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Implementation of Medical Weight Management by Telemedicine

Implementation of Medical Weight Management by Telemedicine

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03283618
Enrollment
30
Registered
2017-09-14
Start date
2015-11-16
Completion date
2017-08-31
Last updated
2017-09-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Obesity, Telemedicine, Weight Loss

Keywords

Weight loss, Video conferencing, Health coaching, Telemedicine, mHealth, Obesity

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.

Interventions

Sponsors

National Institute of General Medical Sciences (NIGMS)
CollaboratorNIH
inHealth Medical Services, Inc.
CollaboratorINDUSTRY
California State University, Long Beach
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
SINGLE (Subject)

Masking description

Following baseline visits, participants were randomized to a video conference or control groups.

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.

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes

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

*

Design outcomes

Primary

MeasureTime frameDescription
Body weight loss (kg)Change in body weight between week 0 and week 12The investigators examined body weight changes between groups baseline (week 0) and post intervention (week12).

Secondary

MeasureTime frameDescription
Comparison of daily step average per day by group.Change in average steps per day between week 0 and week 12The 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.Change in systolic and diastolic blood pressure per day between week 0 and week 12The 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.Pre and Post (a 12 week study)The investigators examined quality of life measured via survey at week 0 and at week 12.
Dietary Quality change from pre to post intervention.Pre and Post (a 12 week study)The investigators examined dietary quality measured via survey at week 0 and at week 12.

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026