Improving Glycemic Control Using a Virtual Weight Control Program Among Adults With Type 2 Diabetes

NCT ID: NCT05663554

Last Updated: 2023-01-20

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: NA
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-01-15
• Study Completion Date: 2024-07-15

Brief Summary

The study is a randomized clinical trial with the primary aim of determining the effectiveness of the WW intervention at reducing HbA1c in patients with type 2 diabetes.

Detailed Description

This study is a 12-month, two-arm, parallel controlled trial. Up to 486 adults with overweight or obesity and type 2 diabetes will be randomized to either 1) intervention or 2) usual care. The intervention arm will participate in a WW program which will include access to weekly Virtual Workshops and the WW App. WW is a widely available, commercial behavioral weight management program that encourages healthy habits in the areas of food, activity, mindset, and sleep, with topics specific to diabetes. Participants in the usual care arm will receive their normal, usual care from their healthcare providers in addition to a session with a Registered Dietician at baseline. All patients will participate in the collection of patient-reported outcomes at baseline and at 6 and 12 months.

Conditions

Diabetes Mellitus, Type 2; Obesity

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

WW Intervention

Participants in the intervention arm will be contacted by a WW Coach and will receive a voucher code that provides 12 months of access to the WW program and instructions for redeeming the code. The program will include access to weekly Virtual Workshops and the WW App. WW is a widely available, commercial behavioral weight management program that encourages healthy habits in the areas of food, activity, mindset, and sleep, with topics specific to diabetes.

Group Type: EXPERIMENTAL

WW Intervention

Intervention Type: BEHAVIORAL

The core of the WW food program is the SmartPoints® system. Briefly, the SmartPoints® system assigns each food and beverage a SmartPoints® value per volume based on four components: calories, sugar, saturated fat, and protein. Certain foods have a SmartPoints® value of zero (ZeroPoint foods). These foods (e.g., lean sources of protein such as skinless chicken breast and vegetables) form the basis of a healthy eating pattern, are at low risk for overconsumption and do not have to be weighed, measured or tracked. Participants were assigned a personalized SmartPoints® Budget, based on reported food and lifestyle preferences, and designed to create an energy deficit, using the Mifflin St-Jeor formula, which uses age, sex, height, and weight to estimate resting energy expenditure.

Usual Care

Patients in the Usual Care Arm will continue to receive routine medical care by their healthcare provider. In addition, at the baseline visit, participants in the Usual Care Arm will receive one 50-minute virtual on-line session of nutrition counseling with a registered dietitian, with additional materials at the time of their 6- and 12-month follow-up assessments, based on current recommendations of the American Diabetes Association

Group Type: ACTIVE_COMPARATOR

Usual Care

Intervention Type: OTHER

The Usual Care group will continue to receive routine medical care by their provider, in addition to receiving one 50-minute virtual on-line session of nutrition counseling with a registered dietitian, with additional materials at the time of their 6- and 12-month follow-up assessments.

Interventions

WW Intervention

The core of the WW food program is the SmartPoints® system. Briefly, the SmartPoints® system assigns each food and beverage a SmartPoints® value per volume based on four components: calories, sugar, saturated fat, and protein. Certain foods have a SmartPoints® value of zero (ZeroPoint foods). These foods (e.g., lean sources of protein such as skinless chicken breast and vegetables) form the basis of a healthy eating pattern, are at low risk for overconsumption and do not have to be weighed, measured or tracked. Participants were assigned a personalized SmartPoints® Budget, based on reported food and lifestyle preferences, and designed to create an energy deficit, using the Mifflin St-Jeor formula, which uses age, sex, height, and weight to estimate resting energy expenditure.

Intervention Type: BEHAVIORAL

Usual Care

The Usual Care group will continue to receive routine medical care by their provider, in addition to receiving one 50-minute virtual on-line session of nutrition counseling with a registered dietitian, with additional materials at the time of their 6- and 12-month follow-up assessments.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• 18.0 - 74.9 years of age
• Participant-reported diagnosis of type 2 diabetes
• HbA1c 7.0%-11% (inclusive)
• Overweight or obesity (BMI 25-50 kg/m2)
• On stable regimen of medications that can affect weight or diabetes outcomes for at least 3 months (brief regimens of medications such as antibiotics, steroids, etc. are permitted)
• Willingness to attend weekly WW Virtual Workshops and participate in WW Digital program
• Access to a smartphone/tablet that can download the WW app
• Willing and able to provide a valid email address for use in the study
• Be able to communicate (oral and written) in English
• Be under the care of a physician who will be responsible for managing the subject's diabetes and a participant who is willing to give release to provide their treating MD with information about the trial
• Be able to provide informed consent

Exclusion Criteria

• Participation in a weight control program within the past 3 months
• Weight loss of ≥ 5 kg in the previous 6 months
• Taking prescription or over-the-counter weight loss medications within last 3 months
• History of weight loss surgery
• History of major surgery within three months of enrollment
• Type 1 diabetes
• Renal insufficiency consisting of potassium over 5.5 mmol/L on a non-hemolyzed specimen, or a creatinine > 2.5 mg/dL
• Albumin < 3 g/dL
• Alanine Aminotransferase > 3 times the upper limit of normal (normal range is 7-56 IU/L)
• More than 1 severe hypoglycemic event (requiring emergency medical services) in the past 12 months, unless the participant's physician provides written clearance for participation
• Hemoglobinopathy that interferes with measurement of HbA1c
• Class II or higher congestive heart failure
• Unstable heart disease (an ongoing workup or treatment for a cardiac symptom such as unstable angina, coronary ischemia)
• Presence of implanted cardiac defibrillator
• Blood pressure ≥160/100 mm Hg. If a potential participant has a blood pressure ≥160/100 mm Hg it is acceptable to re-test this potential participant within one week of the original test
• 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 2 months is acceptable
• Orthopedic limitations that would interfere with ability to engage in regular physical activity
• Uncontrolled gastrointestinal disorders including chronic malabsorptive conditions, peptic ulcer disease, Crohn's disease, chronic diarrhea or active gallbladder disease
• 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
• 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)
• History of clinically diagnosed eating disorder including anorexia nervosa or bulimia nervosa.
• Women who are pregnant, lactating, trying to become pregnant or unwilling to use an effective means of birth control
• 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 day during study participation
• Participation in another clinical trial within 30 days prior to enrollment
• Participation in WW anytime since November 2021
• 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

WW International Inc

INDUSTRY

Sponsor Role: collaborator

Pennington Biomedical Research Center

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Peter T Katzmarzyk, PhD

Role: PRINCIPAL_INVESTIGATOR

Pennington Biomedical Research Center

Monica L Baskin, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Pittsburgh Health Sciences

Jamy D Ard, MD

Role: PRINCIPAL_INVESTIGATOR

Wake Forest University Health Sciences

Locations

Pennington Biomedical Research Center

Baton Rouge, Louisiana, United States

Wake Forest University Health Sciences

Greensboro, North Carolina, United States

University of Pittsburgh Health Sciences

Pittsburgh, Pennsylvania, United States

Countries

United States

Other Identifiers

#PBRC 2022-048

Identifier Type: -

Identifier Source: org_study_id