Effects of Diet Versus Diet Plus Aerobic and Resistant Exercise Program in Overweight Women

Not Applicable

Suspended

• Conditions: Exercise; Overweight
• Interventions: Other: Aerobic and resistance exercises; Other: Regular walking program; Dietary Supplement: Diet program

• Registration Number: NCT05591794
• Lead Sponsor: Bezmialem Vakif University

Brief Summary

Adult women aged 18-50 years and overweight (preobese) with a BMI of 25-30 kg/m2 will be included in the study. Participants will participate in an eight-week diet and diet plus aerobic and resistance exercise program. Patients will be referred from the Nutrition and Diet Polyclinic of Bezmialem Vakıf University to this study, which will be conducted to investigate the effects of exercise program on postural control, musculoskeletal system disorders, functional capacity, and sleep.

Detailed Description

Subjects who accepted to participate in the study will be randomized and divided into two groups as study and control groups. A computer-based randomization program (random.org) will be used to determine the cases to be assigned to the study and control groups. 2 numbers consisting of 12 numbers will be determined by random selection from the numbers between 1 and 24. The first of these number sequences will be considered as the study group and the second as the control group. Each patient included in the study will be asked to draw one of the sealed envelopes in which the numbers 1 to 24 are written. The case will be assigned to the study or control group according to the number sequence in which the drawn number is included. While the women in the study group are expected to perform regular walking with a diet for eight weeks and a 3-day aerobic and resistance exercise program per week, the subjects in the control group will be followed up with diet and regular walking. Initially, participants will be educated on healthy eating habits through one-on-one dietitian consultation. A personalized calorie-restricting nutrition program will be given. According to this program, the daily energy intake of the individual will be reduced to provide 0.5-1.0 kg of body weight loss per week.

Study Timeline

• Study Start: 2022-09-01
• Study First Submitted: 2022-10-12
• Study First Submitted QC: 2022-10-19
• Study First Posted: 2022-10-24
• Status Verified: 2024-03
• Last Update Submitted: 2025-01-31
• Last Update Posted: 2025-02-04
• Primary Completion: 2025-10-01
• Study Completion: 2025-12-01

Recruitment & Eligibility

• Status: SUSPENDED
• Sex: Female
• Target Recruitment: 24

Inclusion Criteria

• BMI between 25-29.9kg/m2
• Being between the ages of 18-50
• Agreeing to participate voluntarily in the study

Exclusion Criteria

• Pregnancy
• Presence of systemic disease that will prevent participation in an aerobic exercise program
• Presence of conditions such as pain or surgery that will prevent participation in an aerobic exercise program
• Participating in a regular exercise program within the last 1 year

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control group	Regular walking program	The women in the control group will be asked to walk for 30 minutes/5 days or 50 minutes/3 days a week while performing a diet program.
Study group	Diet program	The women in the study group will be asked to walk for 30 minutes/5 days or 50 minutes/3 days a week while performing a diet program for eight weeks and aerobic and resistance exercise program 3 days a week.
Study group	Regular walking program	The women in the study group will be asked to walk for 30 minutes/5 days or 50 minutes/3 days a week while performing a diet program for eight weeks and aerobic and resistance exercise program 3 days a week.
Study group	Aerobic and resistance exercises	The women in the study group will be asked to walk for 30 minutes/5 days or 50 minutes/3 days a week while performing a diet program for eight weeks and aerobic and resistance exercise program 3 days a week.
Control group	Diet program	The women in the control group will be asked to walk for 30 minutes/5 days or 50 minutes/3 days a week while performing a diet program.

Primary Outcome Measures

Name	Time	Method
Evaluation of postural control by Biodex Balance System	Change between baseline and 8-week scores of Biodex Balance System.	Postural control evaluation will be performed with "Biodex Balance System®" (Biodex Medical Systems, Shirley, New York, USA) which is a valid and reliable equipment. Three tests will be performed with the device: postural stability test, stability limits test, and modified clinical test of sensory integration of balance. During the evaluation, three measurements of 20 seconds, 10 seconds intervals between each measurement, will be performed in all tests. Higher control over balance is indicated by a lower score of overall, anterior/posterior, and medial/lateral stability index in the PS test. However, a higher score indicates a lower level of postural control in stability limits and modified clinical test of sensory integration of balance tests.

Secondary Outcome Measures

Name	Time	Method
Evaluation of functional capacity by 6 minute walk test	Change between baseline and 8-week scores of 6 Minute Walk Test.	The 6 Minute Walk Test is a sub-maximal exercise test used to assess functional capacity and endurance.
Evaluation of sleep quality by Pittsburgh Sleep Quality Index	Change between baseline and 8-week scores of Pittsburgh Sleep Quality Index.	The Pittsburgh Sleep Quality Index is a self-rated questionnaire which assesses sleep quality and disturbances over a 1-month time interval.
Evaluation of musculoskeletal by Extended Nordic Musculoskeletal Questionnaire	Change between baseline and 8-week scores of Extended Nordic Musculoskeletal Questionnaire.	The Extended Nordic Musculoskeletal Questionnaire is a reliable instrument that measures the prevalence, severity and impact of musculoskeletal symptoms.

Trial Locations

Locations (1)

Bezmialem Vakif University; 🇹🇷 Istanbul, Turkey