Water Beverage Intervention Trial for Reducing Risk Factors of Metabolic Syndrome in Young Mexican Free Living Women
Condition: Metabolic Syndrome
MeSH terms: Metabolic Syndrome; Syndrome
Study type: Interventional

Summary: 
      Research Question: Does replacing Sugar Sweetened (SS) beverages with water consumption
      promote a decrease in triglycerides blood levels over 9 months in overweight women? The
      primary outcome variable is the triglycerides blood level. In addition, the investigators
      will consider as secondary outcome variables the following parameters of metabolic syndrome:
      weight, fasting insulin and glucose, HOMA, HDL-cholesterol, systolic and diastolic blood
      pressure, and waist circumference. The investigators will also consider as an outcome
      variable glycosylated (or glycated) hemoglobin (HbA1c).

      Design: Two groups randomized controlled trial, with an intervention group (water and
      education provision) and control group (education provision only).

      The investigators propose to recruit young adult women aged >18-<45 y who are overweight or
      obese (BMI >25 and <39), and consume at least 250 calories per day from caloric beverages
      (e.g., includes soft drinks, juices, sports drinks, sweetened tea or coffee, and alcoholic
      beverages) The intervention group (water and education provision) will be compared with a
      control condition (education provision only). The intervention has been proposed to be
      carried out for 9 months period with objective measurements of body weight and fat, total
      cholesterol, LDL-C, HDL-C, fasting blood glucose, HbA1C, hydration status, blood pressure,
      and 24 hrs dietary recalls at baseline, 3,6 and 9 months
    

Detailed description: 
      Study subjects

      The investigators propose to recruit young adult women aged 18-45 y who are overweight or
      obese (BMI >25 and <39), with fasting triglyceride level > 150 mg/dl, and consume at least
      250 calories per day from caloric beverages (e.g., includes soft drinks, juices, sports
      drinks, sweetened tea or coffee, and alcoholic beverages). It is important to note that this
      is the average intake from caloric beverages for Mexican adolescent and adult women and
      represents the average Mexican adolescent and young woman behavior

      Recruitment Participants will be recruited at a private weight-reduction clinic in
      Cuernavaca, Morelos (study site). Women will be invited to participate through local
      advertisements. Potential participants will be screened in order to evaluate if they fulfill
      the selection criteria of caloric beverages, BMI and triglyceride levels. Subsequently, in
      order to identify women with a high sweetened-beverage consumption women selected during the
      fist screening will be followed during a one-month period (referred to as the screening stage
      from now on), prior to recruitment into the intervention.

      Screening stage This stage will consist in one month period of follow-up of women who have
      fulfilled the BMI, age, triglyceride and other selection criteria. During this period, three
      simplified 24-hr beverage-oriented dietary recalls (2 during week days and one weekend) will
      be collected approximately 7-10 days apart from each other. These 24 hr-recalls will
      exclusively seek to evaluate high caloric intake coming from sweetened caloric beverages.
      Specifically, the investigators will evaluate the consumption of all commercial and homemade
      caloric sweetened beverages (including juices, "aguas frescas", coffee and tea with added
      sugar). The investigators will also measure triglyceride levels in a blood drop collected
      through finger prick, at the study site. The specimen collection process will be quick, and
      with minimal discomfort for the participants. The investigators will use special lancet and a
      couple of drops of blood will be taken from a nick of a finger and deposited onto special
      analytic strip. Finally, a pregnancy test will be performed at the first visit for
      confirmation purposes.

      Upon conclusion of the screening stage eligible participants will be randomly assigned to
      either the intervention or control group.

      Given that the intervention will require participant's time involvement, throughout the
      intervention period all participants will receive a $15 compensation plus snacks at each
      follow-up visit. This sum was established based on the estimated cost of a time taken for
      work to attend visits and the cost of transportation to and from the clinic.

      The Intervention

      The intervention group (water provision) will be compared with a control condition (control
      group). The intervention has been proposed to be carried out for 9 months period with
      objective measurements of body weight and fat, total cholesterol, LDL-C, HDL-C, fasting blood
      glucose, HbA1C, hydration status, blood pressure, and 24 hrs dietary recalls at baseline, 3,6
      and 9 months. Body weight will be also assessed at other times during the study. Eligible
      subjects, identified during the screening stage, will be randomly assigned either to receive
      water or to the control group. Boyh groups will be identical in all, except for the water
      deliveries and promotion of reducing the intake of sweetened caloric beverage and their
      substitution by an increase in water promotion. In order to pursuing this, specific
      counseling targeting to rationale and strategies for replacing caloric beverages to promote
      weight loss will be provided to the intervention group. In order to ensure that participants
      are not aware to the study group which they belong to (intervention or control group), the
      investigators will provide both groups with the same counseling in nutrition topics, except
      regarding the water consumption information.

      Intervention description (Water group) and contacts: The goal for subjects assigned in the
      water group will be to reduce to a minimum or null the intake of caloric beverages, including
      carbonated (fizzy) and non-carbonated (still) beverages, coffee and tea with sugar, milk or
      cream added, juice drinks, soy beverages, and sugar sweetened "aguas frescas", , energy
      drinks, and smoothies. Participants will be instructed to drink water, replacing the caloric
      beverages mentioned above. Subjects assigned to this group will receive biweekly home
      deliveries of water during the 9 month of the intervention period.

      In order to answer the research questions outlined above, adherence to the beverage reduction
      recommendations must be strongly promoted. To support the modification of beverage intake in
      the intervention group, participants will take part on monthly face to face treatment
      meetings will be held with trained dietician and or weight loss interventionists. These
      meetings will be held at convenient times and will be conducted on an individual basis as
      well as for groups of 8 to 10 participants . Participants will be weighed at each monthly
      meeting and weekly beverage consumption data will be collected. The individual and group
      meetings will cover rationale and strategies for replacing caloric beverages to promote
      weight loss. During the meetings challenges associated with the proposed behavior change and
      potential solutions will be discussed, and behavioral modification strategies to promote
      compliance will also be addressed. In addition, the weight loss interventionists and/or
      trained dieticians will call participants in a biweekly basis in order to maintain
      enthusiasm, ask for water supply status, and help solving challenges faced during the week.

      Water/Beverage Provision:

      To insure water availability, bottled water will be home delivered during the intervention
      period and/or available for pick-up at the monthly follow-up visits. Based on the work of
      Ebbeling et al.( ), the investigators plan to provide between 2 to 3 liters of water per
      person per day with 2 additional servings per day being provided to account for possible
      consumption of other family members, though this will be discouraged. Another option the
      investigators have identified in order to address the issue of consumption of the water
      provided by other family members is to provide an additional water dispenser for the
      household and additional large bottle of water for participants. The investigators will
      insure that participants receive the adequate serving sizes to fit their needs, for instance
      adequate bottle size to take water to workplace or other places. The qualitative component of
      the study will allow us to ascertain the size and number of water bottles to be provide to
      each participant.

      In addition, the investigators will meet with the Bonafont, Mexico, marketing team to discuss
      how consumers use water and bottle size issues. This will be invaluable not only in the
      selection of beverage sizes but also in the design of the water consumption nutrition
      promotion programs.

      Control group and contacts: Like the water group, the subjects in the control group will
      receive general nutrition advice not related to weight or food intake. They will not be
      granted specific information on reducing caloric beverage intake information related to
      beverage consumption and health. Participants in this group will be contacted following the
      same contact schedule and frequency as intervention group participants.
    

Intervention name(s): Water; Education
Intervention type(s): Other; Other
Intervention description(s): Water and education will be provided; Education
Other intervention name(s): Water and education; Education only
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Primary purpose: Prevention
Keywords: Metabolic Syndrome; Water; Obesity; Clinical trial; Prevention