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

NCT01916603 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 2400

Last updated 2013-08-05

No results posted yet for this study

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 improved nutrition and health care practices. The results will likely be generalizable through the primary health care system; considering this is a "program effectiveness" trial conducted under "real life" conditions . Additionally, we will include specific ancillary mechanistic projects to better characterize the intervention and its impact.

Conditions

Interventions

BEHAVIORAL

Normative Intervention

Diet and physical activity counselling-support and breastfeeding promotion till 12 months postpartum

Sponsors & Collaborators

  • National Nutrition and Food Technology Institute

    collaborator OTHER
  • Pontificia Universidad Catolica de Chile

    collaborator OTHER
  • Fondo Nacional de Desarrollo Científico y Tecnológico, Chile

    collaborator OTHER_GOV
  • Ministry of Health, Chile

    collaborator OTHER_GOV
  • University of Chile

    lead OTHER

Principal Investigators

  • Ricardo Uauy, PhD · University of Chile

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
SINGLE_GROUP

Eligibility

Min Age
16 Years
Max Age
40 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-09-30
Primary Completion
2013-09-30
Completion
2017-03-31

Countries

  • Chile

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01916603 on ClinicalTrials.gov