Condition category
Nutritional, Metabolic, Endocrine
Date applied
25/02/2011
Date assigned
28/04/2011
Last edited
05/02/2015
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Prof Ju-Young Kim

ORCID ID

Contact details

166 Gumi-ro Bundang-gu
Gyeonggi-do
Department of Family Medicine
Seoul National University Bundang Hospital
Seongnam
463-707
Korea
South

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

http://www.snubh.org/en/

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

Publication citations

Additional files

Editorial Notes