Type 2 Diabetes MellitusHAPPYNCT03784612
The Healthy Eating with APP TechnologY Study
A study testing App-technology for healthy eating habits in people with Type 2 Diabetes Mellitus and Dietary Habits, run by Karolinska Institutet at 1 site in Sweden.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Type 2 Diabetes Mellitus, Dietary Habits
- What is being tested?
- App-technology for healthy eating habits
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 133 participants
- Where
- 1 siteSweden
- Study dates
- 15 Jan 2019to 31 Aug 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- No specific exclusion criteria apply
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Type 2 Diabetes Mellitus, Dietary Habits
- Being tested
- App-technology for healthy eating habits
- Keywords
- Smartphone application, HbA1c, Blood lipids, Dietary intake
- Medical subject headings
- Diabetes Mellitus, Type 2, Feeding Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
App-technology for healthy eating habitsBehavioural
Access to smartphone-app, including a 12 week healthy eating program. A new theme on healthy dietary habits is presented each week.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: App-technology for healthy eating habits |
| Control group | No intervention | The control group will receive standard care. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in dietary intake
Change in dietary intake assessed using a four day food record.
Measured: Baseline and month 3, and 6
Secondary outcomes (12)
HbA1c
mmol/mol, Heamoglobin A1c
Measured: Baseline and month 3, and 6
Total cholesterol
mmol/L
Measured: Baseline and month 3, and 6
HDL-cholesterol
mmol/L
Measured: Baseline and month 3, and 6
Triglycerides
mmol/L
Measured: Baseline and month 3, and 6
Body Mass Index (BMI)
kg/m2, measured height and weight
Measured: Baseline and month 3, and 6
Body weight
kg, measured
Measured: Baseline and month 3, and 6
Body composition: Body fat
Body fat (kg), measured using a bioelectrical scale
Measured: Baseline and month 3, and 6
Body composition: Fat free mass
Fat free mass (kg), measured using a bioelectrical scale
Measured: Baseline and month 3, and 6
Body composition: Muscle mass
Muscle mass (kg), measured using a bioelectrical scale
Measured: Baseline and month 3, and 6
Body composition: Total body water
Total body water (kg), measured using a bioelectrical scale
Measured: Baseline and month 3, and 6
Waist circumference
cm, measured
Measured: Baseline and month 3, and 6
Blood pressure
mmHg, measured
Measured: Baseline and month 3, and 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Dec 2018
- Study start15 Jan 2019
- Primary completion31 Aug 2023
- Study completion31 Aug 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Type 2 Diabetes MellitusStudies of the same condition, open and under way.
- More trials run by Karolinska InstitutetThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 133 participants (actual)
Sponsor and investigators
- Lead sponsor
- Karolinska Institutet
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Stephanie Bonn, Karolinska Institutet
- Investigators
- Stephanie E Bonn, PhD, Principal investigator, Karolinska Institutet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03784612
- Sponsor's protocol ID
- Dnr: 2018/652-31
- Acronym
- HAPPY
- Status last verified
- Oct 2023
- First submitted
- 14 Dec 2018
- Last updated
- 22 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 40510749Sjoblom L, Stenbeck F, Trolle Lagerros Y, Hantikainen E, Bonn SE. Engagement With a Smartphone-Delivered Dietary Education Intervention and Its Relation to Dietary Intake and Cardiometabolic Risk Markers in People With Type 2 Diabetes: Secondary Analysis of a Randomized Controlled Trial. JMIR Form Res. 2025 May 30;9:e71408. doi: 10.2196/71408.
PubMed 40446320Sjoblom 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.
PubMed 39754157Pitt 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.
PubMed 37821876Trolle 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.
PubMed 33196448
Study at a glance
From the registry record, last updated by the sponsor on 22 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The HAPPY-study: Digital Support for Healthier Eating Habits in Patients with Diabetes Type 2 - a Randomized Clinical Trial Within Primary Care
- ClinicalTrials.gov ID
- NCT03784612
- Acronym / sponsor ID
- HAPPY / Dnr: 2018/652-31
- Conditions
- Type 2 Diabetes Mellitus, Dietary Habits
- Keywords
- Smartphone application, HbA1c, Blood lipids, Dietary intake
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 133 participants (actual)
- Lead sponsor
- Karolinska InstitutetUniversity, hospital or other
- Study start
- 15 Jan 2019 (actual)
- Primary completion
- 31 Aug 2023 (actual)
- Study completion
- 31 Aug 2023 (actual)
- First posted
- 24 Dec 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| App-technology group | Experimental | Behavioral: App-technology for healthy eating habitsParticipants 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. |
| Control group | No intervention | –The control group will receive standard care. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (1 listed)
- No specific exclusion criteria apply
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| App-technology for healthy eating habitsAccess to smartphone-app, including a 12 week healthy eating program. A new theme on healthy dietary habits is presented each week. | Behavioural | App-technology group |
Primary outcome
Change in dietary intake
Time frame: Baseline and month 3, and 6
Change in dietary intake assessed using a four day food record.
12 secondary outcomes
HbA1c
Time frame: Baseline and month 3, and 6
Total cholesterol
Time frame: Baseline and month 3, and 6
HDL-cholesterol
Time frame: Baseline and month 3, and 6
Triglycerides
Time frame: Baseline and month 3, and 6
Body Mass Index (BMI)
Time frame: Baseline and month 3, and 6
Body weight
Time frame: Baseline and month 3, and 6
Body composition: Body fat
Time frame: Baseline and month 3, and 6
Body composition: Fat free mass
Time frame: Baseline and month 3, and 6
Body composition: Muscle mass
Time frame: Baseline and month 3, and 6
Body composition: Total body water
Time frame: Baseline and month 3, and 6
Waist circumference
Time frame: Baseline and month 3, and 6
Blood pressure
Time frame: Baseline and month 3, and 6
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Nov 2024.
- Derived from this study: PubMed 40510749Cecchini 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.
- Derived from this study: PubMed 40446320Sjoblom L, Stenbeck F, Trolle Lagerros Y, Hantikainen E, Bonn SE. Engagement With a Smartphone-Delivered Dietary Education Intervention and Its Relation to Dietary Intake and Cardiometabolic Risk Markers in People With Type 2 Diabetes: Secondary Analysis of a Randomized Controlled Trial. JMIR Form Res. 2025 May 30;9:e71408. doi: 10.2196/71408.
- Derived from this study: PubMed 39754157Sjoblom 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.
- Derived from this study: PubMed 37821876Pitt 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.
- Derived from this study: PubMed 33196448Trolle 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Stephanie E Bonn, PhD principal investigator
Karolinska Institutet
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing App-technology for healthy eating habits in people with Type 2 Diabetes Mellitus and Dietary Habits, run by Karolinska Institutet at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in dietary intake (time frame: Baseline and month 3, and 6). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03784612, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Nov 2024.