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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

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 - Second trial of MOHMS/JICA NCD Project

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000029480
Enrollment
216
Registered
2017-10-10
Start date
2017-09-01
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Obesity

Interventions

(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 prov
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 ar

Sponsors

Japan International Cooperation Agency
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

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.

Exclusion criteria

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.

Design outcomes

Primary

MeasureTime frame
Anthropometry (Weight and height; BMI, Waist circumference), blood pressures and RBS/FBS are collected before and after the intervention.

Secondary

MeasureTime frame
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.

Countries

Asia(except Japan)

Contacts

Public ContactNaomi Hamada

Ministry of Health and Medical Services Wellness Center

naomi.hamada5@gmail.com6793314988

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026