Diet and Physical Activity Counseling and n3-long Chain (PUFA) Supplementation in Obese Pregnant Women

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT02574767
• Date of registration: 07/10/2015
• Prospective Registration: No
• Primary sponsor: University of Chile
• Public title: Diet and Physical Activity Counseling and n3-long Chain (PUFA) Supplementation in Obese Pregnant Women MIGHT
• Scientific title: Effectiveness on Maternal and Offspring Metabolic Control of a Home-based Dietary and Physical Activity Counseling and n3-long Chain Polyunsaturated Fatty Acids (PUFA) Supplementation in Obese Pregnant Women.
• Date of first enrolment: August 2015
• Target sample size: 1002
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02574767
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Prevention. Masking: Double (Participant, Investigator).
• Phase: N/A

Countries of recruitment

Chile

Contacts

• Name: MARIA LUISA GARMENDIA, PhD
• Affiliation: Assistant Professor

Key inclusion & exclusion criteria

Inclusion Criteria:

- =14 weeks gestational age at first prenatal visit

- Body mass index (BMI) >30 Kg/m2 at first prenatal visit

- Have a singleton pregnancy

- Plan to deliver at the "Sotero del Rio Hospital".

Exclusion Criteria:

- Preexisting diabetes (known or diagnosed at first control (Fasting Plasma Glucose >
126 mg/dl or 2h plasma glucose > 200 mg/dl during an oral glucose tolerance test
(OTTG))

- Insulin or metformin use

- Known medical or obstetric complications which restrict physical activity

- History of eating disorders

- High risk for hemorrhagic bleeding

- High risk pregnancy according to national guidelines



Age minimum: 18 Years
Age maximum: 40 Years
Gender: Female

Health Condition(s) or Problem(s) studied

Obesity

Pregnancy

Intervention(s)

Behavioral: Lifestyle counseling

Behavioral: Routine diet & PA

Dietary Supplement: PUFA placebo

Dietary Supplement: PUFA Supplementation

Primary Outcome(s)

Macrosomia [Time Frame: At birth]

Gestational Diabetes Mellitus (GDM) [Time Frame: 24-28 weeks of gestation]

Prevalence of insulin resistance [Time Frame: At birth]

Secondary Outcome(s)

Preterm delivery [Time Frame: At birth]

Proportions of cesareans [Time Frame: At birth]

Excess weight gain during pregnancy [Time Frame: Self reported pre-gestational weight, weight gain will be measured at least three times at 10-14, 24-28, 35-37 weeks of gestation, and also at delivery]

Low Birth Weight [Time Frame: At birth]

Pre-eclampsia [Time Frame: 24-28 weeks of gestation]

Secondary ID(s)

Fondecyt #1150878

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

DSM Nutritional Products, Inc.

Corporación de Apoyo de la Investigación Científica en Nutrición

Fondo Nacional de Desarrollo Científico y Tecnológico, Chile