The Effectiveness on an Application-Based Lifestyle Change Program on Health in Women

The Effectiveness of an Application-Based Lifestyle Change Program on Body Composition, Health, Body Image, and Self-Esteem in Women 30 to 55 Years Old

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

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.

Assessed by administering the Body Shape Questionnaire (BSQ) for subjective measurement. Values range from 1 to 6 with lower scores demonstrating a better outcome.

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.

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.

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.

Assessed by administering the Modified Huet Questionnaire for subjective measurement. Values range from 0 to 3.5 with higher scores demonstrating a better outcome.

Experimental outcome examining the total mean corpuscular hemoglobin concentration via fasted whole blood samples.

Experimental outcome examining the ratio of Blood urea nitrogen to Creatinine via fasted whole blood samples.

Experimental outcome examining the ratio of Cholesterol to High density lipoprotein via fasted whole blood samples.

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.

Inclusion Criteria: Healthy women between 30 and 55 years old Body Mass Index (BMI) between 25 and 35 kg/m^2 Little to no recent exercise training experience (≤ 1 day per week) within the last 6 months and no recent (≤ 3-months) musculoskeletal injuries Willing and able to give written informed consent Able to read, understand, sign and date the informed consent document (English only) Subjects located in the Tampa Bay area who are willing to comply with the schedule visit(s) and study requirements. Consistent access to a smartphone with the ability to navigate an English-language application Exclusion Criteria: Diagnosed cardiovascular, neurological, metabolic, musculoskeletal, renal, pulmonary, hepatic, autoimmune, or endocrine disease Drink heavily (>7 and >14 drinks per week for women and men, respectively) Exercising greater than 1 day per week for the past 6 months Significant food allergies or dietary restrictions Pregnant, breastfeeding (≤ 3-months), or seeking to become pregnant Smoke Peptic ulcer Any malignancy Thrombosis Undergone surgery that affects digestion and absorption Hypo- or hypertensive Undergoing hormone replacement therapy Using hormone boosting supplements (herbal or synthetic) Using drugs that are anti-diabetic, anti-platelet, anti-coagulant, or beta blockers Have participated in a clinical trial within the past 6 months