NCT07221279 · Kennesaw State University
Prescription of Step Counts for Targeted Changes in Body Composition and Cardiometabolic Risk in Overweight/Obese Adults
What this study is about
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.
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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.
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.
Primary outcome measures
weight
Time frame: In phase one of the study, weight will be assessed at baseline (day 1), and 28-30 days later. In phase two of the study, weight will be measured 1) at baseline, 2) four months later, and 3) 8-months later
In phase one of the study, weight will be assessed for purposes of developing a regression model. In phase two of the study, weight will be assessed to establish a step count target, and to track changes during the 8-month intervention.
body composition
Time frame: In phase one of the study, body composition will be assessed at baseline (day 1), and 28-30 days later. In phase two of the study, body composition will assessed 1) at baseline, 2) 4 months later, and 3) 8 months later
In phase one of the study, body composition (percentage of body weight comprised of fat) will be determined for the purposes of developing a regression model to allow prediction of body composition. In phase two of the study, body composition (percentage of body weight comprised of fat) will be assessed to determine baseline levels, and to allow for tracking changes over the 8-month intervention.
Step counts
Time frame: In phase one of the study, step counts will be recorded every day for 4 weeks. In phase two of the study, step counts will be recorded each day for the duration of the 8-month walking intervention
Step counts (steps per day) will be recorded using pedometers that will be carried on the hips or torso. Step counts will be recorded for four weeks during phase one of the study, and for eight months during the intervention phase of the study (phase two).
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- ages of 20 years and older
- otherwise healthy adults on prescription medication to treat hypertension or osteoarthritic conditions are eligible to participate
- sedentary people, or people who report engaging in regular walking (no regular structured exercise for at least the past six months)
- relatively stable weight over the previous 6 months (less than 5% fluctuation in body weight)
Exclusion criteria
- any diagnosed cardiovascular, metabolic, renal, or pulmonary disease, or any diagnosed cognitive dysfunction
- women who are pregnant or plan on becoming pregnant
- people taking prescription medication to regulate plasma glucose, or that affect metabolism (e.g., thyroid medication)
- people who have undergone an increase or decrease in body weight of ≥ 5% over the previous six months
- current smokers
- people who have engaged in a program of structured exercise other than walking (e.g., weight training, jogging, swimming, cycling) within that last six months
- older adults (60-plus years old) who score \> 4 on the Short Blessed Test for geriatric cognitive impairment during the first lab visit will be ineligible to participate
Where
- Kennesaw, Georgia
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Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
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How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Oct 27, 2025 · Source of record for eligibility and locations