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The Healthy Eating With APP technologY Study (HAPPY)

Primary Purpose

Type 2 Diabetes Mellitus, Dietary Habits

Status
Completed
Phase
Not Applicable
Locations
Sweden
Study Type
Interventional
Intervention
App-technology for healthy eating habits
Sponsored by
Karolinska Institutet
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Type 2 Diabetes Mellitus focused on measuring Smartphone application, HbA1c, Blood lipids, Dietary intake

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Karolinska Institutet

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

App-technology group

Control group

Arm Description

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.

The control group will receive standard care.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

HbA1c
mmol/mol, Heamoglobin A1c
Total cholesterol
mmol/L
HDL-cholesterol
mmol/L
Triglycerides
mmol/L
Body Mass Index (BMI)
kg/m2, measured height and weight
Body weight
kg, measured
Body composition: Body fat
Body fat (kg), measured using a bioelectrical scale
Body composition: Fat free mass
Fat free mass (kg), measured using a bioelectrical scale
Body composition: Muscle mass
Muscle mass (kg), measured using a bioelectrical scale
Body composition: Total body water
Total body water (kg), measured using a bioelectrical scale
Waist circumference
cm, measured
Blood pressure
mmHg, measured

Full Information

First Posted
December 14, 2018
Last Updated
October 3, 2023
Sponsor
Karolinska Institutet
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1. Study Identification

Unique Protocol Identification Number
NCT03784612
Brief Title
The Healthy Eating With APP technologY Study
Acronym
HAPPY
Official Title
The HAPPY-study: Digital Support for Healthier Eating Habits in Patients With Diabetes Type 2 - a Randomized Clinical Trial Within Primary Care
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Completed
Study Start Date
January 15, 2019 (Actual)
Primary Completion Date
August 31, 2023 (Actual)
Study Completion Date
August 31, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Karolinska Institutet

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 2 Diabetes Mellitus, Dietary Habits
Keywords
Smartphone application, HbA1c, Blood lipids, Dietary intake

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
133 (Actual)

8. Arms, Groups, and Interventions

Arm Title
App-technology group
Arm Type
Experimental
Arm Description
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.
Arm Title
Control group
Arm Type
No Intervention
Arm Description
The control group will receive standard care.
Intervention Type
Behavioral
Intervention Name(s)
App-technology for healthy eating habits
Intervention Description
Access to smartphone-app, including a 12 week healthy eating program. A new theme on healthy dietary habits is presented each week.
Primary Outcome Measure Information:
Title
Change in dietary intake
Description
Change in dietary intake assessed using a four day food record
Time Frame
Baseline and month 3, and 6
Secondary Outcome Measure Information:
Title
HbA1c
Description
mmol/mol, Heamoglobin A1c
Time Frame
Baseline and month 3, and 6
Title
Total cholesterol
Description
mmol/L
Time Frame
Baseline and month 3, and 6
Title
HDL-cholesterol
Description
mmol/L
Time Frame
Baseline and month 3, and 6
Title
Triglycerides
Description
mmol/L
Time Frame
Baseline and month 3, and 6
Title
Body Mass Index (BMI)
Description
kg/m2, measured height and weight
Time Frame
Baseline and month 3, and 6
Title
Body weight
Description
kg, measured
Time Frame
Baseline and month 3, and 6
Title
Body composition: Body fat
Description
Body fat (kg), measured using a bioelectrical scale
Time Frame
Baseline and month 3, and 6
Title
Body composition: Fat free mass
Description
Fat free mass (kg), measured using a bioelectrical scale
Time Frame
Baseline and month 3, and 6
Title
Body composition: Muscle mass
Description
Muscle mass (kg), measured using a bioelectrical scale
Time Frame
Baseline and month 3, and 6
Title
Body composition: Total body water
Description
Total body water (kg), measured using a bioelectrical scale
Time Frame
Baseline and month 3, and 6
Title
Waist circumference
Description
cm, measured
Time Frame
Baseline and month 3, and 6
Title
Blood pressure
Description
mmHg, measured
Time Frame
Baseline and month 3, and 6
Other Pre-specified Outcome Measures:
Title
Change in dietary intake and eating habits
Description
Assessed using a 94 item food frequency questionnaire (FFQ)
Time Frame
Baseline and month 3, 6 and 12
Title
Change in eating behaviour assessed using Three-Factor Eating Questionnaire-R21 (TFEQ-R21)
Description
Assessed using a 21-item questionnaire
Time Frame
Baseline and month 3, 6 and 12
Title
Change in physical activity assessed using the Active-Q questionnaire
Description
Assessed using a 48 item questionnaire including activities in domains of Daily occupation, transportation, leisure time, and exercise
Time Frame
Baseline and month 3, 6 and 12
Title
Change in self-reported medication use
Description
One question on medication use for blood sugar levels and one questions on medication use for blood lipid levels
Time Frame
Baseline and month 3, 6 and 12
Title
Change in tobacco use habits
Description
Two questions regarding smoking and Swedish snuff use
Time Frame
Baseline and month 3, 6 and 12
Title
Change in sleeping habits
Description
Assessed using a modified 13-item Karolinska Sleep questionnaire
Time Frame
Baseline and month 3, 6 and 12
Title
Change in perceived purpose in Life (PIL)
Description
Assessed using 6-item questionnaire
Time Frame
Baseline and month 3, 6 and 12
Title
Change in perceived stress levels
Description
Assessed using the 14-item perceived stress scale (PSS)
Time Frame
Baseline and month 3, 6 and 12
Title
Change in self-reported diabetes self-efficacy
Description
Assessed using a 20-item questionnaire
Time Frame
Baseline and month 3, 6 and 12
Title
Change in health related quality of life
Description
Assessed using the 36-item RAND-36 questionnaire
Time Frame
Baseline and month 3, 6 and 12
Title
Change in perceived social support from family and friends for healthy eating habits
Description
Assessed using a 3-item questionnaire
Time Frame
Baseline and month 3, 6 and 12

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Stephanie E Bonn, PhD
Organizational Affiliation
Karolinska Institutet
Official's Role
Principal Investigator
Facility Information:
Facility Name
Karolinska Institutet
City
Stockholm
Country
Sweden

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
33196448
Citation
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.
Results Reference
derived

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The Healthy Eating With APP technologY Study

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