Prescription of Step Counts for Targeted Changes in Body Composition and Cardiometabolic Risk in Overweight/Obese Adults

NCT07221279 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 200

Last updated 2025-10-27

No results posted yet for this study

Summary

The prevalence of overweight and obesity remains epidemic in the United States, with some of the highest rates seen in older adults. While this phenomenon is certainly multifactorial, a good deal of evidence suggests that insufficient physical activity (PA) contributes significantly. Pilot data recently collected in a laboratory indicates a strong, inverse relationship between daily step counts and body fatness and cardiometabolic risk (CMR) factors when step counts are expressed relative to fat mass in young adults. This expression of PA may be especially predictive of body composition because it is influenced by factors that influence appetite and energy intake, energy expenditure, and the energy "reservoir" that is represented by body fat stores, all three elements of the "settling point" model of body weight. The strength of this relationship suggests that prescription of step counts that consider current body weight and composition, and weight loss goal, may yield predictable changes in weight and CMR in adults eating ad libitum. The long-term objective of this study is to quantify the relationship between daily step counts and body composition in young, middle aged, and older adults who are overweight/obese and develop a regression model that can be used to prescribe physical activity (daily step counts) for achieving a specific target body weight and predictably improving CMR risk for young, middle-aged, and older adult men and women over eight months while eating ad libitum. To achieve this objective, investigators will undertake two specific aims: 1) quantify the relationship between average steps·kg fat mass-1·day-1 and body composition/CMR profiles in healthy, overweight, and obese adults 20-39 years, 40-59 years, 60-79 years, and 80-plus years old, using inexpensive, widely available triaxial pedometers while eating ad libitum, and 2) quantify the efficacy of employing targeted step counts expressed as steps·kg fat mass-1·day-1 using the model developed in Aim 1 for producing predictable improvements in body composition and CMR factors in overweight and obese adults 20-39, 40-59, 60-79, and 80-plus years old, over 8 months while eating ad libitum. This study will result in a regression model that may significantly improve the way that PA is prescribed for weight management, with vast clinical and public health implications.

Conditions

Interventions

BEHAVIORAL

Step counts for predictable changes in body weight/compositon and cardiometabolic risk

Baseline body weight/composition will be used to establish a step count target that is expected to lead to a predictable 5% weight loss. Participants will be asked use their pedometers and to strive to achieve a step count target for 8 months.

Sponsors & Collaborators

  • Kennesaw State University

    lead OTHER

Principal Investigators

  • Robert Buresh, PhD · Kennesaw State University

Study Design

Allocation
NA
Purpose
PREVENTION
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
20 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2025-01-13
Primary Completion
2027-08-31
Completion
2027-08-31

Countries

  • United States

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07221279 on ClinicalTrials.gov