Clinical Trials Logo

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.


Clinical Trial 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


Related Conditions & MeSH terms


NCT number NCT05813548
Study type Interventional
Source Applied Science & Performance Institute
Contact
Status Completed
Phase N/A
Start date February 28, 2023
Completion date August 30, 2023

See also
  Status Clinical Trial Phase
Completed NCT04506996 - Monday-Focused Tailored Rapid Interactive Mobile Messaging for Weight Management 2 N/A
Active, not recruiting NCT04420936 - Pragmatic Research in Healthcare Settings to Improve Diabetes and Obesity Prevention and Care for Our Program N/A
Terminated NCT03316105 - Effect of T6 Dermatome Electrical Stimulation on Gastroduodenal Motility in Healthy Volunteers N/A
Completed NCT03700736 - The Healthy Moms Study: Comparison of a Post-Partum Weight Loss Intervention Delivered Via Facebook or In-Person Groups N/A
Active, not recruiting NCT04353726 - Knowledge-based Dietary Weight Management. N/A
Completed NCT02948283 - Metformin Hydrochloride and Ritonavir in Treating Patients With Relapsed or Refractory Multiple Myeloma or Chronic Lymphocytic Leukemia Phase 1
Completed NCT03377244 - Healthy Body Healthy Souls in the Marshallese Population N/A
Completed NCT02877004 - LLLT for Reducing Waste Circumference and Weight N/A
Active, not recruiting NCT04327141 - Low Sugar Protein Pacing, Intermittent Fasting Diet in Men and Women N/A
Completed NCT03929198 - Translation of Pritikin Program to the Community N/A
Recruiting NCT05249465 - Spark: Finding the Optimal Tracking Strategy for Weight Loss in a Digital Health Intervention N/A
Recruiting NCT05942326 - Sleep Goal-focused Online Access to Lifestyle Support N/A
Completed NCT00535600 - Effects of Bariatric Surgery on Insulin
Not yet recruiting NCT03601273 - Bariatric Embolization Trial for the Obese Nonsurgical Phase 1
Active, not recruiting NCT04357119 - Common Limb Length in One-anastomosis Gastric Bypass N/A
Completed NCT03210207 - Gastric Plication in Mexican Patients N/A
Completed NCT02945410 - Effect of Caloric Restriction and Protein Intake on Metabolism and Anabolic Sensitivity N/A
Completed NCT02948517 - Time Restricted Feeding for Weight Loss and Cardio-protection N/A
Completed NCT03139760 - POWERSforID: A Telehealth Weight Management System for Adults With Intellectual Disability N/A
Recruiting NCT02559479 - A Study to Assess the Effect of a Normal vs. High Protein Diets in Carbohydrates Metabolism in Obese Subjects With Diabetes or Prediabetes N/A