Individualized Dietary Intervention in Breastfeeding Women: Body Weight and Vitamin A Stores

NCT ID: NCT03640104

Last Updated: 2021-04-28

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-11-01
• Study Completion Date: 2020-02-07

Brief 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.

Conditions

Overweight and Obesity; Vitamin A Deficiency; Dietary Modification; Breastfeeding

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Intervention-Nutrition guidelines

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.

Group Type: EXPERIMENTAL

Intervention-Nutrition guidelines

Intervention Type: BEHAVIORAL

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.

Nutrition Guidelines

Participants will receive general nutritional recommendations according to international standards

Group Type: OTHER

Nutrition guidelines

Intervention Type: BEHAVIORAL

Nutritional recommendations based on international guidelines

Interventions

Intervention-Nutrition guidelines

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.

Intervention Type: BEHAVIORAL

Nutrition guidelines

Nutritional recommendations based on international guidelines

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• BMI ≥ 25
• Predominant breastfeeding
• Signed Informed Consent

Exclusion Criteria

• Multiparity
• Alcohol, drugs, tobacco intake
• Use of dietary supplements
• Active infection (C reactive protein > 6mg/L)
• External nutritional counseling
• Pregnancy during the study period
• Liver disease

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 40 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Centro de Investigación en Alimentación y Desarrollo A.C.

OTHER

Sponsor Role: collaborator

University of Wisconsin, Madison

OTHER

Sponsor Role: collaborator

Universidad de Sonora

OTHER

Sponsor Role: lead

Responsible Party

Verónica López Teros, PhD

Research professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Veronica Lopez-Teros, Dr

Role: PRINCIPAL_INVESTIGATOR

Universidad de Sonora

Locations

Universidad de Sonora

Hermosillo, Sonora, Mexico

Countries

Mexico

Other Identifiers

VLT-001

Identifier Type: -

Identifier Source: org_study_id