Weight Loss Using a Feedback Device in Obese People With the Metabolic Syndrome

NCT03491930 | Withdrawn

• 1 other identifier: JWA-0967
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to determine if a weight loss app (VA MOVE!® Coach App) along with regularly scheduled telephone counseling, will motivate obese people with metabolic syndrome to lose weight and improve the symptoms of the metabolic syndrome, compared to usual weight loss approaches. This study will randomly assign participants to one of two groups, interventional or control. The interventional group will use the app with phone coaching and standard of care for weight loss. The control group will receive standard weight loss care without the app and phone coaching. Weight loss motivation to adopt life-style changes to maintain weight loss and quality of life between the two groups will be compared. The metabolic syndrome (MetS) is a cluster of disorders including high blood pressure, pre-diabetes, the tendency to carry body weight around the waist, and increased fat in the blood. When these problems happen together, there is an increased risk for heart attack, stroke, diabetes and certain cancers. Although the metabolic syndrome is a serious condition, it can be treated with diet, weight loss and increased activity. It can even be reversed using these lifestyle changes. Due to poor success with routine short-term weight loss treatment (group and one-on-one counseling), it is time to address the problem by a different method. Studies have shown feedback devices and weight loss apps have been successful in weight loss and weight maintenance. They are economical (many apps are free), and convenient to use, without attendance at group sessions. Since weight loss is the corner stone for improvement in the symptoms of the MetS, this study will offer a unique approach to support individuals who are committed to losing weight and adopting a healthier lifestyle. Numerous studies demonstrated that feedback via text messaging, and interaction through social networking support groups, in addition to iPhone apps, are all more effective in weight loss measures than group sessions at a hospital site. (Duncan et al., 2011; Greene, Sacks, Piniewski, Kil, \& Hahn, 2012; Shaw et al., 2013; Spring et al., 2013). The benefit of these various methods is that they appear to accelerate weight loss and prevent weight re-gain if employed long-term. With technology changing daily, these approaches must be considered an essential adjunct to, or replacement for, traditional group counselling sessions.

Conditions

Weight Loss; Obesity; Pre-Diabetes; Metabolic Syndrome

Keywords

Weight Loss; Obesity; Pre-Diabetes; Metabolic Syndrome

Outcome Measures

Primary Outcomes (1)

• Change in weight

  Change in weight measured from baseline to end of study participation (3 months). Weight loss app with compliance is expected to result in 2-3 kg loss.

  Baseline up to 3 months

Secondary Outcomes (9)

• Retention

  Baseline up to 3 months

• Change in waist circumference

  Baseline up to 3 months

• Change in BMI

  Baseline up to 3 months

• Change in body composition by Bod Pod

  Baseline up to 3 months

• Change in metabolic parameters

  Baseline up to 3 months

Study Arms (2)

Interventional Cohort

EXPERIMENTAL

VA MOVE! Coach app: Weight loss using the VA MOVE! Coach weight loss app which presents positive feedback, education in nutrition and portion sizes, coping mechanisms, charts and graphs. App will be used for three months. Telephone Coaching: Weekly phone coaching will provide further support and assist with problem solving and goal setting for a three month period. Standard of care for weight loss (the 2013 AHA/ACC/TOS guidelines). Followed for three months. Pre and post weight loss metabolic measurements will be obtained.

Device: VA MOVE! Coach app; Behavioral: Telephone Coaching; Behavioral: Standard of Care for weight loss.

Control Cohort

ACTIVE COMPARATOR

Standard of care for weight loss (2013 AHA/ACC/TOS guidelines). Followed for three months. Pre and post weight loss metabolic measurements will be obtained.

Behavioral: Standard of Care for weight loss.

Interventions

VA MOVE! Coach app DEVICE

The VA MOVE! Coach app promotes weight loss through positive feedback, nutritional education, calorie counts, graphs, charts, and encourages increased activity. Efforts will be supported through weekly phone coaching.

Interventional Cohort

Telephone Coaching BEHAVIORAL

Weekly Telephone Coaching

Interventional Cohort

Standard of Care for weight loss. BEHAVIORAL

Standard of Care for weight loss (2013 American College of Cardiology/American Heart Association Task Force and The Obesity Society (AHA/ACC/TOS) Report,PubMed Identification: 24222017). To include: * Vioscreen food frequency assessment and bionutritionist consult. * Healthy eating nutritional pamphlets (during consult) * Decrease daily caloric intake by 500 cal/day * Increase in physical activity (goal: 10,000 steps per day - measured by pedometer.) * Dietary counseling by Clinician (monthly)

Control Cohort; Interventional Cohort

Eligibility Criteria

• Age: 40 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• BMI≥30 kg/m2;
• fasting glucose ≥ 100mg/dl
• Access to IPhone or Android phone;
• Willing/able to travel to Rockefeller for all study visits;
• Able to speak and understand English;
• Willing to receive weekly phone coaching calls from investigator;
• Willing to monitor and record daily weight and steps in provided notebook.
• At least 2 of the following for women:
• waist circumference ≥88 cm;
• Serum triglycerides ≥150mg/dl to ≤ 500mg/dl;
• HDL cholesterol \<50mg/dl;
• Hypertension: treated or \>130/85 mm/hg untreated during screening
• At least 2 of the following for men:
• Waist circumference ≥ 102 cm;
• Serum triglycerides ≥150mg/dl to ≤ 500mg/dl;

You may not qualify if:

• Diabetes except history of gestational diabetes
• HgA1C greater than 6.5% at screening;
• Pregnancy or intent to become pregnant during study participation (women);
• hypo/hyperthyroidism (based on fasting screening labs);
• currently on steroid therapy;
• currently on weight loss medication;
• history of bariatric weight loss surgery;
• currently on statin therapy;
• participation in a formal weight loss program or using another weight loss app;
• any medical, social or psychological condition that, in the opinion of the investigator, would jeopardize the health or well being of the participant or the integrity of the data.

Sponsors & Collaborators

• Rockefeller University: lead
• Molloy College: collaborator

Study Sites (1)

Rockefeller University

New York, New York, 10065, United States

Location

Related Publications (15)

• American Society of Clinical Oncology. The state of cancer care in America, 2014: a report by the American Society of Clinical Oncology. J Oncol Pract. 2014 Mar;10(2):119-42. doi: 10.1200/JOP.2014.001386. Epub 2014 Mar 10. No abstract available.

  PMID: 24618075 BACKGROUND

• Byrne S, Cooper Z, Fairburn C. Weight maintenance and relapse in obesity: a qualitative study. Int J Obes Relat Metab Disord. 2003 Aug;27(8):955-62. doi: 10.1038/sj.ijo.0802305.

  PMID: 12861237 BACKGROUND

• Cefalu WT, Bray GA, Home PD, Garvey WT, Klein S, Pi-Sunyer FX, Hu FB, Raz I, Van Gaal L, Wolfe BM, Ryan DH. Advances in the Science, Treatment, and Prevention of the Disease of Obesity: Reflections From a Diabetes Care Editors' Expert Forum. Diabetes Care. 2015 Aug;38(8):1567-82. doi: 10.2337/dc15-1081.

  PMID: 26421334 BACKGROUND

• Duncan JM, Janke EA, Kozak AT, Roehrig M, Russell SW, McFadden HG, Demott A, Pictor A, Hedeker D, Spring B. PDA+: A Personal Digital Assistant for Obesity Treatment - an RCT testing the use of technology to enhance weight loss treatment for veterans. BMC Public Health. 2011 Apr 11;11:223. doi: 10.1186/1471-2458-11-223.

  PMID: 21481253 BACKGROUND

• Greene J, Sacks R, Piniewski B, Kil D, Hahn JS. The impact of an online social network with wireless monitoring devices on physical activity and weight loss. J Prim Care Community Health. 2013 Jul 1;4(3):189-94. doi: 10.1177/2150131912469546. Epub 2012 Dec 9.

  PMID: 23799706 BACKGROUND

• Hruby A, Hu FB. The Epidemiology of Obesity: A Big Picture. Pharmacoeconomics. 2015 Jul;33(7):673-89. doi: 10.1007/s40273-014-0243-x.

  PMID: 25471927 BACKGROUND

• Ogden CL, Carroll MD, Fryar CD, Flegal KM. Prevalence of Obesity Among Adults and Youth: United States, 2011-2014. NCHS Data Brief. 2015 Nov;(219):1-8.

  PMID: 26633046 BACKGROUND

• Shaw RJ, Bosworth HB, Silva SS, Lipkus IM, Davis LL, Sha RS, Johnson CM. Mobile health messages help sustain recent weight loss. Am J Med. 2013 Nov;126(11):1002-9. doi: 10.1016/j.amjmed.2013.07.001. Epub 2013 Sep 16.

  PMID: 24050486 BACKGROUND

• Spring B, Duncan JM, Janke EA, Kozak AT, McFadden HG, DeMott A, Pictor A, Epstein LH, Siddique J, Pellegrini CA, Buscemi J, Hedeker D. Integrating technology into standard weight loss treatment: a randomized controlled trial. JAMA Intern Med. 2013 Jan 28;173(2):105-11. doi: 10.1001/jamainternmed.2013.1221.

  PMID: 23229890 BACKGROUND

• DeSilver, Drew. (2016). What's on your table? How America's diet has changed over the decades. Pew Research Center. Retrieved from: http:www.pewresearch.org/fact-tank/2016/12/13/whats-on-your-table-how-americas-diet-has-changed-over-the-decades/

  BACKGROUND

• American Board of Obesity Medicine. www.abom.org

  BACKGROUND

• Center for Disease and Prevention (CDC). (2017). Obesity trends among U.S. adults. Retrieved from: www.cdc.gov/obesity/data/prevalence-maps.html

  BACKGROUND

• Jensen MD, Ryan DH, Apovian CM, Ard JD, Comuzzie AG, Donato KA, Hu FB, Hubbard VS, Jakicic JM, Kushner RF, Loria CM, Millen BE, Nonas CA, Pi-Sunyer FX, Stevens J, Stevens VJ, Wadden TA, Wolfe BM, Yanovski SZ, Jordan HS, Kendall KA, Lux LJ, Mentor-Marcel R, Morgan LC, Trisolini MG, Wnek J, Anderson JL, Halperin JL, Albert NM, Bozkurt B, Brindis RG, Curtis LH, DeMets D, Hochman JS, Kovacs RJ, Ohman EM, Pressler SJ, Sellke FW, Shen WK, Smith SC Jr, Tomaselli GF; American College of Cardiology/American Heart Association Task Force on Practice Guidelines; Obesity Society. 2013 AHA/ACC/TOS guideline for the management of overweight and obesity in adults: a report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines and The Obesity Society. Circulation. 2014 Jun 24;129(25 Suppl 2):S102-38. doi: 10.1161/01.cir.0000437739.71477.ee. Epub 2013 Nov 12. No abstract available.

  PMID: 24222017 BACKGROUND

• Ceccarini M, Borrello M, Pietrabissa G, Manzoni GM, Castelnuovo G. Assessing motivation and readiness to change for weight management and control: an in-depth evaluation of three sets of instruments. Front Psychol. 2015 May 11;6:511. doi: 10.3389/fpsyg.2015.00511. eCollection 2015.

  PMID: 26029126 BACKGROUND

• Hartman SJ, Nelson SH, Cadmus-Bertram LA, Patterson RE, Parker BA, Pierce JP. Technology- and Phone-Based Weight Loss Intervention: Pilot RCT in Women at Elevated Breast Cancer Risk. Am J Prev Med. 2016 Nov;51(5):714-721. doi: 10.1016/j.amepre.2016.06.024. Epub 2016 Sep 2.

  PMID: 27593420 BACKGROUND

Related Links

• Prevalence of the metabolic syndrome in the United States, 2003-2012.
• DeSilver, Drew (2016) Pew Research Center
• American Board of Obesity Medicine
• Practical Guide to the Identification, Evaluation, and Treatment of Overweight and Obesity in Adults. National Institutes of Health. National Heart, Lung, and Blood Institute. NIH Publication Number 00-4084. October 2000

MeSH Terms

Conditions

Weight Loss; Obesity; Glucose Intolerance; Metabolic Syndrome

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

Body Weight Changes; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Hyperglycemia; Glucose Metabolism Disorders; Metabolic Diseases; Insulin Resistance; Hyperinsulinism

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Officials

• Jeanne Walker, NP

  Rockefeller University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical research nurse practitioner

Model Details: A single group of participants will undergo study participation of listed interventions, over a 3 month outpatient period, to assess the effects on weight loss. A control group will receive all of the interactions and testing as the intervention group, except they will not use the weight loss app or receive weekly phone coaching.

Study Record Dates

• First Submitted: April 2, 2018
• First Posted: April 9, 2018
• Study Start: June 1, 2018
• Primary Completion: August 1, 2018
• Study Completion: December 1, 2018
• Last Updated: October 24, 2018

Record last verified: 2018-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)