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

Not Applicable

Completed

• Conditions: Metabolic Syndrome; Obesity
• Interventions: Behavioral: Individualized education; Behavioral: Grouped education

• Registration Number: NCT01040546
• Lead Sponsor: China Medical University Hospital

Brief 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' 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 Timeline

• Study Start: 2007-03
• Primary Completion: 2009-02
• Study Completion: 2009-02
• Status Verified: 2009-12
• Study First Submitted: 2009-12-24
• Study First Submitted QC: 2009-12-28
• Last Update Submitted: 2009-12-28
• Study First Posted: 2009-12-29
• Last Update Posted: 2009-12-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 240

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Individualized education	Individualized education	Individualized consultation of health problem, dietary intake and exercise
Grouped education	Grouped education	Grouped consultation of health problem, dietary intake and exercise

Primary Outcome Measures

Name	Time	Method
Weight, BMI, total body fat and waist circumference	3,6 and 12 months since intervention

Secondary Outcome Measures

Name	Time	Method
Metabolic syndrome and its components	3,6 and 12 months since intervention

Trial Locations

Locations (1)

Department of Famility Medicine,China Medical University Hospital; 🇨🇳 Taichung, Taiwan