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Completed

NCT Number: NCT05813548

The Effectiveness on an Application-Based Lifestyle Change Program on Health in Women

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.

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Key information

Conditions

Body Image Behavior Body Weight Body Weight Changes Health Behavior Health Knowledge, Attitudes, Practice Health-Related Behavior Pathological Conditions, Signs and Symptoms Self Esteem Signs and Symptoms Weight Loss

Age range

30 year–55 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Applied Science and Performance Institute

Tampa, Florida, 33607, United States

About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

FASTer Way Intervention

Other

6-weeks of exercise, building healthy nutritional habits such as intermittent fasting and carb-cycling

Control group intervention

Other

6-weeks of following general exercise and nutrition guidelines from American Heart Association (AHA) and United States Department of Agriculture (USDA), respectively.

Primary outcomes

  1. Changes in Fat Mass

    Time frame: Week 0 and 6

    Total fat mass will be assessed via dual-energy X-ray absorptiometry (DEXA)

  2. Changes in Lean Mass

    Time frame: Week 0 and 6

    Total lean mass will be assessed via dual-energy X-ray absorptiometry (DEXA)

  3. Changes in Total Mass

    Time frame: Week 0 and 6

    Total mass will be assessed via dual-energy X-ray absorptiometry (DEXA)

  4. Changes in Visceral Adipose Tissue (VAT)

    Time frame: Week 0 and 6

    Total VAT will be assessed via dual-energy X-ray absorptiometry (DEXA)

  5. 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)

  6. 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)

  7. 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.

  8. 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.

Secondary outcomes

  1. Changes in Self-Esteem

    Time frame: Week 0 and 6

    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.

  2. Changes in General Health

    Time frame: Week 0 and 6

    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.

  3. Changes in Modified Huet

    Time frame: Week 0 and 6

    Assessed by administering the Modified Huet Questionnaire for subjective measurement. Values range from 0 to 3.5 with higher scores demonstrating a better outcome.

  4. Changes in lower-body strength

    Time frame: Week 0 and 6

    Assessed using the isometric mid-thigh pull

  5. Resting Heart Rate

    Time frame: Week 0 and 6

    Changes in resting heart rate

  6. Resting Systolic Blood Pressure

    Time frame: Week 0 and 6

    Changes in resting systolic blood pressure

  7. Resting Diastolic Blood Pressure

    Time frame: Week 0 and 6

    Changes in resting diastolic blood pressure

  8. Resting Mean Arterial Pressure

    Time frame: Week 0 and 6

    Changes in resting mean arterial pressure

  9. Resting Pulse Wave Velocity

    Time frame: Week 0 and 6

    Changes in pulse wave velocity

  10. Changes in C-reactive protein

    Time frame: Week 0 and 6

    Experimental outcome examining the total C-reactive protein via fasted whole blood samples.

  11. Changes in Apolipoprotein B

    Time frame: Week 0 and 6

    Experimental outcome examining the total Apolipoprotein B via fasted whole blood samples.

  12. Changes in White Blood Cell count

    Time frame: Week 0 and 6

    Experimental outcome examining the total white blood cell count via fasted whole blood samples.

  13. Changes in Red Blood Cell count

    Time frame: Week 0 and 6

    Experimental outcome examining the total red blood cell count via fasted whole blood samples.

  14. Changes in Hemoglobin levels

    Time frame: Week 0 and 6

    Experimental outcome examining the total hemoglobin via fasted whole blood samples.

  15. Changes in Hematocrit levels

    Time frame: Week 0 and 6

    Experimental outcome examining the total hematocrit via fasted whole blood samples.

  16. Changes in Mean Corpuscular Volume

    Time frame: Week 0 and 6

    Experimental outcome examining the total mean corpuscular volume via fasted whole blood samples.

  17. Changes in Mean Corpuscular Hemoglobin

    Time frame: Week 0 and 6

    Experimental outcome examining the total mean corpuscular hemoglobin via fasted whole blood samples.

  18. Changes in Mean Corpuscular Hemoglobin Concentration

    Time frame: Week 0 and 6

    Experimental outcome examining the total mean corpuscular hemoglobin concentration via fasted whole blood samples.

  19. Changes in Red Cell Distribution Width

    Time frame: Week 0 and 6

    Experimental outcome examining the total red cell distribution width via fasted whole blood samples.

  20. Changes in Platelet Count

    Time frame: Week 0 and 6

    Experimental outcome examining the total platelet count via fasted whole blood samples.

  21. Changes in Mean Platelet Volume

    Time frame: Week 0 and 6

    Experimental outcome examining the total mean platelet volume via fasted whole blood samples.

  22. Changes in Granulocyte levels

    Time frame: Week 0 and 6

    Experimental outcome examining the percentage of Granulocytes via fasted whole blood samples.

  23. Changes in Lymphocyte levels

    Time frame: Week 0 and 6

    Experimental outcome examining the percentage of Lymphocytes via fasted whole blood samples.

  24. Changes in Monocyte levels

    Time frame: Week 0 and 6

    Experimental outcome examining the percentage of Monocytes via fasted whole blood samples.

  25. Changes in Eosinophil levels

    Time frame: Week 0 and 6

    Experimental outcome examining the percentage of Eosinophil via fasted whole blood samples.

  26. Changes in Basophil levels

    Time frame: Week 0 and 6

    Experimental outcome examining the percentage of Basophil via fasted whole blood samples.

  27. Changes in Granulocyte count

    Time frame: Week 0 and 6

    Experimental outcome examining total Granulocytes via fasted whole blood samples.

  28. Changes in Lymphocyte count

    Time frame: Week 0 and 6

    Experimental outcome examining total Lymphocytes via fasted whole blood samples.

  29. Changes in Monocyte count

    Time frame: Week 0 and 6

    Experimental outcome examining total Monocytes via fasted whole blood samples.

  30. Changes in Eosinophil count

    Time frame: Week 0 and 6

    Experimental outcome examining total Eosinophils via fasted whole blood samples.

  31. Changes in Basophil count

    Time frame: Week 0 and 6

    Experimental outcome examining total Basophils via fasted whole blood samples.

  32. Changes in Glucose levels

    Time frame: Week 0 and 6

    Experimental outcome examining total glucose via fasted whole blood samples.

  33. Changes in Blood Urea Nitrogen levels

    Time frame: Week 0 and 6

    Experimental outcome examining total blood urea nitrogen via fasted whole blood samples.

  34. Changes in Serum Creatinine levels

    Time frame: Week 0 and 6

    Experimental outcome examining total serum creatinine via fasted whole blood samples.

  35. Changes in Sodium levels

    Time frame: Week 0 and 6

    Experimental outcome examining total sodium via fasted whole blood samples.

  36. Changes in Potassium levels

    Time frame: Week 0 and 6

    Experimental outcome examining total potassium via fasted whole blood samples.

  37. Changes in Chloride levels

    Time frame: Week 0 and 6

    Experimental outcome examining total chloride via fasted whole blood samples.

  38. Changes in Carbon Dioxide levels

    Time frame: Week 0 and 6

    Experimental outcome examining total carbon dioxide via fasted whole blood samples.

  39. Changes in Calcium levels

    Time frame: Week 0 and 6

    Experimental outcome examining total calcium via fasted whole blood samples.

  40. Changes in Total Protein levels

    Time frame: Week 0 and 6

    Experimental outcome examining total Protein via fasted whole blood samples.

  41. Changes in Albumin levels

    Time frame: Week 0 and 6

    Experimental outcome examining total albumin via fasted whole blood samples.

  42. Changes in Globulin levels

    Time frame: Week 0 and 6

    Experimental outcome examining total globulin via fasted whole blood samples.

  43. Changes in Total Bilirubin levels

    Time frame: Week 0 and 6

    Experimental outcome examining total bilirubin via fasted whole blood samples.

  44. Changes in Alkaline Phosphate levels

    Time frame: Week 0 and 6

    Experimental outcome examining total alkaline phosphate via fasted whole blood samples.

  45. Changes in Alanine Transaminase levels

    Time frame: Week 0 and 6

    Experimental outcome examining total Alanine Transaminase via fasted whole blood samples.

  46. Changes in Aspartate Aminotransferase levels

    Time frame: Week 0 and 6

    Experimental outcome examining total Aspartate Aminotransferase via fasted whole blood samples.

  47. Changes in Albumin to Globulin ratio

    Time frame: Week 0 and 6

    Experimental outcome examining the ratio of Albumin to Globulin via fasted whole blood samples.

  48. Changes in Blood Urea Nitrogen to Creatinine ratio

    Time frame: Week 0 and 6

    Experimental outcome examining the ratio of Blood urea nitrogen to Creatinine via fasted whole blood samples.

  49. Changes in estimated Glomerular Filtration Rate

    Time frame: Week 0 and 6

    Experimental outcome examining the Glomerular filtration rate via fasted whole blood samples.

  50. Changes in Total Cholesterol levels

    Time frame: Week 0 and 6

    Experimental outcome examining total cholesterol via fasted whole blood samples.

  51. Changes in Triglyceride levels

    Time frame: Week 0 and 6

    Experimental outcome examining total triglycerides via fasted whole blood samples.

  52. Changes in High Density Lipoprotein levels (HDL)

    Time frame: Week 0 and 6

    Experimental outcome examining total high density lipoprotein via fasted whole blood samples.

  53. Changes in Low Density Lipoprotein levels (LDL)

    Time frame: Week 0 and 6

    Experimental outcome examining total low density lipoprotein via fasted whole blood samples.

  54. Changes in Cholesterol to High Density Lipoprotein ratio

    Time frame: Week 0 and 6

    Experimental outcome examining the ratio of Cholesterol to High density lipoprotein via fasted whole blood samples.

  55. Adverse Effects

    Time frame: Week 0 and 6

    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.

Sponsors and collaborators

Lead sponsor

Applied Science & Performance Institute

Industry

Registry information

Official study 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

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Apr 14, 2023
Registry last updated
Feb 15, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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