The Effectiveness on an Application-Based Lifestyle Change Program on Health in Women
Completed · Not applicable
Conditions studied: Body Image, Self Esteem, Weight Loss, Health Behavior, Health-Related Behavior, Health Knowledge, Attitudes, Practice
In brief
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.
Key facts
- Study ID
- NCT05813548
- Run by
- Applied Science & Performance Institute
- People needed
- 42
- Starts
- 2023-02-28
- Expected to finish
- 2023-08-30
- Last updated by the study team
- 2024-02-15
Who can join
Age: 30 and older, up to 55. Sex: female. Healthy volunteers: accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- Applied Science and Performance Institute — Tampa, Florida, United States
Full record on ClinicalTrials.gov
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