Trials / Completed
CompletedNCT05813548
The Effectiveness on an Application-Based Lifestyle Change Program on Health in Women
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
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 42 (actual)
- Sponsor
- Applied Science & Performance Institute · Industry
- Sex
- Female
- Age
- 30 Years – 55 Years
- Healthy volunteers
- Accepted
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
Conditions
- Body Image
- Self Esteem
- Weight Loss
- Health Behavior
- Health-Related Behavior
- Health Knowledge, Attitudes, Practice
Interventions
| Type | Name | Description |
|---|---|---|
| OTHER | FASTer Way Intervention | 6-weeks of exercise, building healthy nutritional habits such as intermittent fasting and carb-cycling |
| OTHER | Control Group Intervention | 6-weeks of following general exercise and nutrition guidelines from American Heart Association (AHA) and United States Department of Agriculture (USDA), respectively. |
Timeline
- Start date
- 2023-02-28
- Primary completion
- 2023-08-30
- Completion
- 2023-08-30
- First posted
- 2023-04-14
- Last updated
- 2024-02-15
Locations
1 site across 1 country: United States
Source: ClinicalTrials.gov record NCT05813548. Inclusion in this directory is not an endorsement.