Prescription of Step Counts for Targeted Changes in Body Composition and Cardiometabolic Risk in Overweight/Obese Adults

NCT07221279 | Recruiting

• 1 other identifier: 1R15AG081856-01A1
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

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

Keywords

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

Outcome Measures

Primary Outcomes (3)

• weight

  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.

  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

  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.

  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

  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).

  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

Secondary Outcomes (2)

• cardiometabolic risk profiles

  in phase one of the study, cardiometabolic risk factors will be 28-30 days after baseline body composition measurement. In phase two of the study, cardiometabolic risk factors will be assessed at baseline, and 8 months later.

• insulin

  in phase one of the study, insulin will be assessed after carrying a pedometer for 4 weeks; in phase two of the study, insulin will be assessed before and after the 8-month walking intervention.

Study Arms (1)

Regular accumulation of step count targets to achieve predictable weight loss

EXPERIMENTAL

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.

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

Interventions

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

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.

Regular accumulation of step count targets to achieve predictable weight loss

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Kennesaw State University: lead

Study Sites (1)

Kennesaw State Universityh

Kennesaw, Georgia, 30144, United States

RECRUITING

MeSH Terms

Conditions

Dyslipidemias; Metabolic Syndrome; Hypertension; Obesity; Overweight; Motor Activity

Interventions

Weights and Measures

Condition Hierarchy (Ancestors)

Lipid Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Insulin Resistance; Hyperinsulinism; Glucose Metabolism Disorders; Vascular Diseases; Cardiovascular Diseases; Overnutrition; Nutrition Disorders; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Investigative Techniques

Study Officials

• Robert Buresh, PhD

  Kennesaw State University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Robert Buresh, PhD

CONTACT

470-578-6488; rburesh@kennesaw.edu

Brian Kliszczewicz, PhD

CONTACT

bkliszcz@kennesaw.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 12, 2025
• First Posted: October 27, 2025
• Study Start: January 13, 2025
• Primary Completion (Estimated): August 31, 2027
• Study Completion (Estimated): August 31, 2027
• Last Updated: October 27, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF
• Time Frame: Investigators estimate that data derived from phase one of the study will be made available at about the time phase two of the study begins, which may be fall, 2026
• Access Criteria: researchers who have access to public data repositories

Locations

US (1)