The Effectiveness on an Application-Based Lifestyle Change Program on Health in Women
- Conditions
- Body ImageHealth-Related BehaviorHealth Knowledge, Attitudes, PracticeWeight LossSelf EsteemHealth Behavior
- Interventions
- Other: FASTer Way InterventionOther: Control Group Intervention
- Registration Number
- NCT05813548
- Lead Sponsor
- Applied Science & Performance Institute
- Brief 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.
- Detailed 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
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 42
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Treatment FASTer Way Intervention FASTer Way Application-Based Lifestyle Program Control Control Group Intervention General health and dietary guidelines
- Primary Outcome Measures
Name Time Method Changes in Fat Mass Week 0 and 6 Total fat mass will be assessed via dual-energy X-ray absorptiometry (DEXA)
Changes in Lean Mass Week 0 and 6 Total lean mass will be assessed via dual-energy X-ray absorptiometry (DEXA)
Changes in Visceral Adipose Tissue (VAT) Week 0 and 6 Total VAT will be assessed via dual-energy X-ray absorptiometry (DEXA)
Changes in Total Mass Week 0 and 6 Total mass will be assessed via dual-energy X-ray absorptiometry (DEXA)
Changes in Body Shape Week 0 and 6 Assessed by administering the Body Shape Questionnaire (BSQ) for subjective measurement. Values range from 1 to 6 with lower scores demonstrating a better outcome.
Changes in Body Fat Percentage Week 0 and 6 Total body fat percentage will be assessed via dual-energy X-ray absorptiometry (DEXA)
Changes in Body Mass Index Week 0 and 6 Total body mass index will be assessed via dual-energy X-ray absorptiometry (DEXA)
Changes in Body Image Acceptance Week 0 and 6 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.
- Secondary Outcome Measures
Name Time Method Changes in Mean Platelet Volume Week 0 and 6 Experimental outcome examining the total mean platelet volume via fasted whole blood samples.
Changes in Globulin levels Week 0 and 6 Experimental outcome examining total globulin via fasted whole blood samples.
Changes in Aspartate Aminotransferase levels Week 0 and 6 Experimental outcome examining total Aspartate Aminotransferase via fasted whole blood samples.
Changes in Albumin to Globulin ratio Week 0 and 6 Experimental outcome examining the ratio of Albumin to Globulin via fasted whole blood samples.
Changes in Blood Urea Nitrogen to Creatinine ratio Week 0 and 6 Experimental outcome examining the ratio of Blood urea nitrogen to Creatinine via fasted whole blood samples.
Resting Diastolic Blood Pressure Week 0 and 6 Changes in resting diastolic blood pressure
Changes in Self-Esteem Week 0 and 6 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.
Changes in lower-body strength Week 0 and 6 Assessed using the isometric mid-thigh pull
Changes in General Health Week 0 and 6 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.
Changes in Modified Huet Week 0 and 6 Assessed by administering the Modified Huet Questionnaire for subjective measurement. Values range from 0 to 3.5 with higher scores demonstrating a better outcome.
Resting Heart Rate Week 0 and 6 Changes in resting heart rate
Resting Systolic Blood Pressure Week 0 and 6 Changes in resting systolic blood pressure
Changes in Red Cell Distribution Width Week 0 and 6 Experimental outcome examining the total red cell distribution width via fasted whole blood samples.
Changes in Platelet Count Week 0 and 6 Experimental outcome examining the total platelet count via fasted whole blood samples.
Changes in Granulocyte levels Week 0 and 6 Experimental outcome examining the percentage of Granulocytes via fasted whole blood samples.
Resting Mean Arterial Pressure Week 0 and 6 Changes in resting mean arterial pressure
Resting Pulse Wave Velocity Week 0 and 6 Changes in pulse wave velocity
Changes in C-reactive protein Week 0 and 6 Experimental outcome examining the total C-reactive protein via fasted whole blood samples.
Changes in Apolipoprotein B Week 0 and 6 Experimental outcome examining the total Apolipoprotein B via fasted whole blood samples.
Changes in White Blood Cell count Week 0 and 6 Experimental outcome examining the total white blood cell count via fasted whole blood samples.
Changes in Red Blood Cell count Week 0 and 6 Experimental outcome examining the total red blood cell count via fasted whole blood samples.
Changes in Hemoglobin levels Week 0 and 6 Experimental outcome examining the total hemoglobin via fasted whole blood samples.
Changes in Hematocrit levels Week 0 and 6 Experimental outcome examining the total hematocrit via fasted whole blood samples.
Changes in Mean Corpuscular Volume Week 0 and 6 Experimental outcome examining the total mean corpuscular volume via fasted whole blood samples.
Changes in Mean Corpuscular Hemoglobin Week 0 and 6 Experimental outcome examining the total mean corpuscular hemoglobin via fasted whole blood samples.
Changes in Eosinophil levels Week 0 and 6 Experimental outcome examining the percentage of Eosinophil via fasted whole blood samples.
Changes in Basophil levels Week 0 and 6 Experimental outcome examining the percentage of Basophil via fasted whole blood samples.
Changes in Lymphocyte levels Week 0 and 6 Experimental outcome examining the percentage of Lymphocytes via fasted whole blood samples.
Changes in Monocyte levels Week 0 and 6 Experimental outcome examining the percentage of Monocytes via fasted whole blood samples.
Changes in Mean Corpuscular Hemoglobin Concentration Week 0 and 6 Experimental outcome examining the total mean corpuscular hemoglobin concentration via fasted whole blood samples.
Changes in Lymphocyte count Week 0 and 6 Experimental outcome examining total Lymphocytes via fasted whole blood samples.
Changes in Monocyte count Week 0 and 6 Experimental outcome examining total Monocytes via fasted whole blood samples.
Changes in Eosinophil count Week 0 and 6 Experimental outcome examining total Eosinophils via fasted whole blood samples.
Changes in Serum Creatinine levels Week 0 and 6 Experimental outcome examining total serum creatinine via fasted whole blood samples.
Changes in Granulocyte count Week 0 and 6 Experimental outcome examining total Granulocytes via fasted whole blood samples.
Changes in Basophil count Week 0 and 6 Experimental outcome examining total Basophils via fasted whole blood samples.
Changes in Glucose levels Week 0 and 6 Experimental outcome examining total glucose via fasted whole blood samples.
Changes in Sodium levels Week 0 and 6 Experimental outcome examining total sodium via fasted whole blood samples.
Changes in Total Protein levels Week 0 and 6 Experimental outcome examining total Protein via fasted whole blood samples.
Changes in Albumin levels Week 0 and 6 Experimental outcome examining total albumin via fasted whole blood samples.
Changes in Blood Urea Nitrogen levels Week 0 and 6 Experimental outcome examining total blood urea nitrogen via fasted whole blood samples.
Changes in Calcium levels Week 0 and 6 Experimental outcome examining total calcium via fasted whole blood samples.
Changes in Potassium levels Week 0 and 6 Experimental outcome examining total potassium via fasted whole blood samples.
Changes in Chloride levels Week 0 and 6 Experimental outcome examining total chloride via fasted whole blood samples.
Changes in Carbon Dioxide levels Week 0 and 6 Experimental outcome examining total carbon dioxide via fasted whole blood samples.
Changes in Total Bilirubin levels Week 0 and 6 Experimental outcome examining total bilirubin via fasted whole blood samples.
Changes in Alkaline Phosphate levels Week 0 and 6 Experimental outcome examining total alkaline phosphate via fasted whole blood samples.
Changes in Alanine Transaminase levels Week 0 and 6 Experimental outcome examining total Alanine Transaminase via fasted whole blood samples.
Changes in estimated Glomerular Filtration Rate Week 0 and 6 Experimental outcome examining the Glomerular filtration rate via fasted whole blood samples.
Changes in Total Cholesterol levels Week 0 and 6 Experimental outcome examining total cholesterol via fasted whole blood samples.
Changes in Triglyceride levels Week 0 and 6 Experimental outcome examining total triglycerides via fasted whole blood samples.
Changes in High Density Lipoprotein levels (HDL) Week 0 and 6 Experimental outcome examining total high density lipoprotein via fasted whole blood samples.
Changes in Low Density Lipoprotein levels (LDL) Week 0 and 6 Experimental outcome examining total low density lipoprotein via fasted whole blood samples.
Changes in Cholesterol to High Density Lipoprotein ratio Week 0 and 6 Experimental outcome examining the ratio of Cholesterol to High density lipoprotein via fasted whole blood samples.
Adverse Effects Week 0 and 6 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.
Trial Locations
- Locations (1)
Applied Science and Performance Institute
🇺🇸Tampa, Florida, United States