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

NCT03640104 | Completed

• 1 other identifier: VLT-001
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

Food-based intervention; postpartum weight management; hepatic retinol

Outcome Measures

Primary Outcomes (2)

• Total Body weight

  Difference in change (between baseline and final body weight within groups) between the intervention and control group, respectively

  Baseline and 3 months after enrollment

• Vitamin A liver stores

  Stores are calculated as the DR/R ratio. The outcome will be calculated as the difference in change (between baseline and final VA stores within groups) between the intervention and control group, respectively

  Baseline and 3 months after enrollment

Secondary Outcomes (2)

• Body fat mass

  Baseline and 3 months after enrollment

• Retinol

  Baseline and 3 months after enrollment

Study Arms (2)

Intervention-Nutrition guidelines

EXPERIMENTAL

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.

Behavioral: Intervention-Nutrition guidelines

Nutrition Guidelines

OTHER

Participants will receive general nutritional recommendations according to international standards

Behavioral: Nutrition guidelines

Interventions

Intervention-Nutrition guidelines 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.

Intervention-Nutrition guidelines

Nutrition guidelines BEHAVIORAL

Nutritional recommendations based on international guidelines

Nutrition Guidelines

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• BMI ≥ 25
• Predominant breastfeeding
• Signed Informed Consent

You may not qualify if:

• 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

Sponsors & Collaborators

• Universidad de Sonora: lead
• Centro de Investigación en Alimentación y Desarrollo A.C.: collaborator
• University of Wisconsin, Madison: collaborator

Study Sites (1)

Universidad de Sonora

Hermosillo, Sonora, 83000, Mexico

Location

MeSH Terms

Conditions

Overweight; Obesity; Vitamin A Deficiency; Breast Feeding

Interventions

Nutrition Policy

Condition Hierarchy (Ancestors)

Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Avitaminosis; Deficiency Diseases; Malnutrition; Feeding Behavior; Behavior

Intervention Hierarchy (Ancestors)

Health Policy; Public Policy; Social Control Policies; Policy; Health Care Economics and Organizations

Study Officials

• Veronica Lopez-Teros, Dr

  Universidad de Sonora

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research professor

Study Record Dates

• First Submitted: August 17, 2018
• First Posted: August 21, 2018
• Study Start: November 1, 2018
• Primary Completion: February 7, 2020
• Study Completion: February 7, 2020
• Last Updated: April 28, 2021

Record last verified: 2021-04

Data Sharing

• IPD Sharing: Will not share

Locations

ME (1)