An interventional study of VA MOVE! Coach app and Telephone Coaching in Weight Loss, Obesity and Pre-Diabetes, sponsored by Rockefeller University. Withdrawn at 1 site in United States. Open to participants aged 40 Years to 70 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2018-10-24.
Sponsored by Rockefeller University · Not applicable, Interventional, and Health services research
Among 21 studies in Obesity by Rockefeller University — none open to participants now, 1 under way, none of them phase 3. Obesity · Rockefeller University.
Among the 21 studies in Obesity by Rockefeller University, this one is the 17th largest by enrollment of the 17 interventional ones that give a count, is the only one that started in 2018, is one of 15 with no phase, and was the 18th registered.
11,522 studies on the registry are indexed under Obesity; 2,033 are open to participants now.
Browse Obesity studies →None of the 21 studies in Obesity by Rockefeller University is open now.
Of the 1,336 Obesity studies recruiting now, 377 (28%) set no upper age limit and 856 (64%) stop at 75 or younger; 168 take children under 18; 491 take healthy volunteers.
This study: 40 Years to 70 Years · all sexes · healthy volunteers too.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
21 studies; the count open now beside each. This study's row is marked.
First in 2001; this study’s year is marked. 1 started in 2018.
By drug class, each counting the studies that test any of its medicines:
Median enrollment 18 across the 17 interventional studies, 14 across the 4 observational. Of the 19 that completed or were terminated, 2 (11%) have results posted.
This tab as a report to print or save as PDF → With an account.
Rockefeller University is the lead sponsor of 123 studies on the registry; 3 are open to participants now.
Of its 14 completed or terminated interventional studies of FDA-regulated products, 6 (43%) have results posted.
1 of the studies in Obesity by Rockefeller University that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT06424132Rockefeller UniversityThermogenic Silencer Regulatory Factors in Humans | 2026-12-04 |
Among the 21 studies in Obesity by Rockefeller University, from their registry updates:
Nothing recorded among them since 2026-09-25.
This tab as a report to print or save as PDF → With an account.
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.
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.
11,522 studies on the registry are indexed under Obesity; 2,033 are open to participants now.
Browse Obesity studies →Rockefeller University is the lead sponsor of 123 studies on the registry; 3 are open to participants now.
Of its 14 completed or terminated interventional studies of FDA-regulated products, 6 (43%) have results posted.
Compared within Obesity, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Weight Loss. The counts are of registry records indexed under each term, refreshed daily. How we classify →
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
At least 2 of the following for women:
At least 2 of the following for men:
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
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.
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.
Weekly Telephone Coaching
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)
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.
Time frame: Baseline up to 3 months
Retention
Compare the number of drop outs in each group to determine if there is a difference in motivation to lose weight with the app vs standard of care
Time frame: Baseline up to 3 months
Change in waist circumference
Weight loss is expected to reduce central obesity
Time frame: Baseline up to 3 months
Change in BMI
Weight loss is expected to result in decreased BMI
Time frame: Baseline up to 3 months
Change in body composition by Bod Pod
Weight loss is expected to reduce total fat percentage
Time frame: Baseline up to 3 months
Change in metabolic parameters
Improvement in metabolic markers: serum glucose, triglycerides, lipids, White Blood Count,erythrocyte sedimentation rate
Time frame: Baseline up to 3 months
Change in blood pressure
Reduction in systolic BP
Time frame: Baseline up to 3 months
Change in hemoglobin-A1C %
Weight loss and increased activity is expected to reduce Hemoglobin A1C, and indicator of diabetes
Time frame: Baseline up to 3 months
Change in motivation to lose weight and adopt healthier lifestyle
URICA motivation questionnaire will monitor motivation at baseline, 3, and 6 months
Time frame: Baseline up to 6 months
Change in quality of life by "SF-12v2" questionnaire
Monitor change in perception of quality of life while losing weight
Time frame: Baseline up to 3 months
Plan to share: No
Start is estimated for Jun 2018; primary completion for Aug 2018, 2 months later.
How these figures are worked out, and which studies are left out of them.
This study is withdrawn, as verified in Oct 2018. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.