Improving Glycemic Control Using a Virtual Weight Control Program Among Adults With Type 2 Diabetes
Overview
- Phase
- Not Applicable
- Intervention
- WW Intervention
- Conditions
- Diabetes Mellitus, Type 2
- Sponsor
- Pennington Biomedical Research Center
- Locations
- 6
- Primary Endpoint
- Change in HbA1c% at 12 months
- Status
- Withdrawn
- Last Updated
- 4 days ago
Overview
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.
Investigators
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
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
Arms & Interventions
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.
Intervention: WW Intervention
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
Intervention: Usual Care
Outcomes
Primary Outcomes
Change in HbA1c% at 12 months
Time Frame: Baseline and 12 months.
Hemoglobin A1c levels (%) are measured using standard laboratory methods
Change in HbA1c% at 6 months
Time Frame: Baseline and 6 months.
Hemoglobin A1c levels (%) are measured using standard laboratory methods
Secondary Outcomes
- Change in systolic blood pressure at 12 months(Baseline and 12 months)
- Change in diastolic blood pressure at 6 months(Baseline and 6 months)
- Change in waist circumference at 6 months(Baseline and 6 months)
- Percent weight loss at 6 months(Baseline and 6 months)
- Change in waist circumference at 12 months(Baseline and 12 months)
- Change in systolic blood pressure at 6 months(Baseline and 6 months)
- Change in diastolic blood pressure at 12 months(Baseline and 12 months)
- Change in total cholesterol at 6 months(Baseline and 6 months)
- Change in total cholesterol at 12 months(Baseline and 12 months)
- Change in high-density lipoprotein cholesterol at 6 months(Baseline and 6 months)
- Change in quality of life at 12 months(Baseline and 12 months)
- Change in well-being at 6 months(Baseline and 6 months)
- Percent weight loss at 12 months(Baseline and 12 months)
- Change in high-density lipoprotein cholesterol at 12 months(Baseline and 12 months)
- Change in low-density lipoprotein cholesterol at 6 months(Baseline and 6 months)
- Change in low-density lipoprotein cholesterol at 12 months(Baseline and 12 months)
- Change in diabetes distress at 6 months(Baseline and 6 months)
- Change in diabetes distress at 12 months(Baseline and 12 months)
- Change in diabetes medications at 12 months(Baseline and 12 months)
- Change in proportion of patents achieving an HbA1c% <=7% at 12 months(Baseline and 12 months)
- Change in physical activity at 6 months(Baseline and 6 months)
- Change in physical activity at 12 months(Baseline and 12 months)
- Change in quality of life at 6 months(Baseline and 6 months)
- Change in hunger at 6 months(Baseline and 6 months)
- Change in triglycerides at 6 months(Baseline and 6 months)
- Change in triglycerides at 12 months(Baseline and 12 months)
- Change in dietary intake at 6 months(Baseline and 6 months)
- Change in dietary intake at 12 months(Baseline and 12 months)
- Change in perceived stress at 6 months(Baseline and 6 months)
- Change in well-being at 12 months(Baseline and 12 months)
- Change in perceived stress at 12 months(Baseline and 12 months)
- Change in habit strength at 6 months(Baseline and 6 months)
- Change in proportion of patents achieving an HbA1c% <=6.5% at 12 months(Baseline and 12 months)
- Change in restraint/disinhibition at 12 months(Baseline and 12 months)
- Change in body appreciation at 6 months(Baseline and 6 months)
- Change in body appreciation at 12 months(Baseline and 12 months)
- Change in habit strength at 12 months(Baseline and 12 months)
- Change in emotional eating at 6 months(Baseline and 6 months)
- Change in emotional eating at 12 months(Baseline and 12 months)
- Change in food cravings at 12 months(Baseline and 12 months)
- Change in restraint/disinhibition at 6 months(Baseline and 6 months)
- Change in weight bias at 12 months(Baseline and 12 months)
- Change in hunger at 12 months(Baseline and 12 months)
- Change in diabetes medications at 6 months(Baseline and 6 months)
- Change in proportion of patents achieving an HbA1c% <=6.5% at 6 months(Baseline and 6 months)
- Change in proportion of patents achieving an HbA1c% <=7% at 6 months(Baseline and 6 months)
- Change in self compassion at 6 months(Baseline and 6 months)
- Change in food cravings at 6 months(Baseline and 6 months)
- Change in self compassion at 12 months(Baseline and 12 months)
- Change in weight bias at 6 months(Baseline and 6 months)