Metabolic SyndromeNCT01040546
The Effect of a Diet- and Exercise- Related Weight Control Intervention Program on Obesity in Adult Aged 40 and Over
A study testing Individualized education and Grouped education in people with Metabolic Syndrome and Obesity, run by China Medical University Hospital at 1 site in Taiwan.
Trial summary
The purpose of this study is to assess study subjects' adherence to different weight control intervention programs and the effect of intervention programs on physical and biochemical examinations, physical fitness, food intake and exercise behaviors and the prevalence of metabolic syndrome and its components'… Read more about this study
- Who is it for?
- Ages 40 to 75 years
- Conditions the study is for
- Metabolic Syndrome, Obesity
- What is being tested?
- Individualized education and Grouped education
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 240 participants
- Where
- 1 siteTaiwan
- Study dates
- Mar 2007to Feb 2009
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Those with overweight or central obesity (body mass index >= 24 kg/m2) and/or waist circumference >= 90 cm in men or >= 80 cm in women.
Who cannot join
- Those with impaired hearing,
- Those who are handicap,
- Those living outland,
- Those who are older than 75 years old, and
- Those participates that cannot keep to regular follow-up in this study.
Trial locations and contacts
1 site in 1 country.
Taiwan1 site
Department of Famility Medicine,China Medical University Hospital
Taichung
About this study
Official title: The Association of Obesity With Food Intake and Metabolic Syndrome in Adult Aged 40 and Over and the Effect of a Diet- and Exercise- Related Weight Control Intervention Program on Obesity
The purpose of this study is to assess study subjects' adherence to different weight control intervention programs and the effect of intervention programs on physical and biochemical examinations, physical fitness, food intake and exercise behaviors and the prevalence of metabolic syndrome and its components' abnormalities.
Read the detailed description
Obesity and metabolic syndrome increase the risk of developing cardiovascular disease. Besides, they prevail around the world and certainly become the most important health problems globally. Dietary intake and exercise are regarded as the first line approach to reduce the occurrence of obesity and metabolic syndrome. The purpose of this study is to assess study subjects' adherence to different weight control intervention programs and the effect of intervention programs on physical and biochemical examinations, physical fitness, food intake and exercise behaviors and the prevalence of metabolic syndrome and its components' abnormalities.
This is a two-year project. In the first year, we estimated the prevalence of obesity and metabolic syndrome and explored their relationship with dietary intake and exercise status using the cross-sectional framework in subjects aged 40 years and over from Taichung Community Health Study. Then, we conducted a randomized controlled trial to evaluate the effects of three types of weight control educational intervention programs. Obese subjects were randomly allocated into "individualized health education group", "fellowship health education group" and "mail-delivered health education group". The sample size for these three groups was 79, 81, 80, respectively. All subjects received one of three 6-month interventions and were followed up for 1 year and were assessed at 6-month interval.
This study adopted the criteria of WHO for Asia area and the Department of Health (DOH), Executive Yuan, Taiwan to define the obesity. The prevalence of obesity for WHO definition modified for Asians and DOH among Taichung residents aged forty years old and over is 37.34% and 18.79%, respectively. For the effectiveness of weight control educational programs, after 6-month intervention, reductions in weight, BMI, waist, hip, arm, and bad diet habit were observed in all groups. And after 6-month intervention, reductions in BMI is significantly greater in the individualized and fellowship weight control groups than in the "health education group". After 6-month educational intervention, metabolic syndrome in the individualized and fellowship health education groups decreased from 78.48% and 72.84% to 60.76% and 61.73%, respectively, which corresponded to reductions of 17.72% and 11.11% of baseline metabolic syndrome.
Our study's findings indicate that individualized and fellowship health education groups modify food intake and exercise behaviors, and further reduce body composition, level of biomarkers and prevalence of metabolic syndrome and its components abnormalities.
- Conditions
- Metabolic Syndrome, Obesity
- Being tested
- Individualized education, Grouped education
- Keywords
- Obesity, Metabolic syndrome, Weight control educational intervention, Food intake
- Medical subject headings
- Metabolic Syndrome, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Individualized educationBehavioural
We conducted a randomized controlled trial to evaluate the effects of three types of weight control educational intervention programs. Obese subjects were randomly allocated into "individualized health education group", "group weight control education" and "mail-delivered health education group".Obese subjects who were randomly allocated into "individualized health education group" received consulting services provided by a doctor, nutritionist and fitness expert. The interventions were 12 sessions over 6 months.
Grouped educationBehavioural
We conducted a randomized controlled trial to evaluate the effects of three types of weight control educational intervention programs. Obese subjects were randomly allocated into "individualized health education group", "group weight control education" and "mail-delivered health education group".Obese subjects who were randomly allocated into "grouped health education group" attended 12 sessions of group intervention over 6 months.
| Study group | Role | What they receive |
|---|---|---|
| Individualized education | Experimental | Individualized consultation of health problem, dietary intake and exercise Receives: Behavioral: Individualized education |
| Grouped education | Experimental | Grouped consultation of health problem, dietary intake and exercise Receives: Behavioral: Grouped education |
What is being measured
The primary outcome is the main question the study is designed to answer.
Weight, BMI, total body fat and waist circumference
Measured: 3,6 and 12 months since intervention
Secondary outcomes (1)
Metabolic syndrome and its components
Measured: 3,6 and 12 months since intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Dec 2009 (estimated)
- Study startMar 2007
- Primary completionFeb 2009
- Study completionFeb 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metabolic SyndromeStudies of the same condition, open and under way.
- More trials run by China Medical University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 240 participants (actual)
Sponsor and investigators
- Lead sponsor
- China Medical University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Department of Health, Executive Yuan, R.O.C. (Taiwan)
- Investigators
- Cheng-Chieh Lin, Ph.D., Study chair, China Medical University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01040546
- Sponsor's protocol ID
- DOH97-TD-F-113-96002
- Status last verified
- Dec 2009
- First submitted
- 24 Dec 2009
- Last updated
- 29 Dec 2009
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 29 Dec 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Association of Obesity With Food Intake and Metabolic Syndrome in Adult Aged 40 and Over and the Effect of a Diet- and Exercise- Related Weight Control Intervention Program on Obesity
- ClinicalTrials.gov ID
- NCT01040546
- Acronym / sponsor ID
- DOH97-TD-F-113-96002
- Conditions
- Metabolic Syndrome, Obesity
- Keywords
- Obesity, Metabolic syndrome, Weight control educational intervention, Food intake
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 240 participants (actual)
- Lead sponsor
- China Medical University HospitalUniversity, hospital or other
- Collaborators
- Department of Health, Executive Yuan, R.O.C. (Taiwan)
- Study start
- Mar 2007
- Primary completion
- Feb 2009 (actual)
- Study completion
- Feb 2009 (actual)
- First posted
- 29 Dec 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to assess study subjects' adherence to different weight control intervention programs and the effect of intervention programs on physical and biochemical examinations, physical fitness, food intake and exercise behaviors and the prevalence of metabolic syndrome and its components' abnormalities.
Detailed description
Obesity and metabolic syndrome increase the risk of developing cardiovascular disease. Besides, they prevail around the world and certainly become the most important health problems globally. Dietary intake and exercise are regarded as the first line approach to reduce the occurrence of obesity and metabolic syndrome. The purpose of this study is to assess study subjects' adherence to different weight control intervention programs and the effect of intervention programs on physical and biochemical examinations, physical fitness, food intake and exercise behaviors and the prevalence of metabolic syndrome and its components' abnormalities.
This is a two-year project. In the first year, we estimated the prevalence of obesity and metabolic syndrome and explored their relationship with dietary intake and exercise status using the cross-sectional framework in subjects aged 40 years and over from Taichung Community Health Study. Then, we conducted a randomized controlled trial to evaluate the effects of three types of weight control educational intervention programs. Obese subjects were randomly allocated into "individualized health education group", "fellowship health education group" and "mail-delivered health education group". The sample size for these three groups was 79, 81, 80, respectively. All subjects received one of three 6-month interventions and were followed up for 1 year and were assessed at 6-month interval.
This study adopted the criteria of WHO for Asia area and the Department of Health (DOH), Executive Yuan, Taiwan to define the obesity. The prevalence of obesity for WHO definition modified for Asians and DOH among Taichung residents aged forty years old and over is 37.34% and 18.79%, respectively. For the effectiveness of weight control educational programs, after 6-month intervention, reductions in weight, BMI, waist, hip, arm, and bad diet habit were observed in all groups. And after 6-month intervention, reductions in BMI is significantly greater in the individualized and fellowship weight control groups than in the "health education group". After 6-month educational intervention, metabolic syndrome in the individualized and fellowship health education groups decreased from 78.48% and 72.84% to 60.76% and 61.73%, respectively, which corresponded to reductions of 17.72% and 11.11% of baseline metabolic syndrome.
Our study's findings indicate that individualized and fellowship health education groups modify food intake and exercise behaviors, and further reduce body composition, level of biomarkers and prevalence of metabolic syndrome and its components abnormalities.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Individualized education | Experimental | Behavioral: Individualized educationIndividualized consultation of health problem, dietary intake and exercise |
| Grouped education | Experimental | Behavioral: Grouped educationGrouped consultation of health problem, dietary intake and exercise |
Who may qualify
- Ages
- 40 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Those with overweight or central obesity (body mass index >= 24 kg/m2) and/or waist circumference >= 90 cm in men or >= 80 cm in women.
Key exclusion criteria (5 listed)
- Those with impaired hearing,
- Those who are handicap,
- Those living outland,
- Those who are older than 75 years old, and
- Those participates that cannot keep to regular follow-up in this study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Individualized educationWe conducted a randomized controlled trial to evaluate the effects of three types of weight control educational intervention programs. Obese subjects were randomly allocated into "individualized health education group", "group weight control education" and "mail-delivered health education group".Obese subjects who were randomly allocated into "individualized health education group" received consulting services provided by a doctor, nutritionist and fitness expert. The interventions were 12 sessions over 6 months. | Behavioural | Individualized education |
| Grouped educationWe conducted a randomized controlled trial to evaluate the effects of three types of weight control educational intervention programs. Obese subjects were randomly allocated into "individualized health education group", "group weight control education" and "mail-delivered health education group".Obese subjects who were randomly allocated into "grouped health education group" attended 12 sessions of group intervention over 6 months. | Behavioural | Grouped education |
Primary outcome
Weight, BMI, total body fat and waist circumference
Time frame: 3,6 and 12 months since intervention
1 secondary outcome
Metabolic syndrome and its components
Time frame: 3,6 and 12 months since intervention
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Dec 2009.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Cheng-Chieh Lin, Ph.D. study chair
China Medical University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Individualized education and Grouped education in people with Metabolic Syndrome and Obesity, run by China Medical University Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Dec 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Weight, BMI, total body fat and waist circumference (time frame: 3,6 and 12 months since intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Dec 2009.