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

ISRCTN ISRCTN46069848
DOI https://doi.org/10.1186/ISRCTN46069848
Secondary identifying numbers NRF 2010-0022022
Submission date
13/01/2014
Registration date
05/02/2014
Last edited
14/07/2014
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Circulatory System
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data

Plain English summary of protocol

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

Contact information

Prof Jina Choo
Scientific

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

Study information

Study designRandomized controlled trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Other
Study typePrevention
Participant information sheet Not available in web format, please use the contact details below to request a patient information sheet
Scientific titleCommunity-based heart and weight management trial
Study acronymHEART-WEIGHT
Study objectivesPrimary 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(s)Institutional Review Board at Korea University, 01/04/2011, KU-IRB-11-10-A-2
Health condition(s) or problem(s) studiedCardiovascular health
InterventionWe 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 typeOther
Primary outcome measureEndothelial dysfunction, as measured by flow-mediated dilation (FMD), at baseline, 3, 6 and 9 months
Secondary outcome measures1. 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 study start date01/09/2010
Completion date31/08/2013

Eligibility

Participant type(s)Patient
Age groupAdult
Lower age limit18 Years
SexFemale
Target number of participants110
Key inclusion criteria1. 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)
Key exclusion criteria1. 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.
Date of first enrolment01/09/2010
Date of final enrolment31/08/2013

Locations

Countries of recruitment

  • Korea, South

Study participating centre

Anam-Dong
Seoul
136-705
Korea, South

Sponsor information

National Research Foundation of Korea (NRF) (South Korea)
Government

25 Heonreung-ro
Seocho-gu
Seoul
137-748
Korea, South

Website http://www.nrf.re.kr/nrf_eng_cms/
ROR logo "ROR" https://ror.org/013aysd81

Funders

Funder type

Government

National Research Foundation of Korea (NRF) (Korea, South), No. 2010-0022022

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Results article results 10/07/2014 Yes No