Body Weight ChangesNCT04096469
Impact of Diet and Physical Activity Changes on Body Weight, Biomarkers and Quality of Life in Breast Cancer Survivors
A study testing Motivational Interviewing and Traditional Education in people with Body Weight Changes and Mammographic Density, run by Centro de Investigación en Alimentación y Desarrollo A.C. at 1 site in Mexico.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 73 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Body Weight Changes, Mammographic Density, Quality of Life
- What is being tested?
- Motivational Interviewing and Traditional Education
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteMexico
- Study dates
- 1 May 2016to 1 Sep 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 73 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Mexico1 site
Centro de Investigación en Alimentación y Desarrollo
Hermosillo, Sonora, 83304
About this study
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
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.
Read the detailed description
The overall objective was to design and implement an intervention program to promote changes in diet and physical activity that promotes, through the focus of the motivational interview, the increase in the consumption of fruits and vegetables, the decrease in the consumption of fats and the increase in physical activity, to achieve an impact in the reduction of weight and body fat, the improvement in the biomarkers of the disease and in the quality of life in women survivors of BC.
Specific objectives
- Determine the adherence of participants to a healthy lifestyle intervention by analyzing biological markers of dietary intake (alpha and beta carotene, as well as lipid profile) at the beginning of the study and at 4 and 8 months after initiation of the intervention.
- Investigate the impact of the intervention on changes in weight, body mass index, body fat, muscle mass and bone mineral density of women by measuring these variables at the beginning of the study and at 4 and 8 months after intervention.
- Examine the effect of the intervention on biomarkers of the disease: mammographic density, telomere length and telomerase activity, VEGF, DNA methylation and CPTP at baseline and 8 months.
- To evaluate the impact of the intervention program on inflammatory markers: leptin and adiponectin, IL6, IL8, CRP and TNF-α at the beginning, 4 and 8 months after the intervention started.
- Analyze the effect of the intervention on the alterations in sleep quality and quality of life of the women survivors of breast cancer at the beginning, 4 and 8 months after the intervention.
Study Design and Participants
This was a randomized controlled clinical trial with two groups of breast cancer survivors. In the intervention group, we used the strategy of Motivational Interviewing to promote changes in diet and physical activity; the comparison group received an orientation with a traditional educational approach. The intervention program lasted eight months. A total of 60 women from Sonora, Mexico, participated in the study. The women were selected from the State Oncology Center and through social networks. The research protocol was sent to the ethics committee of the Center for Research in Food and Development, A.C. and women signed an informed consent letter to participate in the study.
Visits and monitoring
After the recruitment, application of questionnaires and blood sampling at the first visit (baseline), the participants were randomly assigned to the intervention (n = 30) or the comparison group (n = 30). The orientation was similar in both groups and was carried out in two modalities: in person at the participant's house and by telephone. The first orientation was made within the first 15 days after the first visit (baseline) and was at the participant's home. Within a week of the first initial orientation, the participants were called by phone to continue the monitoring and orientation process. During the first four months, the orientation was every fifteen days, and combined the visits to the participant's house with phone calls. During the next four months, the orientation took place once a month and at the participant's house.
Intervention program for changes in lifestyle
Guidance on lifestyle changes in the intervention group was carried out using the motivational interviewing approach and was conducted by trained personnel for that purpose. The dietary intervention was designed to promote the increase in plasma carotene levels, due to the increase in the consumption of fruits and vegetables. The intervention also promoted the improvement of the lipid profile (due to the decrease in fat consumption) and the control or reduction of body weight.
The diet and physical activity components of the lifestyle change program were progressive, and we managed individualized interventions. Both the diet and the physical activity regimen could be adjusted to any unexpected situation (e.g., Decrease in the number of steps due to stomach problems or ankle sprains) during the entire participation period.
The dietary goals contemplated to reach a consumption of 20% of the total energy coming from fats, the consumption of 6 or more servings of fruits / vegetables a day and the promotion of a healthy body weight, to increase fiber consumption to a greater than 30 grams daily, decrease the consumption of sugary drinks and increase the consumption of protein. The emphasis on dietary fat restriction helped to achieve other dietary goals, such as increased consumption of vegetables and fruits, increased fiber consumption, and mild to moderate body weight loss. To reach the goal of having a fat intake in the diet of 20% of the total energy consumed, a goal of grams of fat was established for each participant.
The component of physical activity consisted of a moderately low aerobic regime with the aim of gradually increasing the number of steps per week, in order to be able to walk at least 4000 steps (in addition to those that are already routine) per day or 28,000 steps per week. In addition, participants were encouraged to reduce sedentary time, by performing simple exercises while sitting and stretching exercises, among others.
The educational materials covered different topics such as knowing how to read and interpret the labels on food, recommendations for buying food, recommendations for eating out and others. The visits and orientation calls included a brief assessment of the food consumed and the physical activity performed the previous day, as well as a review of the list of weekly behavior goals and lifestyle journals, which helped the counselor to assess adherence to lifestyle goals and provide specific encouragement and feedback to the participant. Lifestyle journals were used to assess the intake of fat grams as well as daily steps to assess adherence and identify specific barriers to compliance with behavioral goals.
Comparison group
This group received a notebook that included general health information. As with the intervention group, they were provided with a pedometer and common literature on recommendations to stay physically active. Participants in this group were not asked to record their diet or physical activity, and guidance was provided monthly during the 8-month intervention.
Collection of information
The collection of the information was carried out in the two groups. The sociodemographic and health data of the participants were obtained in the first visit. The anthropometric and body composition measurements, as well as the application of questionnaires on sleep quality and quality of life were carried out at the first visit (day 1), 4 and 8 months after the intervention as well the dietary evaluation. The blood samples for the analysis of carotenoids, lipid profile, , VEGF, DNA methylation, and proinflammatory markers were taken on the first day, at 4 and 8 months. The mammographic density analysis, telomere length, and telomerase activity were carried out at the beginning of the study and at 8 months.
- Conditions
- Body Weight Changes, Mammographic Density, Quality of Life
- Being tested
- Motivational Interviewing, Traditional Education
- Keywords
- breast cancer survivors, diet, physical activity, motivational interviewing, body weight, quality of life, biomarkers
- Medical subject headings
- Body Weight Changes, Motor Activity, Body Weight
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Motivational InterviewingBehavioural
Also called Intervention group
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.
Traditional EducationBehavioural
Also called Comparison group
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Behavioral: Traditional Education |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Body Weight
Change in body weight in kilograms
Measured: 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
Measured: 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.
Measured: 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
Measured: baseline, at four months and eight months
Change in telomere length
Absolute telomere length (kilobase pair) (kbp)
Measured: baseline and at eight months
Change in Bone Mineral Density
The amount of bone mineral in bone tissue in g/cm2
Measured: baseline, at four months and eight months
Secondary outcomes (12)
Change in the activity of telomerase
absorbance in nanometers
Measured: baseline and at eight months
Change in C-reactive protein levels
miligramos por litro (mg/L)
Measured: baseline and at eight months
Change in interleukin 6 levels
picograms per milliliter pfg / mL
Measured: baseline and at eight months
Change in interleukin 8 levels
picograms per milliliter (pg / mL)
Measured: baseline and at eight months
Change in levels of tumor necrosis factor alpha
picograms per milliliter (pg / mL)
Measured: baseline and at eight months
Change in vascular endothelial growth factor levels
Picograms per milliliter (pg / mL)
Measured: baseline and at eight months
Change in leptin levels
nanograms per milliliter (ng / mL).
Measured: baseline and at eight months
Change in adiponectin levels
nanograms per milliliter (ng / mL).
Measured: baseline and at eight months
Change in the percentage of fat mass
Change in percentage
Measured: baseline, at four months and eight months
Change in percentage of muscle mass
Change in percentage
Measured: baseline, at four months and eight months
change in the optimism scale
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.
Measured: baseline, at four months and eight months
change in the anxiety scale
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.
Measured: baseline, at four months and eight months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2019
- Study start1 May 2016
- Primary completion1 Jun 2019
- Study completion1 Sep 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Body Weight ChangesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centro de Investigación en Alimentación y Desarrollo A.C.
- Sponsor type
- University, hospital or other
- Collaborators
- National Council of Science and Technology, Mexico
- Responsible party
- Principal investigator, Graciela Caire Juvera, PhD, Centro de Investigación en Alimentación y Desarrollo A.C.
- Investigators
- Graciela Caire Juvera, PhD, Principal investigator, CIAD
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04096469
- Sponsor's protocol ID
- 60252
- Other IDs
- 262211
- Status last verified
- Oct 2019
- First submitted
- 18 Sep 2019
- Last updated
- 29 Oct 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Actually there is no plan to share IPD to other researchers
Study at a glance
From the registry record, last updated by the sponsor on 29 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04096469
- Acronym / sponsor ID
- 60252
- Conditions
- Body Weight Changes, Mammographic Density, Quality of Life
- Keywords
- breast cancer survivors, diet, physical activity, motivational interviewing, body weight, quality of life, biomarkers
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Centro de Investigación en Alimentación y Desarrollo A.C.University, hospital or other
- Collaborators
- National Council of Science and Technology, Mexico
- Study start
- 1 May 2016 (actual)
- Primary completion
- 1 Jun 2019 (actual)
- Study completion
- 1 Sep 2019 (actual)
- First posted
- 19 Sep 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The overall objective was to design and implement an intervention program to promote changes in diet and physical activity that promotes, through the focus of the motivational interview, the increase in the consumption of fruits and vegetables, the decrease in the consumption of fats and the increase in physical activity, to achieve an impact in the reduction of weight and body fat, the improvement in the biomarkers of the disease and in the quality of life in women survivors of BC.
Specific objectives
- Determine the adherence of participants to a healthy lifestyle intervention by analyzing biological markers of dietary intake (alpha and beta carotene, as well as lipid profile) at the beginning of the study and at 4 and 8 months after initiation of the intervention.
- Investigate the impact of the intervention on changes in weight, body mass index, body fat, muscle mass and bone mineral density of women by measuring these variables at the beginning of the study and at 4 and 8 months after intervention.
- Examine the effect of the intervention on biomarkers of the disease: mammographic density, telomere length and telomerase activity, VEGF, DNA methylation and CPTP at baseline and 8 months.
- To evaluate the impact of the intervention program on inflammatory markers: leptin and adiponectin, IL6, IL8, CRP and TNF-α at the beginning, 4 and 8 months after the intervention started.
- Analyze the effect of the intervention on the alterations in sleep quality and quality of life of the women survivors of breast cancer at the beginning, 4 and 8 months after the intervention.
Study Design and Participants
This was a randomized controlled clinical trial with two groups of breast cancer survivors. In the intervention group, we used the strategy of Motivational Interviewing to promote changes in diet and physical activity; the comparison group received an orientation with a traditional educational approach. The intervention program lasted eight months. A total of 60 women from Sonora, Mexico, participated in the study. The women were selected from the State Oncology Center and through social networks. The research protocol was sent to the ethics committee of the Center for Research in Food and Development, A.C. and women signed an informed consent letter to participate in the study.
Visits and monitoring
After the recruitment, application of questionnaires and blood sampling at the first visit (baseline), the participants were randomly assigned to the intervention (n = 30) or the comparison group (n = 30). The orientation was similar in both groups and was carried out in two modalities: in person at the participant's house and by telephone. The first orientation was made within the first 15 days after the first visit (baseline) and was at the participant's home. Within a week of the first initial orientation, the participants were called by phone to continue the monitoring and orientation process. During the first four months, the orientation was every fifteen days, and combined the visits to the participant's house with phone calls. During the next four months, the orientation took place once a month and at the participant's house.
Intervention program for changes in lifestyle
Guidance on lifestyle changes in the intervention group was carried out using the motivational interviewing approach and was conducted by trained personnel for that purpose. The dietary intervention was designed to promote the increase in plasma carotene levels, due to the increase in the consumption of fruits and vegetables. The intervention also promoted the improvement of the lipid profile (due to the decrease in fat consumption) and the control or reduction of body weight.
The diet and physical activity components of the lifestyle change program were progressive, and we managed individualized interventions. Both the diet and the physical activity regimen could be adjusted to any unexpected situation (e.g., Decrease in the number of steps due to stomach problems or ankle sprains) during the entire participation period.
The dietary goals contemplated to reach a consumption of 20% of the total energy coming from fats, the consumption of 6 or more servings of fruits / vegetables a day and the promotion of a healthy body weight, to increase fiber consumption to a greater than 30 grams daily, decrease the consumption of sugary drinks and increase the consumption of protein. The emphasis on dietary fat restriction helped to achieve other dietary goals, such as increased consumption of vegetables and fruits, increased fiber consumption, and mild to moderate body weight loss. To reach the goal of having a fat intake in the diet of 20% of the total energy consumed, a goal of grams of fat was established for each participant.
The component of physical activity consisted of a moderately low aerobic regime with the aim of gradually increasing the number of steps per week, in order to be able to walk at least 4000 steps (in addition to those that are already routine) per day or 28,000 steps per week. In addition, participants were encouraged to reduce sedentary time, by performing simple exercises while sitting and stretching exercises, among others.
The educational materials covered different topics such as knowing how to read and interpret the labels on food, recommendations for buying food, recommendations for eating out and others. The visits and orientation calls included a brief assessment of the food consumed and the physical activity performed the previous day, as well as a review of the list of weekly behavior goals and lifestyle journals, which helped the counselor to assess adherence to lifestyle goals and provide specific encouragement and feedback to the participant. Lifestyle journals were used to assess the intake of fat grams as well as daily steps to assess adherence and identify specific barriers to compliance with behavioral goals.
Comparison group
This group received a notebook that included general health information. As with the intervention group, they were provided with a pedometer and common literature on recommendations to stay physically active. Participants in this group were not asked to record their diet or physical activity, and guidance was provided monthly during the 8-month intervention.
Collection of information
The collection of the information was carried out in the two groups. The sociodemographic and health data of the participants were obtained in the first visit. The anthropometric and body composition measurements, as well as the application of questionnaires on sleep quality and quality of life were carried out at the first visit (day 1), 4 and 8 months after the intervention as well the dietary evaluation. The blood samples for the analysis of carotenoids, lipid profile, , VEGF, DNA methylation, and proinflammatory markers were taken on the first day, at 4 and 8 months. The mammographic density analysis, telomere length, and telomerase activity were carried out at the beginning of the study and at 8 months.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Motivational Interviewing | Experimental | Behavioral: Motivational InterviewingThe 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. |
| Traditional Education | Active comparator | Behavioral: Traditional EducationThe 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. |
Who may qualify
- Ages
- 18 to 73 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Motivational InterviewingAlso: Intervention groupThe 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. | Behavioural | Motivational Interviewing |
| Traditional EducationAlso: Comparison groupTraditional 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. | Behavioural | Traditional Education |
Primary outcome
Change in Body Weight
Time frame: baseline, at four months and eight months
Change in body weight in kilograms
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
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.
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
Change in telomere length
Time frame: baseline and at eight months
Absolute telomere length (kilobase pair) (kbp)
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
12 secondary outcomes
Change in the activity of telomerase
Time frame: baseline and at eight months
Change in C-reactive protein levels
Time frame: baseline and at eight months
Change in interleukin 6 levels
Time frame: baseline and at eight months
Change in interleukin 8 levels
Time frame: baseline and at eight months
Change in levels of tumor necrosis factor alpha
Time frame: baseline and at eight months
Change in vascular endothelial growth factor levels
Time frame: baseline and at eight months
Change in leptin levels
Time frame: baseline and at eight months
Change in adiponectin levels
Time frame: baseline and at eight months
Change in the percentage of fat mass
Time frame: baseline, at four months and eight months
Change in percentage of muscle mass
Time frame: baseline, at four months and eight months
change in the optimism scale
Time frame: baseline, at four months and eight months
change in the anxiety scale
Time frame: baseline, at four months and eight months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Oct 2019.
- Individual participant dataSharing planned: No. Actually there is no plan to share IPD to other researchers
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Graciela Caire Juvera, PhD principal investigator
CIAD
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Motivational Interviewing and Traditional Education in people with Body Weight Changes and Mammographic Density, run by Centro de Investigación en Alimentación y Desarrollo A.C. at 1 site in Mexico.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Oct 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Mexico. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Body Weight (time frame: baseline, at four months and eight months). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Oct 2019.