Please select the arm or intervention descriptions that belong to the clinical trial below.
Title: RCT Testing the Effectiveness of an Early Obesity Prevention Program
Brief Summary: The proposed study is a randomized controlled trial to test the effectiveness of a primary care, family-centered child obesity prevention program beginning in pregnancy and continuing throughout the first three years of life compared to routine standard of care. The study aims to reduce the prevalence of obesity at age three, improve child diet composition and healthy lifestyle behaviors. Pregnant women will be enrolled from a large urban medical center serving primarily low-income immigrant Latino families. The intervention "Starting Early" will consist of three components. 1) Family Groups: interactive groups coordinated with the child's primary care visits and led by a Nutritionist/ Child Developmental Specialist. 2) Nutritional Video: a culturally-specific bilingual early nutrition video will be incorporated into family group discussions. 3) Plain Language Handouts: given to reinforce the curriculum from the family groups.

The proposed research included in the funding continuation is titled: "Starting Early: Expansion of a Primary Care-Based Early Child Obesity Prevention Program". It adds three major components to the current project: 1) Following the original Starting Early cohort until age 5; 2) Developing and piloting an extended Starting Early preschool intervention for children aged 3-5 years.; 3) Developing and piloting an extended Starting Early prenatal intervention for women in the 1st trimester of pregnancy. A new cohort of 200 women in the first trimester of pregnancy will be recruited for the prenatal intervention; all women will receive the intervention in this feasibility trial.

Hypothesis: Compared to controls, the intervention group will show reduced obesity and improved parent feeding knowledge and increased healthy feeding attitudes, styles and practices


Options:
A: Arm Label: Family groups; Type: EXPERIMENTAL; Interventions: Behavioral: Family groups | Arm Label: Standard care; Type: NO_INTERVENTION; Interventions: N/A | Intervention Type: BEHAVIORAL; Name: Family groups; Assigned to Arm(s): Family groups
B: Arm Label: FBDG group; Type: EXPERIMENTAL; Interventions: Other: FBDG group | Arm Label: Stimulation group; Type: EXPERIMENTAL; Interventions: Other: Stimulation | Arm Label: Combined (FBDG and Stimulation); Type: EXPERIMENTAL; Interventions: Other: FBDG group, Other: Stimulation, Other: Combinded FBDG and stimulation | Arm Label: Control; Type: OTHER; Interventions: Other: Control group | Intervention Type: OTHER; Name: FBDG group; Assigned to Arm(s): Combined (FBDG and Stimulation), FBDG group | Intervention Type: OTHER; Name: Stimulation; Assigned to Arm(s): Combined (FBDG and Stimulation), Stimulation group | Intervention Type: OTHER; Name: Combinded FBDG and stimulation; Assigned to Arm(s): Combined (FBDG and Stimulation) | Intervention Type: OTHER; Name: Control group; Assigned to Arm(s): Control
C: Arm Label: Arm 1: BCC+PNS+CNS; Type: EXPERIMENTAL; Interventions: Behavioral: Nutrition-specific Behaviour change communication (BCC), Dietary Supplement: Nutrient supplement to pregnant women (PNS), Dietary Supplement: Nutrienr supplement to children 6m to 2 years | Arm Label: Arm 2: BCC+PNS; Type: EXPERIMENTAL; Interventions: Behavioral: Nutrition-specific Behaviour change communication (BCC), Dietary Supplement: Nutrient supplement to pregnant women (PNS) | Arm Label: Arm 3: BCC+CNS; Type: EXPERIMENTAL; Interventions: Behavioral: Nutrition-specific Behaviour change communication (BCC), Dietary Supplement: Nutrienr supplement to children 6m to 2 years | Arm Label: Arm 4: BCC only; Type: EXPERIMENTAL; Interventions: Behavioral: Nutrition-specific Behaviour change communication (BCC) | Arm Label: Arm 5: comparison; Type: NO_INTERVENTION; Interventions: N/A | Intervention Type: BEHAVIORAL; Name: Nutrition-specific Behaviour change communication (BCC); Assigned to Arm(s): Arm 1: BCC+PNS+CNS, Arm 2: BCC+PNS, Arm 3: BCC+CNS, Arm 4: BCC only | Intervention Type: DIETARY_SUPPLEMENT; Name: Nutrient supplement to pregnant women (PNS); Assigned to Arm(s): Arm 1: BCC+PNS+CNS, Arm 2: BCC+PNS | Intervention Type: DIETARY_SUPPLEMENT; Name: Nutrienr supplement to children 6m to 2 years; Assigned to Arm(s): Arm 1: BCC+PNS+CNS, Arm 3: BCC+CNS
D: Arm Label: Healthy Start to Feeding Intervention; Type: EXPERIMENTAL; Interventions: Behavioral: Healthy Start to Feeding | Arm Label: Control; Type: NO_INTERVENTION; Interventions: N/A | Intervention Type: BEHAVIORAL; Name: Healthy Start to Feeding; Assigned to Arm(s): Healthy Start to Feeding Intervention

Answer: A