Diet and Physical Activity Counseling and n3-long Chain (PUFA) Supplementation in Obese Pregnant Women
Condition: Obesity; Pregnancy
Study type: Interventional

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.
    

Detailed description: 
      Obesity and related non-communicable chronic diseases (NCDs: cardiovascular diseases, cancer
      and diabetes) represent the main causes of death and disability in Chile as well as
      worldwide. They account for an important proportion of health-care costs and loss of
      productivity, overloading a country's economy, particularly in developing countries. From a
      population perspective, it is now clear that preventing the emergence of these conditions is
      the most effective approach; however most of the current policies fail to incorporate
      scientific knowledge and thus, are not effective or sustainable. There is now compelling
      evidence that although obesity and NCDs are mainly observed in adulthood, the risk for most
      of these conditions originates in the first 1000-days of life (i.e. from pregnancy to two
      years old). Maternal lifestyle and conditions during pregnancy (e.g. maternal obesity) could
      affect not only future maternal health, but also risk for NCDs in the next generation.
      Therefore, pregnancy is a critical window in the implementation of NCDs prevention
      strategies. Most of the interventions on diet and physical activity (PA) during pregnancy
      have focused on decreasing gestational weight gain (GWG). Recent meta-analyses of
      interventions have demonstrated that lifestyle interventions during pregnancy can have a
      positive effect on GWG. Beyond lifestyle interventions, other dietary interventions have been
      proposed such as probiotics, vitamin D or n-3 long chain polyunsaturated fatty acids
      (n3LC-PUFAs) supplementation. Regarding n3LC-PUFAs, differences in plasma fatty acid profiles
      between women with gestational diabetes (GDM) and women without GDM suggest a possible
      alteration in fatty acid metabolism in GDM. Data from systematic reviews show a consistent
      association between marine or algae oil supplementation with higher length of gestation,
      improvement in maternal mood and neural development. Nonetheless, few interventions on diet
      and PA have focused on metabolic control in obese women and their impacts have not been
      consistent. Additionally, few intervention studies have explored the effect of n3LC-PUFAs
      supplementation on pregnant women in the incidence of GDM, with no studies conducted in obese
      pregnant women. Therefore, combining an n3LC-PUFAs supplementation with a lifestyle
      intervention could enhance the metabolic control of obese pregnant women. We propose to
      evaluate the effects of an n3LC-PUFAs supplementation intervention among obese pregnant women
      (independently and combined with a diet and physical activity intervention) on metabolic
      control in mothers and their offspring.

      In 2013 we started in 12 primary health clinics (PHCC) of the South East area of Santiago
      Chile a cluster randomized trial -the Chilean Maternal & Infant Nutrition Cohort Study
      (CHiMINCs)- that aims to improve weight control during pregnancy and offspring growth during
      infancy by enhancing PHCC's maternal and infant weight monitoring systems as well as
      promoting breastfeeding. In the current study we propose to expand that effort trying to
      optimize metabolic control of obese pregnant women and their offspring by combining
      home-based diet and physical activity counseling and n3LC-PUFAs supplementation. Women who
      seek prenatal care in any of the 12 selected PHCC with <14 weeks gestation at first prenatal
      visit; body mass index (BMI) >30 Kg/m2 at first prenatal visit; have a singleton pregnancy
      will be asked to participate. We will recruit 1000 women; 250 women per arm of the study.
      After randomization, obese pregnant women in the intervention group 1 will receive home-based
      Diet & Physical activity (PA) counseling plus 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). Obese
      pregnant women in the intervention group 2 will receive the standard education sessions
      included in the prenatal controls at PHCC but no home-based counseling sessions, plus
      n3LC-PUFAs supplementation of 800 mg of DHA. Obese pregnant women in the intervention group 3
      will receive the home-based diet & PA counseling sessions plus n3LC-PUFAs placebo that will
      consist of S-oil containing 200 mg DHA/day. Placebo will be administered as 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. The control group will receive routine diet & PA
      PHCC counseling sessions plus placebo (4 capsules of 50 mg DHA per day). Measurements will be
      collected at baseline (<14 weeks of pregnancy), mid-pregnancy (24-28 weeks), and at delivery.
      Baseline and 24-28 weeks measurements will be carried out at home.

      Analyses will be done according both to the "intention-to-treat" (i.e. effectiveness
      approach) and "per protocol" (i.e. efficacy approach) principles. In accordance with the 2×2
      factorial design, the diet & PA intervention (Intervention Groups 1 and 3) will be compared
      to the routine care intervention (Intervention Groups 2 and Control Group) and the n3LC-PUFAs
      supplementation intervention (Intervention Groups 1 and 2) will be compared to placebo
      (Intervention Group 3 and Control Group). To evaluate the effects of the two combined
      interventions the outcomes in each of the 3 intervened groups will be compared between them
      and with the outcomes in the control group. 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.
    

Intervention name(s): Lifestyle counseling; PUFA Supplementation; Routine diet & PA; PUFA placebo
Intervention type(s): Behavioral; Dietary Supplement; Behavioral; Dietary Supplement
Intervention description(s): 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.; 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).; 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).; 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.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Prevention
Keywords: Weight gain, Fatty Acids, Omega-3