Please select the outcome measures that correspond 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: Reduction in the prevalence and degree of obesity at age 3 years (3 years); Improvement in infant diet composition (1-3 years); Improvement in infant lifestyle behaviors associated with increased risk of obesity. (1-3 years); Improvement in parent feeding knowledge, attitudes, styles and practices (1-3 years); Reduction in infant and child excess weight gain (1-3 years); Additional Outcome Measures for the Expanded Starting Early Program: Preschool intervention (2-5 years); Additional Outcome Measures for the Expanded Starting Early Program: Prenatal Intervention (2-5 years); Feasibility process measures: (2-5 years); Participant engagement (2-5 years); Participant satisfaction (2-5 years)
B: Nutritional status (baseline (before intervention), endline (6 months after intervention), and follow up (2 years after endline)); Child development (baseline (before intervention), endline (6 months after intervention), and follow up (2 years after endline))
C: Change in Length-for-age Z scores (LAZ) at 3, 6, 12, 18 and 24 months age of children in intervention vs. comparison arms, compared to the baseline LAZ at 7 days of birth. (1, 3, 6, 9, 12, 15, 18, 21 and 24 months of child's age)
D: Weight-for-Length Percentile (Weight and length were measured at both pre-treatment (when infant was 3 months of age) and post-treatment (when infant was 9 months of age).); Appetite Regulation (The BEBQ was completed at both pre-treatment (when infant is 3 months of age) and post-treatment (when infant is 9 months of age).); Fruit and Vegetable Variety (The Block Food Frequency Questionnaire was completed at both pre-treatment (when infant is 3 months of age) and post-treatment (when infant is 9 months of age).)

Answer: A