Clinical trial NCT03784612: The Healthy Eating with APP TechnologY 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Type 2 Diabetes Mellitus
Dietary Habits
Keywords: Smartphone application
HbA1c
Blood lipids
Dietary intake
Lead sponsor: Karolinska Institutet
Sponsor class: OTHER
First posted: 2018-12-24
Enrollment: 133
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.


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

Primary outcomes:
measure: Change in dietary intake
timeFrame: Baseline and month 3, and 6
Secondary outcomes:
measure: HbA1c
timeFrame: Baseline and month 3, and 6
measure: Total cholesterol
timeFrame: Baseline and month 3, and 6
measure: HDL-cholesterol
timeFrame: Baseline and month 3, and 6
measure: Triglycerides
timeFrame: Baseline and month 3, and 6
measure: Body Mass Index (BMI)
timeFrame: Baseline and month 3, and 6
measure: Body weight
timeFrame: Baseline and month 3, and 6
measure: Body composition: Body fat
timeFrame: Baseline and month 3, and 6
measure: Body composition: Fat free mass
timeFrame: Baseline and month 3, and 6
measure: Body composition: Muscle mass
timeFrame: Baseline and month 3, and 6
measure: Body composition: Total body water
timeFrame: Baseline and month 3, and 6
measure: Waist circumference
timeFrame: Baseline and month 3, and 6
measure: Blood pressure
timeFrame: Baseline and month 3, and 6
Other outcomes:
measure: Change in dietary intake and eating habits
timeFrame: Baseline and month 3, 6 and 12
measure: Change in eating behaviour assessed using Three-Factor Eating Questionnaire-R21 (TFEQ-R21)
timeFrame: Baseline and month 3, 6 and 12
measure: Change in physical activity assessed using the Active-Q questionnaire
timeFrame: Baseline and month 3, 6 and 12
measure: Change in self-reported medication use
timeFrame: Baseline and month 3, 6 and 12
measure: Change in tobacco use habits
timeFrame: Baseline and month 3, 6 and 12
measure: Change in sleeping habits
timeFrame: Baseline and month 3, 6 and 12
measure: Change in perceived purpose in Life (PIL)
timeFrame: Baseline and month 3, 6 and 12
measure: Change in perceived stress levels
timeFrame: Baseline and month 3, 6 and 12
measure: Change in self-reported diabetes self-efficacy
timeFrame: Baseline and month 3, 6 and 12
measure: Change in health related quality of life
timeFrame: Baseline and month 3, 6 and 12
measure: Change in perceived social support from family and friends for healthy eating habits
timeFrame: Baseline and month 3, 6 and 12
Locations:
city: Stockholm
country: Sweden
facility: Karolinska Institutet
Study officials:
affiliation: Karolinska Institutet
name: Stephanie E Bonn, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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.