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Clinical Trials/NCT06569121
NCT06569121RecruitingNot Applicable

Efficacy of an Evidence-based Telehealth-delivered Weight-loss Intervention to Enhance Access and Reach Underserved Groups After Stroke

Baylor Research Institute2 sites in 1 country94 target enrollmentStarted: December 7, 2024Last updated:
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Conditions

Trial Snapshot

Phase
Not Applicable
Status
Recruiting
Enrollment
94
Locations
2
Primary Endpoint
Body Weight
Study OverviewStudy DesignEligibility CriteriaOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

Brief Summary

Investigators will conduct a randomized controlled trial (RCT) to assess intervention efficacy of telehealth delivery of the GLB-CVA (tGLB-CVA) compared to a 6-month wait-list control (WLC) in partnership with a diverse group of patient partners and peer mentors.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
Single (Outcomes Assessor)

Eligibility Criteria

Ages
18 Years to 85 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • •Body Mass Index ≥25
  • •All types of stroke
  • •Able to Participate in Physical Activity
  • •≥12 months post first stroke
  • •Have internet, phone, or computer access, or be willing to use one provided by the study team

Exclusion Criteria

  • •Contraindications for physical activity
  • •Low Cognitive Function
  • •Residing in hospital, acute rehab, skilled nursing facility
  • •Not fluent in the English language
  • •Pre-existing eating disorder
  • •Pregnancy

Outcomes

Primary Outcomes

Body Weight

Time Frame: Baseline, 3, 6, 9, 12, 18 month

Body weight (lbs) will be captured via self-weighing using provided BodyTrace Smart Scale, which includes cellular connectivity so weight will be sent directly to the research team. The scales have demonstrated good concordance rates with self-weighing in previous research. Scales will be setup by the research team before being mailed to participants with instructions.

Secondary Outcomes

  • Blood Glucose(Baseline, 3, 6, 9, 12, 18 month)
  • Circumference(Baseline, 3, 6, 9, 12, 18 month)
  • Height(Baseline, 3, 6, 9, 12, 18 month)
  • Body Mass Index (BMI)(Baseline, 3, 6, 9, 12, 18 month)
  • Blood pressure(Baseline, 3, 6, 9, 12, 18 month)
  • Blood Sugar, Hemoglobin A1c (HbA1c)(Baseline, 3, 6, 9, 12, 18 month)
  • High Density Lipoprotein (HDL) cholesterol(Baseline, 3, 6, 9, 12, 18 month)
  • Low Density Lipoprotein (LDL) cholesterol(Baseline, 3, 6, 9, 12, 18 month)
  • Fasting venous sample(Baseline, 3, 6, 9, 12, 18 month)
  • 8-year Diabetes Risk(Baseline, 3, 6, 9, 12, 18 month)
  • Metabolic Syndrome Severity Score(Baseline, 3, 6, 9, 12, 18 month)
  • Behavioral Risk Factor Surveillance System (BRFSS)(Baseline, 3, 6, 9, 12, 18 month)
  • Substance Use(Baseline, 12, 18 month)
  • Neighborhood Environment Walkability Scale (NEWS)(Baseline, 3, 6, 9, 12, 18 month)
  • Social Support for Healthy Eating (SSEH)(Baseline, 3, 6, 9, 12, 18 month)
  • Quality of Life(Baseline, 3, 6, 9, 12, 18 month)
  • Self-Rated Abilities for Health Practice(Baseline, 3, 6, 9, 12, 18 month)
  • Social Support for Physical Activity (SSPA)(Baseline, 3, 6, 9, 12, 18 month)
  • Care Partner Healthy Lifestyle Support Tool(Baseline, 3, 6, 9, 12, 18 month)
  • Telehealth Usability and Satisfaction(6, 12, 18 month)
  • Exit Survey & Interview(12 or 18 month)

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (2)

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