The Healthy Eating With APP technologY Study (HAPPY)

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: Completed
• Conditions: Type 2 Diabetes Mellitus; Dietary Habits
• Intervention / Treatment: Behavioral: App-technology for healthy eating habits

• Study Type: Interventional
• Enrollment (Actual): 133
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Stephanie E Bonn, PhD; Phone Number: 0046851779173; Email: stephanie.bonn@ki.se

Study Locations

• Sweden
  • Stockholm, Sweden
    • Karolinska Institutet

Participation Criteria

Eligibility Criteria

• 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

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

Outcome Measure	Measure Description	Time Frame
Change in dietary intake	Change in dietary intake assessed using a four day food record	Baseline and month 3, and 6

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
HbA1c	mmol/mol, Heamoglobin A1c	Baseline and month 3, and 6
Total cholesterol	mmol/L	Baseline and month 3, and 6
HDL-cholesterol	mmol/L	Baseline and month 3, and 6
Triglycerides	mmol/L	Baseline and month 3, and 6
Body Mass Index (BMI)	kg/m2, measured height and weight	Baseline and month 3, and 6
Body weight	kg, measured	Baseline and month 3, and 6
Body composition: Body fat	Body fat (kg), measured using a bioelectrical scale	Baseline and month 3, and 6
Body composition: Fat free mass	Fat free mass (kg), measured using a bioelectrical scale	Baseline and month 3, and 6
Body composition: Muscle mass	Muscle mass (kg), measured using a bioelectrical scale	Baseline and month 3, and 6
Body composition: Total body water	Total body water (kg), measured using a bioelectrical scale	Baseline and month 3, and 6
Waist circumference	cm, measured	Baseline and month 3, and 6
Blood pressure	mmHg, measured	Baseline and month 3, and 6

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in dietary intake and eating habits	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)	Assessed using a 21-item questionnaire	Baseline and month 3, 6 and 12
Change in physical activity assessed using the Active-Q questionnaire	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	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	Two questions regarding smoking and Swedish snuff use	Baseline and month 3, 6 and 12
Change in sleeping habits	Assessed using a modified 13-item Karolinska Sleep questionnaire	Baseline and month 3, 6 and 12
Change in perceived purpose in Life (PIL)	Assessed using 6-item questionnaire	Baseline and month 3, 6 and 12
Change in perceived stress levels	Assessed using the 14-item perceived stress scale (PSS)	Baseline and month 3, 6 and 12
Change in self-reported diabetes self-efficacy	Assessed using a 20-item questionnaire	Baseline and month 3, 6 and 12
Change in health related quality of life	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	Assessed using a 3-item questionnaire	Baseline and month 3, 6 and 12

Collaborators and Investigators

• Sponsor: Karolinska Institutet
• Investigators: Principal Investigator: Stephanie E Bonn, PhD, Karolinska Institutet

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): January 15, 2019
• Primary Completion (Actual): August 31, 2023
• Study Completion (Actual): August 31, 2023

Study Registration Dates

• First Submitted: December 14, 2018
• First Submitted That Met QC Criteria: December 21, 2018
• First Posted (Actual): December 24, 2018

Study Record Updates

• Last Update Posted (Actual): October 4, 2023
• Last Update Submitted That Met QC Criteria: October 3, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Keywords: HbA1c; Smartphone application; Blood lipids; Dietary intake
• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 2
• Other Study ID 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