Efficacy of a Web-based Tailored Self-management Program

NCT01512069 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 59

Last updated 2014-04-24

No results posted yet for this study

Summary

Life style interventions that promote exercise and a healthy diet, which have the potential to improve health-related quality of life (HRQOL), may be particularly appropriate for cancer survivors. The previous studies suggested that a key strategy to implement sustainable healthy behavior and improve health was providing appropriate feedback and promoting self-efficacy. Web-based program enables to provide the feedback in a timely manner on a daily basis, to continue the healthy behaviors.

Therefore, the investigators developed a web-based, stage-matched Exercise and Diet Planning program, and whether the program can promote significantly greater changes in behavioral outcomes \[goal of exercise (energy expenditure of aerobic exercise ≥ 12.5 kcal/kg/week) and diet (intake of vegetables ≥ 5 serv/day and intake of fruit ≥ 1 serv/day)\], stage of changes for exercise and diet, psychosocial outcomes (HRQOL, fatigue, anxiety and depression) and self-efficacy in implementing goal of exercise and diet among breast cancer survivors in Korea was examined.

Hypotheses were following:

1. Survivors of a group participating in a web-based, stage-matched Exercise and Diet Planning program (hereinafter called the 'intervention group') will show a more advanced stage of change for exercise and diet compared to survivors in the control group.
2. The intervention group will show a higher proportion of attaining goal of exercise (or higher level of energy expenditure of aerobic exercise) compared to the control group.
3. The intervention group will show a higher proportion of attaining goal of diet (or higher level of diet quality) compared to the control group.
4. The intervention group will show a better HRQOL level compared to the control group.
5. The intervention group will show a better self-efficacy level compared to the control group.
6. The intervention group will show a lower fatigue level compared to the control group.
7. The intervention group will show less anxiety compared to the control group.
8. The intervention group will show less depression compared to the control group.

Conditions

Interventions

BEHAVIORAL

Web-based Health Planner on diet and exercise

URL is closed The program is 12-week program, provides tailored information on the exercise and diet based on the stage of motivational readiness of TTM. The program is designed to allow to plan a regular exercise of 12.5 MET per week and to recommend to eat number of portions from six food groups for balanced diet tailored to individual's BMI, ideal body weight, and calories needed per day. The program provide the feedback based on the achievement of goals of the behaviors.

BEHAVIORAL

Non-tailored booklet on exercise and diet

The active control group is provided non-tailored booklet on exercise and diet, whose information is same as web-based program except stage-matching.

Sponsors & Collaborators

  • Seoul National University

    collaborator OTHER
  • Asan Medical Center

    collaborator OTHER
  • Korea University Anam Hospital

    collaborator OTHER
  • National Cancer Center, Korea

    lead OTHER_GOV

Principal Investigators

  • YoungSung Lee, PhD · National Cancer Center

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
20 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-10-31
Primary Completion
2012-03-31
Completion
2012-08-31

Countries

  • South Korea

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01512069 on ClinicalTrials.gov