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

NCT04096469 | Completed

• 2 other identifiers: 60252262211
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Body Weight Changes; Mammographic Density; Quality of Life

Keywords

breast cancer survivors; diet; physical activity; motivational interviewing; body weight; quality of life; biomarkers

Outcome Measures

Primary Outcomes (6)

• Change in Body Weight

  Change in body weight in kilograms

  baseline, at four months and eight months

• Change in Breast Density

  Change in the amount of dense tissue compared to the amount of fatty tissue in the breast on a mammogram reported in percentage

  baseline and at eight months

• Change in Quality life

  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.

  baseline, at four months and eight months

• Change in Sleep Quality

  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

  baseline, at four months and eight months

• Change in telomere length

  Absolute telomere length (kilobase pair) (kbp)

  baseline and at eight months

• Change in Bone Mineral Density

  The amount of bone mineral in bone tissue in g/cm2

  baseline, at four months and eight months

Secondary Outcomes (12)

• Change in the activity of telomerase

  baseline and at eight months

• Change in C-reactive protein levels

  baseline and at eight months

• Change in interleukin 6 levels

  baseline and at eight months

• Change in interleukin 8 levels

  baseline and at eight months

• Change in levels of tumor necrosis factor alpha

  baseline and at eight months

Study Arms (2)

Motivational Interviewing

EXPERIMENTAL

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

Traditional Education

ACTIVE COMPARATOR

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

Interventions

Motivational Interviewing BEHAVIORAL

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.

Also known as: Intervention group

Motivational Interviewing

Traditional Education BEHAVIORAL

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.

Also known as: Comparison group

Traditional Education

Eligibility Criteria

• Age: 18 Years - 73 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Centro de Investigación en Alimentación y Desarrollo A.C.: lead
• National Council of Science and Technology, Mexico: collaborator

Study Sites (1)

Centro de Investigación en Alimentación y Desarrollo

Hermosillo, Sonora, 83304, Mexico

Location

MeSH Terms

Conditions

Body Weight Changes; Motor Activity; Body Weight

Interventions

Motivational Interviewing

Condition Hierarchy (Ancestors)

Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Directive Counseling; Counseling; Mental Health Services; Behavioral Disciplines and Activities; Health Services; Health Care Facilities Workforce and Services

Study Officials

• Graciela Caire Juvera, PhD

  CIAD

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD

Model Details: 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.

Study Record Dates

• First Submitted: September 18, 2019
• First Posted: September 19, 2019
• Study Start: May 1, 2016
• Primary Completion: June 1, 2019
• Study Completion: September 1, 2019
• Last Updated: October 29, 2019

Record last verified: 2019-10

Data Sharing

• IPD Sharing: Will not share

Locations

ME (1)