Improving Glycemic Control Using a Virtual Weight Control Program Among Adults With Type 2 Diabetes
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 试验地点
- 6
- 主要终点
- Change in HbA1c% at 12 months
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
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.
干预措施: WW Intervention (Behavioral)
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
干预措施: Usual Care (Other)
结局指标
主要结局
Change in HbA1c% at 12 months
时间窗: Baseline and 12 months.
Hemoglobin A1c levels (%) are measured using standard laboratory methods
Change in HbA1c% at 6 months
时间窗: Baseline and 6 months.
Hemoglobin A1c levels (%) are measured using standard laboratory methods
次要结局
- 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)