The Healthy Eating with APP TechnologY Study (HAPPY)

November 20, 2024 updated by: Stephanie Bonn, Karolinska Institutet

The HAPPY-study: Digital Support for Healthier Eating Habits in Patients with Diabetes Type 2 - a Randomized Clinical Trial Within Primary Care

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
133

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Sweden
      • Stockholm, Sweden
        • Karolinska Institutet

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

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

Exclusion criteria:

- No specific exclusion criteria apply

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: App-technology group

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
Access to smartphone-app, including a 12 week healthy eating program. A new theme on healthy dietary habits is presented each week.
No Intervention: Control group
The control group will receive standard care.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Change in dietary intake
Time Frame: Baseline and month 3, and 6
Change in dietary intake assessed using a four day food record.
Baseline and month 3, and 6

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
HbA1c
Time Frame: Baseline and month 3, and 6
mmol/mol, Heamoglobin A1c
Baseline and month 3, and 6
Total cholesterol
Time Frame: Baseline and month 3, and 6
mmol/L
Baseline and month 3, and 6
HDL-cholesterol
Time Frame: Baseline and month 3, and 6
mmol/L
Baseline and month 3, and 6
Triglycerides
Time Frame: Baseline and month 3, and 6
mmol/L
Baseline and month 3, and 6
Body Mass Index (BMI)
Time Frame: Baseline and month 3, and 6
kg/m2, measured height and weight
Baseline and month 3, and 6
Body weight
Time Frame: Baseline and month 3, and 6
kg, measured
Baseline and month 3, and 6
Body composition: Body fat
Time Frame: Baseline and month 3, and 6
Body fat (kg), measured using a bioelectrical scale
Baseline and month 3, and 6
Body composition: Fat free mass
Time Frame: Baseline and month 3, and 6
Fat free mass (kg), measured using a bioelectrical scale
Baseline and month 3, and 6
Body composition: Muscle mass
Time Frame: Baseline and month 3, and 6
Muscle mass (kg), measured using a bioelectrical scale
Baseline and month 3, and 6
Body composition: Total body water
Time Frame: Baseline and month 3, and 6
Total body water (kg), measured using a bioelectrical scale
Baseline and month 3, and 6
Waist circumference
Time Frame: Baseline and month 3, and 6
cm, measured
Baseline and month 3, and 6
Blood pressure
Time Frame: Baseline and month 3, and 6
mmHg, measured
Baseline and month 3, and 6

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change in dietary intake and eating habits
Time Frame: Baseline and month 3, 6 and 12
Assessed using a 94 item food frequency questionnaire (FFQ)
Baseline and month 3, 6 and 12
Change in eating behaviour assessed using Three-Factor Eating Questionnaire-R21 (TFEQ-R21)
Time Frame: Baseline and month 3, 6 and 12
Assessed using a 21-item questionnaire
Baseline and month 3, 6 and 12
Change in physical activity assessed using the Active-Q questionnaire
Time Frame: Baseline and month 3, 6 and 12
Assessed using a 48 item questionnaire including activities in domains of Daily occupation, transportation, leisure time, and exercise
Baseline and month 3, 6 and 12
Change in self-reported medication use
Time Frame: Baseline and month 3, 6 and 12
One question on medication use for blood sugar levels and one questions on medication use for blood lipid levels
Baseline and month 3, 6 and 12
Change in tobacco use habits
Time Frame: Baseline and month 3, 6 and 12
Two questions regarding smoking and Swedish snuff use
Baseline and month 3, 6 and 12
Change in sleeping habits
Time Frame: Baseline and month 3, 6 and 12
Assessed using a modified 13-item Karolinska Sleep questionnaire
Baseline and month 3, 6 and 12
Change in perceived purpose in Life (PIL)
Time Frame: Baseline and month 3, 6 and 12
Assessed using 6-item questionnaire
Baseline and month 3, 6 and 12
Change in perceived stress levels
Time Frame: Baseline and month 3, 6 and 12
Assessed using the 14-item perceived stress scale (PSS)
Baseline and month 3, 6 and 12
Change in self-reported diabetes self-efficacy
Time Frame: Baseline and month 3, 6 and 12
Assessed using a 20-item questionnaire
Baseline and month 3, 6 and 12
Change in health related quality of life
Time Frame: Baseline and month 3, 6 and 12
Assessed using the 36-item RAND-36 questionnaire
Baseline and month 3, 6 and 12
Change in perceived social support from family and friends for healthy eating habits
Time Frame: Baseline and month 3, 6 and 12
Assessed using a 3-item questionnaire
Baseline and month 3, 6 and 12

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Karolinska Institutet

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Stephanie E Bonn, PhD, Karolinska Institutet

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 15, 2019

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 31, 2023

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 31, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 14, 2018

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 21, 2018

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 24, 2018

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 22, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 20, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • Dnr: 2018/652-31

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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