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Completed

NCT Number: NCT03784612

The Healthy Eating with APP TechnologY Study

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.

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Key information

Conditions

Type 2 Diabetes Mellitus Behavior Behavior, Animal Diabetes Mellitus Diabetes Mellitus, Type 2 Dietary Habits Endocrine System Diseases Feeding Behavior Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Karolinska Institutet

Stockholm, Sweden

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

App-technology for healthy eating habits

Behavioral

Access to smartphone-app, including a 12 week healthy eating program. A new theme on healthy dietary habits is presented each week.

Primary outcomes

  1. 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

  1. HbA1c

    Time frame: Baseline and month 3, and 6

    mmol/mol, Heamoglobin A1c

  2. Total cholesterol

    Time frame: Baseline and month 3, and 6

    mmol/L

  3. HDL-cholesterol

    Time frame: Baseline and month 3, and 6

    mmol/L

  4. Triglycerides

    Time frame: Baseline and month 3, and 6

    mmol/L

  5. Body Mass Index (BMI)

    Time frame: Baseline and month 3, and 6

    kg/m2, measured height and weight

  6. Body weight

    Time frame: Baseline and month 3, and 6

    kg, measured

  7. Body composition: Body fat

    Time frame: Baseline and month 3, and 6

    Body fat (kg), measured using a bioelectrical scale

  8. Body composition: Fat free mass

    Time frame: Baseline and month 3, and 6

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

  9. Body composition: Muscle mass

    Time frame: Baseline and month 3, and 6

    Muscle mass (kg), measured using a bioelectrical scale

  10. Body composition: Total body water

    Time frame: Baseline and month 3, and 6

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

  11. Waist circumference

    Time frame: Baseline and month 3, and 6

    cm, measured

  12. Blood pressure

    Time frame: Baseline and month 3, and 6

    mmHg, measured

Other outcomes

  1. Change in dietary intake and eating habits

    Time frame: 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)

    Time frame: Baseline and month 3, 6 and 12

    Assessed using a 21-item questionnaire

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

    Time frame: 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

    Time frame: 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

    Time frame: Baseline and month 3, 6 and 12

    Two questions regarding smoking and Swedish snuff use

  6. Change in sleeping habits

    Time frame: Baseline and month 3, 6 and 12

    Assessed using a modified 13-item Karolinska Sleep questionnaire

  7. Change in perceived purpose in Life (PIL)

    Time frame: Baseline and month 3, 6 and 12

    Assessed using 6-item questionnaire

  8. Change in perceived stress levels

    Time frame: Baseline and month 3, 6 and 12

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

  9. Change in self-reported diabetes self-efficacy

    Time frame: Baseline and month 3, 6 and 12

    Assessed using a 20-item questionnaire

  10. Change in health related quality of life

    Time frame: 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

    Time frame: Baseline and month 3, 6 and 12

    Assessed using a 3-item questionnaire

Sponsors and collaborators

Lead sponsor

Karolinska Institutet

Other

Registry information

Official study title

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

Acronym: HAPPY

Important dates

Study start
2019
Primary completion
2023
Study completion
2023
First posted
Dec 24, 2018
Registry last updated
Nov 22, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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