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Clinical Trial Summary

The purpose of this study will be to examine the effectiveness of an application-based lifestyle change program on body composition, body shape, body, image, and self-esteem in females following a 6-week period. The study will be carried out in a randomized, placebo-controlled, parallel manner. Participants will be stratified into quartiles based on their body mass indices during screening and prior to baseline testing. Participants from each quartile will be randomly divided by into experimental or control conditions. Following randomization, participants will be baseline assessed on their body composition using a whole body Dual Energy X-Ray Absorptiometry scan, on their subjective measures of body shape and image using a variety of questionnaires, blood chemistry panel, and lower-body strength using a isometric mid-thigh pull dynamometer. Following baseline testing, participants will undergo 6-weeks of following their respective condition. Participants will be instructed to follow their group-specific guidelines for the 6-week period to the best of their ability. Body shape and image questionnaires and assessments of body composition, blood chemistry, and lower-body strength will be conducted following the week 6 to conclude the study.


Clinical Trial Description

The purpose of this study will be to examine the effectiveness of an application-based lifestyle change program on body composition, body shape, body, image, and self-esteem in females following a 6-week period. The study will be carried out in a randomized, placebo-controlled, parallel manner. Participants will be stratified into quartiles based on their body mass indices during screening and prior to baseline testing. Participants from each quartile will be randomly divided by into experimental or control conditions. Following randomization, participants will be baseline assessed on their body composition using a whole body Dual Energy X-Ray Absorptiometry scan, on their subjective measures of body shape and image using a variety of questionnaires, blood chemistry panel, and lower-body strength using a isometric mid-thigh pull dynamometer. Following baseline testing, participants will undergo 6-weeks of following their respective condition. Participants will be instructed to follow their group-specific guidelines for the 6-week period to the best of their ability. Body shape and image questionnaires and assessments of body composition, blood chemistry, and lower-body strength will be conducted following the week 6 to conclude the study. Participants will be assessed for the following variables on Week 0 and 6: Primary Variables: • Fat-, lean-, total-mass, body fat percentage, body mass index, and visceral adipose tissue via Dual Energy X-Ray Absorptiometry (DEXA) Subjective measures related to body shape, body image, and body acceptance by administering the the following questionnaires - Body Image and Acceptance Action Questionnaire (BI-AAQ) - Body Shape Questionnaire (BSQ) Secondary Variables: - Complete Blood Count (CBC) - Comprehensive Metabolic Panel (CMP) - Blood Lipid Profile - C-Reactive Protein - Apolipoprotein B - Lower-body strength via Isometric Mid-Thigh Pull (IMTP) - Blood pressure - Resting heart rate - Pulse wave velocity Subjective measures related to self-esteem, physical activity, and general health by administering the the following questionnaires - Rosenberg Self-Esteem Scale (RSE) - Modified Huet Questionnaire - General Healthy and Activity Questionnaire ;


Study Design


Related Conditions & MeSH terms


NCT number NCT05813548
Study type Interventional
Source Applied Science & Performance Institute
Contact
Status Completed
Phase N/A
Start date February 28, 2023
Completion date August 30, 2023

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