Condition category
Circulatory System
Date applied
13/01/2014
Date assigned
05/02/2014
Last edited
14/07/2014
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

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

Contact information

Type

Scientific

Primary contact

Prof Jina Choo

ORCID ID

Contact details

Anam-Dong
Seongbuk-Gu
Seoul
136-705
Korea
South

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 measures

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

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

http://www.nrf.re.kr/nrf_eng_cms/

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

Results - basic reporting

Publication summary

2014 results in: http://www.ncbi.nlm.nih.gov/pubmed/25011384

Publication citations

  1. 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.

Additional files

Editorial Notes