NCT01040546

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
240

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Mar 2007

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2007

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2009

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

December 24, 2009

Completed
5 days until next milestone

First Posted

Study publicly available on registry

December 29, 2009

Completed
Last Updated

December 29, 2009

Status Verified

December 1, 2009

Enrollment Period

1.9 years

First QC Date

December 24, 2009

Last Update Submit

December 28, 2009

Conditions

Metabolic SyndromeObesity

Keywords

ObesityMetabolic syndromeWeight control educational interventionFood intake

Outcome Measures

Primary Outcomes (1)

  • Weight, BMI, total body fat and waist circumference

    3,6 and 12 months since intervention

Secondary Outcomes (1)

  • Metabolic syndrome and its components

    3,6 and 12 months since intervention

Study Arms (2)

Individualized education

EXPERIMENTAL

Individualized consultation of health problem, dietary intake and exercise

Behavioral: Individualized education

Grouped education

EXPERIMENTAL

Grouped consultation of health problem, dietary intake and exercise

Behavioral: Grouped education

Interventions

Individualized educationBEHAVIORAL

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.

Individualized education
Grouped educationBEHAVIORAL

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.

Grouped education

Eligibility Criteria

Age40 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Famility Medicine,China Medical University Hospital

Taichung, Taiwan

Location

MeSH Terms

Conditions

Metabolic SyndromeObesity

Condition Hierarchy (Ancestors)

Insulin ResistanceHyperinsulinismGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesOverweightOvernutritionNutrition DisordersBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Cheng-Chieh Lin, Ph.D.

    China Medical University Hospital

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

December 24, 2009

First Posted

December 29, 2009

Study Start

March 1, 2007

Primary Completion

February 1, 2009

Study Completion

February 1, 2009

Last Updated

December 29, 2009

Record last verified: 2009-12

Locations

TW(1)