NCT07221279 Prescription of Step Counts for Targeted Changes in Body Composition and Cardiometabolic Risk in Overweight/Obese Adults
| NCT ID | NCT07221279 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Kennesaw State University |
| Condition | Dyslipidemia |
| Study Type | INTERVENTIONAL |
| Enrollment | 200 participants |
| Start Date | 2025-01-13 |
| Primary Completion | 2027-08-31 |
Eligibility & Interventions
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 200 participants in total. It began in 2025-01-13 with a primary completion date of 2027-08-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
Eligibility Criteria
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
Contact & Investigator
Robert Buresh, PhD
PRINCIPAL INVESTIGATOR
Kennesaw State University
Frequently Asked Questions
Who can join the NCT07221279 clinical trial?
This trial is open to participants of all sexes, aged 20 Years or older, studying Dyslipidemia. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07221279 currently recruiting?
Yes, NCT07221279 is actively recruiting participants. Contact the research team at rburesh@kennesaw.edu for enrollment information.
Where is the NCT07221279 trial being conducted?
This trial is being conducted at Kennesaw, United States.
Who is sponsoring the NCT07221279 clinical trial?
NCT07221279 is sponsored by Kennesaw State University. The principal investigator is Robert Buresh, PhD at Kennesaw State University. The trial plans to enroll 200 participants.