Please select the outcome measures that correspond to the clinical trial below.
Title: ACTIVITAL: Health Promotion Intervention in Ecuadorian Adolescents to Promote Healthy Dietary and Physical Activity Patterns.
Brief Summary: Worldwide, low-income and middle-income countries are undergoing rapid demographic and nutritional changes. Populations tend to move from their traditional food habits towards dietary patterns characterized by a more energy-dense diet, while urbanization and technology (work, transport) play a role in the reduction of their physical activity. This shift towards energy-dense diets and lower levels of physical activity are key determinants of chronic diseases. Nowadays, childhood overweight and obesity are becoming a major threat to public health all in low-income and middle-income countries. Clearly, not properly addressing this health problem will only aggravate the already enormous impact of chronic diseases on the social and economic development of these countries. This study aims to develop a culturally relevant school-based prevention intervention among Ecuadorian adolescents (11-13 years old) in Cuenca. The intervention will target behavioural nutrition and physical activity. Intervention strategies will be developed based on theoretical behavioural change models integrated in two complementary frameworks, i.e. (i) the Intervention Mapping protocol, and (ii) the Comprehensive Participatory Planning and Evaluation protocol.

The study includes two phases:

1. A formative research, which will be conducted in order to understand the causality of the school environment and unhealthy eating and low physical activity levels in school-going adolescents, aged 12-13 years old.
2. A paired, cluster-randomized controlled trial including 1400 adolescents (12-13 years old) from 10 pairs of schools (i.e. clusters). Within each pair of clusters, one cluster will be randomly assigned to the intervention and the other to the control group.


Options:
A: Change in fruits and vegetables and dairy products (Before and after the intervention (0 and 6 wk))
B: Behavioural determinants of physical activity and nutrition by determinant questionnaire (at 15 and 24 months, additionally, these will be measured 18 months after completion of the intervention); Physical activity, physical fitness and sedentarity (questionnaire and accelerometer) (at 15 and 24 months, additionally, these will be measured 18 months after completion of the intervention); Food intake by 24h recall (at 15 and 24 months, additionally, these will be measured 18 months after completion of the intervention)
C: Improved dietary quality (Baseline- 24 months); Increased physical activity (Baseline- 24 months)
D: 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)

Answer: B