Response Evolution Chart | NCT03484637

Studies
Response Evolution Chart

NCT03484637

Sponsor

BiomediKcal

Status

Completed

Last Update Posted

Apr 2, 2018Actual

Enrollment

110Actual

Phase

Not provided

Conditions

Obesity
Overweight
Motivation
Adherence, Patient

Interventions

Lifestyle-medicine intervention

Countries

Colombia

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2018

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 14, 2016Actual

Primary Completion Date

Sep 15, 2017Actual

Completion Date

Mar 24, 2018Actual

First Submitted Date

Mar 25, 2018

First Submission Date that Met QC Criteria

Mar 25, 2018

First Posted Date

Apr 2, 2018Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 25, 2018

Last Update Posted Date

Apr 2, 2018Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

This study evaluates patient response to a motivation evolution chart for a medical-nutrition intervention as a continuation of a previous study: adherence to an overweight and obesity treatment available at: https://www.ncbi.nlm.nih.gov/pubmed/25101227

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Yes

Target Follow-Up Duration

16 Weeks

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

110Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Lifestyle-medicine intervention		Photographic follow-up every 4 weeks	Other: Lifestyle-medicine intervention

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Lifestyle-medicine intervention	Other		Lifestyle-medicine intervention

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Evolution registration by photograph	To register Body Image of patients regarding results to a medical nutrition treatment	16 weeks

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Voluntary assistance
Clinical diagnosis of overweight
Clinical diagnosis of obesity
Patient desire to improve their aesthetic image and health status

Exclusion Criteria:

This study does not consider patients who tried a diet to lose weight in the previous month or earlier

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

99 Years

Standard Ages

AdultOlder Adult

Study Population

Overweight and obese participants who consulted a medical nutrition clinic

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
BiomediKcal - Advanced Medical Nutrition & Lifestyle Center		Barranquilla	Atlántico	080020	Colombia

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
25674363	Background	Kuzmar IE, Cortes-Castell E, Rizo M. Effectiveness of telenutrition in a women's weight loss program. PeerJ. 2015 Feb 3;3:e748. doi: 10.7717/peerj.748. eCollection 2015.
25617544	Background	Kuzmar I, Cortes E, Rizo M. Age group, menarche and regularity of menstrual cycles as efficiency predictors in the treatment of overweight. Nutr Hosp. 2014 Oct 30;31(2):637-41. doi: 10.3305/nh.2015.31.2.7501.

ID	Term
D009765	Obesity
D050177	Overweight
D010349	Patient Compliance
D000074822	Treatment Adherence and Compliance

ID	Term
D044343	Overnutrition
D009748	Nutrition Disorders
D009750	Nutritional and Metabolic Diseases
D001835	Body Weight