A Mobile Aplication for the Promotion of Healthy Lifestyle Habits in Patients With Colorectal Cancer

NCT02837159 | Withdrawn

• 1 other identifier: CO217
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this randomized study is to assess the efficacy of a mobile application for the promotion of healthy lifestyle habits (diet and exercise) in colorectal cancer survivors (CCR).

Conditions

Colorectal Cancer

Keywords

colorectal cancer; Health Life Style Habits; Health

Outcome Measures

Primary Outcomes (1)

• Body Mass Index

  in kg/m2, will be assessed by conducting Dual-energy X-ray absorptiometry (DXA, discovery densitometer from HOLOGIC, QDR 4500W)

  Participants will be followed over 12 months

Secondary Outcomes (8)

• Fat mass

  Patients will be followed over 12 months

• Wait circunferemce

  Patients will be followed over 12 months

• Hip circunferemce

  Patients will be followed over 12 months

• Expenditure energy

  Patients will be followed over 12 months

• Eating habits

  Patients will be followed over 12 months

Study Arms (2)

mHealth application

EXPERIMENTAL

The assessment of the end points will be made at three moments: at baseline, at 8 weeks (at the end of the program) and at 12 months of follow-up. The intervention will consist in: 1)Feedback daily or weekly of physical exercise and diet through the application (notice) according to the records of diet and exercise and following recommendations of International Organizations 2) Participation in three sessions of seminars (1 hour each every 15 days) on habits of life healthy and cancer and the self-regulation through measurements performed by the application 3) Calls weekly to the patients of way individual to comment possible errors or doubts about the application, of 10 min of duration (8 calls).

Other: mHealth application

Usual care

NO INTERVENTION

Usual care

Interventions

mHealth application OTHER

Dietary and physical activity recommendations trough a mobile application

mHealth application

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Have a diagnosed of colorectal cancer (estadio I-IIIa)
• Have finished the primary medical treatment.
• Have a body mass index \> 25
• Have a level of physical activity \< 3 METS
• Have access to a Smartphone

You may not qualify if:

• Physical effort Contraindication from their oncologist
• Anemia
• Presence of pathologies that make more difficult the practice of physical activity such as osteoarthritis.
• Inability to read
• Severe depression, physical deficits or cognitive
• Participation in any program or intervention for weight control

Sponsors & Collaborators

• Universidad de Granada: lead

Study Sites (1)

Universidad de Granada

Granada, 18016, Spain

Location

MeSH Terms

Conditions

Colorectal Neoplasms

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Study Officials

• IRENE CANTARERO VILLANUEVA, PhD

  Universidad de Granada

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dra

Study Record Dates

• First Submitted: July 14, 2016
• First Posted: July 19, 2016
• Study Start: October 1, 2016
• Primary Completion: March 1, 2018
• Study Completion: September 1, 2019
• Last Updated: May 31, 2022

Record last verified: 2022-05

Locations

ES (1)