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

Obesity rates in the United States have steadily increased since the 1980's, doubling between
1980 and 2010 from 15.0% to 36.1% (Cefalu et al., 2015). The prevalence rate of obesity in
adults in the U.S. in 2014 was 37.7%, according to the Centers for Disease Control and
Prevention (CDC) National Center for Health Statistics (Ogden, Carroll, Fryar, & Flegal,
2015) resulting in a rising incidence of type 2 diabetes, heart disease, hypertension, and
some cancers (American Society of Clinical Oncology, 2014). Many contributors to the rise in
obesity rates are cited in the literature: socio-economic, urbanization, sedentary behavior
(Hruby & Hu, 2015), psychological and motivational factors (Byrne, Cooper, & Fairburn, 2003),
and ethnicity and gender (Ogden et al., 2015). ). According to research done by The Pew
Research Center (DeSilver, 2016), daily caloric intake by the average American in 2010 was
2,481 calories, about 23% more than in 1970.

As research into obesity continues, contributing factors include more than excessive dietary
intake and decreased physical activity. Obesity scientists and medical specialists view the
disorder as a systemic dynamic involving the brain, gut, liver, adipose tissue, hormones,
inflammation, and heredity (Cefalu et al., 2015). The condition, recognized by the American
Medical Association as a disease in 2011, resulted in obesity specialists and medical board
certification (American Board of Obesity Medicine, ABOM, 2013).

Though considered a disease in itself, obesity is a major contributor to preventable
morbidity and mortality, as well as to enormous health care costs (American Nurse
Practitioner Foundation, 2013). The estimated cost of obesity and the resultant
co-morbidities in the U.S. in 2015 was $190 billion. This figure represented 21% of total
U.S. healthcare costs (Hruby & Hu, 2015). Furthermore, the excess cost incurred by obese
individuals annually over the non-obese was $1,152 for obese men (for prescription drugs and
hospitalizations), and $3,613 for obese women (Hruby & Hu, 2015).

Nearly 35% of all adults and 50% of those over 60 years of age in the United States, have the
Metabolic Syndrome (MetS) (Aguilar et al 2015). This is especially disturbing since the
population over 60 years of age increases annually, due to the aging of America. Obesity and
the MetS are the underlying factors in most of the chronic illnesses prevalent today:
diabetes, cancer, inflammatory diseases, reduced immunity, heart disease, stroke, and
disability. It is clear that new, pragmatic, cost effective treatment to control the risk
factors and resultant morbidity and mortality, caused by this epidemic, must be aggressively
investigated. Employing apps developed for mobile phones is an obvious choice, if the data
can show evidence that this approach is effective. This is a prime area for nurse
practitioners to initiate research and to add to the scientific knowledge of obesity and its
sequelae (American Nurse Practitioner Foundation, 2013).

This will be the first study of its kind to examine changes in the metabolic markers of the
MetS, body composition and biometrics using a feedback device in the form of a weight loss
app. As such, it has the potential to provide clinicians with evidence based, adjunctive
treatment for this population. This study will provide the seeds for a longer study to
determine the feasibility of using feedback devices to reinforce healthy life styles and
continue or maintain the weight loss. In this way, the participant will be able to achieve
true health benefits and reduced risks of co-morbidities due to obesity and the MetS.
Comparison with a control group will determine if the treatment is more effective than
standard of care for this population.

Motivation and readiness to change:

It is important to assess motivation and readiness to change in individuals who wish to
achieve significant life style behavior changes (Ceccarini, M., et al., (2015). Studies have
shown that risk of disease development can motivate people to adopt new habits. In a
randomized study of weight loss in women at high risk for breast cancer, Hartman, et al
(2016) found that women at risk of developing breast cancer were motivated to improve health
through weight loss. Using weight loss technology (My Fitness Pal) and phone contact, this
intervention resulted in greater weight loss that that of the control group. They concluded
that combining technology supported by phone counselling was effective in weight loss as a
treatment for women at increased risk for breast cancer. There are no current studies of the
effect of motivation on weight loss in people with the metabolic syndrome. However, it is
plausible that given the risks of developing diabetes or heart disease, these people may be
more motivated to use the app and pursue weight loss to prevent complications of the MetS.

Inclusion Criteria:

- 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;

Exclusion Criteria:

- 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.