NCT03037528

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

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
112

participants targeted

Target at P50-P75 for not_applicable diabetes-mellitus-type-2

Timeline
Completed

Started Jan 2017

Longer than P75 for not_applicable diabetes-mellitus-type-2

Geographic Reach
1 country

1 active site

Status
completed

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

First Submitted

Initial submission to the registry

January 27, 2017

Completed
Same day until next milestone

Study Start

First participant enrolled

January 27, 2017

Completed
4 days until next milestone

First Posted

Study publicly available on registry

January 31, 2017

Completed
4.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 4, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 4, 2021

Completed
2.4 years until next milestone

Results Posted

Study results publicly available

November 7, 2023

Completed
Last Updated

November 7, 2023

Status Verified

October 1, 2023

Enrollment Period

4.4 years

First QC Date

January 27, 2017

Results QC Date

June 1, 2022

Last Update Submit

October 7, 2023

Conditions

Diabetes Mellitus, Type 2

Outcome Measures

Primary Outcomes (1)

  • Glycemic Control

    Measured with HbA1c

    12 months

Secondary Outcomes (2)

  • Weight Loss

    12 months

  • Depressive Symptoms

    12 months

Study Arms (8)

Positive Affect, Mindfulness, Tracking

EXPERIMENTAL

Participants will receive information about positive affect and mindfulness, in addition to being asked to actively track what they eat and receiving the core program

Behavioral: diet and lifestyle programBehavioral: positive affect informational materialsBehavioral: mindfulness informational materialsBehavioral: dietary tracking

Mindfulness, Tracking

EXPERIMENTAL

Participants will receive information about mindfulness, be asked to actively track what they eat, and receive the core program.

Behavioral: diet and lifestyle programBehavioral: mindfulness informational materialsBehavioral: dietary tracking

Positive Affect, Tracking

EXPERIMENTAL

Participants will receive information about positive affect, be asked to actively track what they eat, and receive the core program.

Behavioral: diet and lifestyle programBehavioral: positive affect informational materialsBehavioral: dietary tracking

Tracking

EXPERIMENTAL

Participants will be asked to actively track what they eat in addition to receiving the core program.

Behavioral: diet and lifestyle programBehavioral: dietary tracking

Positive Affect, Mindfulness

EXPERIMENTAL

Participants will receive information about positive affect and mindfulness in addition to the core program.

Behavioral: diet and lifestyle programBehavioral: positive affect informational materialsBehavioral: mindfulness informational materials

Positive Affect

EXPERIMENTAL

Participants will receive information about positive affect in addition to the core program.

Behavioral: diet and lifestyle programBehavioral: positive affect informational materials

Mindfulness

EXPERIMENTAL

Participants will receive information about mindfulness in addition to the core program.

Behavioral: diet and lifestyle programBehavioral: mindfulness informational materials

No Extras

EXPERIMENTAL

Participants will receive the core program.

Behavioral: diet and lifestyle program

Interventions

diet and lifestyle programBEHAVIORAL

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

MindfulnessMindfulness, TrackingNo ExtrasPositive AffectPositive Affect, MindfulnessPositive Affect, Mindfulness, TrackingPositive Affect, TrackingTracking
positive affect informational materialsBEHAVIORAL

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

Positive AffectPositive Affect, MindfulnessPositive Affect, Mindfulness, TrackingPositive Affect, Tracking
mindfulness informational materialsBEHAVIORAL

Participants will be taught about mindfulness and mindful eating techniques.

MindfulnessMindfulness, TrackingPositive Affect, MindfulnessPositive Affect, Mindfulness, Tracking
dietary trackingBEHAVIORAL

Participants will be asked to track their diet consistently.

Mindfulness, TrackingPositive Affect, Mindfulness, TrackingPositive Affect, TrackingTracking

Eligibility Criteria

Age21 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Michigan

Ann Arbor, Michigan, 48109, United States

Location

Related Publications (1)

  • Saslow LR, Missel AL, O'Brien A, Kim S, Hecht FM, Moskowitz JT, Bayandorian H, Pietrucha M, Raymond K, Richards B, Liestenfeltz B, Mason AE, Daubenmier J, Aikens JE. Psychological Support Strategies for Adults With Type 2 Diabetes in a Very Low-Carbohydrate Web-Based Program: Randomized Controlled Trial. JMIR Diabetes. 2023 May 11;8:e44295. doi: 10.2196/44295.

    PMID: 37166961DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

Diet

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

Nutritional Physiological PhenomenaDiet, Food, and NutritionPhysiological Phenomena

Results Point of Contact

Title
Laura Saslow
Organization
University of Michigan
saslowl@umich.edu
(734) 764-7836

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

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

January 27, 2017

First Posted

January 31, 2017

Study Start

January 27, 2017

Primary Completion

June 4, 2021

Study Completion

June 4, 2021

Last Updated

November 7, 2023

Results First Posted

November 7, 2023

Record last verified: 2023-10

Data Sharing

IPD Sharing
Will not share

Locations

US(1)