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Clinical Trials/NCT03784612
NCT03784612
Completed
N/A

The HAPPY-study: Digital Support for Healthier Eating Habits in Patients with Diabetes Type 2 - a Randomized Clinical Trial Within Primary Care

Karolinska Institutet1 site133 target enrollmentJanuary 15, 2019
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ConditionsType 2 Diabetes MellitusDietary Habits

Overview

Phase
N/A
Intervention
Not specified
Conditions
Type 2 Diabetes Mellitus
Sponsor
Karolinska Institutet
Enrollment
133
Locations
1
Primary Endpoint
Change in dietary intake
Status
Completed
Last Updated
last year
OverviewInvestigatorsEligibility CriteriaOutcomesSitesSimilar Trials

Overview

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.

Registry
clinicaltrials.gov
Start Date
January 15, 2019
End Date
August 31, 2023
Last Updated
last year
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Stephanie Bonn

PhD, Assistant professor

Karolinska Institutet

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

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

Change in dietary intake

Time Frame: Baseline and month 3, and 6

Change in dietary intake assessed using a four day food record.

Secondary Outcomes

  • Total cholesterol(Baseline and month 3, and 6)
  • HDL-cholesterol(Baseline and month 3, and 6)
  • HbA1c(Baseline and month 3, and 6)
  • Body Mass Index (BMI)(Baseline and month 3, and 6)
  • Body weight(Baseline and month 3, and 6)
  • Body composition: Body fat(Baseline and month 3, and 6)
  • Waist circumference(Baseline and month 3, and 6)
  • Triglycerides(Baseline and month 3, and 6)
  • Body composition: Fat free mass(Baseline and month 3, and 6)
  • Body composition: Muscle mass(Baseline and month 3, and 6)
  • Body composition: Total body water(Baseline and month 3, and 6)
  • Blood pressure(Baseline and month 3, and 6)

Study Sites (1)

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