Ignite Creation Date:
2024-05-06 @ 3:55 PM
Last Modification Date:
2024-10-26 @ 1:59 PM
Study NCT ID:
NCT04804774
Status:
COMPLETED
Last Update Posted:
2022-06-21
First Post:
2021-03-16
Brief Title:
Virtual Weight Control Program Tailored for Adults With Type 2 Diabetes VITAL
Sponsor:
Pennington Biomedical Research Center
Organization:
Pennington Biomedical Research Center
Study Overview
Official Title:
Single-Arm Trial of a Virtual Weight Control Program Tailored for Adults With Type 2 Diabetes on Glycemic Control VITAL
Status:
COMPLETED
Status Verified Date:
2022-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
VITAL
Brief Summary:
The purpose of the study is to evaluate the effect of the WW program on people with Type 2 diabetes and the effect on glycemic control This study will be a 6 month prospective single arm clinical trial coordinated by Pennington Biomedical Research Center Up to 150 participants will be recruited across 3 sites Participants will have Type 2 diabetes and overweightobesity
Detailed Description:
While weight loss 2-5 of total bodyweight with clinical interventions has been shown to improve glycemic control in patients with Type II Diabetes clinic-based interventions are costly and have poor accessibility for the majority of patients Commercial weight loss programs like WW formerly Weight Watchers are more affordable and accessible than clinic-based modalities and have been shown to produce effective weight loss in adults with additional improvements in glycemic control A randomized trial of a modified WW program for patients with Type II Diabetes showed significant reductions in weight and improved glycemic control HbA1c compared to standard of care diabetes nutrition counseling and education Here we extend prior work by leveraging the efficacy of the WW program for Type II Diabetes virtually to increase its reach and its impact on glycemic control This study aims to test a novel web-based weight loss intervention from one of the largest and most evidence-based proprietary weight loss programs in the world
Intervention will consist of the WW program modified for people with Type 2 diabetes including weekly Virtual Workshops and use of the WW App Primary outcomes are any change in HbA1c over the 6-month intervention Secondary endpoints are any change in HbA1c at 3 months as well as changes at 3 and 6 months in weight Diabetes Distress Scale Impact of Weight on Quality of Life Pittsburgh Sleep Quality Index hypoglycemic events WHO-5 Well-being Index and diabetes medication changes
Intervention will consist of the WW program modified for people with Type 2 diabetes including weekly Virtual Workshops and use of the WW App Primary outcomes are any change in HbA1c over the 6-month intervention Secondary endpoints are any change in HbA1c at 3 months as well as changes at 3 and 6 months in weight Diabetes Distress Scale Impact of Weight on Quality of Life Pittsburgh Sleep Quality Index hypoglycemic events WHO-5 Well-being Index and diabetes medication changes
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None