Virtual Enhanced Lifestyle for Metabolic Syndrome (ELM) Proof-of-Concept Study

Browse trials for

• Metabolic Syndrome 1,964
• Syndrome 9,217

Keywords

• Lifestyle

Metabolic Syndrome

1,964 studies on the registry are indexed under Metabolic Syndrome; 330 are open to participants now.

This study's enrollment of 10 is below the median of 60 across 1,460 interventional studies indexed under Metabolic Syndrome.

Lead sponsor

Rush University Medical Center is the lead sponsor of 394 studies on the registry; 61 are open to participants now.

Of its 30 completed or terminated interventional studies of FDA-regulated products, 25 (83%) have results posted.

Study arms

• Experimental
  Virtual ELM

  Behavioral: Virtual ELM

Interventions

• BehavioralVirtual ELM

  Participants will attend 1.5-hour virtual group-based sessions for 12 weeks. The program includes physical activity, cooking demonstrations, and group discussions. All sessions are led by a registered dietitian and health psychologist.

Primary outcomes

1. Fifty percent of participants will lose >5% of baseline weight after completing the intervention at 3 months.

   Weight is recorded in kilograms to the nearest 0.1 kg using a flat scale.

   Time frame: 3 months after baseline assessment

Secondary outcomes

1. Remission of components of metabolic syndrome

   The proportion of participants who are in remission of the metabolic syndrome (MetS) at 3 months will be calculated. MetS is defined by the Joint Interim Statement of the IDF, NHLBI, AHA, WHF, IAS, IASO as having 3 or more risk factors for cardiovascular disease. To be considered in remission of MetS the participant must have less than 3 of the following 5 criteria: 1) Waist circumference based on AHA/NHLBI (ATP III) cut points of ≥ 102 cm for men and ≥ 88 cm for women; 2) Fasting triglycerides ≥150 mg/dL or treatment for elevated triglycerides; 3) Fasting HDL cholesterol \<40 mg/dL in men or \<50 mg/dL in women, or treatment for low HDL; 4) Systolic blood pressure ≥130 m Hg, diastolic blood pressure ≥85 mm Hg, or treatment for hypertension; and 5) Fasting plasma glucose 100-125 mg/dL.

   Time frame: Measured at 3 months from baseline

2. Vegetable consumption

   The proportion of participants who eat 2 cups of vegetables per day. This will be assessed using the National Cancer Institute (NCI) Fruit and Vegetable Intake Screener from the Eating at America's Table Study: All Day Screener.

   Time frame: Measured at 3 months from baseline

3. Physical activity

   The proportion of participants who achieve 150 minutes of at least moderate intensity physical activity per week will be calculated. Activity is measured using an accelerometer (Actigraph wGT3X-BT) worn on the right hip for 7 days and for at least 10 hours/day.

   Time frame: Measured at 3 months from baseline

4. Facets of Mindfulness

   Participants will complete the Five Facet Mindfulness Questionnaire. A subscale comprised of 3-facets (observe, act with awareness, and nonreact) will be utilized to measure mindfulness in ELM. The proportion of participants who improve in a 3-facet mindfulness score of greater than or equal to 1 standard deviation of baseline distribution will be calculated. The scale range for the 5-facet mindfulness questionnaire is 39-195 with a lower score reflecting less mindfulness. The 3-facet scale range is 23-115 with a lower score reflecting less mindfulness.

   Time frame: Measuring change from baseline mindfulness at 3 months

5. Habit formation

   The proportion of participants who improve in habit strength in 4 domains (diet, physical activity, emotional control, and sensory awareness), defined as a mean of ≥ 4 on the Self-Report Habit Index will be calculated. A 5-point Likert scale will be used with a scale range from 0 to 20. A lower score reflects a weaker habit.

   Time frame: Measured at 3 months after baseline

Other outcomes

1. Metabolic syndrome severity score

   MetS components will be assessed as a continuous sex- and race/ethnicity-specific score. The higher the MetS Severity score, the higher risk/severity. (Gurka MJ, Lilly CL, Oliver MN, DeBoer MD. An examination of sex and racial/ethnic differences in the metabolic syndrome among adults: a confirmatory factor analysis and a resulting continuous severity score. Metabolism. 2014;63:218-25).

   Time frame: Measured at 3 months after baseline

2. Weight loss

   Calculate the average weight loss (kg). Weight is recorded in kilograms to the nearest 0.1 kg using a flat scale.

   Time frame: Measuring change from baseline to 3 months

3. Blood pressure (metabolic syndrome component)

   The percent of participants with the blood pressure component of the Metabolic Syndrome as defined by the Joint Interim Statement of the IDF, NHLBI, AHA, WHF, IAS, IASO. The criteria for blood pressure is met when systolic blood pressure ≥130 m Hg, diastolic blood pressure ≥85 mm Hg, or self-reported treatment for hypertension. Average of 3 seated resting blood pressure measurements using NHANES protocol and cuff sizes based on arm circumference. Device is OMRON HEM-907XL Cuff sizes: Small (17.0-22.0 cm) Medium/Adult (22.1-32.0 cm) Large (32.1-42.0 cm) Extra Large (42.0-50.0 cm)

   Time frame: Measured at baseline and 3 months

4. Waist circumference (metabolic syndrome component)

   Percent of participants with the waist circumference component of the Metabolic Syndrome as defined by the Joint Interim Statement of the IDF, NHLBI, AHA, WHF, IAS, IASO. The criteria is based on AHA/NHLBI (ATP III) cut points of ≥ 102 cm for men and ≥ 88 cm for women. Waist circumference will be measured using a tape measure, following the National Heart, Lung, and Blood Institute waist circumference assessment guidelines.

   Time frame: Measured at baseline and 3 months

5. Triglycerides (metabolic syndrome component)

   The percent of participants with the triglyceride component of the Metabolic Syndrome as defined by the Joint Interim Statement of the IDF, NHLBI, AHA, WHF, IAS, IASO. The criteria for elevated triglyceride levels are fasting triglycerides ≥150 mg/dL or treatment for elevated triglycerides. A fasting blood sample will be sent to Quest diagnostics for analysis.

   Time frame: Measured at baseline and 3 months

6. High-Density Lipoproteins (HDL) cholesterol (metabolic syndrome component)

   The percent of participants with the HDL cholesterol component of the Metabolic Syndrome as defined by the Joint Interim Statement of the IDF, NHLBI, AHA, WHF, IAS, IASO. The criteria for low HDL are fasting HDL cholesterol \<40 mg/dL in men or \<50 mg/dL in women, or treatment for low HDL. A fasting blood sample will be sent to Quest diagnostics for analysis.

   Time frame: Measured at baseline and 3 months

7. Fasting plasma glucose (metabolic syndrome component)

   The percent of participants with the fasting glucose component of the Metabolic Syndrome as defined by the Joint Interim Statement of the IDF, NHLBI, AHA, WHF, IAS, IASO. Fasting plasma glucose 100-125 mg/dL (range inclusive) is considered a component of the metabolic syndrome. A fasting blood sample will be sent to Quest diagnostics for analysis.

   Time frame: Measured at baseline and 3 months

8. Body mass index

   The percent of participants who lowered their Body Mass Index (BMI). Height will be recorded in cm to nearest 0.25 cm and weight recorded in kg to nearest 0.1 kg. BMI = weight (kg) / height squared (m). The weight and height will be combined to report BMI in kg/m\^2.

   Time frame: Measuring change from baseline to 3 months

9. Frequency of contacts within health network

   The frequency of contacts within participants' health network.

   Time frame: Measuring change from baseline to 3 months

10. Energy and vitality index

    Percent of participants who improved in the energy and vitality subscale from the Medical Outcomes Study 36-item Short-Form Health Survey (SF-36) version 1. The scale range is 0 to 100 with a low score reflecting a lower energy and vitality.

    Time frame: Measuring change from baseline to 3 months

11. Perceived stress

    Measuring change of perceived stress score from baseline using the 10-item Perceived Stress Scale. The scale range is from 0 to 40. A lower score reflects lower levels of stress.

    Time frame: Measuring change from baseline to 3 months

12. Depressive symptoms

    Measuring change of depressive symptoms from baseline using the 8-item self-report Patient Health Questionnaire Depression Scale (PHQ-8). This scale ranges from 0 to 24 with a lower score reflecting less (or no) depressive symptoms.

    Time frame: Measuring change from baseline to 3 months

13. Hemoglobin A1c levels

    Measuring change in Hemoglobin A1c levels. A blood assay will be analyzed by Quest Diagnostics. Standard safety procedures are used in performing the participant blood draw required for this measure.

    Time frame: Measuring change from baseline to 3 months

14. Sugar-sweetened beverages

    Measuring change in frequency of consumption of sugar-sweetened beverages using the Behavioral Risk Factor Surveillance System - Beverage Items.

    Time frame: Measuring change from baseline to 3 months

15. Eating competence

    Measuring change on eating competence using the 16-item Eating Competence Survey. The scale ranges from 0 to 48 with a higher score reflecting a better outcome.

    Time frame: Measuring change from baseline to 3 months

16. C-reactive protein (hs-CRP)

    Measuring decrease inflammation by using the benchmark of 20% improvement in hs-CRP.

    Time frame: Measuring change from baseline to 3 months

17. Interleukin 6 (IL-6)

    Measuring decrease inflammation by using the benchmark of 20% improvement in IL-6.

    Time frame: Measuring change from baseline to 3 months

18. Fidelity of intervention

    Explore the fidelity of treatment delivery, receipt, and enactment. Treatment delivery is measured by the investigator reviewing the session recordings and completing a standardized form assessing the interventionists' ability to deliver the program as designed. Receipt of treatment is assessed by attendance. Enactment of treatment is self-reported by participants in a 4-item questionnaire after each session.

    Time frame: Measuring during 3-month lifestyle program

19. Feasibility of recruitment

    Explore feasibility of recruitment by reviewing the screened to enrollment ratio. Research staff will also take qualitative notes on the process to inform future recruitment strategies.

    Time frame: Up to 12 weeks