Recruiting

Physical Activity

Sponsor:

Kennesaw State University

Code:

NCT07221279

Conditions

Dyslipidemia

Insulin Resistance Syndrome

Hypertension

Inflammation Chronic

Obesity & Overweight

Eligibility Criteria

Sex: All

Age: 20+

Healthy Volunteers: Accepted

Interventions

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

Study Details

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.

Conditions

Dyslipidemia

Insulin Resistance Syndrome

Hypertension

Inflammation Chronic

Obesity & Overweight

Study ID

NCT07221279

Start date

Jan 13, 2025

Status verified date

Sep, 2025

Completion date

Aug 31, 2027

Anticipated

Primary completion date

Aug 31, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 20+

Healthy Volunteers: Accepted

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

Study Design

Enrollment

200 participants

Anticipated

Intervention Model

Single group

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

experimental: Regular accumulation of step count targets to achieve predictable weight loss

Participants will be provided a step count goal that may be expected to result in a weight loss of 5% of body weight, and will carry a pedometer for 8 months while striving to consistently reach the step count target.

Interventions

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 measure

  • 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 ]
  • 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 ]
  • 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 ]

Central Contacts and Locations

Central contacts

Robert Buresh, PhD

470-578-6488rburesh@kennesaw.edu

Brian Kliszczewicz, PhD

bkliszcz@kennesaw.edu

Locations

Kennesaw State Universityh

Recruiting

Kennesaw, Georgia, United States, 30144

Contacts

Robert Buresh, PhD

4705786488rburesh@kennesaw.edu

More Information

Sponsor

Kennesaw State University

Last update posted

Oct 27, 2025

Last verified

Sep, 2025

Keywords

  • weight management
  • cardiometabolic risk management
  • physical activity
  • walking
  • pedometry

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Kennesaw State University on 2025-10-27.