NCT01136096

Brief Summary

Investigators hypothesized home-based exercise intervention was beneficial to those who have had diabetic risk factor for type 2 diabetes mellitus

Trial Health

87
On Track

Trial Health Score

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

Enrollment
216

participants targeted

Target at P50-P75 for not_applicable diabetes-mellitus

Timeline
Completed

Started Jan 2004

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2004

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2005

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2005

Completed
5 years until next milestone

First Submitted

Initial submission to the registry

May 23, 2010

Completed
11 days until next milestone

First Posted

Study publicly available on registry

June 3, 2010

Completed
Last Updated

June 3, 2010

Status Verified

June 1, 2010

Enrollment Period

1.4 years

First QC Date

May 23, 2010

Last Update Submit

June 2, 2010

Conditions

Diabetes Mellitus

Keywords

diabetesphysical activityadiponectinmetabolic risksexerciseprimary prevention

Outcome Measures

Primary Outcomes (2)

  • Plasma adiponectin level in μg/ml

    Fasting blood samples were centrifuged to obtain plasma and then immediately stored at -20℃. Plasma adiponectin levels were then determined through enzyme-linked immunoassay (ELISA).

    Nine months after the start of the intervention

  • Exercise behavior

    1. Exercise self-efficacy: Measured by exercise self-efficacy questionnaire in score 2. Physical activity: Meausred by 7-day recall questionnaire in kcal/kg/day

    Nine months after the start of the intervention

Secondary Outcomes (6)

  • Insulin resistance

    Three, 6 and 9 months after the start of the intervention

  • Metabolic components

    Three, 6 and 9 months after the start of the intervention

  • Physical fitness

    Three, 6 and 9 months after the start of the intervention

  • Dietary intake

    Three, 6 and 9 months after the start of the intervention

  • Plasma adiponectin level in μg/ml

    Three and 6 months after the start of the intervention

  • +1 more secondary outcomes

Study Arms (2)

Lifestyle counseling

EXPERIMENTAL

To promote participants' exercise behaviors with individualized home-based exercise program was designed based on the Health Belief Model and Transtheoretical Model

Behavioral: Physical activity promoting intervention

Control

OTHER

Received oral instruction and written general education information without individualized exercise program

Behavioral: General instruction and education

Interventions

Physical activity promoting interventionBEHAVIORAL

1. An interview with a physiotherapist 2. An exercise video specially designed by this study including warm-up, aerobic, cool-down and stretching exercises, and/or a simple exerciser to use at home 3. An individualized home-based exercise program based on the Health Belief Model and Transtheoretical Model 4. The daily record to check their body weight, exercise mode and duration 5. Proper diet, caloric intake calculation, metabolic risk factors and prevention of diabetes were taught and a guide book was provided that included all the above mentioned details 6. Telephone reminders of healthy lifestyle including the ways of overcoming barriers of regular exercise every 1 to 2 weeks for 3 months, 1-2 calls a month afterwards and no calls for the last month on a tapered off schedule

Also known as: Home-based exercise, Exercise behavior modification
Lifestyle counseling
General instruction and educationBEHAVIORAL

1. Oral instruction and written general education information about weight control, proper diet and regular exercise in a one-page education brochure that was similar to the way used in the outpatient clinic 2. Telephone reminders of healthy lifestyle every 1 to 2 weeks for 3 months, 1-2 calls a month afterwards and no calls for the last month on a tapered off schedule 3. Without individualized exercise program and interview with a physiotherapist

Also known as: General advice, Medical education
Control

Eligibility Criteria

Age20 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • At least one of the following criteria as following: BMI \>=24 kg/m\*m, hypertension, dyslipidemia, fist-degree relatives of parents with type 2 diabetes, impaired glucose tolerance, gestational diabetes and delivering a babt weighing \>=4.0 kg
  • Ability of understanding Chinese or Taiwanese

You may not qualify if:

  • Diabetes
  • Receiving treatment with insulin or oral hypoglycemic agents
  • Any other serious illness that prohibit them to undertake fitness evaluation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Taiwan University Hospital

Taipei, 100, Taiwan

Location

Related Publications (10)

  • Pan XR, Li GW, Hu YH, Wang JX, Yang WY, An ZX, Hu ZX, Lin J, Xiao JZ, Cao HB, Liu PA, Jiang XG, Jiang YY, Wang JP, Zheng H, Zhang H, Bennett PH, Howard BV. Effects of diet and exercise in preventing NIDDM in people with impaired glucose tolerance. The Da Qing IGT and Diabetes Study. Diabetes Care. 1997 Apr;20(4):537-44. doi: 10.2337/diacare.20.4.537.

    PMID: 9096977BACKGROUND

  • Tuomilehto J, Lindstrom J, Eriksson JG, Valle TT, Hamalainen H, Ilanne-Parikka P, Keinanen-Kiukaanniemi S, Laakso M, Louheranta A, Rastas M, Salminen V, Uusitupa M; Finnish Diabetes Prevention Study Group. Prevention of type 2 diabetes mellitus by changes in lifestyle among subjects with impaired glucose tolerance. N Engl J Med. 2001 May 3;344(18):1343-50. doi: 10.1056/NEJM200105033441801.

    PMID: 11333990BACKGROUND

  • Knowler WC, Barrett-Connor E, Fowler SE, Hamman RF, Lachin JM, Walker EA, Nathan DM; Diabetes Prevention Program Research Group. Reduction in the incidence of type 2 diabetes with lifestyle intervention or metformin. N Engl J Med. 2002 Feb 7;346(6):393-403. doi: 10.1056/NEJMoa012512.

    PMID: 11832527BACKGROUND

  • Esposito K, Pontillo A, Di Palo C, Giugliano G, Masella M, Marfella R, Giugliano D. Effect of weight loss and lifestyle changes on vascular inflammatory markers in obese women: a randomized trial. JAMA. 2003 Apr 9;289(14):1799-804. doi: 10.1001/jama.289.14.1799.

    PMID: 12684358BACKGROUND

  • Arita Y, Kihara S, Ouchi N, Takahashi M, Maeda K, Miyagawa J, Hotta K, Shimomura I, Nakamura T, Miyaoka K, Kuriyama H, Nishida M, Yamashita S, Okubo K, Matsubara K, Muraguchi M, Ohmoto Y, Funahashi T, Matsuzawa Y. Paradoxical decrease of an adipose-specific protein, adiponectin, in obesity. Biochem Biophys Res Commun. 1999 Apr 2;257(1):79-83. doi: 10.1006/bbrc.1999.0255.

    PMID: 10092513BACKGROUND

  • Hotta K, Funahashi T, Arita Y, Takahashi M, Matsuda M, Okamoto Y, Iwahashi H, Kuriyama H, Ouchi N, Maeda K, Nishida M, Kihara S, Sakai N, Nakajima T, Hasegawa K, Muraguchi M, Ohmoto Y, Nakamura T, Yamashita S, Hanafusa T, Matsuzawa Y. Plasma concentrations of a novel, adipose-specific protein, adiponectin, in type 2 diabetic patients. Arterioscler Thromb Vasc Biol. 2000 Jun;20(6):1595-9. doi: 10.1161/01.atv.20.6.1595.

    PMID: 10845877BACKGROUND

  • Ouchi N, Kihara S, Arita Y, Maeda K, Kuriyama H, Okamoto Y, Hotta K, Nishida M, Takahashi M, Nakamura T, Yamashita S, Funahashi T, Matsuzawa Y. Novel modulator for endothelial adhesion molecules: adipocyte-derived plasma protein adiponectin. Circulation. 1999 Dec 21-28;100(25):2473-6. doi: 10.1161/01.cir.100.25.2473.

    PMID: 10604883BACKGROUND

  • King H, Kriska AM. Prevention of type II diabetes by physical training. Epidemiological considerations and study methods. Diabetes Care. 1992 Nov;15(11):1794-9. doi: 10.2337/diacare.15.11.1794.

    PMID: 1468317BACKGROUND

  • Li S, Shin HJ, Ding EL, van Dam RM. Adiponectin levels and risk of type 2 diabetes: a systematic review and meta-analysis. JAMA. 2009 Jul 8;302(2):179-88. doi: 10.1001/jama.2009.976.

    PMID: 19584347BACKGROUND

  • Chen CN, Chuang LM, Korivi M, Wu YT. Home-based exercise may not decrease the insulin resistance in individuals with metabolic syndrome. J Phys Act Health. 2015 Jan;12(1):74-9. doi: 10.1123/jpah.2013-0284. Epub 2014 Feb 5.

    PMID: 24509907DERIVED

MeSH Terms

Conditions

Diabetes MellitusMotor Activity

Interventions

Educational Status

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesBehavior

Intervention Hierarchy (Ancestors)

Socioeconomic FactorsPopulation Characteristics

Study Officials

  • Ying-Tai Wu, Doctor

    National Taiwan University Hospital

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

May 23, 2010

First Posted

June 3, 2010

Study Start

January 1, 2004

Primary Completion

June 1, 2005

Study Completion

June 1, 2005

Last Updated

June 3, 2010

Record last verified: 2010-06

Locations

TW(1)