Impact of Diet and Physical Activity Changes on Body Weight, Biomarkers and Quality of Life in Breast Cancer Survivors
Condition: Body Weight Changes; Mammographic Density; Quality of Life
MeSH terms: Body Weight; Body Weight Changes
Study type: Interventional

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.
    

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

        1. 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.

        2. 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.

        3. 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.

        4. 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.

        5. 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.
    

Intervention name(s): Motivational Interviewing; Traditional Education
Intervention type(s): Behavioral; Behavioral
Intervention description(s): 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 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 intervention name(s): Intervention group; Comparison group
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
Keywords: breast cancer survivors; diet; physical activity; motivational interviewing; body weight; quality of life; biomarkers