Web-Delivered Interventions for Blood Sugar Control for Individuals With Type 2 Diabetes

Not Applicable

Completed

• Conditions: Diabetes Mellitus, Type 2
• Interventions: Behavioral: Multicomponent online program; Behavioral: Breath meter; Behavioral: Text messages; Behavioral: Diet-appropriate foods and cookbooks

• Registration Number: NCT02676648
• Lead Sponsor: University of Michigan

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.

Detailed Description

The research will identify the most promising intervention components. The following components will be tested: dietary adherence testing with a breath meter, text messages, and diet-appropriate foods and cookbooks. The primary goal is to optimize the intervention by examining the HbA1c results at 12 months.

Study Timeline

• Study Start: 2016-02
• Study First Submitted: 2016-02-03
• Study First Submitted QC: 2016-02-03
• Study First Posted: 2016-02-08
• Primary Completion: 2017-11-15
• Study Completion: 2017-11-15
• Status Verified: 2021-08
• Last Update Submitted: 2021-08-06
• Last Update Posted: 2021-08-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 44

Inclusion Criteria

• overweight or obese
• English-speaking
• diagnosis of type 2 diabetes (HbA1c > 6.5%)
• regular access to the internet and text messages

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Exclusion Criteria

• taking diabetes medications other than metformin
• being pregnant or breastfeeding
• currently undergoing cancer treatments
• untreated serious mental illness

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Arm && Interventions

Group	Intervention	Description
Experimental: Condition 1	Text messages	1) core program; 2) breath meter; 3) text messages; 4) diet-appropriate food and cookbooks
Experimental: Condition 1	Diet-appropriate foods and cookbooks	1) core program; 2) breath meter; 3) text messages; 4) diet-appropriate food and cookbooks
Experimental: Condition 1	Multicomponent online program	1) core program; 2) breath meter; 3) text messages; 4) diet-appropriate food and cookbooks
Experimental: Condition 3	Multicomponent online program	1) core program; 2) breath meter
Experimental: Condition 4	Text messages	1) core program; 2) text messages
Experimental: Condition 5	Multicomponent online program	1) core program; 2) diet-appropriate food and cookbooks
Experimental: Condition 6	Breath meter	1) core program; 2) breath meter; 3) text messages
Experimental: Condition 7	Multicomponent online program	1) core program; 2) breath meter; 3) diet-appropriate food and cookbooks
Experimental: Condition 1	Breath meter	1) core program; 2) breath meter; 3) text messages; 4) diet-appropriate food and cookbooks
Experimental: Condition 5	Diet-appropriate foods and cookbooks	1) core program; 2) diet-appropriate food and cookbooks
Experimental: Condition 2	Multicomponent online program	1) core program
Experimental: Condition 4	Multicomponent online program	1) core program; 2) text messages
Experimental: Condition 7	Diet-appropriate foods and cookbooks	1) core program; 2) breath meter; 3) diet-appropriate food and cookbooks
Experimental: Condition 8	Text messages	1) core program; 3) text messages; 4) diet-appropriate food and cookbooks
Experimental: Condition 3	Breath meter	1) core program; 2) breath meter
Experimental: Condition 6	Text messages	1) core program; 2) breath meter; 3) text messages
Experimental: Condition 8	Diet-appropriate foods and cookbooks	1) core program; 3) text messages; 4) diet-appropriate food and cookbooks
Experimental: Condition 7	Breath meter	1) core program; 2) breath meter; 3) diet-appropriate food and cookbooks
Experimental: Condition 6	Multicomponent online program	1) core program; 2) breath meter; 3) text messages
Experimental: Condition 8	Multicomponent online program	1) core program; 3) text messages; 4) diet-appropriate food and cookbooks

Primary Outcome Measures

Name	Time	Method
HbA1c	12 months	Change in HbA1c from baseline to 12 months post baseline

Secondary Outcome Measures

Name	Time	Method
Body Weight Percent Lost	12 months	Change in body weight percentage from baseline to 12 months post baseline

Trial Locations

Locations (1)

University of Michigan; 🇺🇸 Ann Arbor, Michigan, United States