Controlled Diet for Cardiometabolic Risk Factors

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Cardiometabolic Risk Factors+3 MoreControlled Diet - Behavioral
Eligibility
18+
All Sexes
What conditions do you have?
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Study Summary

This trial will study what the best dose of sedentary breaks is to improve cardiovascular risk factors.

Eligible Conditions
  • Cardiometabolic Risk Factors
  • High Blood Pressure
  • Sedentary Lifestyle
  • Diabetes

Treatment Effectiveness

Study Objectives

3 Primary · 8 Secondary · Reporting Duration: Baseline, 0.5 hours, 1 hour, 1.5 hours, 2 hours, 2.5 hours, 3 hours, 3.5 hours, 4 hours, 4.5 hours, 5 hours, 5.5 hours, 6 hours, 6.5 hours, 7 hours, 7.5 hours, 8 hours

4 hours, 8 hours
Utrecht Work Engagement Scale (UWES-9) Score
Work Performance Score
Hour 8
Blood Glucose Area Under the Curve
Blood Insulin Area Under the Curve
Hypoglycemia
Hour 8
Change in Diastolic Blood Pressure from Baseline
Change in Systolic Blood Pressure from Baseline
Proportion of participants with an exaggerated blood pressure response
Hour 8
Proportion of participants reporting physical exhaustion score greater than or equal to 9
Hour 8
Proportion of participants in whom a musculoskeletal injury was observed/reported.
Every 15 minutes over 8-hour trial visit
Net Glucose Incremental Area Under the Curve
Hour 8
Proportion of participants that fully completed the sedentary break protocol.
Up to 8 hours
Proportion of participants reporting Feeling Scale Score less than 0

Trial Safety

Trial Design

2 Treatment Groups

Sedentary Break Condition > Control Condition
1 of 2
Control Condition > Sedentary Break Condition
1 of 2

Experimental Treatment

324 Total Participants · 2 Treatment Groups

Primary Treatment: Controlled Diet · No Placebo Group · N/A

Sedentary Break Condition > Control ConditionExperimental Group · 3 Interventions: Sedentary Break (Walking) Condition, Sitting (Control) Condition, Controlled Diet · Intervention Types: Behavioral, Behavioral, Behavioral
Control Condition > Sedentary Break ConditionExperimental Group · 3 Interventions: Sedentary Break (Walking) Condition, Sitting (Control) Condition, Controlled Diet · Intervention Types: Behavioral, Behavioral, Behavioral

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: baseline, 0.5 hours, 1 hour, 1.5 hours, 2 hours, 2.5 hours, 3 hours, 3.5 hours, 4 hours, 4.5 hours, 5 hours, 5.5 hours, 6 hours, 6.5 hours, 7 hours, 7.5 hours, 8 hours

Who is running the clinical trial?

Columbia UniversityLead Sponsor
1,295 Previous Clinical Trials
1,612,947 Total Patients Enrolled
National Heart, Lung, and Blood Institute (NHLBI)NIH
3,588 Previous Clinical Trials
46,945,675 Total Patients Enrolled
Keith Diaz, PhDPrincipal InvestigatorFlorence Irving Assistant Professor of Behavioral Medicine, CUIMC
Ying Kuen (Ken) Cheung, PhDStudy ChairProfessor of Biostatistics, Department of Biostatistics, CUIMC

Eligibility Criteria

Age 18+ · All Participants · 9 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You are at least 18 years old.
You do not currently smoke cigarettes.