between week 0 and week 12
Secondary outcomes (4)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Pre and Post (a 12 week study)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Sep 2017
- Study start16 Nov 2015
- Primary completion31 Aug 2017
- Study completion31 Aug 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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 blind
- Who is masked
- Participant
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- California State University, Long Beach
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of General Medical Sciences (NIGMS), inHealth Medical Services, Inc.
- Responsible party
- Principal investigator, Michelle Kulovitz Alencar, California State University, Long Beach
- Investigators
- Virginia Gray, PhD, RD, Principal investigator, California State University, Long Beach
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03283618
- Sponsor's protocol ID
- 824851-2
- Other IDs
- 8UL1GM118979-02
- Status last verified
- Sep 2017
- First submitted
- 13 Sep 2017
- Last updated
- 14 Sep 2017
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: It is not yet known if there will be a plan to make IPD available.
Study at a glance
From the registry record, last updated by the sponsor on 14 Sep 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Implementation of Medical Weight Management by Telemedicine
- ClinicalTrials.gov ID
- NCT03283618
- Acronym / sponsor ID
- 824851-2
- Conditions
- Obesity, Weight Loss, Telemedicine
- Keywords
- Weight loss, Video conferencing, Health coaching, Telemedicine, mHealth, Obesity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- California State University, Long BeachUniversity, hospital or other
- Collaborators
- National Institute of General Medical Sciences (NIGMS), inHealth Medical Services, Inc.
- Study start
- 16 Nov 2015 (actual)
- Primary completion
- 31 Aug 2017 (actual)
- Study completion
- 31 Aug 2017 (actual)
- First posted
- 14 Sep 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Control Group | No intervention | –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. |
| Video Conference-based Health Coaching | Experimental | Behavioral: Video Conferencing GroupThe 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Video Conferencing Group | Behavioural | Video Conference-based Health Coaching |
Primary outcome
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).
4 secondary outcomes
Comparison of daily step average per day by group.
Time frame: 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.
Time frame: Change in systolic and diastolic blood pressure per day between week 0 and week 12
Quality of Life change from pre to post intervention.
Time frame: Pre and Post (a 12 week study)
Dietary Quality change from pre to post intervention.
Time frame: Pre and Post (a 12 week study)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Sep 2017.
- Individual participant dataSharing planned: Undecided. It is not yet known if there will be a plan to make IPD available.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Virginia Gray, PhD, RD principal investigator
California State University, Long Beach
Questions about this trial
What is this clinical trial studying?
A study testing Video Conferencing Group in people with Obesity and Weight Loss, run by California State University, Long Beach.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Sep 2017. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Body weight loss (kg) (time frame: Change in body weight between week 0 and week 12). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Sep 2017.