Individualized Dietary Intervention in Breastfeeding Women: Body Weight and Vitamin A Stores
Condition: Overweight and Obesity; Vitamin A Deficiency; Dietary Modification; Breastfeeding
MeSH terms: Night Blindness; Overweight; Vitamin A Deficiency
Study type: Interventional

Summary: 
      Breast milk is the best food during the first 6mo of life because it offers multiple benefits
      for the mother-infant pair. An inadequate maternal diet during pregnancy can lead to excess
      weight gain, leading to negative health consequences for the dyad. In Mexico, an excess of
      body weight coexists with micronutrient deficiencies (double burden of malnutrition). Low
      vitamin A concentration has been observed in northwest Mexico, which can affect the human
      milk composition and increase the risk of VAD in breastfed babies. An individualized dietary
      intervention in the lactating woman will reduce body weight and improve vitamin A status. The
      objective is to assess the effect of an individualized dietary intervention during 3 months
      postpartum on body composition and vitamin A status of lactating women.
    

Detailed description: 
      This protocol was approved by the Bioethics Committee of the Department of Medicine and
      Health Sciences of Universidad de Sonora. A randomized controlled trial will be carried out
      and participant women will be assigned by simple randomization 1:1 to either the intervention
      or control group, upon signing an informed consent. At baseline (2wk postpartum),
      anthropometric (weight, height, mid upper-arm circumference and triceps skinfold thickness)
      and body composition (DXA) measurements as well as the assessment of vitamin A status (serum
      and breastmilk retinol and the modified relative dose response) will be performed. The
      control group will receive only recommendations for a healthy diet in accordance with
      international standards and will be followed up every month to promote adherence and to
      assess their nutritional status. On the other hand, the intervention group will receive an
      individualized macronutrient meal equivalent menu, with nutritional consultations every two
      weeks. The dietary plan will include 1-1.5 g/kg body weight protein, 30% total fat
      (preferably mono and polyunsaturated fatty acids), and vitamin A sources (1300 RAE). After 3
      months of intervention are completed, baseline measurements will be repeated. Statistical
      analysis will include descriptive stats and comparisons between groups (t-tests),
      significance will be defined as P < 0.05.
    

Intervention name(s): Intervention-Nutrition guidelines; Nutrition guidelines
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Subjects will receive an individualized dietary plan according to their nutritional status, socioeconomic and cultural preferences. Protein intake 1-1.5g/kg body weight; 30% fat (mono and polyunsaturated fatty acids), vitamin A sources (1300 RAE). Each subject will have 7 interchangeable options for every meal time, all equivalent in macronutrient content, and every two weeks a new menu will be provided by a nutritionist.; Nutritional recommendations based on international guidelines
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Food-based intervention; postpartum weight management; hepatic retinol