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Clinical Trial Details — Status: Enrolling by invitation

Administrative data

NCT number NCT05530629
Other study ID # Wang Qiang
Secondary ID
Status Enrolling by invitation
Phase N/A
First received
Last updated
Start date August 20, 2022
Est. completion date December 1, 2023

Study information

Verified date September 2022
Source Universiti Putra Malaysia
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Resistance training is a common way of daily exercise which has a remarkable function in healthcare. It has been used in many diseases as a complementary method. Overweight and obesity are the sixth highest risk of death worldwide. In recent years, the data show that the rate of overweight obese among college students shows a significant increasing trend. The common characteristics of overweight and obese people are strong appetite which is difficult to be controled and sedentary. resistance training is a solid supplement to physical education and how to reduce appetite of overweight and obese college female students through resistance training is the key to increase their health by university sport course. The training plan divides the training intensity into three levels including 45-50% one repetition maximum(1RM), 60-65% 1RM, 45-50% 1RM, respectively plus control group. Therefore, this experimental research examines the effectiveness and the differences of three Intensities resistance training on energy intake and appetite regulation among overweight and obese college girl. Finally, to evaluate whether the resistance training can reduce the overweight and obese female college students' energy intake and appetite regulation


Description:

On the basis of consulting relevant literature, this paper designs a 12 week teaching plan of resistance training through experimental design and quantitative research methods, combined with the characteristics of resistance training and the physiological characteristics of obese or overweight people. The purpose of this experiment is to provide a theoretical basis for improving the teaching methods of College Students' physical education, so as to improve the energy intake and appetite regulation of obese and overweight female college students, and then reduce their weight. And compared with ordinary daily physical education courses. Among them, the experimental group was divided into three groups, and the resistance training with intensity of 45-50% 1RM, 60-65% 1RM and 80-85% 1RM was carried out respectively. The control group carried out daily physical education teaching content. The number of participating samples in each group is 18 overweight or obese female college students, and the samples in each group are located in different campuses. The first section of the training program of the experimental groups are warm up (10 mins) which including two parts. The first part is jogging and running indoor or stationary cycling outdoor with low intensity (5 minutes), the second part is muscle stretching: the Chinese eight set of radio kinetics (each movement 8 times) including stretch exercise, check augmentation exercise, kicking exercise, body side exercise, body rotation exercise, whole body exercise, jump exercise, cooling down exercise Then, the main resistance training section of the experimental group includes test press, late pull down, shoulder press, square, leg extension, leg curl, bicep curl, triceps extension, dominant crunches, lower back exercises In the last cool down phase, repeat the same content of muscle stretching as in the first part again. Three times a week, with an interval of more than 48 hours. Each exercise of main resistance training takes 2 sets, and the repetition times of low intensity, medium intensity and high intensity are 16-18 times, 10-12 times and 6-8 times respectively. The rest time between low-intensity, medium-intensity and high-intensity groups is 1 minute, 1-2 minutes and 2-3 minutes respectively. The total duration of each training is about 1 hour, including warm up for about 10 minutes, main training time for about 45 minutes, and final cool down for about 5 minutes. In addition, the maximum strength was retested once at week 1, 5 and 9 respectively The control group only changed the resistance training part to normal P.E. course which carried out general teaching content according to the college syllabus, other settings are the same.


Recruitment information / eligibility

Status Enrolling by invitation
Enrollment 72
Est. completion date December 1, 2023
Est. primary completion date October 15, 2022
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 18 Years to 22 Years
Eligibility Inclusion Criteria: 1. Overweight or obese (BMI> 25) 2. Female 3. College students 4. Healthy Exclusion Criteria: 1. The subjects lack regular and active exercise program in last three months 2. The subjects are not on a diet in last three months. c, Do not have regular menstrual cycle or approaching the normal menstrual cycle

Study Design


Related Conditions & MeSH terms


Intervention

Device:
resistance training
resistance training lasts for 12 weeks, three times a week, one hour each time, and the program of resistance training in the experimental group was divided into 10 exercises: Chest press, Lat pull down, Shoulder press, Squat, Leg extension, Leg curl, Bicep curl, Triceps extension, abdominal crunches, lower back exercises.
Normal P.E. course
Carry out general teaching content according to the college syllabus lasts for 12 weeks , three times a week, one hour each time, and the program of Normal P.E. course in the control group will be Physical recovery exercises, learn and practice queue formation, calisthenics, five step fists, long fist and Basic movements of Gymnastics gradually changed by week.

Locations

Country Name City State
China YiChun Education College Yichun Jiangxi

Sponsors (1)

Lead Sponsor Collaborator
Universiti Putra Malaysia

Country where clinical trial is conducted

China, 

References & Publications (1)

Bales CW, Hawk VH, Granville EO, Rose SB, Shields T, Bateman L, Willis L, Piner LW, Slentz CA, Houmard JA, Gallup D, Samsa GP, Kraus WE. Aerobic and resistance training effects on energy intake: the STRRIDE-AT/RT study. Med Sci Sports Exerc. 2012 Oct;44(1 — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Change from baseline BMI at 6 weeks and 12 weeks. This parameter belongs to Obesity Degree. Pretest: Before experiment; Mid-test: 6 weeks end; Post-test: 12 weeks end.
Primary Change from baseline body fat percentage at 6 weeks and 12 weeks. This parameter belongs to Obesity Degree. Pretest: Before experiment; Mid-test: 6 weeks end; Post-test: 12 weeks end.
Primary Change from baseline waist circumference at 6 weeks and 12 weeks. This parameter belongs to Obesity Degree. Pretest: Before experiment; Mid-test: 6 weeks end; Post-test: 12 weeks end.
Primary Change from baseline energy intake at 6 weeks and 12 weeks. This parameter will be recorded by Quantitative Daily Dietary Intake (QDI): three multiple-pass 24-hr recalls collected at each assessment time point by a research dietitian/technician. Analysis by Food Processor Nutrition Analysis Software (Version 9.6, 2005, ESHA Research, Salem, OR): recalls are analysed for calorie and macronutrient content Pretest: Before experiment; Mid-test: 6 weeks end; Post-test: 12 weeks end.
Primary Change from baseline hunger at 6 weeks and 12 weeks. This parameter will be test by 100-mm visual analogue scale (VAS): test at 6:00-8:00 am following a 10h overnight fast, rate perceive appetite firstly. Then provide with a standardised caloric stimulus, at 30, 60, 90 and 120min post consumption rate perceived appetite again (r = 0.42 - 0.85).
At every time point, both lengths of VAS 100 mm were used to record desire to eat, hunger, fullness, and prospective food consumption. The four standardized questions were:
(i) how strong is your desire to eat? ("very weak" to "very strong"), (ii) how hungry do you feel? ("not hungry at all" to "as hungry as I've ever felt"), (iii) how full do you feel? ("not full at all" to "very full"), and (iv) how much food do you think you can eat? (Prospective food consumption; "nothing at all" to "a large amount") .
Pretest: Before experiment; Mid-test: 6 weeks end; Post-test: 12 weeks end.
Primary Change from baseline fullness at 6 weeks and 12 weeks. This parameter will be test by 100-mm visual analogue scale (VAS): test at 6:00-8:00 am following a 10h overnight fast, rate perceive appetite firstly. Then provide with a standardised caloric stimulus, at 30, 60, 90 and 120min post consumption rate perceived appetite again (r = 0.42 - 0.85).
At every time point, both lengths of VAS 100 mm were used to record desire to eat, hunger, fullness, and prospective food consumption. The four standardized questions were:
(i) how strong is your desire to eat? ("very weak" to "very strong"), (ii) how hungry do you feel? ("not hungry at all" to "as hungry as I've ever felt"), (iii) how full do you feel? ("not full at all" to "very full"), and (iv) how much food do you think you can eat? (Prospective food consumption; "nothing at all" to "a large amount") .
Pretest: Before experiment; Mid-test: 6 weeks end; Post-test: 12 weeks end.
Primary Change from baseline desire to eat at 6 weeks and 12 weeks. This parameter will be test by 100-mm visual analogue scale (VAS): test at 6:00-8:00 am following a 10h overnight fast, rate perceive appetite firstly. Then provide with a standardised caloric stimulus, at 30, 60, 90 and 120min post consumption rate perceived appetite again (r = 0.42 - 0.85).
At every time point, both lengths of VAS 100 mm were used to record desire to eat, hunger, fullness, and prospective food consumption. The four standardized questions were:
(i) how strong is your desire to eat? ("very weak" to "very strong"), (ii) how hungry do you feel? ("not hungry at all" to "as hungry as I've ever felt"), (iii) how full do you feel? ("not full at all" to "very full"), and (iv) how much food do you think you can eat? (Prospective food consumption; "nothing at all" to "a large amount") .
Pretest: Before experiment; Mid-test: 6 weeks end; Post-test: 12 weeks end.
Primary Change from baseline prospective food consumption at 6 weeks and 12 weeks. This parameter will be test by 100-mm visual analogue scale (VAS): test at 6:00-8:00 am following a 10h overnight fast, rate perceive appetite firstly. Then provide with a standardised caloric stimulus, at 30, 60, 90 and 120min post consumption rate perceived appetite again (r = 0.42 - 0.85).
At every time point, both lengths of VAS 100 mm were used to record desire to eat, hunger, fullness, and prospective food consumption. The four standardized questions were:
(i) how strong is your desire to eat? ("very weak" to "very strong"), (ii) how hungry do you feel? ("not hungry at all" to "as hungry as I've ever felt"), (iii) how full do you feel? ("not full at all" to "very full"), and (iv) how much food do you think you can eat? (Prospective food consumption; "nothing at all" to "a large amount") .
Pretest: Before experiment; Mid-test: 6 weeks end; Post-test: 12 weeks end.
Primary Change from baseline glucose at 6 weeks and 12 weeks. Blood is collected into Vacutainers (BectonDickinson, Franklin Lakes, NJ) containing SST Gel (Becton Dickinson), Ethylenediaminetetraacetic acid(EDTA), or heparin and is immediately placed on ice and centrifuged (4 C, 1500g, 15 min). The serum or plasma obtained is stored in multiple aliquots at 75 C until assayed (in duplicate).
Glucose is determined by the glucose oxidase method (Sigma-Aldrich Corp; 3.8% and 4.9% inter- and intraassay coefficients of variation) (70~140mg/dl or 3.9~7.8mmol/l)
Pretest: Before experiment; Mid-test: 6 weeks end; Post-test: 12 weeks end.
Primary Change from baseline leptin at 6 weeks and 12 weeks. Blood is collected into Vacutainers (BectonDickinson, Franklin Lakes, NJ) containing Serum-separating tube(SST) Gel (Becton Dickinson), EDTA, or heparin and is immediately placed on ice and centrifuged (4 C, 1500g, 15 min). The serum or plasma obtained is stored in multiple aliquots at 75 C until assayed (in duplicate).
Serum leptin is determined by an ELISA with a commercially available kit (EIA-2395, DRG, Marburg, Germany; 5.9% intraassay precision; 6.8% interassay accuracy; sensitivity of 0.5ng/ml).
Pretest: Before experiment; Mid-test: 6 weeks end; Post-test: 12 weeks end.
Primary Change from baseline adiponectin at 6 weeks and 12 weeks. Blood is collected into Vacutainers (BectonDickinson, Franklin Lakes, NJ) containing SST Gel (Becton Dickinson), EDTA, or heparin and is immediately placed on ice and centrifuged (4 C, 1500g, 15 min). The serum or plasma obtained is stored in multiple aliquots at 75 C until assayed (in duplicate).
Plasma adiponectin is analysed with a commercially available radioimmunoassay (RIA) (Linco Research, Inc., St. Charles, mo; 6.9% intraassay precision; 7.8% interassay accuracy; sensitivity of 0.5ng/ml.) (3~30µg/mL).
Pretest: Before experiment; Mid-test: 6 weeks end; Post-test: 12 weeks end.
Primary Change from baseline NPY at 6 weeks and 12 weeks. Blood is collected into Vacutainers (BectonDickinson, Franklin Lakes, NJ) containing SST Gel (Becton Dickinson), EDTA, or heparin and is immediately placed on ice and centrifuged (4 C, 1500g, 15 min). The serum or plasma obtained is stored in multiple aliquots at 75 C until assayed (in duplicate).
Neuropeptide Y is measured by Liquid Chromatography with tandem mass spectrometry (LC-MS/MS) (NPY; Phoenix Europe Gesellschaft mit beschränkter Haftung (GmbH), Karlsruhe, Germany; Sensitivity of 0.13 ng/ml; Intra-assay variability <5%) (51.23~209.65 pg/ml).
Pretest: Before experiment; Mid-test: 6 weeks end; Post-test: 12 weeks end.
Primary Change from baseline Insulin at 6 weeks and 12 weeks. Blood is collected into Vacutainers (BectonDickinson, Franklin Lakes, NJ) containing SST Gel (Becton Dickinson), EDTA, or heparin and is immediately placed on ice and centrifuged (4 C, 1500g, 15 min). The serum or plasma obtained is stored in multiple aliquots at 75 C until assayed (in duplicate).
Insulin is measured with an immunoassay (Access Immunoassay System, Beckman Coulter, Fullerton, California (CA); 4.9% intraassay precision; 3.8% interassay accuracy; sensitivity of 0.5 µu/ml) (60-100mg/dl).
Pretest: Before experiment; Mid-test: 6 weeks end; Post-test: 12 weeks end.
Primary Change from baseline meal-time at 6 weeks and 12 weeks. This parameter record by Quantitative Daily Dietary Intake (QDI): three multiple-pass 24-hr recalls collected at each assessment time point by a research dietitian/technician. Analysis by Food Processor Nutrition Analysis Software (Version 9.6, 2005, ESHA Research, Salem, OR): recalls are analysed for the percentage of day and night total kcals intake separately. Pretest: Before experiment; Mid-test: 6 weeks end; Post-test: 12 weeks end.
Primary Change from baseline stress of eating at 6 weeks and 12 weeks. This parameter measured by The Salzburg Stress Eating Scale (SSES) which is the first to specifically address the relationship of stress experiences and coping failure on the one hand and increases or decreases in food intake on the other hand. Higher SSES scores indicate eating more when stressed, while lower scores indicate eating less when stressed. Pretest: Before experiment; Mid-test: 6 weeks end; Post-test: 12 weeks end.
Primary Change from baseline physical activity level at 6 weeks and 12 weeks. This parameter measured by Global Physical Activity Questionnaire (GPAQ). The GPAQ covers several components of physical activity, such as intensity, duration, and frequency, and it assesses three domains in which physical activity is performed (occupational physical activity, transport-related physical activity, and physical activity during discretionary or leisure time) comprising 16 questions (P1-P16). Since it was developed by World Health Organization (WHO) in 2002, the GPAQ has undergone a research program which shows that it is valid and reliable. It has become the most common tool in diagnostic and evaluation studies of physical activity globally. Pretest: Before experiment; Mid-test: 6 weeks end; Post-test: 12 weeks end.
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