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

February 14, 2024 updated by: Applied Science & Performance Institute

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

42

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Florida
      • Tampa, Florida, United States, 33607
        • Applied Science and Performance Institute

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Treatment
FASTer Way Application-Based Lifestyle Program
Other: FASTer Way Intervention
6-weeks of exercise, building healthy nutritional habits such as intermittent fasting and carb-cycling
Active Comparator: Control
General health and dietary guidelines
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Changes in Fat Mass
Time Frame: Week 0 and 6
Total fat mass will be assessed via dual-energy X-ray absorptiometry (DEXA)
Week 0 and 6
Changes in Lean Mass
Time Frame: Week 0 and 6
Total lean mass will be assessed via dual-energy X-ray absorptiometry (DEXA)
Week 0 and 6
Changes in Total Mass
Time Frame: Week 0 and 6
Total mass will be assessed via dual-energy X-ray absorptiometry (DEXA)
Week 0 and 6
Changes in Visceral Adipose Tissue (VAT)
Time Frame: Week 0 and 6
Total VAT will be assessed via dual-energy X-ray absorptiometry (DEXA)
Week 0 and 6
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)
Week 0 and 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)
Week 0 and 6
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.
Week 0 and 6
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.
Week 0 and 6

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Week 0 and 6
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.
Week 0 and 6
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.
Week 0 and 6
Changes in lower-body strength
Time Frame: Week 0 and 6
Assessed using the isometric mid-thigh pull
Week 0 and 6
Resting Heart Rate
Time Frame: Week 0 and 6
Changes in resting heart rate
Week 0 and 6
Resting Systolic Blood Pressure
Time Frame: Week 0 and 6
Changes in resting systolic blood pressure
Week 0 and 6
Resting Diastolic Blood Pressure
Time Frame: Week 0 and 6
Changes in resting diastolic blood pressure
Week 0 and 6
Resting Mean Arterial Pressure
Time Frame: Week 0 and 6
Changes in resting mean arterial pressure
Week 0 and 6
Resting Pulse Wave Velocity
Time Frame: Week 0 and 6
Changes in pulse wave velocity
Week 0 and 6
Changes in C-reactive protein
Time Frame: Week 0 and 6
Experimental outcome examining the total C-reactive protein via fasted whole blood samples.
Week 0 and 6
Changes in Apolipoprotein B
Time Frame: Week 0 and 6
Experimental outcome examining the total Apolipoprotein B via fasted whole blood samples.
Week 0 and 6
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.
Week 0 and 6
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.
Week 0 and 6
Changes in Hemoglobin levels
Time Frame: Week 0 and 6
Experimental outcome examining the total hemoglobin via fasted whole blood samples.
Week 0 and 6
Changes in Hematocrit levels
Time Frame: Week 0 and 6
Experimental outcome examining the total hematocrit via fasted whole blood samples.
Week 0 and 6
Changes in Mean Corpuscular Volume
Time Frame: Week 0 and 6
Experimental outcome examining the total mean corpuscular volume via fasted whole blood samples.
Week 0 and 6
Changes in Mean Corpuscular Hemoglobin
Time Frame: Week 0 and 6
Experimental outcome examining the total mean corpuscular hemoglobin via fasted whole blood samples.
Week 0 and 6
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.
Week 0 and 6
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.
Week 0 and 6
Changes in Platelet Count
Time Frame: Week 0 and 6
Experimental outcome examining the total platelet count via fasted whole blood samples.
Week 0 and 6
Changes in Mean Platelet Volume
Time Frame: Week 0 and 6
Experimental outcome examining the total mean platelet volume via fasted whole blood samples.
Week 0 and 6
Changes in Granulocyte levels
Time Frame: Week 0 and 6
Experimental outcome examining the percentage of Granulocytes via fasted whole blood samples.
Week 0 and 6
Changes in Lymphocyte levels
Time Frame: Week 0 and 6
Experimental outcome examining the percentage of Lymphocytes via fasted whole blood samples.
Week 0 and 6
Changes in Monocyte levels
Time Frame: Week 0 and 6
Experimental outcome examining the percentage of Monocytes via fasted whole blood samples.
Week 0 and 6
Changes in Eosinophil levels
Time Frame: Week 0 and 6
Experimental outcome examining the percentage of Eosinophil via fasted whole blood samples.
Week 0 and 6
Changes in Basophil levels
Time Frame: Week 0 and 6
Experimental outcome examining the percentage of Basophil via fasted whole blood samples.
Week 0 and 6
Changes in Granulocyte count
Time Frame: Week 0 and 6
Experimental outcome examining total Granulocytes via fasted whole blood samples.
Week 0 and 6
Changes in Lymphocyte count
Time Frame: Week 0 and 6
Experimental outcome examining total Lymphocytes via fasted whole blood samples.
Week 0 and 6
Changes in Monocyte count
Time Frame: Week 0 and 6
Experimental outcome examining total Monocytes via fasted whole blood samples.
Week 0 and 6
Changes in Eosinophil count
Time Frame: Week 0 and 6
Experimental outcome examining total Eosinophils via fasted whole blood samples.
Week 0 and 6
Changes in Basophil count
Time Frame: Week 0 and 6
Experimental outcome examining total Basophils via fasted whole blood samples.
Week 0 and 6
Changes in Glucose levels
Time Frame: Week 0 and 6
Experimental outcome examining total glucose via fasted whole blood samples.
Week 0 and 6
Changes in Blood Urea Nitrogen levels
Time Frame: Week 0 and 6
Experimental outcome examining total blood urea nitrogen via fasted whole blood samples.
Week 0 and 6
Changes in Serum Creatinine levels
Time Frame: Week 0 and 6
Experimental outcome examining total serum creatinine via fasted whole blood samples.
Week 0 and 6
Changes in Sodium levels
Time Frame: Week 0 and 6
Experimental outcome examining total sodium via fasted whole blood samples.
Week 0 and 6
Changes in Potassium levels
Time Frame: Week 0 and 6
Experimental outcome examining total potassium via fasted whole blood samples.
Week 0 and 6
Changes in Chloride levels
Time Frame: Week 0 and 6
Experimental outcome examining total chloride via fasted whole blood samples.
Week 0 and 6
Changes in Carbon Dioxide levels
Time Frame: Week 0 and 6
Experimental outcome examining total carbon dioxide via fasted whole blood samples.
Week 0 and 6
Changes in Calcium levels
Time Frame: Week 0 and 6
Experimental outcome examining total calcium via fasted whole blood samples.
Week 0 and 6
Changes in Total Protein levels
Time Frame: Week 0 and 6
Experimental outcome examining total Protein via fasted whole blood samples.
Week 0 and 6
Changes in Albumin levels
Time Frame: Week 0 and 6
Experimental outcome examining total albumin via fasted whole blood samples.
Week 0 and 6
Changes in Globulin levels
Time Frame: Week 0 and 6
Experimental outcome examining total globulin via fasted whole blood samples.
Week 0 and 6
Changes in Total Bilirubin levels
Time Frame: Week 0 and 6
Experimental outcome examining total bilirubin via fasted whole blood samples.
Week 0 and 6
Changes in Alkaline Phosphate levels
Time Frame: Week 0 and 6
Experimental outcome examining total alkaline phosphate via fasted whole blood samples.
Week 0 and 6
Changes in Alanine Transaminase levels
Time Frame: Week 0 and 6
Experimental outcome examining total Alanine Transaminase via fasted whole blood samples.
Week 0 and 6
Changes in Aspartate Aminotransferase levels
Time Frame: Week 0 and 6
Experimental outcome examining total Aspartate Aminotransferase via fasted whole blood samples.
Week 0 and 6
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.
Week 0 and 6
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.
Week 0 and 6
Changes in estimated Glomerular Filtration Rate
Time Frame: Week 0 and 6
Experimental outcome examining the Glomerular filtration rate via fasted whole blood samples.
Week 0 and 6
Changes in Total Cholesterol levels
Time Frame: Week 0 and 6
Experimental outcome examining total cholesterol via fasted whole blood samples.
Week 0 and 6
Changes in Triglyceride levels
Time Frame: Week 0 and 6
Experimental outcome examining total triglycerides via fasted whole blood samples.
Week 0 and 6
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.
Week 0 and 6
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.
Week 0 and 6
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.
Week 0 and 6
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.
Week 0 and 6

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Applied Science & Performance Institute

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 28, 2023

Primary Completion (Actual)

August 30, 2023

Study Completion (Actual)

August 30, 2023

Study Registration Dates

First Submitted

April 3, 2023

First Submitted That Met QC Criteria

April 13, 2023

First Posted (Actual)

April 14, 2023

Study Record Updates

Last Update Posted (Actual)

February 15, 2024

Last Update Submitted That Met QC Criteria

February 14, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 012023

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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