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
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 42
- 试验地点
- 2
- 主要终点
- Changes in Fat Mass
研究概览
简要总结
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.
详细描述
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)
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 30 Years 至 55 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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
- •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
结局指标
主要结局
Changes in Fat Mass
时间窗: Week 0 and 6
Total fat mass will be assessed via dual-energy X-ray absorptiometry (DEXA)
Changes in Lean Mass
时间窗: Week 0 and 6
Total lean mass will be assessed via dual-energy X-ray absorptiometry (DEXA)
Changes in Visceral Adipose Tissue (VAT)
时间窗: Week 0 and 6
Total VAT will be assessed via dual-energy X-ray absorptiometry (DEXA)
Changes in Body Mass Index
时间窗: Week 0 and 6
Total body mass index will be assessed via dual-energy X-ray absorptiometry (DEXA)
Changes in Total Mass
时间窗: Week 0 and 6
Total mass will be assessed via dual-energy X-ray absorptiometry (DEXA)
Changes in Body Shape
时间窗: 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
时间窗: Week 0 and 6
Total body fat percentage will be assessed via dual-energy X-ray absorptiometry (DEXA)
Changes in Body Image Acceptance
时间窗: 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.
次要结局
- Resting Heart Rate(Week 0 and 6)
- Resting Diastolic Blood Pressure(Week 0 and 6)
- Changes in Self-Esteem(Week 0 and 6)
- Changes in lower-body strength(Week 0 and 6)
- Changes in Modified Huet(Week 0 and 6)
- Changes in General Health(Week 0 and 6)
- Resting Systolic Blood Pressure(Week 0 and 6)
- Changes in Granulocyte levels(Week 0 and 6)
- Changes in Hemoglobin levels(Week 0 and 6)
- Changes in Red Cell Distribution Width(Week 0 and 6)
- Changes in Platelet Count(Week 0 and 6)
- Resting Mean Arterial Pressure(Week 0 and 6)
- Resting Pulse Wave Velocity(Week 0 and 6)
- Changes in C-reactive protein(Week 0 and 6)
- Changes in Apolipoprotein B(Week 0 and 6)
- Changes in White Blood Cell count(Week 0 and 6)
- Changes in Red Blood Cell count(Week 0 and 6)
- Changes in Hematocrit levels(Week 0 and 6)
- Changes in Mean Corpuscular Volume(Week 0 and 6)
- Changes in Mean Corpuscular Hemoglobin(Week 0 and 6)
- Changes in Mean Platelet Volume(Week 0 and 6)
- Changes in Eosinophil levels(Week 0 and 6)
- Changes in Basophil levels(Week 0 and 6)
- Changes in Lymphocyte levels(Week 0 and 6)
- Changes in Monocyte levels(Week 0 and 6)
- Changes in Mean Corpuscular Hemoglobin Concentration(Week 0 and 6)
- Changes in Lymphocyte count(Week 0 and 6)
- Changes in Monocyte count(Week 0 and 6)
- Changes in Eosinophil count(Week 0 and 6)
- Changes in Serum Creatinine levels(Week 0 and 6)
- Changes in Granulocyte count(Week 0 and 6)
- Changes in Basophil count(Week 0 and 6)
- Changes in Glucose levels(Week 0 and 6)
- Changes in Sodium levels(Week 0 and 6)
- Changes in Blood Urea Nitrogen levels(Week 0 and 6)
- Changes in Calcium levels(Week 0 and 6)
- Changes in Total Protein levels(Week 0 and 6)
- Changes in Albumin levels(Week 0 and 6)
- Changes in Globulin levels(Week 0 and 6)
- Changes in Potassium levels(Week 0 and 6)
- Changes in Chloride levels(Week 0 and 6)
- Changes in Carbon Dioxide levels(Week 0 and 6)
- Changes in Total Bilirubin levels(Week 0 and 6)
- Changes in Alkaline Phosphate levels(Week 0 and 6)
- Changes in Alanine Transaminase levels(Week 0 and 6)
- Changes in Aspartate Aminotransferase levels(Week 0 and 6)
- Changes in Albumin to Globulin ratio(Week 0 and 6)
- Changes in Blood Urea Nitrogen to Creatinine ratio(Week 0 and 6)
- Changes in estimated Glomerular Filtration Rate(Week 0 and 6)
- Changes in Total Cholesterol levels(Week 0 and 6)
- Changes in Triglyceride levels(Week 0 and 6)
- Changes in High Density Lipoprotein levels (HDL)(Week 0 and 6)
- Changes in Low Density Lipoprotein levels (LDL)(Week 0 and 6)
- Changes in Cholesterol to High Density Lipoprotein ratio(Week 0 and 6)
- Adverse Effects(Week 0 and 6)