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NCT Number: NCT03815214

Take Off Pounds After Stroke Trial (TOPS)

The Take Off Pounds after Stroke (TOPS) trial is a Prospective Randomized Open-Label Blinded Endpoint (PROBE) study that will test a 12-week high protein, calorie restricted, partial meal replacement program, compared to enhanced standard care, for efficacy in achieving clinically significant weight loss without impairment of physical function patients with elevated body mass index (BMI) following a recent ischemic stroke.

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Key information

Conditions

Stroke Body Weight Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Hemiparesis Nervous System Diseases Neurologic Manifestations Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Overweight Paresis Pathological Conditions, Signs and Symptoms Signs and Symptoms Vascular Diseases

Age range

18 year–99 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Yale New Haven Hospital, New Haven, Connecticut, United States

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About this study

The TOPS trial is designed as a PROBE study to test the feasibility, safety, and efficacy of a 12-week high protein, calorie restricted, partial meal replacement program, compared to enhanced standard care, in achieving clinically significant weight loss without impairment of physical function when initiated within 90 days following ischemic stroke in patients with BMI 27-to-49.9 kg/m2.

Participants will be randomized in a 1-1 ratio to the partial meal replacement program (diet intervention) or enhanced standard care (control) with randomization stratified by recruitment center (BIDMC, Yale) and baseline diet consistency status (Modified Consistency Diet vs Regular Consistency Diet). Baseline diet consistency status was selected as a stratification factor because it is expected that patients with difficulty swallowing (dysphagia) after stroke that results in need for modifications to food/liquids will have a different weight loss trajectory than patients who are able to safely consume a regular diet. The follow-up duration will be 12 weeks for all subjects.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Acute ischemic stroke within 90 days of randomization
  • Age >=18
  • BMI 27-49.9 mg/kg2
  • Able to meet all nutritional and fluid needs by oral intake.
  • Ready to undergo behavioral change
  • Able and willing to provide written informed consent
  • Maximum weight <=350 lbs

Exclusion criteria

  • Medical contraindication to weight loss or diet, including the following: renal disease requiring dialysis, taking lithium, or end stage liver or renal disease considered incompatible with diet intervention by patient's personal healthcare provider or the study PI
  • Enrollment in a conflicting clinical trial (defined as a trial with an intervention known to affect weight or with an exclusion for participation in another trial)
  • Pregnancy or desire to become pregnant, or currently breastfeeding
  • High-risk of malnutrition using a standard screen
  • Trajectory of recent weight loss (i.e., loss of at least 12 lbs in the 3 months preceding screening)
  • Allergy to soy based food products
  • Require thickening of liquids due to dysphagia
  • Inability to communicate with study team
  • Inability to speak English
  • Irreversible medical conditions likely to affect short-term survival (predicted survival of less than one year)

Treatment and study plan

Partial meal replacement program

Behavioral

Four meals consist of meal replacements made by OPTAVIA, such as shakes, soups, bars, biscuits, hot drinks, and puddings. Meal replacements will be provided to subjects without charge. For two other daily meals, subjects or their caregivers will be taught how to prepare meals consisting of 5-7 ounces (cooked) of a low-fat protein, 3 servings of non-starchy vegetables, and up to 2 servings of healthy fats.

Dietary Counseling

Behavioral

Participants will receive one 45-minute counseling session on a healthy diet

Primary outcomes

  1. Proportion of subjects achieving at least a 5% weight loss

    Time frame: 12 weeks

    Proportion of subjects achieving at least a 5% weight loss from baseline to 12 weeks in the intervention group compared to the control group

Other outcomes

  1. Change in blood pressure

    Time frame: 12 weeks

    Change in blood pressure from baseline to 12 weeks

  2. Change in Waist Circumference

    Time frame: 12 weeks

    Change in waist circumference from baseline to 12 weeks

  3. Change in Body Mass Index

    Time frame: 12 weeks

    Change in Body Mass Index from baseline to 12 weeks

  4. Change in modified Rankin scale

    Time frame: 12 weeks

    Change in modified Rankin scale from baseline to 12 weeks

Sponsors and collaborators

Lead sponsor

Beth Israel Deaconess Medical Center

Other

Collaborators

  • Yale University

Registry information

Acronym: TOPS

Important dates

Study start
2019
Primary completion
2021
Study completion
2021
First posted
Jan 24, 2019
Registry last updated
Aug 23, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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