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Trial registered on ANZCTR


Registration number
ACTRN12621000497808
Ethics application status
Approved
Date submitted
4/03/2020
Date registered
29/04/2021
Date last updated
29/04/2021
Date data sharing statement initially provided
29/04/2021
Type of registration
Retrospectively registered

Titles & IDs
Public title
Lifestyle and dietary group guidance through mobile application
Scientific title
Lifestyle and dietary group guidance through mobile application (mHealth) promoting weight loss, randomised controlled trial
Secondary ID [1] 300673 0
None
Universal Trial Number (UTN)
U1111-1248-8761
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
obesity 316474 0
nutrition 316538 0
dietary changes 316539 0
Condition category
Condition code
Diet and Nutrition 314719 314719 0 0
Obesity

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Intervention group participants use a MealLogger-smartphone application to keep visual food journal, self-monitor mood, sleep and stress level, share their meals and physical activities with their peer group members and receive virtual coaching from nutritionist. The nutritionist will provide a short feedback to participants approximately in every other week via application for example the nutritionist will give guidance to make healthier food choices making a comment in participants meal photo and also encourages to find and maintain healhty lifestyle. Intervention group meets virtually six times in the intervention period using video conferencing software. One meeting takes 1,5 hour. The meeting is led by the nutritionist. Virtual meetings have a different theme every time and they deal e.g. own resources, motivation, making and maintaining a lifestyle change, healhty diet and physical activity. The group members can also interact with each other and with the nutritionist. Participants will be also provided a printed participant handbook specifically designed for this study, leaflet of healthy eating and weight loss, educational information and tasks via application three times per week. The intervention is based on cognitive behavioral approach and it promotes intuitive eating. The use of application varies in intervention period and includes intervals (it is personalised). One intervention group has 15-18 participants. Intervention period lasts 6 months. The intervention adherence will be measured by the data from the application e.g. user logins, meal photos, likes, comments and exercise entries made in application.
Intervention code [1] 317001 0
Lifestyle
Comparator / control treatment
The control group participants receive leaflet of healthy eating and weight loss. The leaflet is same as in the intervention group. The leaflet is called Paino hallintaan by Suomen Ravitsemusterapeuttien Yhdistys.
Control group
Active

Outcomes
Primary outcome [1] 323069 0
Weight change (kg). Weight will be measured in light clothing and without shoes to the nearest 0,1 kilogram using a calibrated scale in the study centre.
Timepoint [1] 323069 0
Baseline, 3 month , 6 month (primary timepoint), 1 year, 2 year
Primary outcome [2] 323070 0
Quality of life using the RAND-36 questionnaire
Timepoint [2] 323070 0
Baseline, 3 month, 6 month (primary timepoint), 1 year, 2 year
Secondary outcome [1] 380687 0
Dietary intake (three day food diary)
Timepoint [1] 380687 0
Baseline, 3 month, 6 month, 1 year, 2 year
Secondary outcome [2] 380688 0
Eating behaviors studied by Three-Factor Eating Questionnaire R18 (TFEQ-R18)
Timepoint [2] 380688 0
Baseline, 3 month, 6 month, 1 year, 2 year
Secondary outcome [3] 380693 0
Before intervention focus group interviews are conducted to find out experiences on weight loss and weight management. Approximately 15 participants will be taking part of the interviews assigned by investigator in video conference. Interviews are conducted in three sessions, five participants per group one researcher acting as the primary moderator. The sessions will be audio-recorded by video conference software. The interviews are semi-structured and duration is approximately one hour.
Timepoint [3] 380693 0
Baseline
Secondary outcome [4] 380694 0
Overall interaction with the application will be measured continuously throughout the intervention period by data from the application's usage database: the coach´s activity, user logins, meal photos, likes, comments, exercise entries made in application (e.g. steps, type of exercise), sleep, stress, mood and social support received and given.
Timepoint [4] 380694 0
Invertion period: from baseline to 6 months.
Secondary outcome [5] 388302 0
Fasting blood sugar
Timepoint [5] 388302 0
Baseline, 6 month, 1 year
Secondary outcome [6] 388303 0
Hemoglobin A1c
Timepoint [6] 388303 0
Baseline, 6 month, 1 year
Secondary outcome [7] 388304 0
total cholesterol assessed by blood test
Timepoint [7] 388304 0
Baseline, 6 month, 1 year
Secondary outcome [8] 388305 0
HDL cholesterol assessed by blood test
Timepoint [8] 388305 0
Baseline, 6 month, 1 year
Secondary outcome [9] 388306 0
LDL cholesterol assessed by blood test
Timepoint [9] 388306 0
Baseline, 6 month, 1 year
Secondary outcome [10] 388307 0
triglycerides assessed by blood test
Timepoint [10] 388307 0
Baseline, 6 month, 1 year
Secondary outcome [11] 388308 0
alanine aminotransferase assessed by blood test
Timepoint [11] 388308 0
Baseline, 6 month, 1 year
Secondary outcome [12] 388309 0
glutamyl transferase assessed by blood test
Timepoint [12] 388309 0
Baseline, 6 month, 1 year
Secondary outcome [13] 388310 0
Self-efficacy by Schwarzer & Renner 2000
Timepoint [13] 388310 0
Baseline, 3 month, 6 month, 1 year, 2 year
Secondary outcome [14] 388311 0
Habit strength by Holloway & Watson 2002
Timepoint [14] 388311 0
Baseline, 3 month, 6 month, 1 year, 2 year
Secondary outcome [15] 388312 0
Physical activity using RM42 activity meter in one week time period
Timepoint [15] 388312 0
Baseline, 3 month, 6 month, 1 year, 2 year
Secondary outcome [16] 388313 0
Sleep using RM42 activity meter in one week time period
Timepoint [16] 388313 0
Baseline, 3 month, 6 month, 1 year, 2 year

Eligibility
Key inclusion criteria
The inclusion criteria are:
- age 50-65 years old
- weight and height consistent with a body mass index (BMI) between 25-40 kg/m²
- Finnish fluency
- ownership of an iOS or Android smartphone and willingness to use mobile application for 6 months and attend 5 visits at the study centre
Minimum age
50 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
The exclusion criteria are:
- cardiovascular event in < 6 months
- a condition or medication that would influence weight (for example weight loss medication or weight loss surgery)
- have had weight loss of 5 kg or more in the past 3 months or intending to participate in another weight loss programme in study period
- profound cognitive, developmental or psychiatric disorders, or psychiatric hospitalization in < 12 months
- insulin-treated diabetes

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
A computer based random generator will randomize the participants.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Participants will be randomised to study groups in equal ratios. Randomisation will be stratified by BMI (25.0-29.9 and 30.0-40.0) to ensure group balance. The randomisation sequence will be developed by independent statistician.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Date of first participant enrolment
Anticipated
Actual
27/01/2020
Date of last participant enrolment
Anticipated
Actual
6/08/2020
Date of last data collection
Anticipated
30/12/2022
Actual
Sample size
Target
120
Accrual to date
Final
73
Recruitment outside Australia
Country [1] 22400 0
Finland
State/province [1] 22400 0

Funding & Sponsors
Funding source category [1] 305112 0
Charities/Societies/Foundations
Name [1] 305112 0
Funding Centre for Social Welfare and Health Organisations STEA
Country [1] 305112 0
Finland
Primary sponsor type
Charities/Societies/Foundations
Name
Society for Gerontological Nutrition in Finland
Address
Malmin kauppatie 26, 00700 Helsinki
Country
Finland
Secondary sponsor category [1] 305476 0
None
Name [1] 305476 0
Address [1] 305476 0
Country [1] 305476 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 305488 0
Helsinki University Hospital Ethical Committee
Ethics committee address [1] 305488 0
Stenbäckinkatu 9, 00290 Helsinki
Ethics committee country [1] 305488 0
Finland
Date submitted for ethics approval [1] 305488 0
29/05/2019
Approval date [1] 305488 0
29/08/2019
Ethics approval number [1] 305488 0

Summary
Brief summary
Overweight and obese (BMI 25-40 kg/m²), 50-65 years adults (n=120) will be recruited for 6-month intervention period with 2 years follow up. Participants in the intervention group use a smartphone application to keep visual food journal, share their meals and activities with their peer group members and receive virtual coaching from nutritionist. The intervention is based on cognitive behavioral approach. The control group receives no intervention. Main outcome measures are weight change and health related quality of life, assessed with RAND-36-questionnaire. Self-efficacy and habit strength will be assessed with scales. Blood fasting glucose, lipids, weight and waist circumference will be measured. Food intake will be measured on three-day food diary and eating behaviours with Three-Factor Eating Questionnaire R18. Overall interaction with the application will be measured continuously throughout the intervention period. Coach´s activity, user logins, meal photos, likes, comments, exercise entries made in application, sleep, stress level and mood will be analysed.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 100534 0
Dr Merja Suominen
Address 100534 0
Society for Gerontological Nutrition in Finland, Malmin kauppatie 26, 00700 Helsinki.
Country 100534 0
Finland
Phone 100534 0
+358505841995
Fax 100534 0
Email 100534 0
[email protected]
Contact person for public queries
Name 100535 0
Heli Salmenius-Suominen
Address 100535 0
Society for Gerontological Nutrition in Finland, Malmin kauppatie 26, 00700 Helsinki.
Country 100535 0
Finland
Phone 100535 0
+358405036811
Fax 100535 0
Email 100535 0
[email protected]
Contact person for scientific queries
Name 100536 0
Heli Salmenius-Suominen
Address 100536 0
Society for Gerontological Nutrition in Finland, Malmin kauppatie 26, 00700 Helsinki.
Country 100536 0
Finland
Phone 100536 0
+358405036811
Fax 100536 0
Email 100536 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
This possibility was not included in the research plan.


What supporting documents are/will be available?




Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.