Recruiting

Weight Loss

Sponsor:

VA Office of Research and Development

Code:

NCT06322030

Conditions

Stroke

Eligibility Criteria

Sex: All

Age: 40 - 70+

Healthy Volunteers: Not accepted

Interventions

FOCUS-15 Lifestyle Management Program

Exercise Training

Study Details

Brief summary:

Weight loss interventions for neurologically health individuals have established benefits for improving physical and psychosocial function. The investigators believe that Veterans who have had a stroke would realize similar benefits and that the effects would be enhanced with concurrent exercise training. The investigators will study the effects of a 15-week lifestyle management program to determine if it can effectively improve some of the physical and psychosocial problems common in Veterans who have had a stroke.

Conditions

Stroke

Study ID

NCT06322030

Start date

May 1, 2024

Status verified date

May, 2026

Completion date

Mar 31, 2028

Anticipated

Primary completion date

Dec 31, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 40 - 70+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • A diagnosis of stroke at least 6 months prior
  • BMI > 30 kg/m2
  • Residual paresis in the lower extremity (Fugl-Meyer LE motor score <34)
  • Ability to follow instructions, complete training and testing and to communicate exertion, pain and distress
  • Provision of informed consent

  • Individuals who meet inclusion criteria must complete an exercise tolerance test and be cleared for participation by the study cardiologist

Exclusion Criteria:

  • Unable to ambulate at least 150 feet or experienced intermittent claudication while walking
  • Unstable cardiac arrhythmias, hypertrophic cardiomyopathy, severe aortic stenosis, angina or dyspnea at rest or during ADL's
  • Dementia
  • Life expectancy <1 yr
  • History of DVT or pulmonary embolism within 6 months
  • Uncontrolled diabetes with recent weight loss, diabetic coma, or frequent insulin reactions
  • Severe hypertension with systolic >200 mmHg and diastolic >110 mmHg at rest
  • Current enrollment in a rehabilitation trial to enhance motor or psychosocial recovery

Study Design

Enrollment

99 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Diet

15 week weight management program

no intervention: Control

waitlist control

experimental: Exercise

exercise training

experimental: Diet + Exercise

15 week weight management program + exercise training

Interventions

FOCUS-15 Lifestyle Management Program

15 week weight management program

Exercise Training

15 weeks of progressive exercise training

Primary outcome measure

  • Change in distance walk in 6 minute Walk Test [ Time Frame: approximately 15 weeks ]

Central Contacts and Locations

Central contacts

Sarah A Jackson, BA MA

(843) 789-6700sarah.jackson@va.gov

Locations

Ralph H. Johnson VA Medical Center, Charleston, SC

Recruiting

Charleston, South Carolina, United States, 29401-5703

Contacts

R. Amanda C LaRue, PhD

843-789-6707Rutha.Larue@va.gov

Thad Abrams, MD

(319) 338-0581thad.abrams@va.gov

Principal Investigator:

Chris M Gregory, PhD

More Information

Sponsor

VA Office of Research and Development

Last update posted

May 15, 2026

Last verified

May, 2026

Keywords

  • obesity
  • weight loss
  • quality of life

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by VA Office of Research and Development on 2026-05-15.