Weight Loss Using a Feedback Device in Obese People With the Metabolic Syndrome
NCT03491930 · Status: WITHDRAWN · Phase: NA · Type: INTERVENTIONAL
Last updated 2018-10-24
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
Interventions
- DEVICE
-
VA MOVE! Coach app
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.
- BEHAVIORAL
-
Telephone Coaching
Weekly Telephone Coaching
- BEHAVIORAL
-
Standard of Care for weight loss.
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)
Sponsors & Collaborators
-
Molloy College
collaborator OTHER -
Rockefeller University
lead OTHER
Principal Investigators
-
Jeanne Walker, NP · Rockefeller University
Study Design
- Allocation
- RANDOMIZED
- Purpose
- HEALTH_SERVICES_RESEARCH
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 40 Years
- Max Age
- 70 Years
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2018-06-30
- Primary Completion
- 2018-08-31
- Completion
- 2018-12-31
Countries
- United States
Study Locations
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