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Impact of Diet and Physical Activity Changes on Body Weight, Biomarkers and Quality of Life in Breast Cancer Survivors

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04096469
Recruitment Status : Completed
First Posted : September 19, 2019
Last Update Posted : October 29, 2019
Sponsor:
Collaborator:
National Council of Science and Technology, Mexico
Information provided by (Responsible Party):
Graciela Caire Juvera, PhD, Centro de Investigación en Alimentación y Desarrollo A.C.

Brief Summary:
This study is a randomized controlled clinical trial of two arms, which included 60 women survivors of breast cancer of the state of Sonora, Mexico.The intervention is for 8 months and includes home visits every 15 days for the first four months and monthly for the last four months.The objective was to evaluate the effect of a diet and physical activity intervention program using the motivational interviewing (MI) strategy compared to an orientation with a traditional educational approach to improve anthropometric variables such as body weight, fat, muscle mass and bone mineral density, as well as biomarkers of the disease such as mammographic density, telomere length, telomerase activity, DNA methylation, ceramide-1-phosphate transport protein (CPTP), vascular endothelial growth factor (VEGF), C-reactive protein (CRP), interlucin 6 (IL-6) , interlucin 8 (IL-8), tumor necrosis factor alpha (TNF-α), leptin and adiponectin. Finally, the study also aims to improve psychological variables such as quality of life, sleep quality, anxiety and optimism.

Condition or disease Intervention/treatment Phase
Body Weight Changes Mammographic Density Quality of Life Behavioral: Motivational Interviewing Behavioral: Traditional Education Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: The intervention group received the motivational interviewing and the comparison group an orientation with a traditional educational approach. Both groups were followed for 8 months and the changes in the variables of interest were analyzed.
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Intervention Program to Promote Changes in Diet and Physical Activity and to Evaluate Its Impact on Body Weight, Biomarkers of Disease and Quality of Life in Breast Cancer Survivors
Actual Study Start Date : May 1, 2016
Actual Primary Completion Date : June 1, 2019
Actual Study Completion Date : September 1, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Motivational Interviewing
The intervention group received a guidance regarding their diet and physical activity using the motivational interviewing strategy to improve adherence to healthy behaviors. Participants received a guide with a motivational interviewing approach, which served as the basis for the interview process. The objectives in the intervention group were to consume four vegetables and two fruits a day, seven days a week, increase fiber consumption to more than 30 g daily, reduce fat consumption to no more 20% of the total energy consumed, decrease the consumption of sugary drinks and increase protein intake. Another goal was to increase the number of steps to 4,000 additional steps to those who have already walked.
Behavioral: Motivational Interviewing
The motivational interviewing strengthens the motivation and commitment to achieve a specific change through the induction and exploration of the reasons for modifying behavior. All this within an atmosphere of acceptance and compassion. It is about extracting the possible solutions to the change that is faced from the individual and his environment and not from the professional. This strategy is achieved by looking for the patient to feel motivated, and to express their problem and thus create discrepancy so that they evaluate their actions and reflect on the changes they should make.
Other Name: Intervention group

Active Comparator: Traditional Education
The comparison group received a guide on medical care and nutrition with a traditional educational approach. The indication was to read and learn about the health-related topics included in the booklet that was given to them. These participants were visited in the same way as the intervention group to answer questions and monitor participation throughout the intervention.
Behavioral: Traditional Education
Traditional education refers to the normal care given to breast cancer survivors. That is, they receive recommendations about their physical activity and diet but without any motivational approach.
Other Name: Comparison group




Primary Outcome Measures :
  1. Change in Body Weight [ Time Frame: baseline, at four months and eight months ]
    Change in body weight in kilograms

  2. Change in Breast Density [ Time Frame: baseline and at eight months ]
    Change in the amount of dense tissue compared to the amount of fatty tissue in the breast on a mammogram reported in percentage

  3. Change in Quality life [ Time Frame: baseline, at four months and eight months ]
    Change in score of the scale of the Quality of Life Patient/Cancer Survivor Version. questionnaire carried out by Ferrell et al., (2012). This questionnaire analyzes the dimensions of physical, emotional, social, and spiritual well-being through a Likert scale. The minimum score to be obtained is 42 and the maximum score is 210 points, where the higher the score, the better the quality of life and the lower the score, the worse the quality of life.

  4. Change in Sleep Quality [ Time Frame: baseline, at four months and eight months ]
    Change in score of the scale of the Pittsburgh Sleep Quality Index. This questionnaire uses a Likert-type scale and provides an overall score of the quality of sleep in a range of 0 to 21, where the highest score refers to greater difficulties in all areas of sleep and a lower score gives a better sleep quality

  5. Change in telomere length [ Time Frame: baseline and at eight months ]
    Absolute telomere length (kilobase pair) (kbp)

  6. Change in Bone Mineral Density [ Time Frame: baseline, at four months and eight months ]
    The amount of bone mineral in bone tissue in g/cm2


Secondary Outcome Measures :
  1. Change in the activity of telomerase [ Time Frame: baseline and at eight months ]
    absorbance in nanometers

  2. Change in C-reactive protein levels [ Time Frame: baseline and at eight months ]
    miligramos por litro (mg/L)

  3. Change in interleukin 6 levels [ Time Frame: baseline and at eight months ]
    picograms per milliliter pfg / mL

  4. Change in interleukin 8 levels [ Time Frame: baseline and at eight months ]
    picograms per milliliter (pg / mL)

  5. Change in levels of tumor necrosis factor alpha [ Time Frame: baseline and at eight months ]
    picograms per milliliter (pg / mL)

  6. Change in vascular endothelial growth factor levels [ Time Frame: baseline and at eight months ]
    Picograms per milliliter (pg / mL)

  7. Change in leptin levels [ Time Frame: baseline and at eight months ]
    nanograms per milliliter (ng / mL).

  8. Change in adiponectin levels [ Time Frame: baseline and at eight months ]
    nanograms per milliliter (ng / mL).

  9. Change in the percentage of fat mass [ Time Frame: baseline, at four months and eight months ]
    Change in percentage

  10. Change in percentage of muscle mass [ Time Frame: baseline, at four months and eight months ]
    Change in percentage

  11. change in the optimism scale [ Time Frame: baseline, at four months and eight months ]
    The Revised Vital Orientation Test (LOT-R) was used, which is made up of a total of 10 items with a Likert response with five response options (from 0 = "strongly disagree" to 4 = "strongly agree "). The higher the level of optimism, the higher the level of optimism.

  12. change in the anxiety scale [ Time Frame: baseline, at four months and eight months ]
    The State-Trait Anxiety Inventory, STAI was used. This questionnaire has twenty items for each of the subscales that are state anxiety and trait anxiety, with an alternative Likert response scale (from 0 = "nothing" to 3 = "a lot" for state anxiety and for trait anxiety of 0 = "Almost never" to 3 = "almost always"). Totals range from 0 to 60 for each subscale, a higher score reflects higher levels of anxiety.



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Ages Eligible for Study:   18 Years to 73 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Women over 18 with a diagnosis of stage II-IV invasive breast cancer
  • Have at least 6 weeks and no more than 2 years of completing your therapy at the time of recruitment
  • Do not present metastasis
  • Not having a special diet or rigorous physical activity
  • Not suffer any chronic illness or physical limitation
  • Not have depression problems
  • Sign the informed consent letter

Exclusion Criteria

  • Have restrictions for physical activity
  • Strict diet or be a vegetarian
  • Body mass index below 18
  • Having undergone surgery to lose weight
  • Having excision in both breasts or having implants

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04096469


Locations
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Mexico
Centro de Investigación en Alimentación y Desarrollo
Hermosillo, Sonora, Mexico, 83304
Sponsors and Collaborators
Centro de Investigación en Alimentación y Desarrollo A.C.
National Council of Science and Technology, Mexico
Investigators
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Principal Investigator: Graciela Caire Juvera, PhD CIAD
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Responsible Party: Graciela Caire Juvera, PhD, PhD, Centro de Investigación en Alimentación y Desarrollo A.C.
ClinicalTrials.gov Identifier: NCT04096469    
Other Study ID Numbers: 60252
262211 ( Other Identifier: Conacyt )
First Posted: September 19, 2019    Key Record Dates
Last Update Posted: October 29, 2019
Last Verified: October 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Actually there is no plan to share IPD to other researchers

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Graciela Caire Juvera, PhD, Centro de Investigación en Alimentación y Desarrollo A.C.:
breast cancer survivors
diet
physical activity
motivational interviewing
body weight
quality of life
biomarkers
Additional relevant MeSH terms:
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Body Weight
Body Weight Changes
Signs and Symptoms