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

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

Interventions

BEHAVIORAL

Lifestyle counseling

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.

DIETARY_SUPPLEMENT

PUFA Supplementation

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).

BEHAVIORAL

Routine diet & PA

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).

DIETARY_SUPPLEMENT

PUFA placebo

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.

Sponsors & Collaborators

• Fondo Nacional de Desarrollo Científico y Tecnológico, Chile

  collaborator OTHER_GOV

• DSM Nutritional Products, Inc.

  collaborator INDUSTRY

• Corporación de Apoyo de la Investigación Científica en Nutrición

  collaborator OTHER

• University of Chile

  lead OTHER

Principal Investigators

• MARIA LUISA GARMENDIA, PhD · Assistant Professor

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

DOUBLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

40 Years

Sex

FEMALE

Healthy Volunteers

No

Timeline & Regulatory

Start

2015-08-31

Primary Completion

2019-02-28

Completion

2019-02-28

Countries

• Chile

Study Locations