Clinical trial NCT05663554: Improving Glycemic Control Using a Virtual Weight Control Program Among Adults With Type 2 Diabetes
Official title: Improving Glycemic Control Using a Virtual Weight Control Program Among Adults With Type 2 Diabetes
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Diabetes Mellitus, Type 2
Obesity
Lead sponsor: Pennington Biomedical Research Center
Sponsor class: OTHER
Collaborators: name: WW International Inc
First posted: 2022-12-23
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Change in HbA1c% at 6 months
timeFrame: Baseline and 6 months.
measure: Change in HbA1c% at 12 months
timeFrame: Baseline and 12 months.
Secondary outcomes:
measure: Percent weight loss at 6 months
timeFrame: Baseline and 6 months
measure: Percent weight loss at 12 months
timeFrame: Baseline and 12 months
measure: Change in waist circumference at 6 months
timeFrame: Baseline and 6 months
measure: Change in waist circumference at 12 months
timeFrame: Baseline and 12 months
measure: Change in systolic blood pressure at 6 months
timeFrame: Baseline and 6 months
measure: Change in systolic blood pressure at 12 months
timeFrame: Baseline and 12 months
measure: Change in diastolic blood pressure at 6 months
timeFrame: Baseline and 6 months
measure: Change in diastolic blood pressure at 12 months
timeFrame: Baseline and 12 months
measure: Change in total cholesterol at 6 months
timeFrame: Baseline and 6 months
measure: Change in total cholesterol at 12 months
timeFrame: Baseline and 12 months
measure: Change in high-density lipoprotein cholesterol at 6 months
timeFrame: Baseline and 6 months
measure: Change in high-density lipoprotein cholesterol at 12 months
timeFrame: Baseline and 12 months
measure: Change in low-density lipoprotein cholesterol at 6 months
timeFrame: Baseline and 6 months
measure: Change in low-density lipoprotein cholesterol at 12 months
timeFrame: Baseline and 12 months
measure: Change in triglycerides at 6 months
timeFrame: Baseline and 6 months
measure: Change in triglycerides at 12 months
timeFrame: Baseline and 12 months
measure: Change in physical activity at 6 months
timeFrame: Baseline and 6 months
measure: Change in physical activity at 12 months
timeFrame: Baseline and 12 months
measure: Change in dietary intake at 6 months
timeFrame: Baseline and 6 months
measure: Change in dietary intake at 12 months
timeFrame: Baseline and 12 months
measure: Change in perceived stress at 6 months
timeFrame: Baseline and 6 months
measure: Change in perceived stress at 12 months
timeFrame: Baseline and 12 months
measure: Change in diabetes distress at 6 months
timeFrame: Baseline and 6 months
measure: Change in diabetes distress at 12 months
timeFrame: Baseline and 12 months
measure: Change in quality of life at 6 months
timeFrame: Baseline and 6 months
measure: Change in quality of life at 12 months
timeFrame: Baseline and 12 months
measure: Change in well-being at 6 months
timeFrame: Baseline and 6 months
measure: Change in well-being at 12 months
timeFrame: Baseline and 12 months
measure: Change in habit strength at 6 months
timeFrame: Baseline and 6 months
measure: Change in habit strength at 12 months
timeFrame: Baseline and 12 months
measure: Change in emotional eating at 6 months
timeFrame: Baseline and 6 months
measure: Change in emotional eating at 12 months
timeFrame: Baseline and 12 months
measure: Change in hunger at 6 months
timeFrame: Baseline and 6 months
measure: Change in hunger at 12 months
timeFrame: Baseline and 12 months
measure: Change in diabetes medications at 6 months
timeFrame: Baseline and 6 months
measure: Change in diabetes medications at 12 months
timeFrame: Baseline and 12 months
measure: Change in proportion of patents achieving an HbA1c% <=6.5% at 6 months
timeFrame: Baseline and 6 months
measure: Change in proportion of patents achieving an HbA1c% <=6.5% at 12 months
timeFrame: Baseline and 12 months
measure: Change in proportion of patents achieving an HbA1c% <=7% at 6 months
timeFrame: Baseline and 6 months
measure: Change in proportion of patents achieving an HbA1c% <=7% at 12 months
timeFrame: Baseline and 12 months
measure: Change in food cravings at 6 months
timeFrame: Baseline and 6 months
measure: Change in food cravings at 12 months
timeFrame: Baseline and 12 months
measure: Change in self compassion at 6 months
timeFrame: Baseline and 6 months
measure: Change in self compassion at 12 months
timeFrame: Baseline and 12 months
measure: Change in restraint/disinhibition at 6 months
timeFrame: Baseline and 6 months
measure: Change in restraint/disinhibition at 12 months
timeFrame: Baseline and 12 months
measure: Change in body appreciation at 6 months
timeFrame: Baseline and 6 months
measure: Change in body appreciation at 12 months
timeFrame: Baseline and 12 months
measure: Change in weight bias at 6 months
timeFrame: Baseline and 6 months
measure: Change in weight bias at 12 months
timeFrame: Baseline and 12 months
Other outcomes:
Locations:
city: Baton Rouge
country: United States
facility: Pennington Biomedical Research Center
state: Louisiana
city: Greensboro
country: United States
facility: Wake Forest University Health Sciences
state: North Carolina
city: Pittsburgh
country: United States
facility: University of Pittsburgh Health Sciences
state: Pennsylvania
Study officials:
affiliation: Pennington Biomedical Research Center
name: Peter T Katzmarzyk, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Pittsburgh Health Sciences
name: Monica L Baskin, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Wake Forest University Health Sciences
name: Jamy D Ard, MD
role: PRINCIPAL_INVESTIGATOR
References: