Plain English Summary
Background and study aims
The aim of the study is to find out about the different effects of three exercise modes (aerobic, resistance and combined exercises) on heart disease risk factors in a weight management intervention for women with abdominal obesity.
Who can participate?
Healthy women aged between 18 and 65 years and waist circumference (≥85 cm)
What does the study involve?
Eligible participants were invited to an orientation where they were provided a detailed study overview, asked for consent, and screened for additional inclusion criteria. Participants were randomly allocated to one of three different exercise groups: aerobic training only, resistance training only, and a combination of aerobic and resistance training.
What are the possible benefits and risks of participating?
Benefits to those taking part include weight loss and improvements in heart disease risk factors. Possible diverse side effects from exercise test for measuring cardiorespiratory fitness and exercise training. The exercise was planned to be supervised by trained researchers and exercise trainers. No risks were expected over the entire study period.
Where is the study run from?
The study has been set up by the Korea University in collaboration with University of Seoul.
When is the study starting and how long is it expected to run for?
The study started in September 2010 and ran until August 2013. Participants were enrolled on the study for a period of almost one year.
Who is funding the study?
National Research Foundation of Korea (NRF) (South Korea).
Who is the main contact?
Professor Jina Choo
Trial website
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
NRF 2010-0022022
Study information
Scientific title
Community-based heart and weight management trial
Acronym
HEART-WEIGHT
Study hypothesis
Primary hypothesis: in a weight management intervention different exercise modes (aerobic, resistance and combined exercises) would have significant differential effects on markers of subclinical atherosclerosis, cardiometabolic risk factors, and psychosocial/behavioral factors among women with abdominal obesity.
Secondary hypotheses: to determine associations between psychosocial/behavioral factors, associations between psychosocial/behavioral factors and cardiometabolic factors, and associations between abdominal obesity and cardiometabolic/subclinical atherosclerosis markers using both baseline and longitudinal data.
Ethics approval
Institutional Review Board at Korea University, 01/04/2011, KU-IRB-11-10-A-2
Study design
Randomized controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Other
Trial type
Prevention
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
Cardiovascular health
Intervention
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-alone intervention for the first 3 months and a diet-plus-exercise intervention for the next 9 months according to exercise modes; 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. Aerobic training only
2. Resistance training only
3. A combination of aerobic and resistance training
The intervention assignment was implemented with a different ratio (n=50 for aerobic exercise, n=30 for resistance exercise, and n=30 for combination exercise) by means of a random allocation computer program. Initially, the aerobic exercise group (n=50) was randomly allocated into two groups, one group with (n=30) and the other group without a behavioral therapy (n=20). Since there were no significant differences in any study variables between the aerobic exercise groups with and without behavioral therapy, we pooled the participants of the two groups into one aerobic exercise group (n=50) for the present study. This study was a single-blinded trial; 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.
Intervention type
Other
Phase
Not Applicable
Drug names
Primary outcome measure
Endothelial dysfunction, as measured by flow-mediated dilation (FMD), at baseline, 3, 6 and 9 months
Secondary outcome measures
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
Overall trial start date
01/09/2010
Overall trial end date
31/08/2013
Reason abandoned (if study stopped)
Eligibility
Participant 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)
Participant type
Patient
Age group
Adult
Gender
Female
Target number of participants
110
Participant 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.
Recruitment start date
01/09/2010
Recruitment end date
31/08/2013
Locations
Countries of recruitment
Korea, South
Trial participating centre
Anam-Dong
Seoul
136-705
Korea, South
Sponsor information
Organisation
National Research Foundation of Korea (NRF) (South Korea)
Sponsor details
25 Heonreung-ro
Seocho-gu
Seoul
137-748
Korea
South
Sponsor type
Government
Website
Funders
Funder type
Government
Funder name
National Research Foundation of Korea (NRF) (Korea, South), No. 2010-0022022
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list
2014 results in: http://www.ncbi.nlm.nih.gov/pubmed/25011384
Publication citations
-
Results
Choo J, Lee J, Cho JH, Burke LE, Sekikawa A, Jae SY, Effects of weight management by exercise modes on markers of subclinical atherosclerosis and cardiometabolic profile among women with abdominal obesity: a randomized controlled trial., BMC Cardiovasc Disord, 2014, 14, 82, doi: 10.1186/1471-2261-14-82.