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

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ClinicalTrials.gov Identifier: NCT01916603
Recruitment Status : Unknown
Verified July 2013 by Ricardo Uauy, University of Chile.
Recruitment status was:  Not yet recruiting
First Posted : August 5, 2013
Last Update Posted : August 5, 2013
Information provided by (Responsible Party):

Study Description
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 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.

Condition or disease Intervention/treatment
Obesity Weight Gain Metabolic Diseases Birth Weight Infant Nutrition Disorders Behavioral: Normative Intervention

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Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 2400 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary Purpose: Prevention
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 and Long-term Health.
Study Start Date : September 2013
Estimated Primary Completion Date : September 2013
Estimated Study Completion Date : March 2017

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: Normative intervention
Normative intervention on diet & physical & breastfeeding: diet and physical activity counselling-support and breastfeeding promotion till 12 months postpartum
Behavioral: Normative Intervention
Diet and physical activity counselling-support and breastfeeding promotion till 12 months postpartum
No Intervention: Routine care
Routine antenatal care according to national guidelines

Outcome Measures

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

Secondary Outcome Measures :
  1. 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.

  2. 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.

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   16 Years to 40 Years   (Child, Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Women seeking care before 15 weeks of pregnancy, residents within catchment area of selected Primary Health Care Centers, who are not planning to move in the next two years will be invited to participate in the study

Exclusion Criteria:

  • Pregnant women classified as high risk according to the norms of the Chilean Ministry of Health(MoH) and/or underweight (BMI<18.5)
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01916603

Contact: Maria L Garmendia, PhD 56229781402 mgarmendia@inta.uchile.cl

Institute of Nutrition and Food Technology Not yet recruiting
Santiago, Región Metropolitana, Chile, 7830490
Contact: Maria L Garmendia, PhD    56224583539    mgarmendia@inta.uchile.cl   
Principal Investigator: Ricardo Uauy, PhD         
Sub-Investigator: Maria L Garmendia, PhD         
Sub-Investigator: Camila L Corvalán, PhD         
Sub-Investigator: Daniel V López de Romaña, PhD         
Sub-Investigator: Juan P Kusanovic, A.Professor         
Sub-Investigator: Karla A Silva         
Sub-Investigator: Michael Velten         
Sub-Investigator: Macarena Mayol         
Sub-Investigator: Paola C Casanello, PhD         
Sub-Investigator: María S López         
Sub-Investigator: Marcela A Araya, PhD         
Sponsors and Collaborators
University of Chile
National Nutrition and Food Technology Institute
Pontificia Universidad Catolica de Chile
Fondo Nacional de Desarrollo Científico y Tecnológico, Chile
Ministry of Health, Chile
Principal Investigator: Ricardo Uauy, PhD University of Chile
More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Ricardo Uauy, Ph.D. Doctor in Philosophy, University of Chile
ClinicalTrials.gov Identifier: NCT01916603     History of Changes
Other Study ID Numbers: Fondecyt #1130277
First Posted: August 5, 2013    Key Record Dates
Last Update Posted: August 5, 2013
Last Verified: July 2013

Additional relevant MeSH terms:
Body Weight
Birth Weight
Weight Gain
Metabolic Diseases
Nutrition Disorders
Infant Nutrition Disorders
Signs and Symptoms
Body Weight Changes