HAPPY: The Healthy Eating With APP technologY Study

• Sponsor: Karolinska Institutet (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT03784612
• Collaborator: (none)
• Enrollment: 200
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 41.5
• Patients Per Site Per Month: 4.8

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Type 2 Diabetes Mellitus; Dietary Habits	Behavioral: App-technology for healthy eating habits	N/A

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 200 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: None (Open Label)
• Primary Purpose: Supportive Care
• Official Title: The HAPPY-study: Digital Support for Healthier Eating Habits in Patients With Diabetes Type 2 - a Randomized Clinical Trial Within Primary Care
• Actual Study Start Date: Jan 15, 2019
• Anticipated Primary Completion Date: Jun 30, 2022
• Anticipated Study Completion Date: Jun 30, 2022

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

1. Change in dietary intake [Baseline and month 3, and 6]

   Change in dietary intake assessed using a four day food record

Secondary Outcome Measures

1. HbA1c [Baseline and month 3, and 6]

   mmol/mol, Heamoglobin A1c

2. Total cholesterol [Baseline and month 3, and 6]

   mmol/L

3. HDL-cholesterol [Baseline and month 3, and 6]

   mmol/L

4. Triglycerides [Baseline and month 3, and 6]

   mmol/L

5. Body Mass Index (BMI) [Baseline and month 3, and 6]

   kg/m2, measured height and weight

6. Body weight [Baseline and month 3, and 6]

   kg, measured

7. Body composition: Body fat [Baseline and month 3, and 6]

   Body fat (kg), measured using a bioelectrical scale

8. Body composition: Fat free mass [Baseline and month 3, and 6]

   Fat free mass (kg), measured using a bioelectrical scale

9. Body composition: Muscle mass [Baseline and month 3, and 6]

   Muscle mass (kg), measured using a bioelectrical scale

10. Body composition: Total body water [Baseline and month 3, and 6]

    Total body water (kg), measured using a bioelectrical scale

11. Waist circumference [Baseline and month 3, and 6]

    cm, measured

12. Blood pressure [Baseline and month 3, and 6]

    mmHg, measured

Other Outcome Measures

1. Change in dietary intake and eating habits [Baseline and month 3, 6 and 12]

   Assessed using a 94 item food frequency questionnaire (FFQ)

2. Change in eating behaviour assessed using Three-Factor Eating Questionnaire-R21 (TFEQ-R21) [Baseline and month 3, 6 and 12]

   Assessed using a 21-item questionnaire

3. Change in physical activity assessed using the Active-Q questionnaire [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

4. Change in self-reported medication use [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

5. Change in tobacco use habits [Baseline and month 3, 6 and 12]

   Two questions regarding smoking and Swedish snuff use

6. Change in sleeping habits [Baseline and month 3, 6 and 12]

   Assessed using a modified 13-item Karolinska Sleep questionnaire

7. Change in perceived purpose in Life (PIL) [Baseline and month 3, 6 and 12]

   Assessed using 6-item questionnaire

8. Change in perceived stress levels [Baseline and month 3, 6 and 12]

   Assessed using the 14-item perceived stress scale (PSS)

9. Change in self-reported diabetes self-efficacy [Baseline and month 3, 6 and 12]

   Assessed using a 20-item questionnaire

10. Change in health related quality of life [Baseline and month 3, 6 and 12]

    Assessed using the 36-item RAND-36 questionnaire

11. Change in perceived social support from family and friends for healthy eating habits [Baseline and month 3, 6 and 12]

    Assessed using a 3-item questionnaire

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Karolinska Institutet	Stockholm		Sweden

Sponsors and Collaborators

• Karolinska Institutet

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Stephanie Bonn, PhD, Assistant professor, Karolinska Institutet
• ClinicalTrials.gov Identifier: NCT03784612
• Other Study ID Numbers: Dnr: 2018/652-31
• First Posted: Dec 24, 2018
• Last Update Posted: Sep 13, 2021
• Last Verified: Sep 1, 2021

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Stephanie Bonn, PhD, Assistant professor, Karolinska Institutet: Smartphone application; HbA1c; Blood lipids; Dietary intake
• Additional relevant MeSH terms: Diabetes Mellitus, Type 2

Study Results

No Results Posted as of Sep 13, 2021