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

NCT02574767 | Completed

• 1 other identifier: Fondecyt #1150878
• Study Type: interventional
• Target: 1,002
• Locations: 1 country
• Sites: 1

Brief Summary

In Chile, 1 out of 4 pregnant women is obese (BMI \> 30 kg/m2). This impacts negatively the health of the mother and the offspring during pregnancy. Lifestyle interventions are the primary prevention strategy for gestational diabetes in obese women; however, these interventions have shown null or limited effectiveness. In animals, n-3 long-chain polyunsaturated fatty acid (n3LC-PUFAs) have shown to increase insulin sensitivity through higher production and secretion of adipokines, enhanced fatty acids oxidation, reduction of lipogenesis, and direct anti-inflammatory effects; however evidence in humans and during pregnancy is still very limited. Combining a lifestyle intervention with n3LC-PUFAs supplementation could enhance the metabolic control of obese pregnant women. Objective: to assess the effectiveness of two prenatal nutritional interventions (home-based diet and physical activity counseling and/or n3LC-PUFAs supplementation) delivered to obese pregnant women in achieving better metabolic control in both the mother (lower incidence of gestational diabetes mellitus) and the offspring (lower incidence of macrosomia and lower prevalence of insulin resistance at birth). Methods: this study is a cluster-randomized trial in which obese pregnant women from 12 primary health care centers (PHCC) will be stratified by socio-economic status (SES) and randomized to one of four parallel study arms. We will recruit 1000 women allocated to: 1 Home-based Diet and physical activity (PA) plus n3LC-PUFAs supplementation (Intervention Group 1, n=250); 2. Routine diet \& PA counseling care plus n3LC-PUFAs supplementation (Intervention Group 2, n=250); 3. Home-based Diet and Physical activity plus placebo for n3LC-PUFA supplementation (Intervention Group 3, n=250); 4. Routine diet \& PA counseling plus placebo (Control Group, n=250). Expected results: we expect that the intervention will contribute to achieving a better metabolic control during pregnancy. Ultimately, we expect that this study will contribute to advance the understanding of how to develop and implement effective actions to promote healthier pregnancies and therefore, healthier lives for mothers and their offsprings.

Conditions

Obesity; Pregnancy

Keywords

Weight gain, Fatty Acids, Omega-3

Outcome Measures

Primary Outcomes (3)

• Gestational Diabetes Mellitus (GDM)

  According to ADA 2011 guidelines (fasting glucose ≥92 mg/dL and/or 2 h after ≥153 mg/dL)

  24-28 weeks of gestation

• Macrosomia

  Birth weight greater than 4000 g

  At birth

• Prevalence of insulin resistance

  Prevalence of insulin resistance (IR) defined as cord blood homeostasis model assessment-estimated insulin resistance (HOMA-IR) \> 2.60 at birth.

  At birth

Secondary Outcomes (5)

• Low Birth Weight

  At birth

• Excess weight gain during pregnancy

  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

• Pre-eclampsia

  24-28 weeks of gestation

• Preterm delivery

  At birth

• Proportions of cesareans

  At birth

Study Arms (4)

Lifestyle counseling + PUFA supplement

EXPERIMENTAL

Home-based Diet and Physical activity plus n3LC-PUFAs supplementation

Behavioral: Lifestyle counseling; Dietary Supplement: PUFA Supplementation

Routine diet & PA + PUFA Supplementation

EXPERIMENTAL

Routine Diet \& Physical Activity counseling care plus n3LC-PUFAs supplementation.

Dietary Supplement: PUFA Supplementation; Behavioral: Routine diet & PA

Lifestyle counseling + PUFA placebo

EXPERIMENTAL

Home-based Diet and Physical Activity plus placebo for n3LC-PUFAs supplementation.

Behavioral: Lifestyle counseling; Dietary Supplement: PUFA placebo

Routine diet & PA + PUFA placebo

PLACEBO COMPARATOR

Routine Diet \& Physical Activity counseling plus placebo for n3LC-PUFAs supplementation.

Behavioral: Routine diet & PA; Dietary Supplement: PUFA placebo

Interventions

Lifestyle counseling BEHAVIORAL

Obese pregnant women from PHCC randomized to this group will receive Home-based Diet \& Physical activity (PA) counseling. Home-based intervention will consider 2 home visits of one hour of duration. During this session dietary educational and behavioral will be discussed with the participants and their families tailoring the contents based on the specific contexts.

Lifestyle counseling + PUFA placebo; Lifestyle counseling + PUFA supplement

PUFA Supplementation DIETARY_SUPPLEMENT

Obese pregnant women from PHCC randomized to this group will receive n3LC-PUFAs oral supplementation based on Schizochytrium oil (S-oil) containing 800 mg docosahexaenoic (DHA) acid/day, which will be administered as capsular preparations containing 200 mg DHA/capsule (4 capsules/day).

Lifestyle counseling + PUFA supplement; Routine diet & PA + PUFA Supplementation

Routine diet & PA BEHAVIORAL

Obese pregnant women from PHCC randomized to this group will receive will receive routine diet \& PA counseling (i.e. they will receive the standard education sessions included in the prenatal controls at PHCC but no home-based counseling sessions).

Routine diet & PA + PUFA Supplementation; Routine diet & PA + PUFA placebo

PUFA placebo DIETARY_SUPPLEMENT

Obese pregnant women from PHCC randomized to this group will receive capsular preparations containing 50 mg DHA/capsule (4 capsules/day), given that evidence suggests that it would be unethical not to provide DHA during pregnancy. Placebo will be delivered in the same way that the n3LC-PUFA supplementation.

Lifestyle counseling + PUFA placebo; Routine diet & PA + PUFA placebo

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• ≤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".

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Chile: lead
• Fondo Nacional de Desarrollo Científico y Tecnológico, Chile: collaborator
• DSM Nutritional Products, Inc.: collaborator
• Corporación de Apoyo de la Investigación Científica en Nutrición: collaborator

Study Sites (1)

Institute of Nutrition and Food Technology

Santiago, Chile

Location

Related Publications (2)

• Garmendia ML, Casanello P, Flores M, Kusanovic JP, Uauy R. The effects of a combined intervention (docosahexaenoic acid supplementation and home-based dietary counseling) on metabolic control in obese and overweight pregnant women: the MIGHT study. Am J Obstet Gynecol. 2021 May;224(5):526.e1-526.e25. doi: 10.1016/j.ajog.2020.10.048. Epub 2020 Nov 2.

  PMID: 33152314 DERIVED

• Garmendia ML, Corvalan C, Casanello P, Araya M, Flores M, Bravo A, Kusanovic JP, Olmos P, Uauy R. Effectiveness on maternal and offspring metabolic control of a home-based dietary counseling intervention and DHA supplementation in obese/overweight pregnant women (MIGHT study): A randomized controlled trial-Study protocol. Contemp Clin Trials. 2018 Jul;70:35-40. doi: 10.1016/j.cct.2018.05.007. Epub 2018 May 17.

  PMID: 29777864 DERIVED

MeSH Terms

Conditions

Obesity; Weight Gain

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Body Weight Changes

Study Officials

• MARIA LUISA GARMENDIA, PhD

  Assistant Professor

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant professor

Study Record Dates

• First Submitted: October 7, 2015
• First Posted: October 14, 2015
• Study Start: August 1, 2015
• Primary Completion: February 1, 2019
• Study Completion: February 1, 2019
• Last Updated: May 30, 2019

Record last verified: 2015-10

Locations

CL (1)