Clinical Trial: Diet, Physical Activity and Breastfeeding Intervention on Maternal Nutrition, Offspring Growth and Development

Study Status: Completed
Recruit Status: Unknown status
Study Type: Interventional

Official Title: Effectiveness of a Normative Intervention (Diet, Physical Activity and Breastfeeding) on Maternal Nutrition and Offspring Growth and Development: Nutrition in the First 1000 Days Key to Healthy Growth

Brief Summary: NCDs are observed mostly in adults, however there is strong evidence that suggests NCDs origin early in life, thus the first 1000 days of life (conception to age 2yrs). Studies show that maternal BMI before conception and during pregnancy predict future risk of obesity and associated metabolic conditions in both mother and offspring. Weight gain during the first two years of life is also critical in defining the infant's predisposition to obesity during adulthood. Objective: to assess the effectiveness of delivering a primary health care intervention to enhance compliance with updated nutrition and health care (diet, physical activity and breastfeeding) standards from early pregnancy through the first year of life. Methods: cluster randomized controlled trial (CRCT), designed as a public health intervention "program effectiveness" study (i.e. intervention will be available through the established national health system under standard operating conditions). A cluster unit will be a primary health care centers (PHCC) in South-East Santiago 12 PHCC will be randomly allocated to: enhanced nutrition and health care (intervention group) or routine nutrition and health care (control group).We will recruit 200 women in each of 12 PHCC; assuming a 20% loss to f-up we will complete 960 women per arm. After randomization, pregnant women in the intervention PHCCs starting at their first pre-natal visit (< 15 wks.) will receive, diet and physical activity (PA) counseling-support based on updated recommendations and monitoring goals for weight gain & glycemic control and breastfeeding (BF) promotion till 12 m postpartum. Pregnant women who attend control PHCCs will receive routine antenatal care according to national guidelines. Expected results: participants in the intervention PHCCs will benefit by achieving adequate nutritional status & metabolic control, during and early after, pregnancy as well as adequate infant growth & development as a result of i

Detailed Summary:

Introduction: in Chile as well as in most of the world, obesity and related chronic diseases (cardiovascular diseases, cancer and diabetes (NCDs)) are presently the main causes of death and disability. Although these conditions are observed mostly in adulthood, there is now considerable evidence that indicates that they are rooted in the first 1000 days of life (from -1 to + 2yrs of life).

Several studies show that maternal BMI before conception and during pregnancy predict future risk of obesity and associated metabolic conditions for both mother and offspring. Weight gain during the first two years of life is also critical, not only to ensure infant survival, but also in defining the infant's predisposition to the emergence of chronic diseases during adulthood. From a population perspective, the most effective approach to counteract the epidemic of obesity and NCDs is to prevent them. Recommendations for healthy diets and physical activity during pregnancy and infancy, as well as monitoring of nutrition goals are currently available in the Chilean primary health care system. However, most of these recommendations are not up to date and virtually all are poorly implemented. Objective: to assess the effectiveness of delivering (via primary health centers) an intervention that enhances compliance with up to date nutrition and health care standards (regarding diet, physical activity and breastfeeding promotion) during pregnancy and the first year of life. The main goal is that mothers achieve adequate nutritional status & metabolic control, during and early after pregnancy, and that infants grow and develop healthily (adequate linear and ponderal growth according to WHO standard, while avoiding excess BMI gains) Methods: this is a cluster randomized controlled trial (CRCT), designed as a public health "program effectiveness" study (i.e. intervention will be av
Sponsor: University of Chile

Current Primary Outcome:

  • Weight gain and nutritional status in mothers [ Time Frame: 36-40 weeks of gestation ]
  • Weight retention [ Time Frame: 12 months post-partum ]
  • Glycaemic control [ Time Frame: At 20-24 weeks of pregnancy ]
  • Lactation rates [ Time Frame: At 12 months post-partum ]
  • Initiation and duration of breastfeeding (exclusive and total) [ Time Frame: Birth-12 months ]
  • Weight, length and BMI growth in infants [ Time Frame: During the first year of life ]
  • Psychomotor development (based on abbreviated scale) [ Time Frame: During the first year of life ]


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Implementation [ Time Frame: At 30 months into the recruitment ]
    Implementation: compliance to protocol by health personnel, midwives & dieticians per center, time allocated to the actions of the interventions, etc.
  • Participant compliance variables [ Time Frame: At 30 months into the recruitment ]
    Variables relate to the adoption by participants of the respective program activities: adherence to diet/physical activity prescriptions, adequate referral, attendance to dietician's clinic, lactation workshops, etc.


Original Secondary Outcome: Same as current

Information By: University of Chile

Dates:
Date Received: July 4, 2013
Date Started: September 2013
Date Completion: March 2017
Last Updated: August 1, 2013
Last Verified: July 2013