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

Inclusion Criteria:18.0 - 74.9 years of ageParticipant-reported diagnosis of type 2 diabetesHbA1c 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 programAccess to a smartphone/tablet that can download the WW appWilling and able to provide a valid email address for use in the studyBe able to communicate (oral and written) in EnglishBe 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 trialBe able to provide informed consentExclusion Criteria:Participation in a weight control program within the past 3 monthsWeight loss of ≥ 5 kg in the previous 6 monthsTaking prescription or over-the-counter weight loss medications within last 3 monthsHistory of weight loss surgeryHistory of major surgery within three months of enrollmentType 1 diabetesRenal insufficiency consisting of potassium over 5.5 mmol/L on a non-hemolyzed specimen, or a creatinine > 2.5 mg/dLAlbumin < 3 g/dLAlanine 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 participationHemoglobinopathy that interferes with measurement of HbA1cClass II or higher congestive heart failureUnstable heart disease (an ongoing workup or treatment for a cardiac symptom such as unstable angina, coronary ischemia)Presence of implanted cardiac defibrillatorBlood 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 testThyroid 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 acceptableOrthopedic limitations that would interfere with ability to engage in regular physical activityUncontrolled gastrointestinal disorders including chronic malabsorptive conditions, peptic ulcer disease, Crohn's disease, chronic diarrhea or active gallbladder diseaseCurrent 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 enrolledDementia, 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 controlCurrently 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 participationParticipation in another clinical trial within 30 days prior to enrollmentParticipation in WW anytime since November 2021Any 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

Source: ClinicalTrials.gov (NCT05663554). StuddyBuddy aggregates publicly available trial information.

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

Summary

Eligibility Criteria