Diabetes Mellitus
Conditions
Keywords
diabetes, physical activity, adiponectin, metabolic risks, exercise, primary prevention
Brief summary
Investigators hypothesized home-based exercise intervention was beneficial to those who have had diabetic risk factor for type 2 diabetes mellitus
Detailed description
This randomized clinical trial was designed to investigate whether a home-based exercise could improve adiponectin levels, exercise behavior and metabolic risk factors (insulin resistance, metabolic components and physical fitness) in subjects with at least a diabetic risk factor for type 2 diabetes mellitus. Participants were randomly allocated to either a control group or a home-based exercise group. All participants were evaluated for outcome measures at baseline, and at 3-month 6-month and 9-month follow-up after engaging in the intervention.
Interventions
BEHAVIORALPhysical activity promoting intervention
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
BEHAVIORALGeneral instruction and education
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
Sponsors
Department of Health, Executive Yuan, R.O.C. (Taiwan)
National Taiwan University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
20 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
* 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
Exclusion criteria
* Diabetes * Receiving treatment with insulin or oral hypoglycemic agents * Any other serious illness that prohibit them to undertake fitness evaluation
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Plasma adiponectin level in μg/ml | Nine months after the start of the intervention | 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). |
| Exercise behavior | Nine months after the start of the intervention | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Physical fitness | Three, 6 and 9 months after the start of the intervention | 1. Body composition (kg/m\^2): Body mass index that was weight in kilograms divided by the square of height in meter 2. Flexibility (cm): Meausred by sit-and-reach test 3. Grip strength (Nm): Measured by Jamar handheld dynameter 4. Muscle endurance (times/min): Measured by sit-up test 5. Cardiopulmonary fitness (3-minute step test) |
| Dietary intake | Three, 6 and 9 months after the start of the intervention | Measured by 24-hour recall guestionnaire in kcal/kg/day |
| Insulin resistance | Three, 6 and 9 months after the start of the intervention | plasma inulin level (μU/ml) meausred by AxSYM with HOMA-IR was caculated |
| Exercise behavior | Three and 6 months after the start of the intervention | 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 |
| Plasma adiponectin level in μg/ml | Three and 6 months after the start of the intervention | 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) |
| Metabolic components | Three, 6 and 9 months after the start of the intervention | 1. Waist circumference (cm) 2. Fasting blood samples were centrifuged to obtain plasma for plasma triglycerides (TG) and high-density lipoprotein (HDL) levels in mg/dl 3. Plasma fasting glucose (FG) levels were measured in mg/dl by using the glucose oxidase membrane/hydrogen peroxide electrode method with the Antsense II analyzer (Bayer-Sankyo Co., Tokyo, Japan) 4. Systolic blood pressure (SBP) and dystolic blood pressure (DBP) in mmHg |
Countries
Taiwan
Outcome results
None listed