Implementation of Medical Weight Management by Telemedicine

Obesity Clinical Trial

Official title:

Implementation of Medical Weight Management by Telemedicine

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03283618
• Other study ID #: 824851-2
• Secondary ID: 8UL1GM118979-02
• Status: Completed
• Phase: N/A
• First received: September 13, 2017
• Last updated: September 13, 2017
• Start date: November 16, 2015
• Est. completion date: August 31, 2017

Study information

• Verified date: September 2017
• Source: California State University, Long Beach
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: August 31, 2017
• Est. primary completion date: August 31, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Body Weight
• Obesity
• Telemedicine
• Weight Loss

Intervention

Behavioral:
• Video Conferencing Group

Locations

Country	Name	City	State
n/a

Sponsors (3)

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

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Body weight loss (kg)	The investigators examined body weight changes between groups baseline (week 0) and post intervention (week12).	Change in body weight between week 0 and week 12
Secondary	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.	Change in average steps per day between week 0 and week 12
Secondary	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.	Change in systolic and diastolic blood pressure per day between week 0 and week 12
Secondary	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.	Pre and Post (a 12 week study)
Secondary	Dietary Quality change from pre to post intervention.	The investigators examined dietary quality measured via survey at week 0 and at week 12.	Pre and Post (a 12 week study)