Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
Scientific title
A pilot randomised controlled trial to measure the effectiveness of tailored text message-based weight reduction program
Acronym
Study hypothesis
The intervention to be evaluated in this trial is a six-month program of automatically generated tailored text messages sent to the participant's mobile phone.
Ethics approval
Institutional Review Board of Seoul National University Bundang Hospital approved on the 30th December 2010 (ref: B-1012/117-003)
Study design
Two parallel group randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Other
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
Obesity
Intervention
Two groups to be compared:
1. Control group: participants will receive tuition in weight-control, BMI measure, education materials
2. Intervention group: participants will receive tuition in weight-control, BMI measure, education materials, plus patient-tailored interactive SMS text messages every other day
Intervention type
Other
Phase
Not Applicable
Drug names
Primary outcome measures
Body weight: The percentage of body weight change in 6 months. Weight is measured at baseline, 1, 3, and 6 months in light clothing by bioelectrical analysis methods
We also plan to obtain self administered questionnaires such as eating behavior, physical activity using International Physical Acitivity Questionnaire (IPAQ-short form) and Korean version of Obesity related Quality of Life Scale at baseline and 6 months later
Secondary outcome measures
1. BMI
2. Body composition
3. Quality of life
4. Eating habits
5. Physical activity
Overall trial start date
01/04/2011
Overall trial end date
30/09/2011
Reason abandoned
Eligibility
Participant inclusion criteria
1. Obese people - body mass index (BMI) over 25
2. Able to read Korean and can provide written informed consent
3. Is seriously considering weight reduction
4. Aged over 20 years, either sex
5. Has a mobile phone and is familiar with sending and receiving SMS text messages
6. Is willing to participate in study and follow study procedures
7. Is not currently enroled in another formal weight reduction study or program
8. Is not using diet pill at randomisation date
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
Total approximately 200 (100 in each of the intervention groups)
Participant exclusion criteria
1. Do not meet all of the inclusion criteria
2. Past 3-month comorbidities, for example cerebral apoplexy, coronary artery diseases
3. Past 3-month coronary artery intervention or surgery
4. Has heart failure or anorexia nervosa or terminal cancer
Recruitment start date
01/04/2011
Recruitment end date
30/09/2011
Locations
Countries of recruitment
Korea, South
Trial participating centre
166 Gumi-ro Bundang-gu, Gyeonggi-do
Seongnam
463-707
Korea, South
Sponsor information
Organisation
Seoul National University Bundang Hospital (South Korea)
Sponsor details
300 Gumi-ro Bundang-gu
Seongnam-si
Gyeonggi-do
Department of Education and Research
Seongnam
463-707
Korea
South
Sponsor type
Hospital/treatment centre
Website
Funders
Funder type
Hospital/treatment centre
Funder name
Seoul National University Bundang Hospital (South Korea)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary
2015 results in: http://www.ncbi.nlm.nih.gov/pubmed/25648325