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Community-based heart and weight management trial ('Heart and Weightless')

Community-based heart and weight management trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN46069848
Enrollment
110
Registered
2014-02-05
Start date
2010-09-01
Completion date
Unknown
Last updated
2015-01-13

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

Conditions

Cardiovascular health Circulatory System

Interventions

We conducted two consecutive types of intervention (diet alone vs diet plus exercise intervention) in a sequence over 12 months in a weight management program. The 12-month study period had a diet-alo
the diet-alone intervention was implemented by requesting all three groups not to do exercise for the first 3 months. The study was a randomized intervention with three different exercise groups: 1.
assessors for all outcomes were blinded to participant group assignment, and all outcome data were kept blinded until the final data entry for the 12-month assessment was completed.

Sponsors

National Research Foundation of Korea (NRF) (South Korea)
Lead Sponsor

Eligibility

Sex/Gender
Female

Inclusion criteria

Inclusion criteria: 1. Healthy women aged between 18 and 65 years 2. Elevated waist circumference (greater than or equal to 85 cm) according to the criteria for abdominal obesity as defined by the Korean Society for the Study of Obesity (Lee et al. 2007) 3. Willing to be randomly assigned to one of three different exercise modes (i.e., aerobic, resistance and combination exercise training)

Exclusion criteria

Exclusion criteria: 1. Current medical conditions such as cardiovascular diseases, diabetes or cancers requiring physician supervision 2. Physical limitations restricting exercise ability 3. Use of hormone therapy 4. Participation in weight loss intervention during the last year 5. Weight change in the 4 weeks prior to participation in our study.

Design outcomes

Primary

MeasureTime frame
Endothelial dysfunction, as measured by flow-mediated dilation (FMD), at baseline, 3, 6 and 9 months

Secondary

MeasureTime frame
1. Aortic stiffness, as measured by carotid-femoral pulse wave velocity 2. Carotid atherosclerosis, as measured by carotid intima-media thickness 3. Cardiometabolic factors 4. Psychosocial factors 5. Quality of life Measured at baseline, 3, 6 and 9 months

Countries

Korea, South

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Mar 20, 2026