UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000029480
Receipt No. R000033654
Scientific Title Effects of nutrition advice and exercise interventions on body weight and cardiovascular disease risk factors in obese adults: study protocol for a randomized controlled trial
Date of disclosure of the study information 2017/10/10
Last modified on 2019/07/01

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information
Public title Effects of nutrition advice and exercise interventions on body weight and cardiovascular disease risk factors in obese adults: study protocol for a randomized controlled trial
Acronym Second trial of MOHMS/JICA NCD Project
Scientific Title Effects of nutrition advice and exercise interventions on body weight and cardiovascular disease risk factors in obese adults: study protocol for a randomized controlled trial
Scientific Title:Acronym Second trial of MOHMS/JICA NCD Project
Region
Asia(except Japan)

Condition
Condition Obesity
Classification by specialty
Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To assess and compare the effectiveness of both dietary intervention and physical activity interventions based on the individualized motivational counselling and group based counseling within the workplace setting to produce weight loss in overweight and obese adults in selected population in Fiji
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Anthropometry (Weight and height; BMI, Waist circumference), blood pressures and RBS/FBS are collected before and after the intervention.
Key secondary outcomes Body fat, triglycerides, HbA1c, cholesterol and HDL-cholesterol are collected before and after the intervention. Psychosocial health is measured before and after the intervention. In-depth interviews is carried out only after the intervention.

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control No treatment
Stratification NO
Dynamic allocation NO
Institution consideration
Blocking NO
Concealment

Intervention
No. of arms 3
Purpose of intervention Educational,Counseling,Training
Type of intervention
Behavior,custom
Interventions/Control_1 (n=72); Individualized motivational counselling with moderate intensity exercise and dietary change. Pedometer, T-shirts, Self-monitoring tools and copies of Fijian national dietary and PA guidelines are provided to the participants. Three counseling sessions are provided to these participants: First counseling lasts 45 minutes, second counseling for 30 minutes is taken place one month after the first counseling and the final counseling for 30 minutes is provided two month after the first counseling.Phone call follow-ups (10min.) are provided by counselors in between counseling. (Total number of calls: 3 times) The total period of intervention is three monthes. Aerobics classes for 60 minutes sessions are provided 4 times in a week.
Interventions/Control_2 (n=73); Group-based motivational counselling program with moderate intensity exercise and dietary change. Pedometer, T-shirts, Self-monitoring tools and copies of Fijian national dietary and PA guidelines are provided to the participants. Group counseling sessions for 90 minutes are provided for three times during the period of three months: Second counseling is taken place one month after the first counseling. Third counseling is taken place two month after the first counseling. Aerobics classes for 60 minutes sessions are provided 4 times in a week.
Interventions/Control_3 (n=71) Self-monitoring tools and copies of Fijian national dietary and PA guidelines are provided. No other intervention is provided to this group. The study aims to involve 216 Fijian adults with obesity (BMI over 30) aged 18 to 65 years.
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit
18 years-old <=
Age-upper limit
65 years-old >=
Gender Male and Female
Key inclusion criteria Participants in this study consits of a target sample of 216 adults with obesity (BMI over 30) aged 18 to 65 years. Individuals taking medication for blood pressure, blodd lipids, with a diagnosis of diabetes mellutus (type1 or type2) are included in this study only after the physician's consultation.
Key exclusion criteria Pregnant women and participants who are no suitable for the study after physicain's evaluation are excluded. the examination by physician incude cardiac and musculoskeletal status evaluations, risk evaluation concerning exercise tolerance and family backgound-related diseases.
Target sample size 216

Research contact person
Name of lead principal investigator
1st name Naomi
Middle name
Last name Hamada
Organization Ministry of Health and Medical Services
Division name Wellness Center
Zip code 0000
Address Level 3, Namosi House 88 Amy Street, Suva, Fiji
TEL 6793314988
Email naomi.hamada5@gmail.com

Public contact
Name of contact person
1st name Naomi
Middle name
Last name Hamada
Organization Ministry of Health and Medical Services
Division name Wellness Center
Zip code 0000
Address Level 3, Namosi House 88 Amy Street, Suva, Fiji
TEL 6793314988
Homepage URL
Email naomi.hamada5@gmail.com

Sponsor
Institute Japan International Cooperation Agency
Institute
Department

Funding Source
Organization Japan International Cooperation Agency
Organization
Division
Category of Funding Organization Japanese Governmental office
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization Ministry of Health& Medical Services Fiji/JICA
Address Level3, Namosi House 88 Amy Street, Suva, Fiji
Tel 679-331-4988
Email naomi.hamada5@gmail.com

Secondary IDs
Secondary IDs NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information
2017 Year 10 Month 10 Day

Related information
URL releasing protocol
Publication of results Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status No longer recruiting
Date of protocol fixation
2017 Year 09 Month 01 Day
Date of IRB
Anticipated trial start date
2017 Year 09 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2017 Year 10 Month 10 Day
Last modified on
2019 Year 07 Month 01 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033654

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.