Weight Loss Using a Feedback Device in Obese People With the Metabolic Syndrome
Withdrawn before enrolling · Not applicable
Conditions studied: Weight Loss, Obesity, Pre-Diabetes, Metabolic Syndrome
In brief
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.
Key facts
- Study ID
- NCT03491930
- Run by
- Rockefeller University
- People needed
- 0
- Starts
- 2018-06-01
- Expected to finish
- 2018-12-01
- Last updated by the study team
- 2018-10-24
Who can join
Age: 40 and older, up to 70. Sex: any. Healthy volunteers: accepted.
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;
- HDL cholesterol <40mg/dl;
- Hypertension: treated or >130/85 mm/hg untreated during screening;
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.
Where it is running
- Rockefeller University — New York, New York, United States
Full record on ClinicalTrials.gov
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