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Trial record 42 of 76 for:    Long-chain fatty acids

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

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ClinicalTrials.gov Identifier: NCT02574767
Recruitment Status : Completed
First Posted : October 14, 2015
Last Update Posted : May 30, 2019
Sponsor:
Collaborators:
Fondo Nacional de Desarrollo Científico y Tecnológico, Chile
DSM Nutritional Products, Inc.
Corporación de Apoyo de la Investigación Científica en Nutrición
Information provided by (Responsible Party):
Marí-a Luisa Garmendia, University of Chile

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.


Condition or disease Intervention/treatment Phase
Obesity Pregnancy Behavioral: Lifestyle counseling Dietary Supplement: PUFA Supplementation Behavioral: Routine diet & PA Dietary Supplement: PUFA placebo Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1002 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Prevention
Official 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.
Study Start Date : August 2015
Actual Primary Completion Date : February 2019
Actual Study Completion Date : February 2019

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MedlinePlus related topics: Health Checkup

Arm Intervention/treatment
Experimental: Lifestyle counseling + PUFA supplement
Home-based Diet and Physical activity plus n3LC-PUFAs supplementation
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).

Experimental: Routine diet & PA + PUFA Supplementation
Routine Diet & Physical Activity counseling care plus n3LC-PUFAs supplementation.
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).

Experimental: Lifestyle counseling + PUFA placebo
Home-based Diet and Physical Activity plus placebo for n3LC-PUFAs supplementation.
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 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.

Placebo Comparator: Routine diet & PA + PUFA placebo
Routine Diet & Physical Activity counseling plus placebo for n3LC-PUFAs supplementation.
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.




Primary Outcome Measures :
  1. Gestational Diabetes Mellitus (GDM) [ Time Frame: 24-28 weeks of gestation ]
    According to ADA 2011 guidelines (fasting glucose ≥92 mg/dL and/or 2 h after ≥153 mg/dL)

  2. Macrosomia [ Time Frame: At birth ]
    Birth weight greater than 4000 g

  3. Prevalence of insulin resistance [ Time Frame: At birth ]
    Prevalence of insulin resistance (IR) defined as cord blood homeostasis model assessment-estimated insulin resistance (HOMA-IR) > 2.60 at birth.


Secondary Outcome Measures :
  1. Low Birth Weight [ Time Frame: At birth ]
    Birth weight below 2500 g

  2. 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 ]
    Weight at delivery minus the pregestational weight

  3. Pre-eclampsia [ Time Frame: 24-28 weeks of gestation ]
    Blood pressure ≥ 140 mm Hg systolic or ≥ 90 mm Hg diastolic

  4. Preterm delivery [ Time Frame: At birth ]
    Child´s birth < 37 weeks gestational age

  5. Proportions of cesareans [ Time Frame: At birth ]
    Proportion of children delivered via cesarean section divided total of deliveries



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Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02574767


Locations
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Chile
Institute of Nutrition and Food Technology
Santiago, Chile
Sponsors and Collaborators
University of Chile
Fondo Nacional de Desarrollo Científico y Tecnológico, Chile
DSM Nutritional Products, Inc.
Corporación de Apoyo de la Investigación Científica en Nutrición
Investigators
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Principal Investigator: MARIA LUISA GARMENDIA, PhD Assistant Professor

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Marí-a Luisa Garmendia, Assistant professor, University of Chile
ClinicalTrials.gov Identifier: NCT02574767     History of Changes
Other Study ID Numbers: Fondecyt #1150878
First Posted: October 14, 2015    Key Record Dates
Last Update Posted: May 30, 2019
Last Verified: October 2015

Keywords provided by Marí-a Luisa Garmendia, University of Chile:
Weight gain, Fatty Acids, Omega-3