Video Conferencing and In-person Health Coaching on Weight Loss, Physical Activity, and Metabolic Control

NCT03278951 | Completed

• 2 other identifiers: 965182-68UL1GM118979-02
• Study Type: interventional
• Target: 30
• Locations: 0 countries
• Sites: N/A

Brief Summary

The purpose of this study was to determine how 12 weeks of health coaching with individualized feedback and education in combination with mobile health devices (a digital wireless body weight scale and wireless activity tracker) influences body weight, waist circumference, physical activity levels, and select blood-borne markers of health (fasting blood glucose, hemoglobin A1c, and insulin). The individualized health coaching, education, and feedback was delivered by either video conferencing or direct, in-person consultation. All education materials including (i.e. video modules, exercise manuals, nutrition manuals) were designed and compiled by a team of health professionals from (inHealth Medical Services, Inc.). These materials focused on incorporating behavioral principles of self-monitoring, exercise, nutrition, goal setting, and behavior modification. Each participant was randomly assigned into one of two intervention groups (a video conferencing or in-person group) or a control group.

Conditions

Obesity; Weight Loss; Telemedicine

Keywords

Weight loss; video conferencing; mHealth; Telemedicine; glycemic control

Outcome Measures

Primary Outcomes (1)

• Weight loss in (kg)

  Investigators examined body weight changes between groups baseline (week 0) and post intervention (week12).

  Change in weight between baseline (week 0) and post intervention (week 12)

Secondary Outcomes (5)

• Comparison of daily step average per day by group (n=10 for each group).

  Average steps per day/week over a 12 week period.

• Hba1c pre and post intervention

  Pre and Post (a 12 week study)

• Insulin pre and post intervention

  Pre and Post (a 12 week study)

• Blood glucose pre and post intervention

  Pre and Post (a 12 week study)

• Homeostasis Model Assessment Insulin resistance (HOMA-IR)

  Pre and Post (a 12 week study)

Study Arms (3)

Control Group

NO INTERVENTION

The control group received the mHealth devices but no health coaching or feedback. Participants in this group completed the same pre- and post-intervention measurements.

Video Conferencing Health Coaching

EXPERIMENTAL

The video conferencing group participants met via the eClinicalWorks® app using their smartphone, and met 12 times with the registered dietitian (RD) and 12 times with the exercise physiologist to discuss exercise and diet goals.

Behavioral: Video Conferencing Group

In Person Health Coaching

EXPERIMENTAL

The in person group participants met 12 times with the registered dietitian (RD) and 12 times with the exercise physiologist over the course of the study to discuss both diet and exercise regimens.

Behavioral: In Person Group

Interventions

Video Conferencing Group BEHAVIORAL

Video Conferencing Health Coaching

In Person Group BEHAVIORAL

In Person Health Coaching

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Fluent in English spoken and written at a high-school level, Non-diabetic Obese according to body mass index (BMI) standards (\> 30 kg/m2), Weigh less than 396 pounds, Live a sedentary lifestyle defined as \< 7,000 steps per day Had 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; History of uncontrolled high blood pressure (defined as a systolic blood pressure ≥ 140mmHg and/or diastolic blood pressure ≥90 mmHg confirmed by measurements on two separate occasions); 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

• University of New Mexico: lead
• National Institute of General Medical Sciences (NIGMS): collaborator
• inHealth Medical Services, Inc.: collaborator

Related Publications (13)

• Hubble JP, Pahwa R, Michalek DK, Thomas C, Koller WC. Interactive video conferencing: a means of providing interim care to Parkinson's disease patients. Mov Disord. 1993 Jul;8(3):380-2. doi: 10.1002/mds.870080326.

  PMID: 8341308 BACKGROUND

• Rollo ME, Hutchesson MJ, Burrows TL, Krukowski RA, Harvey JR, Hoggle LB, Collins CE. Video Consultations and Virtual Nutrition Care for Weight Management. J Acad Nutr Diet. 2015 Aug;115(8):1213-25. doi: 10.1016/j.jand.2015.03.016. Epub 2015 May 16. No abstract available.

  PMID: 25986214 BACKGROUND

• Davis RM, Hitch AD, Salaam MM, Herman WH, Zimmer-Galler IE, Mayer-Davis EJ. TeleHealth improves diabetes self-management in an underserved community: diabetes TeleCare. Diabetes Care. 2010 Aug;33(8):1712-7. doi: 10.2337/dc09-1919. Epub 2010 May 18.

  PMID: 20484125 BACKGROUND

• Olsen JM, Nesbitt BJ. Health coaching to improve healthy lifestyle behaviors: an integrative review. Am J Health Promot. 2010 Sep-Oct;25(1):e1-e12. doi: 10.4278/ajhp.090313-LIT-101.

  PMID: 20809820 BACKGROUND

• Huber JM, Shapiro JS, Wieland ML, Croghan IT, Vickers Douglas KS, Schroeder DR, Hathaway JC, Ebbert JO. Telecoaching plus a portion control plate for weight care management: a randomized trial. Trials. 2015 Jul 30;16:323. doi: 10.1186/s13063-015-0880-1.

  PMID: 26223309 BACKGROUND

• Ferrante JM, Piasecki AK, Ohman-Strickland PA, Crabtree BF. Family physicians' practices and attitudes regarding care of extremely obese patients. Obesity (Silver Spring). 2009 Sep;17(9):1710-6. doi: 10.1038/oby.2009.62. Epub 2009 Mar 12.

  PMID: 19282824 BACKGROUND

• Bennett JA, Perrin NA, Hanson G, Bennett D, Gaynor W, Flaherty-Robb M, Joseph C, Butterworth S, Potempa K. Healthy aging demonstration project: nurse coaching for behavior change in older adults. Res Nurs Health. 2005 Jun;28(3):187-97. doi: 10.1002/nur.20077.

  PMID: 15884026 BACKGROUND

• Shaw RJ, Steinberg DM, Bonnet J, Modarai F, George A, Cunningham T, Mason M, Shahsahebi M, Grambow SC, Bennett GG, Bosworth HB. Mobile health devices: will patients actually use them? J Am Med Inform Assoc. 2016 May;23(3):462-6. doi: 10.1093/jamia/ocv186. Epub 2016 Jan 17.

  PMID: 26911820 BACKGROUND

• Jeon E, Park HA. Development of a smartphone application for clinical-guideline-based obesity management. Healthc Inform Res. 2015 Jan;21(1):10-20. doi: 10.4258/hir.2015.21.1.10. Epub 2015 Jan 31.

  PMID: 25705553 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

• Kivela K, Elo S, Kyngas H, Kaariainen M. The effects of health coaching on adult patients with chronic diseases: a systematic review. Patient Educ Couns. 2014 Nov;97(2):147-57. doi: 10.1016/j.pec.2014.07.026. Epub 2014 Aug 1.

  PMID: 25127667 BACKGROUND

• Hersey JC, Khavjou O, Strange LB, Atkinson RL, Blair SN, Campbell S, Hobbs CL, Kelly B, Fitzgerald TM, Kish-Doto J, Koch MA, Munoz B, Peele E, Stockdale J, Augustine C, Mitchell G, Arday D, Kugler J, Dorn P, Ellzy J, Julian R, Grissom J, Britt M. The efficacy and cost-effectiveness of a community weight management intervention: a randomized controlled trial of the health weight management demonstration. Prev Med. 2012 Jan;54(1):42-9. doi: 10.1016/j.ypmed.2011.09.018. Epub 2011 Oct 6.

  PMID: 22001689 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 DERIVED

MeSH Terms

Conditions

Obesity; Weight Loss

Condition Hierarchy (Ancestors)

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

Study Officials

• Ann Gibson, PhD

  University of New Mexico

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Following baseline visits, participants were randomized to a viideo conference (VC(, in person (IP) or control (CG) groups via the website https://www.randomlists.com/team-generator.
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: All participants were randomized in a balanced fashion and stratified by sex into either one of the two intervention groups (VC or in-person group) or a control group.

Study Record Dates

• First Submitted: September 7, 2017
• First Posted: September 12, 2017
• Study Start: January 30, 2016
• Primary Completion: May 20, 2017
• Study Completion: May 30, 2017
• Last Updated: September 14, 2017

Record last verified: 2017-09