Weight LossNCT03491930
Weight Loss Using a Feedback Device in Obese People With the Metabolic Syndrome
A study testing VA MOVE! Coach app and Telephone Coaching in people with Weight Loss and Obesity, run by Rockefeller University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Weight Loss, Obesity, Pre-Diabetes
- What is being tested?
- VA MOVE! Coach app and Telephone Coaching
- Type of treatment
- Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2018to Dec 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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;
Show all 17Show fewer
- 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;
Who cannot join
- 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;
Show all 10Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: What is the Effect of a Feedback Device on Weight Loss and Metabolic Measurements in Obese People With the Metabolic Syndrome?
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.
Read the 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.
- Conditions
- Weight Loss, Obesity, Pre-Diabetes, Metabolic Syndrome
- Being tested
- VA MOVE! Coach app, Telephone Coaching, Standard of Care for weight loss.
- Keywords
- Weight Loss, Obesity, Pre-Diabetes, Metabolic Syndrome
- Medical subject headings
- Weight Loss, Obesity, Glucose Intolerance, Metabolic Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VA MOVE! Coach appDevice
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.
Telephone CoachingBehavioural
Weekly Telephone Coaching
Standard of Care for weight loss.Behavioural
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)
| Study group | Role | What they receive |
|---|---|---|
| Interventional Cohort | Experimental | 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. Receives: Device: VA MOVE! Coach app; Behavioral: Telephone Coaching; Behavioral: Standard of Care for weight loss. |
| Control Cohort | Active comparator | 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. Receives: Behavioral: Standard of Care for weight loss. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline up to 3 months
Secondary outcomes (9)
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
Measured: Baseline up to 3 months
Change in waist circumference
Weight loss is expected to reduce central obesity
Measured: Baseline up to 3 months
Change in BMI
Weight loss is expected to result in decreased BMI
Measured: Baseline up to 3 months
Change in body composition by Bod Pod
Weight loss is expected to reduce total fat percentage
Measured: Baseline up to 3 months
Change in metabolic parameters
Improvement in metabolic markers: serum glucose, triglycerides, lipids, White Blood Count,erythrocyte sedimentation rate
Measured: Baseline up to 3 months
Change in blood pressure
Reduction in systolic BP
Measured: Baseline up to 3 months
Change in hemoglobin-A1C %
Weight loss and increased activity is expected to reduce Hemoglobin A1C, and indicator of diabetes
Measured: 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
Measured: 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
Measured: Baseline up to 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Apr 2018
- Study startJun 2018 (estimated)
- Primary completionAug 2018 (estimated)
- Study completionDec 2018 (estimated)
Why it stopped: Study never initiated. PI withdrew protocol with the IRB.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (15)Papers the sponsor has linked to this study.
- Other trials for Weight LossStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rockefeller University
- Sponsor type
- University, hospital or other
- Collaborators
- Molloy College
- Responsible party
- Principal investigator, Jeanne Walker, Rockefeller University
- Investigators
- Jeanne Walker, NP, Principal investigator, Rockefeller University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03491930
- Sponsor's protocol ID
- JWA-0967
- Status last verified
- Oct 2018
- First submitted
- 2 Apr 2018
- Last updated
- 24 Oct 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
American Society of Clinical Oncology. The state of cancer care in America, 2014: a report by the American Society of Clinical Oncology. J Oncol Pract. 2014 Mar;10(2):119-42. doi: 10.1200/JOP.2014.001386. Epub 2014 Mar 10. No abstract available.
PubMed 24618075Byrne S, Cooper Z, Fairburn C. Weight maintenance and relapse in obesity: a qualitative study. Int J Obes Relat Metab Disord. 2003 Aug;27(8):955-62. doi: 10.1038/sj.ijo.0802305.
PubMed 12861237Cefalu WT, Bray GA, Home PD, Garvey WT, Klein S, Pi-Sunyer FX, Hu FB, Raz I, Van Gaal L, Wolfe BM, Ryan DH. Advances in the Science, Treatment, and Prevention of the Disease of Obesity: Reflections From a Diabetes Care Editors' Expert Forum. Diabetes Care. 2015 Aug;38(8):1567-82. doi: 10.2337/dc15-1081.
PubMed 26421334Duncan JM, Janke EA, Kozak AT, Roehrig M, Russell SW, McFadden HG, Demott A, Pictor A, Hedeker D, Spring B. PDA+: A Personal Digital Assistant for Obesity Treatment - an RCT testing the use of technology to enhance weight loss treatment for veterans. BMC Public Health. 2011 Apr 11;11:223. doi: 10.1186/1471-2458-11-223.
PubMed 21481253Greene J, Sacks R, Piniewski B, Kil D, Hahn JS. The impact of an online social network with wireless monitoring devices on physical activity and weight loss. J Prim Care Community Health. 2013 Jul 1;4(3):189-94. doi: 10.1177/2150131912469546. Epub 2012 Dec 9.
PubMed 23799706Hruby A, Hu FB. The Epidemiology of Obesity: A Big Picture. Pharmacoeconomics. 2015 Jul;33(7):673-89. doi: 10.1007/s40273-014-0243-x.
PubMed 25471927Ogden CL, Carroll MD, Fryar CD, Flegal KM. Prevalence of Obesity Among Adults and Youth: United States, 2011-2014. NCHS Data Brief. 2015 Nov;(219):1-8.
PubMed 26633046Shaw RJ, Bosworth HB, Silva SS, Lipkus IM, Davis LL, Sha RS, Johnson CM. Mobile health messages help sustain recent weight loss. Am J Med. 2013 Nov;126(11):1002-9. doi: 10.1016/j.amjmed.2013.07.001. Epub 2013 Sep 16.
PubMed 24050486Spring B, Duncan JM, Janke EA, Kozak AT, McFadden HG, DeMott A, Pictor A, Epstein LH, Siddique J, Pellegrini CA, Buscemi J, Hedeker D. Integrating technology into standard weight loss treatment: a randomized controlled trial. JAMA Intern Med. 2013 Jan 28;173(2):105-11. doi: 10.1001/jamainternmed.2013.1221.
PubMed 23229890DeSilver, Drew. (2016). What's on your table? How America's diet has changed over the decades. Pew Research Center. Retrieved from: http:www.pewresearch.org/fact-tank/2016/12/13/whats-on-your-table-how-americas-diet-has-changed-over-the-decades/
American Board of Obesity Medicine. www.abom.org
Center for Disease and Prevention (CDC). (2017). Obesity trends among U.S. adults. Retrieved from: www.cdc.gov/obesity/data/prevalence-maps.html
Jensen MD, Ryan DH, Apovian CM, Ard JD, Comuzzie AG, Donato KA, Hu FB, Hubbard VS, Jakicic JM, Kushner RF, Loria CM, Millen BE, Nonas CA, Pi-Sunyer FX, Stevens J, Stevens VJ, Wadden TA, Wolfe BM, Yanovski SZ, Jordan HS, Kendall KA, Lux LJ, Mentor-Marcel R, Morgan LC, Trisolini MG, Wnek J, Anderson JL, Halperin JL, Albert NM, Bozkurt B, Brindis RG, Curtis LH, DeMets D, Hochman JS, Kovacs RJ, Ohman EM, Pressler SJ, Sellke FW, Shen WK, Smith SC Jr, Tomaselli GF; American College of Cardiology/American Heart Association Task Force on Practice Guidelines; Obesity Society. 2013 AHA/ACC/TOS guideline for the management of overweight and obesity in adults: a report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines and The Obesity Society. Circulation. 2014 Jun 24;129(25 Suppl 2):S102-38. doi: 10.1161/01.cir.0000437739.71477.ee. Epub 2013 Nov 12. No abstract available.
PubMed 24222017Ceccarini M, Borrello M, Pietrabissa G, Manzoni GM, Castelnuovo G. Assessing motivation and readiness to change for weight management and control: an in-depth evaluation of three sets of instruments. Front Psychol. 2015 May 11;6:511. doi: 10.3389/fpsyg.2015.00511. eCollection 2015.
PubMed 26029126Hartman SJ, Nelson SH, Cadmus-Bertram LA, Patterson RE, Parker BA, Pierce JP. Technology- and Phone-Based Weight Loss Intervention: Pilot RCT in Women at Elevated Breast Cancer Risk. Am J Prev Med. 2016 Nov;51(5):714-721. doi: 10.1016/j.amepre.2016.06.024. Epub 2016 Sep 2.
PubMed 27593420
Study at a glance
From the registry record, last updated by the sponsor on 24 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- What is the Effect of a Feedback Device on Weight Loss and Metabolic Measurements in Obese People With the Metabolic Syndrome?
- ClinicalTrials.gov ID
- NCT03491930
- Acronym / sponsor ID
- JWA-0967
- Conditions
- Weight Loss, Obesity, Pre-Diabetes, Metabolic Syndrome
- Keywords
- Weight Loss, Obesity, Pre-Diabetes, Metabolic Syndrome
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Study never initiated. PI withdrew protocol with the IRB.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Rockefeller UniversityUniversity, hospital or other
- Collaborators
- Molloy College
- Study start
- Jun 2018 (estimated)
- Primary completion
- Aug 2018 (estimated)
- Study completion
- Dec 2018 (estimated)
- First posted
- 9 Apr 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Interventional Cohort | Experimental | Device: VA MOVE! Coach app, Behavioral: Telephone Coaching, Behavioral: Standard of Care for weight loss.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. |
| Control Cohort | Active comparator | 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. |
Who may qualify
- Ages
- 40 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (17 listed)
- 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;
Key exclusion criteria (10 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| VA MOVE! Coach appThe 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. | Device | Interventional Cohort |
| Telephone CoachingWeekly Telephone Coaching | Behavioural | Interventional Cohort |
| 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) | Behavioural | Control Cohort, Interventional Cohort |
Primary outcome
Change in weight
Time frame: Baseline up to 3 months
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.
9 secondary outcomes
Retention
Time frame: Baseline up to 3 months
Change in waist circumference
Time frame: Baseline up to 3 months
Change in BMI
Time frame: Baseline up to 3 months
Change in body composition by Bod Pod
Time frame: Baseline up to 3 months
Change in metabolic parameters
Time frame: Baseline up to 3 months
Change in blood pressure
Time frame: Baseline up to 3 months
Change in hemoglobin-A1C %
Time frame: Baseline up to 3 months
Change in motivation to lose weight and adopt healthier lifestyle
Time frame: Baseline up to 6 months
Change in quality of life by "SF-12v2" questionnaire
Time frame: Baseline up to 3 months
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Oct 2018.
- Background: PubMed 24618075American Society of Clinical Oncology. The state of cancer care in America, 2014: a report by the American Society of Clinical Oncology. J Oncol Pract. 2014 Mar;10(2):119-42. doi: 10.1200/JOP.2014.001386. Epub 2014 Mar 10. No abstract available.
- Background: PubMed 12861237Byrne S, Cooper Z, Fairburn C. Weight maintenance and relapse in obesity: a qualitative study. Int J Obes Relat Metab Disord. 2003 Aug;27(8):955-62. doi: 10.1038/sj.ijo.0802305.
- Background: PubMed 26421334Cefalu WT, Bray GA, Home PD, Garvey WT, Klein S, Pi-Sunyer FX, Hu FB, Raz I, Van Gaal L, Wolfe BM, Ryan DH. Advances in the Science, Treatment, and Prevention of the Disease of Obesity: Reflections From a Diabetes Care Editors' Expert Forum. Diabetes Care. 2015 Aug;38(8):1567-82. doi: 10.2337/dc15-1081.
- Background: PubMed 21481253Duncan JM, Janke EA, Kozak AT, Roehrig M, Russell SW, McFadden HG, Demott A, Pictor A, Hedeker D, Spring B. PDA+: A Personal Digital Assistant for Obesity Treatment - an RCT testing the use of technology to enhance weight loss treatment for veterans. BMC Public Health. 2011 Apr 11;11:223. doi: 10.1186/1471-2458-11-223.
- Background: PubMed 23799706Greene J, Sacks R, Piniewski B, Kil D, Hahn JS. The impact of an online social network with wireless monitoring devices on physical activity and weight loss. J Prim Care Community Health. 2013 Jul 1;4(3):189-94. doi: 10.1177/2150131912469546. Epub 2012 Dec 9.
- Background: PubMed 25471927Hruby A, Hu FB. The Epidemiology of Obesity: A Big Picture. Pharmacoeconomics. 2015 Jul;33(7):673-89. doi: 10.1007/s40273-014-0243-x.
- Background: PubMed 26633046Ogden CL, Carroll MD, Fryar CD, Flegal KM. Prevalence of Obesity Among Adults and Youth: United States, 2011-2014. NCHS Data Brief. 2015 Nov;(219):1-8.
- Background: PubMed 24050486Shaw RJ, Bosworth HB, Silva SS, Lipkus IM, Davis LL, Sha RS, Johnson CM. Mobile health messages help sustain recent weight loss. Am J Med. 2013 Nov;126(11):1002-9. doi: 10.1016/j.amjmed.2013.07.001. Epub 2013 Sep 16.
- Background: PubMed 23229890Spring B, Duncan JM, Janke EA, Kozak AT, McFadden HG, DeMott A, Pictor A, Epstein LH, Siddique J, Pellegrini CA, Buscemi J, Hedeker D. Integrating technology into standard weight loss treatment: a randomized controlled trial. JAMA Intern Med. 2013 Jan 28;173(2):105-11. doi: 10.1001/jamainternmed.2013.1221.
- BackgroundDeSilver, Drew. (2016). What's on your table? How America's diet has changed over the decades. Pew Research Center. Retrieved from: http:www.pewresearch.org/fact-tank/2016/12/13/whats-on-your-table-how-americas-diet-has-changed-over-the-decades/
- BackgroundAmerican Board of Obesity Medicine. www.abom.org
- BackgroundCenter for Disease and Prevention (CDC). (2017). Obesity trends among U.S. adults. Retrieved from: www.cdc.gov/obesity/data/prevalence-maps.html
- Prevalence of the metabolic syndrome in the United States, 2003-2012.Link provided by the sponsor.
- CDC-National Diabetes Statistics Report (2017): Estimates of diabetes and its burden in the United StatesLink provided by the sponsor.
- DeSilver, Drew (2016) Pew Research CenterLink provided by the sponsor.
- American Board of Obesity MedicineLink provided by the sponsor.
- Practical Guide to the Identification, Evaluation, and Treatment of Overweight and Obesity in Adults. National Institutes of Health. National Heart, Lung, and Blood Institute. NIH Publication Number 00-4084. October 2000Link provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jeanne Walker, NP principal investigator
Rockefeller University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing VA MOVE! Coach app and Telephone Coaching in people with Weight Loss and Obesity, run by Rockefeller University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 17 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 24 Oct 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in weight (time frame: Baseline up to 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03491930, which also lists 15 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Oct 2018.