The Effect of a Diet- and Exercise- Related Weight Control Intervention Program on Obesity in Adult Aged 40 and Over

This study has been completed.
Sponsor:
Collaborator:
Department of Health, Executive Yuan, R.O.C. (Taiwan)
Information provided by:
China Medical University Hospital
ClinicalTrials.gov Identifier:
NCT01040546
First received: December 24, 2009
Last updated: December 28, 2009
Last verified: December 2009
  Purpose

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.


Condition Intervention
Metabolic Syndrome
Obesity
Behavioral: Individualized education
Behavioral: Grouped education

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Health Services Research
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

Resource links provided by NLM:


Further study details as provided by China Medical University Hospital:

Primary Outcome Measures:
  • Weight, BMI, total body fat and waist circumference [ Time Frame: 3,6 and 12 months since intervention ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Metabolic syndrome and its components [ Time Frame: 3,6 and 12 months since intervention ] [ Designated as safety issue: Yes ]

Enrollment: 240
Study Start Date: March 2007
Study Completion Date: February 2009
Primary Completion Date: February 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Individualized education
Individualized consultation of health problem, dietary intake and exercise
Behavioral: Individualized education
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.
Experimental: Grouped education
Grouped consultation of health problem, dietary intake and exercise
Behavioral: Grouped education
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.

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.

  Eligibility

Ages Eligible for Study:   40 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01040546

Locations
Taiwan
Department of Famility Medicine,China Medical University Hospital
Taichung, Taiwan
Sponsors and Collaborators
China Medical University Hospital
Department of Health, Executive Yuan, R.O.C. (Taiwan)
Investigators
Study Chair: Cheng-Chieh Lin, Ph.D. China Medical University Hospital, Taiwan
  More Information

No publications provided

Responsible Party: Cheng-Chieh Lin, Ph.D., China Medical University
ClinicalTrials.gov Identifier: NCT01040546     History of Changes
Other Study ID Numbers: DOH97-TD-F-113-96002
Study First Received: December 24, 2009
Last Updated: December 28, 2009
Health Authority: Taiwan: Department of Health

Keywords provided by China Medical University Hospital:
Obesity
Metabolic syndrome
Weight control educational intervention
Food intake

Additional relevant MeSH terms:
Obesity
Metabolic Syndrome X
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms
Insulin Resistance
Hyperinsulinism
Glucose Metabolism Disorders
Metabolic Diseases

ClinicalTrials.gov processed this record on August 19, 2014