Please select the arm or intervention descriptions that belong to the clinical trial below.
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.
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.


Options:
A: Arm Label: Docosa-hexaenoic Acid (DHA); Type: ACTIVE_COMPARATOR; Interventions: Dietary Supplement: Docosa-hexaenoic acid (DHA) | Arm Label: Placebo; Type: PLACEBO_COMPARATOR; Interventions: Dietary Supplement: Placebo | Intervention Type: DIETARY_SUPPLEMENT; Name: Docosa-hexaenoic acid (DHA); Assigned to Arm(s): Docosa-hexaenoic Acid (DHA) | Intervention Type: DIETARY_SUPPLEMENT; Name: Placebo; Assigned to Arm(s): Placebo
B: Arm Label: Marinol; Type: ACTIVE_COMPARATOR; Interventions: Dietary Supplement: Marinol D-40 | Arm Label: Nutrition counseling; Type: NO_INTERVENTION; Interventions: N/A | Intervention Type: DIETARY_SUPPLEMENT; Name: Marinol D-40; Assigned to Arm(s): Marinol
C: Arm Label: 1; Type: ACTIVE_COMPARATOR; Interventions: Dietary Supplement: DHA Supplements | Arm Label: 2; Type: PLACEBO_COMPARATOR; Interventions: Dietary Supplement: Placebo Supplements | Intervention Type: DIETARY_SUPPLEMENT; Name: DHA Supplements; Assigned to Arm(s): 1 | Intervention Type: DIETARY_SUPPLEMENT; Name: Placebo Supplements; Assigned to Arm(s): 2
D: Arm Label: Lifestyle counseling + PUFA supplement; Type: EXPERIMENTAL; Interventions: Behavioral: Lifestyle counseling, Dietary Supplement: PUFA Supplementation | Arm Label: Routine diet & PA + PUFA Supplementation; Type: EXPERIMENTAL; Interventions: Dietary Supplement: PUFA Supplementation, Behavioral: Routine diet & PA | Arm Label: Lifestyle counseling + PUFA placebo; Type: EXPERIMENTAL; Interventions: Behavioral: Lifestyle counseling, Dietary Supplement: PUFA placebo | Arm Label: Routine diet & PA + PUFA placebo; Type: PLACEBO_COMPARATOR; Interventions: Behavioral: Routine diet & PA, Dietary Supplement: PUFA placebo | Intervention Type: BEHAVIORAL; Name: Lifestyle counseling; Assigned to Arm(s): Lifestyle counseling + PUFA placebo, Lifestyle counseling + PUFA supplement | Intervention Type: DIETARY_SUPPLEMENT; Name: PUFA Supplementation; Assigned to Arm(s): Lifestyle counseling + PUFA supplement, Routine diet & PA + PUFA Supplementation | Intervention Type: BEHAVIORAL; Name: Routine diet & PA; Assigned to Arm(s): Routine diet & PA + PUFA Supplementation, Routine diet & PA + PUFA placebo | Intervention Type: DIETARY_SUPPLEMENT; Name: PUFA placebo; Assigned to Arm(s): Lifestyle counseling + PUFA placebo, Routine diet & PA + PUFA placebo

Answer: D