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

Withdrawn before enrolling · Not applicable

Conditions studied: Diabetes Mellitus, Type 2, Obesity

In brief

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.

Key facts

Study ID

NCT05663554

Run by

Pennington Biomedical Research Center

People needed

0

Starts

2023-01-15

Expected to finish

2024-07-15

Last updated by the study team

2026-04-28

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• 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

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.