The Healthy Eating With APP technologY Study

Type 2 Diabetes Mellitus Clinical Trial

— 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03784612
• Other study ID #: Dnr: 2018/652-31
• Status: Completed
• Phase: N/A
• Start date: January 15, 2019
• Est. completion date: August 31, 2023

Study information

• Verified date: October 2023
• Source: Karolinska Institutet
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 133
• Est. completion date: August 31, 2023
• Est. primary completion date: August 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 2
• Dietary Habits
• Type 2 Diabetes Mellitus

Intervention

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.

Locations

Country	Name	City	State
Sweden	Karolinska Institutet	Stockholm

Sponsors (1)

Lead Sponsor	Collaborator
Karolinska Institutet

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Change in dietary intake and eating habits	Assessed using a 94 item food frequency questionnaire (FFQ)	Baseline and month 3, 6 and 12
Other	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
Other	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
Other	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
Other	Change in tobacco use habits	Two questions regarding smoking and Swedish snuff use	Baseline and month 3, 6 and 12
Other	Change in sleeping habits	Assessed using a modified 13-item Karolinska Sleep questionnaire	Baseline and month 3, 6 and 12
Other	Change in perceived purpose in Life (PIL)	Assessed using 6-item questionnaire	Baseline and month 3, 6 and 12
Other	Change in perceived stress levels	Assessed using the 14-item perceived stress scale (PSS)	Baseline and month 3, 6 and 12
Other	Change in self-reported diabetes self-efficacy	Assessed using a 20-item questionnaire	Baseline and month 3, 6 and 12
Other	Change in health related quality of life	Assessed using the 36-item RAND-36 questionnaire	Baseline and month 3, 6 and 12
Other	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
Primary	Change in dietary intake	Change in dietary intake assessed using a four day food record	Baseline and month 3, and 6
Secondary	HbA1c	mmol/mol, Heamoglobin A1c	Baseline and month 3, and 6
Secondary	Total cholesterol	mmol/L	Baseline and month 3, and 6
Secondary	HDL-cholesterol	mmol/L	Baseline and month 3, and 6
Secondary	Triglycerides	mmol/L	Baseline and month 3, and 6
Secondary	Body Mass Index (BMI)	kg/m2, measured height and weight	Baseline and month 3, and 6
Secondary	Body weight	kg, measured	Baseline and month 3, and 6
Secondary	Body composition: Body fat	Body fat (kg), measured using a bioelectrical scale	Baseline and month 3, and 6
Secondary	Body composition: Fat free mass	Fat free mass (kg), measured using a bioelectrical scale	Baseline and month 3, and 6
Secondary	Body composition: Muscle mass	Muscle mass (kg), measured using a bioelectrical scale	Baseline and month 3, and 6
Secondary	Body composition: Total body water	Total body water (kg), measured using a bioelectrical scale	Baseline and month 3, and 6
Secondary	Waist circumference	cm, measured	Baseline and month 3, and 6
Secondary	Blood pressure	mmHg, measured	Baseline and month 3, and 6