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

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ClinicalTrials.gov Identifier: NCT03491930
Recruitment Status : Withdrawn (Study never initiated. PI withdrew protocol with the IRB.)
First Posted : April 9, 2018
Last Update Posted : October 24, 2018
Sponsor:
Collaborator:
Molloy College
Information provided by (Responsible Party):
Jeanne Walker, Rockefeller University

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.


Condition or disease Intervention/treatment Phase
Weight Loss Obesity Pre-Diabetes Metabolic Syndrome Device: VA MOVE! Coach app Behavioral: Telephone Coaching Behavioral: Standard of Care for weight loss. Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
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.
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: What is the Effect of a Feedback Device on Weight Loss and Metabolic Measurements in Obese People With the Metabolic Syndrome?
Estimated Study Start Date : June 2018
Estimated Primary Completion Date : August 2018
Estimated Study Completion Date : December 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Interventional Cohort

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
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.

Behavioral: Telephone Coaching
Weekly Telephone Coaching

Behavioral: 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)

Active Comparator: Control Cohort

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.

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)




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. Retention [ Time Frame: Baseline up to 3 months ]
    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

  2. Change in waist circumference [ Time Frame: Baseline up to 3 months ]
    Weight loss is expected to reduce central obesity

  3. Change in BMI [ Time Frame: Baseline up to 3 months ]
    Weight loss is expected to result in decreased BMI

  4. Change in body composition by Bod Pod [ Time Frame: Baseline up to 3 months ]
    Weight loss is expected to reduce total fat percentage

  5. Change in metabolic parameters [ Time Frame: Baseline up to 3 months ]
    Improvement in metabolic markers: serum glucose, triglycerides, lipids, White Blood Count,erythrocyte sedimentation rate

  6. Change in blood pressure [ Time Frame: Baseline up to 3 months ]
    Reduction in systolic BP

  7. Change in hemoglobin-A1C % [ Time Frame: Baseline up to 3 months ]
    Weight loss and increased activity is expected to reduce Hemoglobin A1C, and indicator of diabetes

  8. Change in motivation to lose weight and adopt healthier lifestyle [ Time Frame: Baseline up to 6 months ]
    URICA motivation questionnaire will monitor motivation at baseline, 3, and 6 months

  9. Change in quality of life by "SF-12v2" questionnaire [ Time Frame: Baseline up to 3 months ]
    Monitor change in perception of quality of life while losing weight



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   40 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03491930


Locations
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United States, New York
Rockefeller University
New York, New York, United States, 10065
Sponsors and Collaborators
Rockefeller University
Molloy College
Investigators
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Principal Investigator: Jeanne Walker, NP Rockefeller University

Additional Information:
Publications:
DeSilver, 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. Erratum in: Circulation. 2014 Jun 24;129(25 Suppl 2):S139-40.

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Responsible Party: Jeanne Walker, Clinical research nurse practitioner, Rockefeller University
ClinicalTrials.gov Identifier: NCT03491930     History of Changes
Other Study ID Numbers: JWA-0967
First Posted: April 9, 2018    Key Record Dates
Last Update Posted: October 24, 2018
Last Verified: October 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Jeanne Walker, Rockefeller University:
Weight Loss
Obesity
Pre-Diabetes
Metabolic Syndrome
Additional relevant MeSH terms:
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Metabolic Syndrome
Prediabetic State
Glucose Intolerance
Syndrome
Body Weight
Weight Loss
Disease
Pathologic Processes
Signs and Symptoms
Body Weight Changes
Insulin Resistance
Hyperinsulinism
Glucose Metabolism Disorders
Metabolic Diseases
Diabetes Mellitus
Endocrine System Diseases
Hyperglycemia