search
Back to results

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

Primary Purpose

Metabolic Syndrome, Obesity

Status
Completed
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
Individualized education
Grouped education
Sponsored by
China Medical University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Metabolic Syndrome focused on measuring Obesity, Metabolic syndrome, Weight control educational intervention, Food intake

Eligibility Criteria

40 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Department of Famility Medicine,China Medical University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Individualized education

Grouped education

Arm Description

Individualized consultation of health problem, dietary intake and exercise

Grouped consultation of health problem, dietary intake and exercise

Outcomes

Primary Outcome Measures

Weight, BMI, total body fat and waist circumference

Secondary Outcome Measures

Metabolic syndrome and its components

Full Information

First Posted
December 24, 2009
Last Updated
December 28, 2009
Sponsor
China Medical University Hospital
Collaborators
Department of Health, Executive Yuan, R.O.C. (Taiwan)
search

1. Study Identification

Unique Protocol Identification Number
NCT01040546
Brief Title
The Effect of a Diet- and Exercise- Related Weight Control Intervention Program on Obesity in Adult Aged 40 and Over
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
Study Type
Interventional

2. Study Status

Record Verification Date
December 2009
Overall Recruitment Status
Completed
Study Start Date
March 2007 (undefined)
Primary Completion Date
February 2009 (Actual)
Study Completion Date
February 2009 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
China Medical University Hospital
Collaborators
Department of Health, Executive Yuan, R.O.C. (Taiwan)

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Metabolic Syndrome, Obesity
Keywords
Obesity, Metabolic syndrome, Weight control educational intervention, Food intake

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
240 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Individualized education
Arm Type
Experimental
Arm Description
Individualized consultation of health problem, dietary intake and exercise
Arm Title
Grouped education
Arm Type
Experimental
Arm Description
Grouped consultation of health problem, dietary intake and exercise
Intervention Type
Behavioral
Intervention Name(s)
Individualized education
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Grouped education
Intervention Description
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.
Primary Outcome Measure Information:
Title
Weight, BMI, total body fat and waist circumference
Time Frame
3,6 and 12 months since intervention
Secondary Outcome Measure Information:
Title
Metabolic syndrome and its components
Time Frame
3,6 and 12 months since intervention

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Cheng-Chieh Lin, Ph.D.
Organizational Affiliation
China Medical University Hospital,Taiwan
Official's Role
Study Chair
Facility Information:
Facility Name
Department of Famility Medicine,China Medical University Hospital
City
Taichung
Country
Taiwan

12. IPD Sharing Statement

Learn more about this trial

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

We'll reach out to this number within 24 hrs