Clinical trial NCT03491930: Weight Loss Using a Feedback Device in Obese People With the Metabolic Syndrome
Official title: What is the Effect of a Feedback Device on Weight Loss and Metabolic Measurements in Obese People With the Metabolic Syndrome?
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Weight Loss
Obesity
Pre-Diabetes
Metabolic Syndrome
Keywords: Weight Loss
Obesity
Pre-Diabetes
Metabolic Syndrome
Lead sponsor: Rockefeller University
Sponsor class: OTHER
Collaborators: name: Molloy College
First posted: 2018-04-09
Enrollment: 0
Sex: ALL
Minimum age (years): 40
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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.
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

Detailed description: 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Change in weight
timeFrame: Baseline up to 3 months
Secondary outcomes:
measure: Retention
timeFrame: Baseline up to 3 months
measure: Change in waist circumference
timeFrame: Baseline up to 3 months
measure: Change in BMI
timeFrame: Baseline up to 3 months
measure: Change in body composition by Bod Pod
timeFrame: Baseline up to 3 months
measure: Change in metabolic parameters
timeFrame: Baseline up to 3 months
measure: Change in blood pressure
timeFrame: Baseline up to 3 months
measure: Change in hemoglobin-A1C %
timeFrame: Baseline up to 3 months
measure: Change in motivation to lose weight and adopt healthier lifestyle
timeFrame: Baseline up to 6 months
measure: Change in quality of life by "SF-12v2" questionnaire
timeFrame: Baseline up to 3 months
Other outcomes:
Locations:
city: New York
country: United States
facility: Rockefeller University
state: New York
Study officials:
affiliation: Rockefeller University
name: Jeanne Walker, NP
role: PRINCIPAL_INVESTIGATOR
References:
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