UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000029480 |
|---|---|
| Receipt number | 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 | 2022/10/17 14:40:45 |
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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
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
naomi.hamada5@gmail.com
Sponsor or person
Institute
Japan International Cooperation Agency
Institute
Department
Personal name
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
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
216
Results
There were significant improvements in weight, BMI, and systolic blood pressure in individual counseling group (G1) and group-based counseling group (G2) compared with control group (G3). No changes were observed in the biochemical measurements.
Results date posted
| 2022 | Year | 10 | Month | 17 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
None
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
| 2022 | Year | 10 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033654
