UMIN-CTR Clinical Trial

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	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
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000033654