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OpenTrials
Completed

NCT Number: NCT03037528

Examination of Psychological Tools and Tracking in an Online Intervention for 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

Age range

21 year–70 year

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 core of the program, administered to all participants, includes recommendations to follow a very low carbohydrate, ketogenic diet. The researchers will test whether adding the following experimental components will enhance the intervention's ability to improve health outcomes: (1) active vs. periodic self-monitoring of dietary intake using an "app"; (2) training vs. no training in positive affect; and (3) training vs. no training in mindfulness and mindful eating.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Weight: Body Mass Index of 25-45 kg/m2 or greater.
  • Current HbA1c of 6.5% or higher
  • Regular access to the internet

Exclusion criteria

  • Taking glucose lowering medications other than metformin
  • Being pregnant or breastfeeding
  • Currently undergoing cancer treatments
  • Active use of a weight loss program or medications
  • Self-reported impaired renal or hepatic function
  • Self-reported untreated thyroid condition
  • Vegetarian or vegan
  • Weight loss surgery within the past year
  • Medical concerns that prevent participants from following the assigned protocol

Treatment and study plan

diet and lifestyle program

Behavioral

Participants will be taught how to follow a very low carbohydrate, ketogenic diet, become more physically active, and get adequate sleep.

positive affect informational materials

Behavioral

Participants will be taught about positive affect skills, such as gratitude, positive reappraisal, and personal strengths.

mindfulness informational materials

Behavioral

Participants will be taught about mindfulness and mindful eating techniques.

dietary tracking

Behavioral

Participants will be asked to track their diet consistently.

Primary outcomes

  1. Glycemic Control

    Time frame: 12 months

    Measured with HbA1c

Secondary outcomes

  1. Weight Loss

    Time frame: 12 months

    Measured with percent change in body weight

  2. Depressive Symptoms

    Time frame: 12 months

    Measured with Patient Health Questionnaire-8. Eight items, each of which is scored 0 to 3, for a 0 to 24 severity score, with higher being a worse outcome.

Sponsors and collaborators

Lead sponsor

University of Michigan

Other

Collaborators

  • National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Registry information

Important dates

Study start
2017
Primary completion
2021
Study completion
2021
First posted
Jan 31, 2017
Registry last updated
Nov 7, 2023

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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