A Remote Delivered Lifestyle Therapeutics Program

NCT04201028 | Completed

• 1 other identifier: 2021.96
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

Heart disease is the leading cause of death in the United States. The overall risk for heart disease is a composite measure of various modifiable factors including blood pressure, cholesterol, and tobacco use; which are exacerbated by a sedentary lifestyle, unhealthy diet, and being overweight. Approximately 32% of the adult U.S. population has high blood pressure and 46% of them have uncontrolled hypertension. Successful management of high blood pressure and other cardiovascular risk is a complex process that requires significant lifestyle changes but adopting and adhering to these changes is challenging. A promise approach to overcoming these challenges is utilizing health coaching. The purpose of this research study is to compare at home devices for blood pressure and weight measurements (DEV) group compared to not using any at home devices Group (NODEV). Both groups will be supported throughout this study by meeting with obesity medicine doctor monthly in office and have a virtual health coaching visits throughout the study duration.

Conditions

Body Weight Changes; Weight Loss; Healthy Diet; Obesity

Keywords

telehealth; video conferencing; blood pressure; lipids; weight loss; usual care; obesity medicine

Outcome Measures

Primary Outcomes (2)

• Weight loss

  Investigators examined body weight changes between groups baseline (week 0) and post intervention (week 26).

  Change in weight between baseline (week 0) and post intervention (week 26) ]

• Blood Pressure

  Investigators examined blood pressure changes between groups baseline (week 0) and post intervention (week 26).

  Change in blood pressure between baseline (week 0) and post intervention (week 26) ]

Secondary Outcomes (2)

• HbA1c

  Pre and Post (a 26 week study)

• Lipid Panel

  Pre and Post (a 26 week study)

Study Arms (2)

Video Conferencing Health Coaching with devices

EXPERIMENTAL

The DEV group participants will meet via the DiscoverHealth® app using their smartphone, and met 18 times with the registered dietitian (RD) to discuss exercise and diet goals. Participants in this group were provided with a blood pressure and body weight scale which connected to the CoachCare App®.

Behavioral: Video Conferencing Health Coaching with devices

Video Conferencing Health Coaching with no devices

EXPERIMENTAL

The NODEV group participants meet via the DiscoverHealth® app using their smartphone, and met 18 times with the registered dietitian (RD) for health coaching to discuss exercise and diet goals. Participants in this group did not receive devices.

Behavioral: Video Conferencing Health Coaching with no devices

Interventions

Video Conferencing Health Coaching with devices BEHAVIORAL

Devices

Video Conferencing Health Coaching with devices

Video Conferencing Health Coaching with no devices BEHAVIORAL

No Devices

Video Conferencing Health Coaching with no devices

Eligibility Criteria

• Age: 20 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Fluent in English spoken and written at a high-school level, Obese according to body mass index (BMI) standards (\> 30 kg/m2), Weigh less than 500 pounds, have access to an Apple® iPhone or Android® smart phone

You may not qualify if:

• Participants were excluded if they have stated having an Immunodeficiency disorder Kidney disease; Type II diabetes; Asthma, COPD, Heart attack or stroke within the past 12 months; Presence of a partial or full artificial limb; Known dementia, brain cancer, eating disorders, history of significant neurological or psychiatric disorder or any other psychological condition; Medications, dietary supplements, or substances advertised to modify metabolism or body weight; Undergone major surgery less than 4 weeks prior to enrollment in the study; or were actively losing weight.

Sponsors & Collaborators

• Coastal Carolina University: lead
• inHealth Medical Services, Inc.: collaborator

Study Sites (1)

Sleep Health Clinic

Bradenton, Florida, 34209, United States

Location

Related Publications (4)

• Svetkey LP, Simons-Morton D, Vollmer WM, Appel LJ, Conlin PR, Ryan DH, Ard J, Kennedy BM. Effects of dietary patterns on blood pressure: subgroup analysis of the Dietary Approaches to Stop Hypertension (DASH) randomized clinical trial. Arch Intern Med. 1999 Feb 8;159(3):285-93. doi: 10.1001/archinte.159.3.285.

  PMID: 9989541 BACKGROUND

• Alencar MK, Johnson K, Mullur R, Gray V, Gutierrez E, Korosteleva O. The efficacy of a telemedicine-based weight loss program with video conference health coaching support. J Telemed Telecare. 2019 Apr;25(3):151-157. doi: 10.1177/1357633X17745471. Epub 2017 Dec 3.

  PMID: 29199544 BACKGROUND

• Johnson KE, Alencar MK, Coakley KE, Swift DL, Cole NH, Mermier CM, Kravitz L, Amorim FT, Gibson AL. Telemedicine-Based Health Coaching Is Effective for Inducing Weight Loss and Improving Metabolic Markers. Telemed J E Health. 2019 Feb;25(2):85-92. doi: 10.1089/tmj.2018.0002. Epub 2018 May 30.

  PMID: 29847222 BACKGROUND

• American Heart Association; American College of Cardiology; Obesity Society. Reprint: 2013 AHA/ACC/TOS Guideline for the Management of Overweight and Obesity in Adults. J Am Pharm Assoc (2003). 2014 Jan-Feb;54(1):e3. doi: 10.1331/japha.2014.14502. No abstract available.

  PMID: 24898716 BACKGROUND

MeSH Terms

Conditions

Body Weight Changes; Weight Loss; Obesity

Interventions

Equipment and Supplies

Condition Hierarchy (Ancestors)

Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: CARE PROVIDER
• Masking Details: Following baseline visits, participants were randomized to a no device (NODEV) or device (DEV) group via the website https://www.randomlists.com/team-generator.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Exercise and Sport Science

Model Details: All participants were randomized in a balanced fashion and stratified by sex into either one of the two intervention groups no device (NODEV) group or a device (DEV) group.

Study Record Dates

• First Submitted: December 13, 2019
• First Posted: December 16, 2019
• Study Start: January 6, 2021
• Primary Completion: January 31, 2022
• Study Completion: February 12, 2022
• Last Updated: October 6, 2022

Record last verified: 2022-10

Locations

US (1)