Body ImageNCT05813548
The Effectiveness on an Application-Based Lifestyle Change Program on Health in Women
A study testing FASTer Way Intervention in people with Body Image and Self Esteem, run by Applied Science & Performance Institute at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 30 to 55 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Body Image, Self Esteem, Weight Loss
- What is being tested?
- FASTer Way Intervention
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 1 siteUnited States
- Study dates
- 28 Feb 2023to 30 Aug 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 55 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 15Show fewer
- 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 locations and contacts
1 site in 1 country.
United States1 site
Applied Science and Performance Institute
Tampa, Florida, 33607
About this study
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
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.
Read the 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
- Being tested
- FASTer Way Intervention, Control Group Intervention
- Keywords
- Mobile Application, Phone Application, Body Composition
- Medical subject headings
- Weight Loss, Health Behavior, Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FASTer Way InterventionOther
6-weeks of exercise, building healthy nutritional habits such as intermittent fasting and carb-cycling
Control Group InterventionOther
6-weeks of following general exercise and nutrition guidelines from American Heart Association (AHA) and United States Department of Agriculture (USDA), respectively.
| Study group | Role | What they receive |
|---|---|---|
| Treatment | Experimental | FASTer Way Application-Based Lifestyle Program Receives: Other: FASTer Way Intervention |
| Control | Active comparator | General health and dietary guidelines Receives: Other: Control Group Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in Fat Mass
Total fat mass will be assessed via dual-energy X-ray absorptiometry (DEXA)
Measured: Week 0 and 6
Changes in Lean Mass
Total lean mass will be assessed via dual-energy X-ray absorptiometry (DEXA)
Measured: Week 0 and 6
Changes in Total Mass
Total mass will be assessed via dual-energy X-ray absorptiometry (DEXA)
Measured: Week 0 and 6
Changes in Visceral Adipose Tissue (VAT)
Total VAT will be assessed via dual-energy X-ray absorptiometry (DEXA)
Measured: Week 0 and 6
Changes in Body Fat Percentage
Total body fat percentage will be assessed via dual-energy X-ray absorptiometry (DEXA)
Measured: Week 0 and 6
Changes in Body Mass Index
Total body mass index will be assessed via dual-energy X-ray absorptiometry (DEXA)
Measured: Week 0 and 6
Changes in Body Shape
Assessed by administering the Body Shape Questionnaire (BSQ) for subjective measurement. Values range from 1 to 6 with lower scores demonstrating a better outcome.
Measured: Week 0 and 6
Changes in Body Image Acceptance
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.
Measured: Week 0 and 6
Secondary outcomes (55)
Changes in Self-Esteem
Assessed by administering the Rosenberg Self-Esteem Scale (RSE) for subjective measurement. Values range from 1 to 4 with higher scores demonstrating a better outcome.
Measured: Week 0 and 6
Changes in General Health
Assessed by administering the General Health and Activity Questionnaire for subjective measurement. Values range from 0 to 20 with higher scores demonstrating a better outcome.
Measured: Week 0 and 6
Changes in Modified Huet
Assessed by administering the Modified Huet Questionnaire for subjective measurement. Values range from 0 to 3.5 with higher scores demonstrating a better outcome.
Measured: Week 0 and 6
Changes in lower-body strength
Assessed using the isometric mid-thigh pull
Measured: Week 0 and 6
Resting Heart Rate
Changes in resting heart rate
Measured: Week 0 and 6
Resting Systolic Blood Pressure
Changes in resting systolic blood pressure
Measured: Week 0 and 6
Resting Diastolic Blood Pressure
Changes in resting diastolic blood pressure
Measured: Week 0 and 6
Resting Mean Arterial Pressure
Changes in resting mean arterial pressure
Measured: Week 0 and 6
Resting Pulse Wave Velocity
Changes in pulse wave velocity
Measured: Week 0 and 6
Changes in C-reactive protein
Experimental outcome examining the total C-reactive protein via fasted whole blood samples.
Measured: Week 0 and 6
Changes in Apolipoprotein B
Experimental outcome examining the total Apolipoprotein B via fasted whole blood samples.
Measured: Week 0 and 6
Changes in White Blood Cell count
Experimental outcome examining the total white blood cell count via fasted whole blood samples.
Measured: Week 0 and 6
Changes in Red Blood Cell count
Experimental outcome examining the total red blood cell count via fasted whole blood samples.
Measured: Week 0 and 6
Changes in Hemoglobin levels
Experimental outcome examining the total hemoglobin via fasted whole blood samples.
Measured: Week 0 and 6
Changes in Hematocrit levels
Experimental outcome examining the total hematocrit via fasted whole blood samples.
Measured: Week 0 and 6
Changes in Mean Corpuscular Volume
Experimental outcome examining the total mean corpuscular volume via fasted whole blood samples.
Measured: Week 0 and 6
Changes in Mean Corpuscular Hemoglobin
Experimental outcome examining the total mean corpuscular hemoglobin via fasted whole blood samples.
Measured: Week 0 and 6
Changes in Mean Corpuscular Hemoglobin Concentration
Experimental outcome examining the total mean corpuscular hemoglobin concentration via fasted whole blood samples.
Measured: Week 0 and 6
Changes in Red Cell Distribution Width
Experimental outcome examining the total red cell distribution width via fasted whole blood samples.
Measured: Week 0 and 6
Changes in Platelet Count
Experimental outcome examining the total platelet count via fasted whole blood samples.
Measured: Week 0 and 6
Changes in Mean Platelet Volume
Experimental outcome examining the total mean platelet volume via fasted whole blood samples.
Measured: Week 0 and 6
Changes in Granulocyte levels
Experimental outcome examining the percentage of Granulocytes via fasted whole blood samples.
Measured: Week 0 and 6
Changes in Lymphocyte levels
Experimental outcome examining the percentage of Lymphocytes via fasted whole blood samples.
Measured: Week 0 and 6
Changes in Monocyte levels
Experimental outcome examining the percentage of Monocytes via fasted whole blood samples.
Measured: Week 0 and 6
Changes in Eosinophil levels
Experimental outcome examining the percentage of Eosinophil via fasted whole blood samples.
Measured: Week 0 and 6
Changes in Basophil levels
Experimental outcome examining the percentage of Basophil via fasted whole blood samples.
Measured: Week 0 and 6
Changes in Granulocyte count
Experimental outcome examining total Granulocytes via fasted whole blood samples.
Measured: Week 0 and 6
Changes in Lymphocyte count
Experimental outcome examining total Lymphocytes via fasted whole blood samples.
Measured: Week 0 and 6
Changes in Monocyte count
Experimental outcome examining total Monocytes via fasted whole blood samples.
Measured: Week 0 and 6
Changes in Eosinophil count
Experimental outcome examining total Eosinophils via fasted whole blood samples.
Measured: Week 0 and 6
Changes in Basophil count
Experimental outcome examining total Basophils via fasted whole blood samples.
Measured: Week 0 and 6
Changes in Glucose levels
Experimental outcome examining total glucose via fasted whole blood samples.
Measured: Week 0 and 6
Changes in Blood Urea Nitrogen levels
Experimental outcome examining total blood urea nitrogen via fasted whole blood samples.
Measured: Week 0 and 6
Changes in Serum Creatinine levels
Experimental outcome examining total serum creatinine via fasted whole blood samples.
Measured: Week 0 and 6
Changes in Sodium levels
Experimental outcome examining total sodium via fasted whole blood samples.
Measured: Week 0 and 6
Changes in Potassium levels
Experimental outcome examining total potassium via fasted whole blood samples.
Measured: Week 0 and 6
Changes in Chloride levels
Experimental outcome examining total chloride via fasted whole blood samples.
Measured: Week 0 and 6
Changes in Carbon Dioxide levels
Experimental outcome examining total carbon dioxide via fasted whole blood samples.
Measured: Week 0 and 6
Changes in Calcium levels
Experimental outcome examining total calcium via fasted whole blood samples.
Measured: Week 0 and 6
Changes in Total Protein levels
Experimental outcome examining total Protein via fasted whole blood samples.
Measured: Week 0 and 6
Changes in Albumin levels
Experimental outcome examining total albumin via fasted whole blood samples.
Measured: Week 0 and 6
Changes in Globulin levels
Experimental outcome examining total globulin via fasted whole blood samples.
Measured: Week 0 and 6
Changes in Total Bilirubin levels
Experimental outcome examining total bilirubin via fasted whole blood samples.
Measured: Week 0 and 6
Changes in Alkaline Phosphate levels
Experimental outcome examining total alkaline phosphate via fasted whole blood samples.
Measured: Week 0 and 6
Changes in Alanine Transaminase levels
Experimental outcome examining total Alanine Transaminase via fasted whole blood samples.
Measured: Week 0 and 6
Changes in Aspartate Aminotransferase levels
Experimental outcome examining total Aspartate Aminotransferase via fasted whole blood samples.
Measured: Week 0 and 6
Changes in Albumin to Globulin ratio
Experimental outcome examining the ratio of Albumin to Globulin via fasted whole blood samples.
Measured: Week 0 and 6
Changes in Blood Urea Nitrogen to Creatinine ratio
Experimental outcome examining the ratio of Blood urea nitrogen to Creatinine via fasted whole blood samples.
Measured: Week 0 and 6
Changes in estimated Glomerular Filtration Rate
Experimental outcome examining the Glomerular filtration rate via fasted whole blood samples.
Measured: Week 0 and 6
Changes in Total Cholesterol levels
Experimental outcome examining total cholesterol via fasted whole blood samples.
Measured: Week 0 and 6
Changes in Triglyceride levels
Experimental outcome examining total triglycerides via fasted whole blood samples.
Measured: Week 0 and 6
Changes in High Density Lipoprotein levels (HDL)
Experimental outcome examining total high density lipoprotein via fasted whole blood samples.
Measured: Week 0 and 6
Changes in Low Density Lipoprotein levels (LDL)
Experimental outcome examining total low density lipoprotein via fasted whole blood samples.
Measured: Week 0 and 6
Changes in Cholesterol to High Density Lipoprotein ratio
Experimental outcome examining the ratio of Cholesterol to High density lipoprotein via fasted whole blood samples.
Measured: Week 0 and 6
Adverse Effects
Defined as participants self-reported adverse effects. Items that will be surveyed are headache, dizziness, nausea, vomiting, indigestion, blurred vision, lethargy, swelling, itching, chest pain, heart palpitations, difficulty breathing, lethargy, and muscle cramps.
Measured: Week 0 and 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Apr 2023
- Study start28 Feb 2023
- Primary completion30 Aug 2023
- Study completion30 Aug 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Body ImageStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- Applied Science & Performance Institute
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05813548
- Sponsor's protocol ID
- 012023
- Status last verified
- Feb 2024
- First submitted
- 3 Apr 2023
- Last updated
- 15 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Ottinger CR, Gheith RH, Sharp MH, Davis JM, Lowery RP, Wilson JM. A randomized controlled trial to assess the effectiveness of a mobile application-based lifestyle change program (FASTer Way) on body composition, biochemical and hematological health markers, body image, and self-esteem in overweight women. Mhealth. 2025 Mar 20;11:13. doi: 10.21037/mhealth-24-62. eCollection 2025.
PubMed 40248760
Study at a glance
From the registry record, last updated by the sponsor on 15 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05813548
- Acronym / sponsor ID
- 012023
- Conditions
- Body Image, Self Esteem, Weight Loss, Health Behavior, Health-Related Behavior, Health Knowledge, Attitudes, Practice
- Keywords
- Mobile Application, Phone Application, Body Composition
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- Applied Science & Performance InstituteIndustry (pharma, biotech, devices)
- Study start
- 28 Feb 2023 (actual)
- Primary completion
- 30 Aug 2023 (actual)
- Study completion
- 30 Aug 2023 (actual)
- First posted
- 14 Apr 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment | Experimental | Other: FASTer Way InterventionFASTer Way Application-Based Lifestyle Program |
| Control | Active comparator | Other: Control Group InterventionGeneral health and dietary guidelines |
Who may qualify
- Ages
- 30 to 55 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- 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)
Key exclusion criteria (15 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| FASTer Way Intervention6-weeks of exercise, building healthy nutritional habits such as intermittent fasting and carb-cycling | Other | Treatment |
| Control Group Intervention6-weeks of following general exercise and nutrition guidelines from American Heart Association (AHA) and United States Department of Agriculture (USDA), respectively. | Other | Control |
Primary outcome
Changes in Fat Mass
Time frame: Week 0 and 6
Total fat mass will be assessed via dual-energy X-ray absorptiometry (DEXA)
Changes in Lean Mass
Time frame: Week 0 and 6
Total lean mass will be assessed via dual-energy X-ray absorptiometry (DEXA)
Changes in Total Mass
Time frame: Week 0 and 6
Total mass will be assessed via dual-energy X-ray absorptiometry (DEXA)
Changes in Visceral Adipose Tissue (VAT)
Time frame: Week 0 and 6
Total VAT will be assessed via dual-energy X-ray absorptiometry (DEXA)
Changes in Body Fat Percentage
Time frame: Week 0 and 6
Total body fat percentage will be assessed via dual-energy X-ray absorptiometry (DEXA)
Changes in Body Mass Index
Time frame: Week 0 and 6
Total body mass index will be assessed via dual-energy X-ray absorptiometry (DEXA)
Changes in Body Shape
Time frame: 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 Image Acceptance
Time frame: 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.
55 secondary outcomes
Changes in Self-Esteem
Time frame: Week 0 and 6
Changes in General Health
Time frame: Week 0 and 6
Changes in Modified Huet
Time frame: Week 0 and 6
Changes in lower-body strength
Time frame: Week 0 and 6
Resting Heart Rate
Time frame: Week 0 and 6
Resting Systolic Blood Pressure
Time frame: Week 0 and 6
Resting Diastolic Blood Pressure
Time frame: Week 0 and 6
Resting Mean Arterial Pressure
Time frame: Week 0 and 6
Resting Pulse Wave Velocity
Time frame: Week 0 and 6
Changes in C-reactive protein
Time frame: Week 0 and 6
Changes in Apolipoprotein B
Time frame: Week 0 and 6
Changes in White Blood Cell count
Time frame: Week 0 and 6
Changes in Red Blood Cell count
Time frame: Week 0 and 6
Changes in Hemoglobin levels
Time frame: Week 0 and 6
Changes in Hematocrit levels
Time frame: Week 0 and 6
Changes in Mean Corpuscular Volume
Time frame: Week 0 and 6
Changes in Mean Corpuscular Hemoglobin
Time frame: Week 0 and 6
Changes in Mean Corpuscular Hemoglobin Concentration
Time frame: Week 0 and 6
Changes in Red Cell Distribution Width
Time frame: Week 0 and 6
Changes in Platelet Count
Time frame: Week 0 and 6
Changes in Mean Platelet Volume
Time frame: Week 0 and 6
Changes in Granulocyte levels
Time frame: Week 0 and 6
Changes in Lymphocyte levels
Time frame: Week 0 and 6
Changes in Monocyte levels
Time frame: Week 0 and 6
Changes in Eosinophil levels
Time frame: Week 0 and 6
Changes in Basophil levels
Time frame: Week 0 and 6
Changes in Granulocyte count
Time frame: Week 0 and 6
Changes in Lymphocyte count
Time frame: Week 0 and 6
Changes in Monocyte count
Time frame: Week 0 and 6
Changes in Eosinophil count
Time frame: Week 0 and 6
Changes in Basophil count
Time frame: Week 0 and 6
Changes in Glucose levels
Time frame: Week 0 and 6
Changes in Blood Urea Nitrogen levels
Time frame: Week 0 and 6
Changes in Serum Creatinine levels
Time frame: Week 0 and 6
Changes in Sodium levels
Time frame: Week 0 and 6
Changes in Potassium levels
Time frame: Week 0 and 6
Changes in Chloride levels
Time frame: Week 0 and 6
Changes in Carbon Dioxide levels
Time frame: Week 0 and 6
Changes in Calcium levels
Time frame: Week 0 and 6
Changes in Total Protein levels
Time frame: Week 0 and 6
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Feb 2024.
- Derived from this study: PubMed 40248760Ottinger CR, Gheith RH, Sharp MH, Davis JM, Lowery RP, Wilson JM. A randomized controlled trial to assess the effectiveness of a mobile application-based lifestyle change program (FASTer Way) on body composition, biochemical and hematological health markers, body image, and self-esteem in overweight women. Mhealth. 2025 Mar 20;11:13. doi: 10.21037/mhealth-24-62. eCollection 2025.
Related trials for Body Image
Active, not recruiting
Dance Study for Post-surgical Pain in Breast Cancer Survivors
Breast Cancer, Survivorship
Not yet recruiting
Expand Your Horizon-Spanish
Body Image, Body Image Dissatisfaction
Recruiting
The Effects of Weight and Nutrition Education on Weight Control Beliefs, Body Image, Self-Esteem and Eating Patterns in Undergraduate Dieters
Dietary Restraint
Recruiting
Evaluation of a Brief Influencer-Delivered Body Image Video
Body Image
RecruitingObservational study
Advanced Radiotherapy (ART) in Gynecological Cancer Patients (GYN-ART)
Gynecologic Cancer, Radiotherapy Side Effect
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing FASTer Way Intervention in people with Body Image and Self Esteem, run by Applied Science & Performance Institute at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in Fat Mass (time frame: Week 0 and 6). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05813548, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Feb 2024.