Web-Delivered Interventions for Blood Sugar Control for Individuals With Type 2 Diabetes
Randomized Trial of Web-Delivered Interventions for Blood Sugar Control for Individuals With Type 2 Diabetes
1 other identifier
interventional
44
1 country
1
Brief Summary
The goal of the research is to optimize an online and mobile multicomponent 12-month diet and lifestyle intervention for improving the blood glucose control of individuals with type 2 diabetes.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable diabetes-mellitus-type-2
Started Feb 2016
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2016
CompletedFirst Submitted
Initial submission to the registry
February 3, 2016
CompletedFirst Posted
Study publicly available on registry
February 8, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 15, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
November 15, 2017
CompletedAugust 9, 2021
August 1, 2021
1.8 years
February 3, 2016
August 6, 2021
Conditions
Outcome Measures
Primary Outcomes (1)
HbA1c
Change in HbA1c from baseline to 12 months post baseline
12 months
Secondary Outcomes (1)
Body Weight Percent Lost
12 months
Study Arms (8)
Experimental: Condition 1
EXPERIMENTAL1\) core program; 2) breath meter; 3) text messages; 4) diet-appropriate food and cookbooks
Experimental: Condition 2
EXPERIMENTAL1\) core program
Experimental: Condition 3
EXPERIMENTAL1\) core program; 2) breath meter
Experimental: Condition 4
EXPERIMENTAL1\) core program; 2) text messages
Experimental: Condition 5
EXPERIMENTAL1\) core program; 2) diet-appropriate food and cookbooks
Experimental: Condition 6
EXPERIMENTAL1\) core program; 2) breath meter; 3) text messages
Experimental: Condition 7
EXPERIMENTAL1\) core program; 2) breath meter; 3) diet-appropriate food and cookbooks
Experimental: Condition 8
EXPERIMENTAL1\) core program; 3) text messages; 4) diet-appropriate food and cookbooks
Interventions
The core program includes information developed in earlier research with individuals with type 2 diabetes, now modified for online delivery: very low-carbohydrate diet taught with lectures on video, handouts, quizzes, and surveys. We also teach participants about the importance of physical activity and adequate sleep, in addition to psychological skills (positive affect, mindful eating) intending to help with intervention adherence.
We will send participants a breath meter to test ketones in their breath, to assess dietary adherence.
We will send participants text messages, to support intervention adherence.
We will send participants diet-appropriate foods and cookbooks, to support intervention adherence.
Eligibility Criteria
You may qualify if:
- overweight or obese
- English-speaking
- diagnosis of type 2 diabetes (HbA1c \> 6.5%)
- regular access to the internet and text messages
You may not qualify if:
- taking diabetes medications other than metformin
- being pregnant or breastfeeding
- currently undergoing cancer treatments
- untreated serious mental illness
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of Michigan
Ann Arbor, Michigan, 48109, United States
Related Publications (1)
Saslow LR, Moskowitz JT, Mason AE, Daubenmier J, Liestenfeltz B, Missel AL, Bayandorian H, Aikens JE, Kim S, Hecht FM. Intervention Enhancement Strategies Among Adults With Type 2 Diabetes in a Very Low-Carbohydrate Web-Based Program: Evaluating the Impact With a Randomized Trial. JMIR Diabetes. 2020 Sep 9;5(3):e15835. doi: 10.2196/15835.
PMID: 32902391BACKGROUND
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Laura Saslow, PhD
University of Michigan
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- FACTORIAL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Assistant Professor
Study Record Dates
First Submitted
February 3, 2016
First Posted
February 8, 2016
Study Start
February 1, 2016
Primary Completion
November 15, 2017
Study Completion
November 15, 2017
Last Updated
August 9, 2021
Record last verified: 2021-08
Data Sharing
- IPD Sharing
- Will not share