Clinical trial NCT05813548: The Effectiveness on an Application-Based Lifestyle Change Program on Health in Women
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Body Image
Self Esteem
Weight Loss
Health Behavior
Health-Related Behavior
Health Knowledge, Attitudes, Practice
Keywords: Mobile Application
Phone Application
Body Composition
Lead sponsor: Applied Science & Performance Institute
Sponsor class: INDUSTRY
First posted: 2023-04-14
Enrollment: 42
Sex: FEMALE
Minimum age (years): 30
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

Eligibility criteria: 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

Primary outcomes:
measure: Changes in Fat Mass
timeFrame: Week 0 and 6
measure: Changes in Lean Mass
timeFrame: Week 0 and 6
measure: Changes in Total Mass
timeFrame: Week 0 and 6
measure: Changes in Visceral Adipose Tissue (VAT)
timeFrame: Week 0 and 6
measure: Changes in Body Fat Percentage
timeFrame: Week 0 and 6
measure: Changes in Body Mass Index
timeFrame: Week 0 and 6
measure: Changes in Body Shape
timeFrame: Week 0 and 6
measure: Changes in Body Image Acceptance
timeFrame: Week 0 and 6
Secondary outcomes:
measure: Changes in Self-Esteem
timeFrame: Week 0 and 6
measure: Changes in General Health
timeFrame: Week 0 and 6
measure: Changes in Modified Huet
timeFrame: Week 0 and 6
measure: Changes in lower-body strength
timeFrame: Week 0 and 6
measure: Resting Heart Rate
timeFrame: Week 0 and 6
measure: Resting Systolic Blood Pressure
timeFrame: Week 0 and 6
measure: Resting Diastolic Blood Pressure
timeFrame: Week 0 and 6
measure: Resting Mean Arterial Pressure
timeFrame: Week 0 and 6
measure: Resting Pulse Wave Velocity
timeFrame: Week 0 and 6
measure: Changes in C-reactive protein
timeFrame: Week 0 and 6
measure: Changes in Apolipoprotein B
timeFrame: Week 0 and 6
measure: Changes in White Blood Cell count
timeFrame: Week 0 and 6
measure: Changes in Red Blood Cell count
timeFrame: Week 0 and 6
measure: Changes in Hemoglobin levels
timeFrame: Week 0 and 6
measure: Changes in Hematocrit levels
timeFrame: Week 0 and 6
measure: Changes in Mean Corpuscular Volume
timeFrame: Week 0 and 6
measure: Changes in Mean Corpuscular Hemoglobin
timeFrame: Week 0 and 6
measure: Changes in Mean Corpuscular Hemoglobin Concentration
timeFrame: Week 0 and 6
measure: Changes in Red Cell Distribution Width
timeFrame: Week 0 and 6
measure: Changes in Platelet Count
timeFrame: Week 0 and 6
measure: Changes in Mean Platelet Volume
timeFrame: Week 0 and 6
measure: Changes in Granulocyte levels
timeFrame: Week 0 and 6
measure: Changes in Lymphocyte levels
timeFrame: Week 0 and 6
measure: Changes in Monocyte levels
timeFrame: Week 0 and 6
measure: Changes in Eosinophil levels
timeFrame: Week 0 and 6
measure: Changes in Basophil levels
timeFrame: Week 0 and 6
measure: Changes in Granulocyte count
timeFrame: Week 0 and 6
measure: Changes in Lymphocyte count
timeFrame: Week 0 and 6
measure: Changes in Monocyte count
timeFrame: Week 0 and 6
measure: Changes in Eosinophil count
timeFrame: Week 0 and 6
measure: Changes in Basophil count
timeFrame: Week 0 and 6
measure: Changes in Glucose levels
timeFrame: Week 0 and 6
measure: Changes in Blood Urea Nitrogen levels
timeFrame: Week 0 and 6
measure: Changes in Serum Creatinine levels
timeFrame: Week 0 and 6
measure: Changes in Sodium levels
timeFrame: Week 0 and 6
measure: Changes in Potassium levels
timeFrame: Week 0 and 6
measure: Changes in Chloride levels
timeFrame: Week 0 and 6
measure: Changes in Carbon Dioxide levels
timeFrame: Week 0 and 6
measure: Changes in Calcium levels
timeFrame: Week 0 and 6
measure: Changes in Total Protein levels
timeFrame: Week 0 and 6
measure: Changes in Albumin levels
timeFrame: Week 0 and 6
measure: Changes in Globulin levels
timeFrame: Week 0 and 6
measure: Changes in Total Bilirubin levels
timeFrame: Week 0 and 6
measure: Changes in Alkaline Phosphate levels
timeFrame: Week 0 and 6
measure: Changes in Alanine Transaminase levels
timeFrame: Week 0 and 6
measure: Changes in Aspartate Aminotransferase levels
timeFrame: Week 0 and 6
measure: Changes in Albumin to Globulin ratio
timeFrame: Week 0 and 6
measure: Changes in Blood Urea Nitrogen to Creatinine ratio
timeFrame: Week 0 and 6
measure: Changes in estimated Glomerular Filtration Rate
timeFrame: Week 0 and 6
measure: Changes in Total Cholesterol levels
timeFrame: Week 0 and 6
measure: Changes in Triglyceride levels
timeFrame: Week 0 and 6
measure: Changes in High Density Lipoprotein levels (HDL)
timeFrame: Week 0 and 6
measure: Changes in Low Density Lipoprotein levels (LDL)
timeFrame: Week 0 and 6
measure: Changes in Cholesterol to High Density Lipoprotein ratio
timeFrame: Week 0 and 6
measure: Adverse Effects
timeFrame: Week 0 and 6
Other outcomes:
Locations:
city: Tampa
country: United States
facility: Applied Science and Performance Institute
state: Florida
Study officials:
References: