The Effectiveness on an Application-Based Lifestyle Change Program on Health in Women
Condition: Body Image; Self Esteem; Weight Loss; Health Behavior; Health-Related Behavior; Health Knowledge, Attitudes, Practice
MeSH terms: Weight Loss
Study type: Interventional

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.
    

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
    

Intervention name(s): FASTer Way Intervention; Control Group Intervention
Intervention type(s): Other; Other
Intervention description(s): 6-weeks of exercise, building healthy nutritional habits such as intermittent fasting and carb-cycling; 6-weeks of following general exercise and nutrition guidelines from American Heart Association (AHA) and United States Department of Agriculture (USDA), respectively.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Mobile Application; Phone Application; Body Composition