The Healthy Eating with APP TechnologY Study

Not Applicable

Completed

• Conditions: Dietary Habits; Type 2 Diabetes Mellitus
• Interventions: Behavioral: App-technology for healthy eating habits

• Registration Number: NCT03784612
• Lead Sponsor: Karolinska Institutet

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-12-14
• Study First Submitted QC: 2018-12-21
• Study First Posted: 2018-12-24
• Study Start: 2019-01-15
• Primary Completion: 2023-08-31
• Study Completion: 2023-08-31
• Status Verified: 2023-10
• Last Update Submitted: 2024-11-20
• Last Update Posted: 2024-11-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 133

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

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
App-technology group	App-technology for healthy eating habits	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.

Primary Outcome Measures

Name	Time	Method
Change in dietary intake	Baseline and month 3, and 6	Change in dietary intake assessed using a four day food record.

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Karolinska Institutet; 🇸🇪 Stockholm, Sweden