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

NCT05813548 | Completed

• 1 other identifier: 012023
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Body Image; Self Esteem; Weight Loss; Health Behavior; Health-Related Behavior; Health Knowledge, Attitudes, Practice

Keywords

Mobile Application; Phone Application; Body Composition

Outcome Measures

Primary Outcomes (8)

• Changes in Fat Mass

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

  Week 0 and 6

• Changes in Lean Mass

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

  Week 0 and 6

• Changes in Total Mass

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

  Week 0 and 6

• Changes in Visceral Adipose Tissue (VAT)

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

  Week 0 and 6

• Changes in Body Fat Percentage

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

  Week 0 and 6

• Changes in Body Mass Index

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

  Week 0 and 6

• 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

• 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 Outcomes (55)

• Changes in Self-Esteem

  Week 0 and 6

• Changes in General Health

  Week 0 and 6

• Changes in Modified Huet

  Week 0 and 6

• Changes in lower-body strength

  Week 0 and 6

• Resting Heart Rate

  Week 0 and 6

Study Arms (2)

Treatment

EXPERIMENTAL

FASTer Way Application-Based Lifestyle Program

Other: FASTer Way Intervention

Control

ACTIVE COMPARATOR

General health and dietary guidelines

Other: Control Group Intervention

Interventions

FASTer Way Intervention OTHER

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

Treatment

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.

Control

Eligibility Criteria

• Age: 30 Years - 55 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Applied Science & Performance Institute: lead

Study Sites (1)

Applied Science and Performance Institute

Tampa, Florida, 33607, United States

Location

Related Publications (1)

• Ottinger CR, Gheith RH, Sharp MH, Davis JM, Lowery RP, Wilson JM. A randomized controlled trial to assess the effectiveness of a mobile application-based lifestyle change program (FASTer Way) on body composition, biochemical and hematological health markers, body image, and self-esteem in overweight women. Mhealth. 2025 Mar 20;11:13. doi: 10.21037/mhealth-24-62. eCollection 2025.

  PMID: 40248760 DERIVED

MeSH Terms

Conditions

Weight Loss; Health Behavior; Behavior

Condition Hierarchy (Ancestors)

Body Weight Changes; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 3, 2023
• First Posted: April 14, 2023
• Study Start: February 28, 2023
• Primary Completion: August 30, 2023
• Study Completion: August 30, 2023
• Last Updated: February 15, 2024

Record last verified: 2024-02

Locations

US (1)