- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04804774
Virtual Weight Control Program Tailored for Adults With Type 2 Diabetes (VITAL) (VITAL)
Single-Arm Trial of a Virtual Weight Control Program Tailored for Adults With Type 2 Diabetes on Glycemic Control (VITAL)
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
While weight loss (2-5% of total bodyweight) with clinical interventions has been shown to improve glycemic control in patients with Type II Diabetes clinic-based interventions are costly and have poor accessibility for the majority of patients. Commercial weight loss programs like WW (formerly Weight Watchers) are more affordable and accessible than clinic-based modalities, and have been shown to produce effective weight loss in adults with additional improvements in glycemic control. A randomized trial of a modified WW program for patients with Type II Diabetes showed significant reductions in weight and improved glycemic control (HbA1c) compared to standard of care diabetes nutrition counseling and education. Here, we extend prior work by leveraging the efficacy of the WW program for Type II Diabetes, virtually, to increase its reach and its impact on glycemic control. This study aims to test a novel, web-based weight loss intervention from one of the largest and most evidence-based proprietary weight loss programs in the world.
Intervention will consist of the WW program modified for people with Type 2 diabetes including weekly Virtual Workshops and use of the WW App. Primary outcomes are any change in HbA1c% over the 6-month intervention. Secondary endpoints are any change in HbA1c% at 3 months, as well as changes at 3 and 6 months in weight, Diabetes Distress Scale, Impact of Weight on Quality of Life, Pittsburgh Sleep Quality Index, hypoglycemic events, WHO-5 Well-being Index, and diabetes medication changes.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Florida
-
Gainesville, Florida, United States, 32611
- University of Florida
-
-
Louisiana
-
Baton Rouge, Louisiana, United States, 70808
- Pennington Biomedical Research
-
-
Virginia
-
Richmond, Virginia, United States, 23284
- Virginia Commonwealth University
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 1. Participant reported diagnosis of Type 2 diabetes 2. HbA1c between 7%-11% (inclusive) 3. BMI 27-50 kg/m2 (inclusive) 4. Age range - 18 - 70 years (inclusive) 5. On stable regimen of all medications (including diabetes) for at least 3 months (brief regimens of medications such as antibiotics, steroids, etc. are permitted) 6. Willingness to attend weekly WW Virtual Workshops and to participate in WW Digital program 7. Access to a iOS smart phone device with internet 8. Willing to follow all requirements of study protocol including blood draws at baseline, week 12, and week 24.
9. Willing and able to provide a valid email address for use in the study 10. Must be able to communicate (oral and written) in English 11. Under the care of a physician who will be responsible for managing the subject's diabetes and a subject who is willing to give release to provide their treating MD with information about the trial
Exclusion Criteria:
1. Participation in a weight control program within the past 3 months 2. Weight loss of ≥ 5 kg in the previous 6 months 3. Taking prescription or OTC weight loss medications within last 4 weeks 4. History of a surgical procedure for weight loss at any time (e.g. gastroplasty, gastric by-pass, gastrectomy or partial gastrectomy, adjustable banding, gastric sleeve) 5. History of major surgery within three months of enrollment 6. Currently taking other medications that affect weight (e.g., paroxetine, tricyclics, anti-psychotics) 7. Type 1 diabetes 8. Those on insulin or insulin secretagogues 9. Renal insufficiency consisting of potassium over 5.5 (mmol/L) on a non-hemolyzed specimen, or a creatinine over 2.5 mg/dL 10. Bilirubin over 3 (mg/dL) or an albumin less than 3 (g/dL) 11. ALT > 3 (IU/L) times the upper limit of normal (normal range is 7-56) 12. Evidence of more than 1 severe hypoglycemic event (episode requiring emergency medical services) in the past 12 months, unless the participant's treating physician provides written clearance for participation.
13. Hemoglobinopathy that interferes with measurement of hemoglobin A1c 14. Those on higher doses of diuretics (furosemide 40mg or higher or comparable) 15. Unstable heart disease (an ongoing workup or treatment for a cardiac symptom such as unstable angina, coronary ischemia) 16. Presence of implanted cardiac defibrillator 17. Blood pressure ≥180/100 mm Hg. If a potential participant has a BP above the inclusion criteria it is acceptable to re-test this potential participant within one week of the original test.
18. Thyroid disease for which the participant is untreated or has had treatment changed within the last 6 months. History of thyroid disease or current thyroid disease treated with a stable medication regimen for at least 6 months is acceptable 19. Orthopedic limitations that would interfere with ability to engage in regular physical activity 20. Uncontrolled gastrointestinal disorders including chronic malabsorptive conditions, peptic ulcer disease, Crohn's disease, chronic diarrhea or active gallbladder disease 21. Current cancer or cancer treatment, or a history of cancer or cancer treatment within the last 3 years. Persons with successfully resected non-melanoma carcinoma of the skin may be enrolled.
22. Dementia, psychiatric illness, or substance abuse that may interfere with adherence (e.g. illness that is currently unstable or resistant to first-line therapy; substance abuse in the past year), 23. History within the past five years of clinically diagnosed eating disorders including anorexia nervosa or bulimia nervosa.
24. Women who are pregnant, lactating, trying to become pregnant or unwilling to use an effective means of birth control 25. Currently consuming >14 alcoholic drinks (1 drink = 12 fl oz beer, 4 fl oz wine or 1.5 fl oz liquor) per week and unwilling to limit intake to less than 3 drinks per drinking day during study participation 26. Participation in another clinical trial within 30 days prior to enrollment. 27. Any other condition or factor which in the opinion of the study physician or investigator makes it inadvisable for the candidate to participate in the trial
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: WW program modified for people with Type 2 diabetes
Includes weekly Virtual Workshops and use of the WW App.
|
This 6-month intervention includes the use of WW's mobile app, weekly virtual workshops, and private online community.
The program involves: self-monitoring of weight, dietary intake, and physical activity; dietary changes; increasing physical activity; shift in mindset; and behavioral strategies to manage goals.
Participants will set goals and weigh-in with a coach via virtual workshop weekly and be encouraged to use the app and private online community daily.
The virtual workshop features a behavior change technique and enables the participant to practice it to support their goals.
Participants are given a personalized food plan based on expert healthy eating guidelines, an activity plan to promote regular physical activity and techniques to help shift mindset for lasting change.
The coach will help with goal setting, overcoming setbacks, and follow-up on progress toward goals weekly.
Participants will be encouraged to participate in a private Facebook group for motivational support.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
HbA1c
Time Frame: 6 months
|
Change in % HbA1c
|
6 months
|
Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Jessica G LaRose, PhD, Virginia Commonwealth University
- Principal Investigator: John W Apolzan, PhD, Pennington Biomedical Research Center
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- PBRC2021-014
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Overweight and Obesity
-
University Hospital, LilleNational Research Agency, France; European Union; University of Lille Nord de... and other collaboratorsNot yet recruitingOverweight and Obesity | Overweight, Childhood | Overweight, Infant
-
Washington University School of MedicinePatient-Centered Outcomes Research Institute; Pennington Biomedical Research... and other collaboratorsActive, not recruitingOvernutrition | Nutrition Disorders | Overweight | Body Weight | Pediatric Obesity | Body Weight Changes | Childhood Obesity | Weight Gain | Adolescent Obesity | Obesity, Childhood | Overweight and Obesity | Overweight or Obesity | Overweight AdolescentsUnited States
-
Institut Investigacio Sanitaria Pere VirgiliCompletedObesity, Childhood | Overweight and Obesity | Overweight, ChildhoodSpain
-
Memorial Sloan Kettering Cancer CenterRecruitingObesity | Overweight | Overweight and Obesity | Obese | Overweight or ObesityUnited States
-
Holbaek SygehusUniversity of Copenhagen; University of Florida; University of Minnesota; Hebrew... and other collaboratorsRecruitingChildhood Overweight and ObesityDenmark
-
Universidade do Extremo Sul Catarinense - Unidade...RecruitingObesity | Overweight and Obesity | Obesity; Endocrine | Overweight, Obesity and Other HyperalimentationBrazil
-
Mexican National Institute of Public HealthUNICEFCompleted
-
Universidade do PortoFundação para a Ciência e a Tecnologia; Administração Regional de Saúde do... and other collaboratorsCompletedOverweight and ObesityPortugal
-
University of British ColumbiaTerminatedOverweight and ObesityCanada
-
National Taiwan University HospitalCompleted
Clinical Trials on WW program modified for people with Type 2 diabetes
-
University of OxfordNIHR Collaboration for Leadership in Applied Health Research and Care (Oxford)CompletedType 2 Diabetes MellitusUnited Kingdom
-
MajianhuaUnknown
-
Landeskrankenanstalten-BetriebsgesellschaftEuropean CommissionCompletedDiabetes Mellitus Type 2Austria
-
McGill UniversityJuvenile Diabetes Research Foundation; Canadian Institutes of Health Research... and other collaboratorsEnrolling by invitationType 1 Diabetes Mellitus With HypoglycemiaCanada
-
Shepherd Center, Atlanta GAPatient-Centered Outcomes Research Institute; University of Colorado, Denver; Massachusetts General Hospital and other collaboratorsCompleted
-
Dr. Orit HamielMaccabi Healthcare Services, Israel; Academic College of Tel Aviv-JaffaCompleted
-
Colorado State UniversityAmerican Occupational Therapy FoundationUnknown
-
Education University of Hong KongTung Wah College; Guangzhou University of Chinese Medicine; Xinhua Hospital,... and other collaboratorsCompleted
-
University of Sao PauloUnknown
-
Joslin Diabetes CenterCompletedObesity | Diabetes Mellitus, Type 2United States