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

Primary Purpose

Overweight and Obesity, Vitamin A Deficiency, Dietary Modification

Status
Completed
Phase
Not Applicable
Locations
Mexico
Study Type
Interventional
Intervention
Intervention-Nutrition guidelines
Nutrition guidelines
Sponsored by
Universidad de Sonora
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Overweight and Obesity focused on measuring Food-based intervention, postpartum weight management, hepatic retinol

Eligibility Criteria

18 Years - 40 Years (Adult)FemaleAccepts Healthy Volunteers

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

Sites / Locations

  • Universidad de Sonora

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

Intervention-Nutrition guidelines

Nutrition Guidelines

Arm Description

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.

Participants will receive general nutritional recommendations according to international standards

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Body fat mass
Difference in change (between baseline and final body fat mass within groups) between the intervention and control group, respectively
Retinol
Difference in change (between baseline and final retinol concentration within groups) between the intervention and control group, respectively

Full Information

First Posted
August 17, 2018
Last Updated
April 26, 2021
Sponsor
Universidad de Sonora
Collaborators
Centro de Investigación en Alimentación y Desarrollo A.C., University of Wisconsin, Madison
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1. Study Identification

Unique Protocol Identification Number
NCT03640104
Brief Title
Individualized Dietary Intervention in Breastfeeding Women: Body Weight and Vitamin A Stores
Official Title
Effect of an Individualized Dietary Intervention on the Body Composition and Vitamin A Status of Breastfeeding Women
Study Type
Interventional

2. Study Status

Record Verification Date
April 2021
Overall Recruitment Status
Completed
Study Start Date
November 1, 2018 (Actual)
Primary Completion Date
February 7, 2020 (Actual)
Study Completion Date
February 7, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universidad de Sonora
Collaborators
Centro de Investigación en Alimentación y Desarrollo A.C., University of Wisconsin, Madison

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Overweight and Obesity, Vitamin A Deficiency, Dietary Modification, Breastfeeding
Keywords
Food-based intervention, postpartum weight management, hepatic retinol

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Intervention-Nutrition guidelines
Arm Type
Experimental
Arm Description
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.
Arm Title
Nutrition Guidelines
Arm Type
Other
Arm Description
Participants will receive general nutritional recommendations according to international standards
Intervention Type
Behavioral
Intervention Name(s)
Intervention-Nutrition guidelines
Intervention Description
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
Intervention Name(s)
Nutrition guidelines
Intervention Description
Nutritional recommendations based on international guidelines
Primary Outcome Measure Information:
Title
Total Body weight
Description
Difference in change (between baseline and final body weight within groups) between the intervention and control group, respectively
Time Frame
Baseline and 3 months after enrollment
Title
Vitamin A liver stores
Description
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
Time Frame
Baseline and 3 months after enrollment
Secondary Outcome Measure Information:
Title
Body fat mass
Description
Difference in change (between baseline and final body fat mass within groups) between the intervention and control group, respectively
Time Frame
Baseline and 3 months after enrollment
Title
Retinol
Description
Difference in change (between baseline and final retinol concentration within groups) between the intervention and control group, respectively
Time Frame
Baseline and 3 months after enrollment

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Veronica Lopez-Teros, Dr
Organizational Affiliation
Universidad de Sonora
Official's Role
Principal Investigator
Facility Information:
Facility Name
Universidad de Sonora
City
Hermosillo
State/Province
Sonora
ZIP/Postal Code
83000
Country
Mexico

12. IPD Sharing Statement

Plan to Share IPD
No

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

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