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

NCT05663554 | Withdrawn

• 1 other identifier: #PBRC 2022-048
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 3

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.

Conditions

Diabetes Mellitus, Type 2; Obesity

Outcome Measures

Primary Outcomes (2)

• Change in HbA1c% at 6 months

  Hemoglobin A1c levels (%) are measured using standard laboratory methods

  Baseline and 6 months.

• Change in HbA1c% at 12 months

  Hemoglobin A1c levels (%) are measured using standard laboratory methods

  Baseline and 12 months.

Secondary Outcomes (50)

• Percent weight loss at 6 months

  Baseline and 6 months

• Percent weight loss at 12 months

  Baseline and 12 months

• Change in waist circumference 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

Study Arms (2)

WW Intervention

EXPERIMENTAL

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.

Behavioral: WW Intervention

Usual Care

ACTIVE COMPARATOR

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

Other: Usual Care

Interventions

WW Intervention BEHAVIORAL

The core of the WW food program is the SmartPoints® system. Briefly, the SmartPoints® system assigns each food and beverage a SmartPoints® value per volume based on four components: calories, sugar, saturated fat, and protein. Certain foods have a SmartPoints® value of zero (ZeroPoint foods). These foods (e.g., lean sources of protein such as skinless chicken breast and vegetables) form the basis of a healthy eating pattern, are at low risk for overconsumption and do not have to be weighed, measured or tracked. Participants were assigned a personalized SmartPoints® Budget, based on reported food and lifestyle preferences, and designed to create an energy deficit, using the Mifflin St-Jeor formula, which uses age, sex, height, and weight to estimate resting energy expenditure.

WW Intervention

Usual Care OTHER

The Usual Care group will continue to receive routine medical care by their provider, in addition to receiving 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.

Usual Care

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

Sponsors & Collaborators

• WW International Inc: collaborator
• Pennington Biomedical Research Center: lead

Study Sites (3)

Pennington Biomedical Research Center

Baton Rouge, Louisiana, 70808, United States

Location

Wake Forest University Health Sciences

Greensboro, North Carolina, 27157, United States

Location

University of Pittsburgh Health Sciences

Pittsburgh, Pennsylvania, 15261, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Obesity

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Overweight; Overnutrition; Nutrition Disorders; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Peter T Katzmarzyk, PhD

  Pennington Biomedical Research Center

  PRINCIPAL INVESTIGATOR

• Monica L Baskin, PhD

  University of Pittsburgh Health Sciences

  PRINCIPAL INVESTIGATOR

• Jamy D Ard, MD

  Wake Forest University Health Sciences

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 15, 2022
• First Posted: December 23, 2022
• Study Start: January 15, 2023
• Primary Completion: July 15, 2024
• Study Completion: July 15, 2024
• Last Updated: April 28, 2026

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: Data and supporting information will be available 1 year after the publication of the primary outcome paper.
• Access Criteria: Upon reasonable request to the Principal Investigator.

Locations

US (3)