NCT03784612

Brief Summary

The aim of this study is to investigate the effect of using new app-based technology to improve dietary habits, compared to usual care in patients with type 2 diabetes. The hypothesis is that the intervention, i.e. using the new technology an an app-based course for healthy eating habits, will have a greater positive effect on dietary habits and biological markers, including HbA1c and serum lipids, than usual care.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
133

participants targeted

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

Timeline
Completed

Started Jan 2019

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

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

December 14, 2018

Completed
10 days until next milestone

First Posted

Study publicly available on registry

December 24, 2018

Completed
22 days until next milestone

Study Start

First participant enrolled

January 15, 2019

Completed
4.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 31, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 31, 2023

Completed
Last Updated

November 22, 2024

Status Verified

October 1, 2023

Enrollment Period

4.6 years

First QC Date

December 14, 2018

Last Update Submit

November 20, 2024

Conditions

Type 2 Diabetes MellitusDietary Habits

Keywords

Smartphone applicationHbA1cBlood lipidsDietary intake

Outcome Measures

Primary Outcomes (1)

  • Change in dietary intake

    Change in dietary intake assessed using a four day food record.

    Baseline and month 3, and 6

Secondary Outcomes (12)

  • HbA1c

    Baseline and month 3, and 6

  • Total cholesterol

    Baseline and month 3, and 6

  • HDL-cholesterol

    Baseline and month 3, and 6

  • Triglycerides

    Baseline and month 3, and 6

  • Body Mass Index (BMI)

    Baseline and month 3, and 6

  • +7 more secondary outcomes

Other Outcomes (11)

  • Change in dietary intake and eating habits

    Baseline and month 3, 6 and 12

  • Change in eating behaviour assessed using Three-Factor Eating Questionnaire-R21 (TFEQ-R21)

    Baseline and month 3, 6 and 12

  • Change in physical activity assessed using the Active-Q questionnaire

    Baseline and month 3, 6 and 12

  • +8 more other outcomes

Study Arms (2)

App-technology group

EXPERIMENTAL

Participants in the App-technology group arm will use a newly developed smartphone application ("app"), containing a 12-week healthy eating program. Intervention: App-technology for healthy eating habits.

Behavioral: App-technology for healthy eating habits

Control group

NO INTERVENTION

The control group will receive standard care.

Interventions

App-technology for healthy eating habitsBEHAVIORAL

Access to smartphone-app, including a 12 week healthy eating program. A new theme on healthy dietary habits is presented each week.

App-technology group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Have a diagnosis of type 2 diabetes
  • years of age or older
  • Ability to communicate in Swedish
  • Own and use a smartphone with a personal digital ID

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Karolinska Institutet

Stockholm, Sweden

Location

Related Publications (4)

  • Cecchini V, Sjoblom L, Lagerros YT, Bonn SE. The Effect of a Mobile Health Dietary Education Intervention on Ultra-processed Food Consumption in Patients with Type 2 Diabetes: A Randomized Controlled Trial. Curr Dev Nutr. 2025 Apr 28;9(6):107454. doi: 10.1016/j.cdnut.2025.107454. eCollection 2025 Jun.

    PMID: 40510749DERIVED

  • Sjoblom L, Hantikainen E, Dahlgren A, Trolle Lagerros Y, Bonn SE. The effect of an app-based dietary education on dietary intake and cardiometabolic risk markers in people with type 2 diabetes: results from a randomized controlled trial. Nutr J. 2025 Jan 4;24(1):2. doi: 10.1186/s12937-024-01069-2.

    PMID: 39754157DERIVED

  • Pitt S, Sjoblom L, Balter K, Trolle Lagerros Y, Bonn SE. The effect of an app-based dietary intervention on diet-related greenhouse gas emissions - results from a randomized controlled trial. Int J Behav Nutr Phys Act. 2023 Oct 11;20(1):123. doi: 10.1186/s12966-023-01523-0.

    PMID: 37821876DERIVED

  • Trolle Lagerros Y, Dahlgren A, Sjoblom L, Bonn SE. Digital Support for Healthier Eating Habits Among Patients With Type 2 Diabetes: Protocol for a Randomized Clinical Trial Within Primary Care (HAPPY Trial). JMIR Res Protoc. 2020 Nov 16;9(11):e24422. doi: 10.2196/24422.

    PMID: 33196448DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 2Feeding Behavior

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesBehavior, AnimalBehavior

Study Officials

  • Stephanie E Bonn, PhD

    Karolinska Institutet

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PhD, Assistant professor

Study Record Dates

First Submitted

December 14, 2018

First Posted

December 24, 2018

Study Start

January 15, 2019

Primary Completion

August 31, 2023

Study Completion

August 31, 2023

Last Updated

November 22, 2024

Record last verified: 2023-10

Data Sharing

IPD Sharing
Will not share

Locations

SE(1)