NCT02146885

Brief Summary

The first step in any clinical intervention against obesity involves sustained lifestyle changes. Researcher can use these strategies to beneficial the effects of weight and on cardiovascular risk. The researcher develope methods for assessing the effectiveness use optical technology to make such assessments, specifically in the area of fatty tissue can predict the effectiveness of the intervention in causing weight reduction and treating metabolic disease.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
21

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jan 2013

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 8, 2013

Completed
1.4 years until next milestone

First Submitted

Initial submission to the registry

May 19, 2014

Completed
7 days until next milestone

First Posted

Study publicly available on registry

May 26, 2014

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 13, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 13, 2017

Completed
Last Updated

November 1, 2022

Status Verified

October 1, 2022

Enrollment Period

4 years

First QC Date

May 19, 2014

Last Update Submit

October 28, 2022

Conditions

Overweight

Outcome Measures

Primary Outcomes (1)

  • Weight Control

    3 months

Study Arms (1)

Weight Control

Weight Control

Other: Weight Control

Interventions

Weight ControlOTHER

Weight Control

Weight Control

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Study population will be selected from University of California Irvine Medical Center Department of Cardiology, preventive cardiology intervention program.

You may qualify if:

  • Body Mass Index greater than 25, overweight
  • Participation in Weight Loss program

You may not qualify if:

  • A medical history of myocardial infarction or cerebrovascular stroke
  • Pregnancy or planned pregnancy during the course of the study period

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Beckman Laser Institute

Irvine, California, 92612, United States

Location

MeSH Terms

Conditions

Overweight

Condition Hierarchy (Ancestors)

OvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Shaista Malik, MD

    Beckman Laser Institute, UCI

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
CROSS SECTIONAL
Target Duration
3 Months
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Shaista Malik, M.D., Assistant Professor-Cardiology

Study Record Dates

First Submitted

May 19, 2014

First Posted

May 26, 2014

Study Start

January 8, 2013

Primary Completion

January 13, 2017

Study Completion

January 13, 2017

Last Updated

November 1, 2022

Record last verified: 2022-10

Locations

US(1)