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Completed

NCT Number: NCT02676648

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

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.

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Key information

Conditions

Diabetes Mellitus, Type 2 Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Michigan

Ann Arbor, Michigan, 48109, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

Multicomponent online program

Behavioral

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.

Breath meter

Behavioral

We will send participants a breath meter to test ketones in their breath, to assess dietary adherence.

Text Messages

Behavioral

We will send participants text messages, to support intervention adherence.

Diet-appropriate foods and cookbooks

Behavioral

We will send participants diet-appropriate foods and cookbooks, to support intervention adherence.

Primary outcomes

  1. HbA1c

    Time frame: 12 months

    Change in HbA1c from baseline to 12 months post baseline

Secondary outcomes

  1. Body Weight Percent Lost

    Time frame: 12 months

    Change in body weight percentage from baseline to 12 months post baseline

Sponsors and collaborators

Lead sponsor

University of Michigan

Other

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Feb 8, 2016
Registry last updated
Aug 9, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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