NCT07221279Recruiting
Prescription of Step Counts for Targeted Changes in Body Composition and Cardiometabolic Risk in Overweight/Obese Adults
Source: ClinicalTrials.gov · Last updated 27 Oct 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 200 (estimated)
- First submitted
- 12 Sept 2025
- Start date
- 13 Jan 2025
- Primary completion date
- 31 Aug 2027
- Lead sponsor
- Kennesaw State University
- Diseases
- Obesity, High blood pressure
- NCT number
- NCT07221279
What you commit to
- Study type: Interventional
- Planned participants: 200
- From 13 Jan 2025 to the primary completion date, 31 Aug 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Lab values
- 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
Who the study is looking for
- 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)
Age in the registry: 20 years to - · Sex: All · Accepts healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Kennesaw State Universityh Coordinator of this site? Confirm its status | Kennesaw | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.