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

Weight Loss Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05813548
• Other study ID #: 012023
• Status: Completed
• Phase: N/A
• Start date: February 28, 2023
• Est. completion date: August 30, 2023

Study information

• Verified date: February 2024
• Source: Applied Science & Performance Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 42
• Est. completion date: August 30, 2023
• Est. primary completion date: August 30, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 30 Years to 55 Years

Eligibility

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

Related Conditions & MeSH terms

• Body Image
• Health Behavior
• Health Knowledge, Attitudes, Practice
• Self Esteem
• Weight Loss

Intervention

Other:
• FASTer Way Intervention
6-weeks of exercise, building healthy nutritional habits such as intermittent fasting and carb-cycling
• 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.

Locations

Country	Name	City	State
United States	Applied Science and Performance Institute	Tampa	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Applied Science & Performance Institute

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes in Fat Mass	Total fat mass will be assessed via dual-energy X-ray absorptiometry (DEXA)	Week 0 and 6
Primary	Changes in Lean Mass	Total lean mass will be assessed via dual-energy X-ray absorptiometry (DEXA)	Week 0 and 6
Primary	Changes in Total Mass	Total mass will be assessed via dual-energy X-ray absorptiometry (DEXA)	Week 0 and 6
Primary	Changes in Visceral Adipose Tissue (VAT)	Total VAT will be assessed via dual-energy X-ray absorptiometry (DEXA)	Week 0 and 6
Primary	Changes in Body Fat Percentage	Total body fat percentage will be assessed via dual-energy X-ray absorptiometry (DEXA)	Week 0 and 6
Primary	Changes in Body Mass Index	Total body mass index will be assessed via dual-energy X-ray absorptiometry (DEXA)	Week 0 and 6
Primary	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.	Week 0 and 6
Primary	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.	Week 0 and 6
Secondary	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.	Week 0 and 6
Secondary	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.	Week 0 and 6
Secondary	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.	Week 0 and 6
Secondary	Changes in lower-body strength	Assessed using the isometric mid-thigh pull	Week 0 and 6
Secondary	Resting Heart Rate	Changes in resting heart rate	Week 0 and 6
Secondary	Resting Systolic Blood Pressure	Changes in resting systolic blood pressure	Week 0 and 6
Secondary	Resting Diastolic Blood Pressure	Changes in resting diastolic blood pressure	Week 0 and 6
Secondary	Resting Mean Arterial Pressure	Changes in resting mean arterial pressure	Week 0 and 6
Secondary	Resting Pulse Wave Velocity	Changes in pulse wave velocity	Week 0 and 6
Secondary	Changes in C-reactive protein	Experimental outcome examining the total C-reactive protein via fasted whole blood samples.	Week 0 and 6
Secondary	Changes in Apolipoprotein B	Experimental outcome examining the total Apolipoprotein B via fasted whole blood samples.	Week 0 and 6
Secondary	Changes in White Blood Cell count	Experimental outcome examining the total white blood cell count via fasted whole blood samples.	Week 0 and 6
Secondary	Changes in Red Blood Cell count	Experimental outcome examining the total red blood cell count via fasted whole blood samples.	Week 0 and 6
Secondary	Changes in Hemoglobin levels	Experimental outcome examining the total hemoglobin via fasted whole blood samples.	Week 0 and 6
Secondary	Changes in Hematocrit levels	Experimental outcome examining the total hematocrit via fasted whole blood samples.	Week 0 and 6
Secondary	Changes in Mean Corpuscular Volume	Experimental outcome examining the total mean corpuscular volume via fasted whole blood samples.	Week 0 and 6
Secondary	Changes in Mean Corpuscular Hemoglobin	Experimental outcome examining the total mean corpuscular hemoglobin via fasted whole blood samples.	Week 0 and 6
Secondary	Changes in Mean Corpuscular Hemoglobin Concentration	Experimental outcome examining the total mean corpuscular hemoglobin concentration via fasted whole blood samples.	Week 0 and 6
Secondary	Changes in Red Cell Distribution Width	Experimental outcome examining the total red cell distribution width via fasted whole blood samples.	Week 0 and 6
Secondary	Changes in Platelet Count	Experimental outcome examining the total platelet count via fasted whole blood samples.	Week 0 and 6
Secondary	Changes in Mean Platelet Volume	Experimental outcome examining the total mean platelet volume via fasted whole blood samples.	Week 0 and 6
Secondary	Changes in Granulocyte levels	Experimental outcome examining the percentage of Granulocytes via fasted whole blood samples.	Week 0 and 6
Secondary	Changes in Lymphocyte levels	Experimental outcome examining the percentage of Lymphocytes via fasted whole blood samples.	Week 0 and 6
Secondary	Changes in Monocyte levels	Experimental outcome examining the percentage of Monocytes via fasted whole blood samples.	Week 0 and 6
Secondary	Changes in Eosinophil levels	Experimental outcome examining the percentage of Eosinophil via fasted whole blood samples.	Week 0 and 6
Secondary	Changes in Basophil levels	Experimental outcome examining the percentage of Basophil via fasted whole blood samples.	Week 0 and 6
Secondary	Changes in Granulocyte count	Experimental outcome examining total Granulocytes via fasted whole blood samples.	Week 0 and 6
Secondary	Changes in Lymphocyte count	Experimental outcome examining total Lymphocytes via fasted whole blood samples.	Week 0 and 6
Secondary	Changes in Monocyte count	Experimental outcome examining total Monocytes via fasted whole blood samples.	Week 0 and 6
Secondary	Changes in Eosinophil count	Experimental outcome examining total Eosinophils via fasted whole blood samples.	Week 0 and 6
Secondary	Changes in Basophil count	Experimental outcome examining total Basophils via fasted whole blood samples.	Week 0 and 6
Secondary	Changes in Glucose levels	Experimental outcome examining total glucose via fasted whole blood samples.	Week 0 and 6
Secondary	Changes in Blood Urea Nitrogen levels	Experimental outcome examining total blood urea nitrogen via fasted whole blood samples.	Week 0 and 6
Secondary	Changes in Serum Creatinine levels	Experimental outcome examining total serum creatinine via fasted whole blood samples.	Week 0 and 6
Secondary	Changes in Sodium levels	Experimental outcome examining total sodium via fasted whole blood samples.	Week 0 and 6
Secondary	Changes in Potassium levels	Experimental outcome examining total potassium via fasted whole blood samples.	Week 0 and 6
Secondary	Changes in Chloride levels	Experimental outcome examining total chloride via fasted whole blood samples.	Week 0 and 6
Secondary	Changes in Carbon Dioxide levels	Experimental outcome examining total carbon dioxide via fasted whole blood samples.	Week 0 and 6
Secondary	Changes in Calcium levels	Experimental outcome examining total calcium via fasted whole blood samples.	Week 0 and 6
Secondary	Changes in Total Protein levels	Experimental outcome examining total Protein via fasted whole blood samples.	Week 0 and 6
Secondary	Changes in Albumin levels	Experimental outcome examining total albumin via fasted whole blood samples.	Week 0 and 6
Secondary	Changes in Globulin levels	Experimental outcome examining total globulin via fasted whole blood samples.	Week 0 and 6
Secondary	Changes in Total Bilirubin levels	Experimental outcome examining total bilirubin via fasted whole blood samples.	Week 0 and 6
Secondary	Changes in Alkaline Phosphate levels	Experimental outcome examining total alkaline phosphate via fasted whole blood samples.	Week 0 and 6
Secondary	Changes in Alanine Transaminase levels	Experimental outcome examining total Alanine Transaminase via fasted whole blood samples.	Week 0 and 6
Secondary	Changes in Aspartate Aminotransferase levels	Experimental outcome examining total Aspartate Aminotransferase via fasted whole blood samples.	Week 0 and 6
Secondary	Changes in Albumin to Globulin ratio	Experimental outcome examining the ratio of Albumin to Globulin via fasted whole blood samples.	Week 0 and 6
Secondary	Changes in Blood Urea Nitrogen to Creatinine ratio	Experimental outcome examining the ratio of Blood urea nitrogen to Creatinine via fasted whole blood samples.	Week 0 and 6
Secondary	Changes in estimated Glomerular Filtration Rate	Experimental outcome examining the Glomerular filtration rate via fasted whole blood samples.	Week 0 and 6
Secondary	Changes in Total Cholesterol levels	Experimental outcome examining total cholesterol via fasted whole blood samples.	Week 0 and 6
Secondary	Changes in Triglyceride levels	Experimental outcome examining total triglycerides via fasted whole blood samples.	Week 0 and 6
Secondary	Changes in High Density Lipoprotein levels (HDL)	Experimental outcome examining total high density lipoprotein via fasted whole blood samples.	Week 0 and 6
Secondary	Changes in Low Density Lipoprotein levels (LDL)	Experimental outcome examining total low density lipoprotein via fasted whole blood samples.	Week 0 and 6
Secondary	Changes in Cholesterol to High Density Lipoprotein ratio	Experimental outcome examining the ratio of Cholesterol to High density lipoprotein via fasted whole blood samples.	Week 0 and 6
Secondary	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.	Week 0 and 6