The Effectiveness on an Application-Based Lifestyle Change Program on Health in Women
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About
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.
Full 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
Enrollment
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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
Trial design
Primary purpose
Allocation
Interventional model
Masking
42 participants in 2 patient groups
Trial contacts and locations
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Central trial contact
Ryan Lowery, Ph. D.; Raad Gheith, M.A.
Data sourced from clinicaltrials.gov
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