Prescription of Step Counts for Targeted Changes in Body Composition and Cardiometabolic Risk in Overweight/Obese Adults
Public ClinicalTrials.gov record NCT07221279. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT07221279
- Recruitment status
- Recruiting
- Study type
- Interventional
- Phase
- Not applicable
- Enrollment
- 200 participants
Conditions and interventions
Conditions
Interventions
Behavioral
Eligibility (public fields only)
- Age range
- 20 Years and older
- Sex
- All
- Healthy volunteers
- Accepts healthy volunteers
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Jan 12, 2025
- Primary completion
- Aug 30, 2027
- Completion
- Aug 30, 2027
- Last update posted
- Oct 26, 2025
2025 – 2027
United States locations
- U.S. sites
- 1
- U.S. states
- 1
- U.S. cities
- 1
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Kennesaw State Universityh | Kennesaw | Georgia | 30144 | Recruiting |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT07221279, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Oct 26, 2025 · Synced Sep 6, 2026
Related: full search, browse by condition, browse by drug or therapy, browse by sponsor, browse by U.S. city.
Open the official record
The complete protocol, eligibility criteria, and contact information for NCT07221279 live on ClinicalTrials.gov.