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.
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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
42
6-weeks of exercise, building healthy nutritional habits such as intermittent fasting and carb-cycling
6-weeks of following general exercise and nutrition guidelines from American Heart Association (AHA) and United States Department of Agriculture (USDA), respectively.
Applied Science and Performance Institute
Tampa, Florida, United States
Changes in Fat Mass
Total fat mass will be assessed via dual-energy X-ray absorptiometry (DEXA)
Time frame: Week 0 and 6
Changes in Lean Mass
Total lean mass will be assessed via dual-energy X-ray absorptiometry (DEXA)
Time frame: Week 0 and 6
Changes in Total Mass
Total mass will be assessed via dual-energy X-ray absorptiometry (DEXA)
Time frame: Week 0 and 6
Changes in Visceral Adipose Tissue (VAT)
Total VAT will be assessed via dual-energy X-ray absorptiometry (DEXA)
Time frame: Week 0 and 6
Changes in Body Fat Percentage
Total body fat percentage will be assessed via dual-energy X-ray absorptiometry (DEXA)
Time frame: Week 0 and 6
Changes in Body Mass Index
Total body mass index will be assessed via dual-energy X-ray absorptiometry (DEXA)
Time frame: Week 0 and 6
Changes in Body Shape
Assessed by administering the Body Shape Questionnaire (BSQ) for subjective measurement. Values range from 1 to 6 with lower scores demonstrating a better outcome.
Time frame: Week 0 and 6
Changes in Body Image Acceptance
Assessed by administering the Body Image and Acceptance Action Questionnaire (BI-AAQ) for subjective measurement. Values range from 1 to 7 with lower scores demonstrating a better outcome.
Time frame: Week 0 and 6
Changes in Self-Esteem
Assessed by administering the Rosenberg Self-Esteem Scale (RSE) for subjective measurement. Values range from 1 to 4 with higher scores demonstrating a better outcome.
Time frame: Week 0 and 6
Changes in General Health
Assessed by administering the General Health and Activity Questionnaire for subjective measurement. Values range from 0 to 20 with higher scores demonstrating a better outcome.
Time frame: Week 0 and 6
Changes in Modified Huet
Assessed by administering the Modified Huet Questionnaire for subjective measurement. Values range from 0 to 3.5 with higher scores demonstrating a better outcome.
Time frame: Week 0 and 6
Changes in lower-body strength
Assessed using the isometric mid-thigh pull
Time frame: Week 0 and 6
Resting Heart Rate
Changes in resting heart rate
Time frame: Week 0 and 6
Resting Systolic Blood Pressure
Changes in resting systolic blood pressure
Time frame: Week 0 and 6
Resting Diastolic Blood Pressure
Changes in resting diastolic blood pressure
Time frame: Week 0 and 6
Resting Mean Arterial Pressure
Changes in resting mean arterial pressure
Time frame: Week 0 and 6
Resting Pulse Wave Velocity
Changes in pulse wave velocity
Time frame: Week 0 and 6
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Changes in C-reactive protein
Experimental outcome examining the total C-reactive protein via fasted whole blood samples.
Time frame: Week 0 and 6
Changes in Apolipoprotein B
Experimental outcome examining the total Apolipoprotein B via fasted whole blood samples.
Time frame: Week 0 and 6
Changes in White Blood Cell count
Experimental outcome examining the total white blood cell count via fasted whole blood samples.
Time frame: Week 0 and 6
Changes in Red Blood Cell count
Experimental outcome examining the total red blood cell count via fasted whole blood samples.
Time frame: Week 0 and 6
Changes in Hemoglobin levels
Experimental outcome examining the total hemoglobin via fasted whole blood samples.
Time frame: Week 0 and 6
Changes in Hematocrit levels
Experimental outcome examining the total hematocrit via fasted whole blood samples.
Time frame: Week 0 and 6
Changes in Mean Corpuscular Volume
Experimental outcome examining the total mean corpuscular volume via fasted whole blood samples.
Time frame: Week 0 and 6
Changes in Mean Corpuscular Hemoglobin
Experimental outcome examining the total mean corpuscular hemoglobin via fasted whole blood samples.
Time frame: Week 0 and 6
Changes in Mean Corpuscular Hemoglobin Concentration
Experimental outcome examining the total mean corpuscular hemoglobin concentration via fasted whole blood samples.
Time frame: Week 0 and 6
Changes in Red Cell Distribution Width
Experimental outcome examining the total red cell distribution width via fasted whole blood samples.
Time frame: Week 0 and 6
Changes in Platelet Count
Experimental outcome examining the total platelet count via fasted whole blood samples.
Time frame: Week 0 and 6
Changes in Mean Platelet Volume
Experimental outcome examining the total mean platelet volume via fasted whole blood samples.
Time frame: Week 0 and 6
Changes in Granulocyte levels
Experimental outcome examining the percentage of Granulocytes via fasted whole blood samples.
Time frame: Week 0 and 6
Changes in Lymphocyte levels
Experimental outcome examining the percentage of Lymphocytes via fasted whole blood samples.
Time frame: Week 0 and 6
Changes in Monocyte levels
Experimental outcome examining the percentage of Monocytes via fasted whole blood samples.
Time frame: Week 0 and 6
Changes in Eosinophil levels
Experimental outcome examining the percentage of Eosinophil via fasted whole blood samples.
Time frame: Week 0 and 6
Changes in Basophil levels
Experimental outcome examining the percentage of Basophil via fasted whole blood samples.
Time frame: Week 0 and 6
Changes in Granulocyte count
Experimental outcome examining total Granulocytes via fasted whole blood samples.
Time frame: Week 0 and 6
Changes in Lymphocyte count
Experimental outcome examining total Lymphocytes via fasted whole blood samples.
Time frame: Week 0 and 6
Changes in Monocyte count
Experimental outcome examining total Monocytes via fasted whole blood samples.
Time frame: Week 0 and 6
Changes in Eosinophil count
Experimental outcome examining total Eosinophils via fasted whole blood samples.
Time frame: Week 0 and 6
Changes in Basophil count
Experimental outcome examining total Basophils via fasted whole blood samples.
Time frame: Week 0 and 6
Changes in Glucose levels
Experimental outcome examining total glucose via fasted whole blood samples.
Time frame: Week 0 and 6
Changes in Blood Urea Nitrogen levels
Experimental outcome examining total blood urea nitrogen via fasted whole blood samples.
Time frame: Week 0 and 6
Changes in Serum Creatinine levels
Experimental outcome examining total serum creatinine via fasted whole blood samples.
Time frame: Week 0 and 6
Changes in Sodium levels
Experimental outcome examining total sodium via fasted whole blood samples.
Time frame: Week 0 and 6
Changes in Potassium levels
Experimental outcome examining total potassium via fasted whole blood samples.
Time frame: Week 0 and 6
Changes in Chloride levels
Experimental outcome examining total chloride via fasted whole blood samples.
Time frame: Week 0 and 6
Changes in Carbon Dioxide levels
Experimental outcome examining total carbon dioxide via fasted whole blood samples.
Time frame: Week 0 and 6
Changes in Calcium levels
Experimental outcome examining total calcium via fasted whole blood samples.
Time frame: Week 0 and 6
Changes in Total Protein levels
Experimental outcome examining total Protein via fasted whole blood samples.
Time frame: Week 0 and 6
Changes in Albumin levels
Experimental outcome examining total albumin via fasted whole blood samples.
Time frame: Week 0 and 6
Changes in Globulin levels
Experimental outcome examining total globulin via fasted whole blood samples.
Time frame: Week 0 and 6
Changes in Total Bilirubin levels
Experimental outcome examining total bilirubin via fasted whole blood samples.
Time frame: Week 0 and 6
Changes in Alkaline Phosphate levels
Experimental outcome examining total alkaline phosphate via fasted whole blood samples.
Time frame: Week 0 and 6
Changes in Alanine Transaminase levels
Experimental outcome examining total Alanine Transaminase via fasted whole blood samples.
Time frame: Week 0 and 6
Changes in Aspartate Aminotransferase levels
Experimental outcome examining total Aspartate Aminotransferase via fasted whole blood samples.
Time frame: Week 0 and 6
Changes in Albumin to Globulin ratio
Experimental outcome examining the ratio of Albumin to Globulin via fasted whole blood samples.
Time frame: Week 0 and 6
Changes in Blood Urea Nitrogen to Creatinine ratio
Experimental outcome examining the ratio of Blood urea nitrogen to Creatinine via fasted whole blood samples.
Time frame: Week 0 and 6
Changes in estimated Glomerular Filtration Rate
Experimental outcome examining the Glomerular filtration rate via fasted whole blood samples.
Time frame: Week 0 and 6
Changes in Total Cholesterol levels
Experimental outcome examining total cholesterol via fasted whole blood samples.
Time frame: Week 0 and 6
Changes in Triglyceride levels
Experimental outcome examining total triglycerides via fasted whole blood samples.
Time frame: Week 0 and 6
Changes in High Density Lipoprotein levels (HDL)
Experimental outcome examining total high density lipoprotein via fasted whole blood samples.
Time frame: Week 0 and 6
Changes in Low Density Lipoprotein levels (LDL)
Experimental outcome examining total low density lipoprotein via fasted whole blood samples.
Time frame: Week 0 and 6
Changes in Cholesterol to High Density Lipoprotein ratio
Experimental outcome examining the ratio of Cholesterol to High density lipoprotein via fasted whole blood samples.
Time frame: Week 0 and 6
Adverse Effects
Defined as participants self-reported adverse effects. Items that will be surveyed are headache, dizziness, nausea, vomiting, indigestion, blurred vision, lethargy, swelling, itching, chest pain, heart palpitations, difficulty breathing, lethargy, and muscle cramps.
Time frame: Week 0 and 6